Tag: Pharma

Not Enough Bullets

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By agreeing to pay penalties without admitting wrongdoing, the pharmaceutical companies that flooded the United States with opioids will be able to deduct billions from their taxes as a result.

Needless to say, the laws involving this need to change, pronto:

Four companies that agreed to pay a combined $26 billion to settle claims about their roles in the opioid crisis plan to deduct some of those costs from their taxes and recoup around $1 billion apiece.

In recent months, as details of the blockbuster settlement were still being worked out, pharmaceutical giant Johnson & Johnson and the “big three” drug distributors — McKesson, AmerisourceBergen and Cardinal Health — all updated their financial projections to include large tax benefits stemming from the expected deal, a Washington Post analysis of regulatory filings found.

The Dublin, Ohio-based Cardinal Health said earlier this month it planned to collect a $974 million cash refund because it claimed its opioid-related legal costs as a “net operating loss carryback” — a tax provision Congress included in last year’s coronavirus bailout package as a way to help companies struggling during the pandemic.

The deductions may deepen public anger toward companies that prosecutors say played key roles in a destructive public health crisis that kills tens of thousands of Americans every year. In lawsuits filed by dozens of states and local jurisdictions, public officials have argued that the companies, among other corporate defendants, flooded the country with billions of highly addictive pills and ignored signs they were being steered to people who abused them. 

Gee, you think that allowing these companies to turn their malevolent activities into tax breaks might be a bit controversial? 

………

All four firms disavow any wrongdoing or legal responsibility. The companies have said they produced government-approved prescription pills, distributed them to registered pharmacies and took steps to try to prevent their misuse.

U.S. tax laws generally restrict companies from deducting the cost of legal settlements from their taxes, with one major exception: damages paid to victims as restitution for misdeeds. Still, Congress has placed stricter limits on such deductions in recent years, and some tax experts say the Internal Revenue Service could challenge the companies’ attempts to deduct opioid settlement costs.

Harry Cullen, a Brooklyn-based activist who has worked to hold drug companies accountable for the epidemic, said it is “incredibly insulting” that companies would try deduct the settlement payments. “As if they are donating it to these people who they harmed in the first place.”

I would also note that the entire “No admission of guilt” settlement regime needs to end.

When the end result is, “No harm, no foul, pay 15% of what you made thought your evil deeds,” these companies will continue to do harm to society.

Our Own Marketing Department of the Sirius Cybernetics Corporation*

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I am referring of course, to the “White Shoe” consultancy firm McKinsey & Company, which has increasingly made justifying the illegal and immoral, and whose latest bit of evil was a proposal for Perdue Pharma to pay distributors a bounty for overdose deaths, because, like any good dope dealer, it’s all about the Benjamins.

The short version is that in order to convince distributors not to share their concerns about how Oxycontin was resulting in an explosion of deaths with regulators, or ending their relationship with Perdue, McKinsey & Company proposed a $14,810.00 payment for death or hospitalization.

It’s blood money, and it is a criminal conspiracy to bribe those distributors not to take actions that would harm the bottom line.

Even if the Sacklers and their Evil Minions™ never took up this suggestion, it is a felony to even discuss this, and McKinsey is guilty.

They really need to get the Arthur Anderson treatment.

Their name, and memory, should be effaced:

When Purdue Pharma agreed last month to plead guilty to criminal charges involving OxyContin, the Justice Department noted the role an unidentified consulting company had played in driving sales of the addictive painkiller even as public outrage grew over widespread overdoses.

Documents released last week in a federal bankruptcy court in New York show that the adviser was McKinsey & Company, the world’s most prestigious consulting firm. The 160 pages include emails and slides revealing new details about McKinsey’s advice to the Sackler family, Purdue’s billionaire owners, and the firm’s now notorious plan to “turbocharge” OxyContin sales at a time when opioid abuse had already killed hundreds of thousands of Americans.

In a 2017 presentation, according to the records, which were filed in court on behalf of multiple state attorneys general, McKinsey laid out several options to shore up sales. One was to give Purdue’s distributors a rebate for every OxyContin overdose attributable to pills they sold.

The presentation estimated how many customers of companies including CVS and Anthem might overdose. It projected that in 2019, for example, 2,484 CVS customers would either have an overdose or develop an opioid use disorder. A rebate of $14,810 per “event” meant that Purdue would pay CVS $36.8 million that year.

………

Though McKinsey has not been charged by the federal government or sued, it began to worry about legal repercussions in 2018, according to the documents. After Massachusetts filed a lawsuit against Purdue, Martin Elling, a leader for McKinsey’s North American pharmaceutical practice, wrote to another senior partner, Arnab Ghatak: “It probably makes sense to have a quick conversation with the risk committee to see if we should be doing anything” other than “eliminating all our documents and emails. Suspect not but as things get tougher there someone might turn to us.”

Why the F%$# haven’t they been charged? 

They not only engaged in a criminal conspiracy which would include bribery and other racketeering, they initiated the proposal to do so.

Mr. Ghatak, who also advised Purdue, replied: “Thanks for the heads up. Will do.”

It is not known whether consultants at the firm went on to destroy any records.

The two men were among the highest-ranking consultants at McKinsey. Five years earlier, the documents show, they emailed colleagues about a meeting in which McKinsey persuaded the Sacklers to aggressively market OxyContin.

The meeting “went very well — the room was filled with only family, including the elder statesman Dr. Raymond,” wrote Mr. Ghatak, referring to Purdue’s co-founder, the physician Raymond Sackler, who would die in 2017.

Mr. Elling concurred. “By the end of the meeting,” he wrote, “the findings were crystal clear to everyone and they gave a ringing endorsement of moving forward fast.”

………

McKinsey’s involvement in the opioid crisis came to light early last year, with the release of documents from Massachusetts, which is among the states suing Purdue. Those records show that McKinsey was helping Purdue find a way “to counter the emotional messages from mothers with teenagers that overdosed” from OxyContin.

………

“This is the banality of evil, M.B.A. edition,” Anand Giridharadas, a former McKinsey consultant who reviewed the documents, said of the firm’s work with Purdue. “They knew what was going on. And they found a way to look past it, through it, around it, so as to answer the only questions they cared about: how to make the client money and, when the walls closed in, how to protect themselves.”

………

McKinsey put together briefing materials that anticipated questions Purdue would receive. [At an FDA oversight hearing] One possible question: “Who at Purdue takes personal responsibility for these deaths?”

The proposed answer: “We all feel responsible.

Shut them down, and shame and jail anyone associated with McKinsey and Company.

They are ineluctably evil.

*Immortalized by Douglas Adams as, “A bunch of mindless jerks who’ll be the first against the wall when the revolution comes.“

Took Them Long Enough

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About 3 months ago, I wrote about how Gilead Pharmaceuticals, the company that is trying to sell Remdesivir as a Covid-19 cure, was suppressing another drug that is cheaper to make, and appears to have lower toxicity because it has less time left on its patent.

Well, the news is now beginning to hit the mainstream, if this story from ABC News is a part of a trend:

After initial excitement about the discovery of a promising treatment for some coronavirus patients, executives with Gilead Sciences are now facing harsh criticism over the initial business decisions they’ve made in the midst of a pandemic.

 In recent days, state leaders and a government watchdog group have leveled complaints against the company for the price point it set for its antiviral drug remdesivir, a promising treatment shown to diminish recovery time in hospitalized coronavirus patients, and for allegedly not more quickly pursing a potentially cheaper alternative. Gilead holds exclusive manufacturing rights for remdesivir.

 “Gilead, on the one hand, has a product that helps people” said Dr. Erin Fox, the senior pharmacy director at the University of Utah. “But on the other hand, it does feel like they’re taking advantage of the situation.”

Seriously, Dr. Fox, taking advantage of the situation is a core business strategy of rat-f%$#s like Gliead.

In a letter to Gilead executives and federal health officials last week, government watchdog group Public Citizen encouraged the company to investigate whether another of its patented antivirals, called GS-441524, could serve as a viable and less expensive substitute to remdesivir, even though it may make the company less money.

 The health research experts at Public Citizen, joined in signing the letter by two cancer medicine experts at University of Texas’s MD Anderson Cancer Center, argue that the cheaper drug “is very similar in chemical structure and activity to remdesivir” — and may even “offer significant advantages over remdesivir.” The watchdog group posits that Gilead may be withholding it because its patent expires five years sooner than does remdesivir’s, the company would stand to profit more if remdesivir remained the only available treatment.

“It is unclear why Gilead and federal scientists have not been pursuing GS-441524 as aggressively as remdesivir,” the letter continues, “but we cannot help but note that there are significant financial incentives tied to Gilead’s current patent holdings.”

I would note that there is a thriving black market for GS-441524, because it has been shown to be remarkably effective against an almost universally fatal condition in cats called Feline Infectious Peritonitis, which is caused by a ……… wait for it ……… a corona virus.

Gilead decided not to market GS-441524 to veterinarians because they were looking at human applications, and side-effects on cats might interfere with more lucrative human applications.

Let’s be clear:  Gilead wants to murder your cats.

Weep for the Overpaid Executives

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There are claims that Russia is trying to steal coronavirus vaccine research from the US, UK, and Canada.

The hand wringing over this is kind of silly for two reasons:

  • The more people who have access to this research, the more chance there is for a successful vaccine to be developed and manufactured.
  • The only people who could possibly be harmed are big-pharma profiteers.

I’m sorry, but, “Think of the overpaid pharmaceutical executives’ bonuses,” is just not something that inspires me to paroxysms of fear.

The Perverse Incentives of Big Pharma

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It turns out that, in addition to remdesivir, Gilead has a drug with is less toxic, probably more effective, and easier to make, but they are refusing to test it because it has less life on its patent.

Once again, we see how rent-seeking through patents is the problem, and not the solution for developing new drugs.

Here is the money quote on all of this to my mind, “The attractive profile of GS-441524 from both manufacturing and clinical perspectives raises this question: Why hasn’t Gilead opted to advance this compound to the clinic? We would be remiss for not mentioning patents, and thus profits. The first patent on GS-441524 was issued in 2009, while the first patent for remdesivir was issued in 2017.”

Gilead has a long history of sacrificing the public health to the altar of profits, so this should be no surprise.

As for the potential of GS-441524, there is significant evidence that it is at least as good, if notbetter than, remdesivir:

In the midst of a pandemic like Covid-19, for which there are no FDA-approved drug treatments, hope is important. That’s one reason why remdesivir, an antiviral drug that Gilead Sciences originally made to fight Ebola, has been propelled into the spotlight with the hope that it can stop, or at least curtail, the ravages of SARS-CoV-2, the virus that causes Covid-19.

………

As chemists, we are troubled by the challenges to mass producing remdesivir. We aren’t alone. On the day that results from the two trials emerged, Gilead CEO Daniel O’Day praised the chemists behind the drug, saying he is “proud of the team because this is a complicated chemical process. It takes many, many steps.”

But does it really have to be that complicated? O’Day’s admission is interesting given that Gilead has another compound in its pipeline that is easier to make, has been shown to be effective against coronavirus in animal models, and is potentially as effective as remdesivir, if not more so.

………

Some background: Remdesivir works by interfering with the cellular machinery that allows viruses to replicate inside a human host. It is a pro-drug, meaning it must be metabolized and undergo a sequence of five bioactivation steps before it becomes GS-441524 triphosphate, the active compound that impedes viral replication.

Remdesivir isn’t Gilead’s only antiviral nucleoside analogue. The company has also developed GS-441524, another pro-drug that, as its name suggests, the body also converts into GS-441524 triphosphate, but in just in three steps. GS-441524 is easier to synthesize than remdesivir, requiring three steps instead of the seven needed for remdesivir.

Researchers initially thought that remdesivir would be activated more quickly than GS-441524 in human cells infected with the SARS and MERS coronaviruses. Yet data from primary human airway epithelial cells — one of the most clinically relevant cell-based models of the human lung — showed no statistically significant difference in potency between the two compounds. These data align with previous reports on the similar effectiveness of remdesivir and GS-441524 in coronavirus-infected cat cells. When GS-441524 was used to treat cats with feline infectious peritonitis, a progressive and usually fatal disease caused by a coronavirus, it displayed remarkable safety and therapeutic efficacy, with 96% of cats recovering after treatment.

………

Data in cats and primates have pointed to GS-441524’s safety. In the study using GS-441524 to treat feline coronavirus, the researchers noted its “impressive” safety profile when administered at high doses, and reported that no systemic signs of toxicity were observed over 12 to 30 weeks of treatment. In primates, GS-441524 was found to be present at high concentrations in the blood (1,000-times higher than remdesivir) with no apparent adverse effects.

………

When viewed through a different lens, the initial results from the NIAID-sponsored trial are more encouraging than they would seem. The active agent, GS-441524 triphosphate, clearly exerts antiviral activity against SARS-CoV-2 in humans, as supported by the accelerated recovery rates in advanced Covid-19 patients enrolled in the trial. Our analysis of preclinical and clinical trial data strongly suggests that early and direct administration of GS-441524 should be considered as a synthetically simpler and potentially more effective alternative to remdesivir, especially as GS-441524’s remarkable safety would enable higher dosing.

Not Enough Bullets

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You just knew that Gilead would be looting the crap out of any potential use of remdesivir, because looting is what they do.

Well now we have an idea, because the Institute for Clinical and Economic Review, (ICER) which is funded in part by pharma and insurance companies has an estimate as to the fair price.

ICER is not generally considered a corrupt organization, or a rent-a-crowd for big pharma, but it very much is a product of the reality that is the US drug industry.

Their number?  $4,460 over the course of treatment, which is positively larcenous:

How much should Gilead Sciences charge for its now-authorized COVID-19 therapy remdesivir? Up to $4,460 per patient, an influential pricing watchdog figures.

While Gilead has yet to present a marketing plan for the first coronavirus treatment to have shown clinical benefits in a well-designed randomized study, the Institute for Clinical and Economic Review (ICER)—which routinely weighs in on drug costs—says the drug is cost-effective at $4,460 per course of treatment.

Even at $1,000 per patient, less than a quarter of ICER’s fair price, Gilead could rake in $1 billion in sales this year—at least theoretically. The company’s now bolstering supply with the aim to treat 1 million patients by the end of the year, Jefferies analyst Michael Yee said in a Sunday note.

This drug was developed with US research money, and if further tests show that it does work, the US government should exercise Bayh-Dole march-in rights and give compulsory license generics manufacturers.

Yes

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David Sirota asks, “Will Big Pharma Fleece Us On A COVID Treatment That We Helped Fund?“

This has been another episode of simple answers to simple questions.

On a more serious notes, extreme rent seeking is arguably the central tenet of the US economy these days.

If Remdesivir proves to be a good treatment for Covid-19, it will be sold for tens, if not hundreds, of times the cost of manufacture, and most of the development of the drug was paid for by the taxpayers.

Speaking of Evil………

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German ministers have reacted angrily following reports US president Donald Trump offered a German medical company “large sums of money” for exclusive rights to a Covid-19 vaccine.

“Germany is not for sale,” economy minister Peter Altmaier told broadcaster ARD, reacting to a front page report in Welt am Sonntag newspaper headlined “Trump vs Berlin”.

The newspaper reported Trump offered $1bn to Tübingen-based biopharmaceutical company CureVac to secure the vaccine “only for the United States”.

………

The report prompted fury in Berlin. “German researchers are taking a leading role in developing medication and vaccines as part of global cooperation networks,” foreign minister Heiko Maas told the Funke Mediengruppe research network. “We cannot allow a situation where others want to exclusively acquire the results of their research,” said Maas, of the centre-left SPD.

“International co-operation is important now, not national self-interest,” said Erwin Rüddel, a conservative lawmaker on the German parliament’s health committee.

Christian Lindner, leader of the liberal FDP party, accused Trump of electioneering, saying: “Obviously Trump will use any means available in an election campaign.”

The German health minister, Jens Spahn, said a takeover of CureVac by the Trump administration was “off the table”. CureVac would only develop vaccine “for the whole world”, Spahn said, “not for individual countries”.

Trump thinks that if he can take the vaccine from the rest of the world, he can sell it as, “Making America Great Again,” in Nivember.

This really is unbelievably malicious.

When You are Paying $3500 for a Coronavirus Vaccine, Thank Mainstream DEmocrats

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We now see the sordid story of how the Clinton administration, with an assist from Joe Biden killed the possibility of meaningful price controls of drugs:

Before a vaccine to combat the coronavirus pandemic is within view, the Trump administration has already walked back its initial refusal to promise that any remedy would be affordable to the general public. “We can’t control that price because we need the private sector to invest,” Alex Azar, Health and Human Services secretary and a former drug industry executive, told Congress.

After extraordinary blowback, the administration insisted that in the end, any treatment would indeed be affordable. President Donald Trump on Monday morning tweeted that he would be meeting with “the major pharmaceutical companies today at the White House about progress on a vaccine and cure. Progress being made!” The federal government, though, under the Clinton administration, traded away one of the key tools it could use to make good on the promise of affordability.

………

That’s how much of the pharmaceutical industry’s research and development is funded. The public puts in the money, and private companies keep whatever profits they can command. But it wasn’t always that way. Before 1995, drug companies were required to sell drugs funded with public money at a reasonable price. Under the Clinton administration, that changed.

In the 1994 midterms, the Republican Revolution, built largely around a reaction to Bill Clinton’s attempt to reform the health care system, swept Democrats out of Congress. On its heels, in April 1995, the Clinton administration capitulated to pharmaceutical industry pressure and rescinded the longstanding “reasonable pricing” rule.

………

The move was controversial, and a House member from Vermont, independent Bernie Sanders, offered an amendment to reinstate the rule. It failed on a largely party-line vote, 242-180.

Then in 2000, Sanders authored and passed a bipartisan amendment in the House to reimpose the “reasonable pricing” rule. In the Senate, a similar measure was pushed by the late Paul Wellstone of Minnesota.

………

Then-Sen. Joe Biden of Delaware voted to table Wellstone’s amendment, and it was defeated 56-39.

This shot of sh%$ is why the the status quo, and Status Quo Joe, are not a viable alternative for the future.

In order for progressive policies to work, the Neoliberal embrace of looting must be abandoned.

What Is an Emergency without Looting?

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Given that he is a former pharmaceutical executive, this is not a surprise:

Members of Congress and advocacy groups are voicing outrage after Health and Human Services Secretary Alex Azar—a former pharmaceutical executive—repeatedly refused during House testimony Wednesday to guarantee that any coronavirus vaccine or treatment developed with taxpayer money will be affordable for all in the U.S., not just the rich.

………

During testimony before the House Energy and Commerce Committee Wednesday, Azar was pressed multiple times to vow that vaccines and treatments for the coronavirus will be priced fairly and made affordable for all U.S. households.

“We would want to ensure that we’d work to make it affordable,” Azar told Rep. Jan Schakowsky (D-Ill.), “but we can’t control that price because we need the private sector to invest.”

You don’t need the private sector to invest.

The research will be government funded, and you have tools, such as a threat to invoke Biden-Dole march in rights on most of their patent portfolio, to coerce basic human decency out of these firms.

Welcome to the Post Antibiotic World

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The perverse incentives of our drug exclusivity regime looks to result in the collapse of antibiotic research and development, because, unlike things like cholesterol and diabetes meds, antibiotics are only taken for a few days, so the profits are not there to get financing for drug development.

The pharmaceutical industry will demand higher prices, extended exclusivity periods, and other subsidies.

I will suggest reducing the subsidies on drugs for chronic conditions, which is what pulls money from antibiotics.

Also, ban antibiotic use in livestock, which contributes to the evolution of antibiotic strains of microbes:

At a time when germs are growing more resistant to common antibiotics, many companies that are developing new versions of the drugs are hemorrhaging money and going out of business, gravely undermining efforts to contain the spread of deadly, drug-resistant bacteria.

………

Experts say the grim financial outlook for the few companies still committed to antibiotic research is driving away investors and threatening to strangle the development of new lifesaving drugs at a time when they are urgently needed.

“This is a crisis that should alarm everyone,” said Dr. Helen Boucher, an infectious disease specialist at Tufts Medical Center and a member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria.

The problem is straightforward: The companies that have invested billions to develop the drugs have not found a way to make money selling them. Most antibiotics are prescribed for just days or weeks — unlike medicines for chronic conditions like diabetes or rheumatoid arthritis that have been blockbusters — and many hospitals have been unwilling to pay high prices for the new therapies. Political gridlock in Congress has thwarted legislative efforts to address the problem.

The challenges facing antibiotic makers come at time when many of the drugs designed to vanquish infections are becoming ineffective against bacteria and fungi, as overuse of the decades-old drugs has spurred them to develop defenses against the medicines.

Drug-resistant infections now kill 35,000 people in the United States each year and sicken 2.8 million, according a report from the Centers for Disease Control and Prevention released last month. Without new therapies, the United Nations says the global death toll could soar to 10 million by 2050.

………

Public health experts say the crisis calls for government intervention. Among the ideas that have wide backing are increased reimbursements for new antibiotics, federal funding to stockpile drugs effective against resistant germs and financial incentives that would offer much needed aid to start-ups and lure back the pharmaceutical giants. Despite bipartisan support, legislation aimed at addressing the problem has languished in Congress.

“If this doesn’t get fixed in the next six to 12 months, the last of the Mohicans will go broke and investors won’t return to the market for another decade or two,” said Chen Yu, a health care venture capitalist who has invested in the field.

Well, Chen Yu would say that, wouldn’t he?

He’s in the business of extracting money from monopoly rents and subsidies, so he is calling for additional monopoly rents and subsides.

What he really wants is this times 10:

Many of the new drugs are not cheap, at least when compared to older generics that can cost a few dollars a pill. A typical course of Xerava, a newly approved antibiotic that targets multi-drug-resistant infections, can cost as much as $2,000.

The problem is that no one can see beyond the for-profit model, looting, and subsidies:

Some of the sector’s biggest players have coalesced around a raft of interventions and incentives that would treat antibiotics as a global good. They include extending the exclusivity for new antibiotics to give companies more time to earn back their investments and creating a program to buy and store critical antibiotics much the way the federal government stockpiles emergency medication for possible pandemics or bioterror threats like anthrax and smallpox.

The solution to this is, dare I say it? Socialism.

As opposed to government subsidies, government ownership.

Not Enough Bullets

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Literally the Least Tufts Could Do

The Sackler family, are having major butt-hurt because Tufts University is pulling their names from their buildings.

Let’s see, you created a dangerous product, aggressively and dishonestly marketed it across the nation, when caught you looted your company in advance of your bankruptcy, and your non-bankrupt foreign company is STILL trying to hook people on your poison.

Why wouldn’t an institution best known for its medical program want to have anything with you?

The Sackler family is pushing back after Tufts University removed the family name from its buildings and programs due to the family’s link to the ongoing opioid epidemic, according to a report in The New York Times.

In a letter to Tufts’ president, a lawyer for the family wrote that the removal was “contrary to basic notions of fairness” and “a breach of the many binding commitments made by the University dating back to 1980 in order to secure the family’s support, including millions of dollars in donations for facilities and critical medical research.”

Tufts made the decision to remove the family name after getting the results of an independent review of the university’s relationship with the Sacklers and OxyContin-maker Purdue Pharma, which the Sacklers own. Both the family and the company have been accused of helping to spark the crisis by aggressively marketing the powerful painkiller and misleading doctors, patients, and regulators about its addictiveness.

………

The review found that Purdue did intend to use the relationship to advance its interests. And, according to the report, in some cases, it was successful in influencing the academic institution. “Moreover, we conclude that there was an appearance of too close a relationship between Purdue, the Sacklers, and Tufts,” the report said.

The letter from the Sackler family lawyer hinted at the possibility of legal action.

………

Although, not all of the Sackler family is involved with OxyContin. Of the original three Sackler brothers involved in Purdue, one of them—Arthur—died before the painkiller was introduced, and his brothers bought out his stake in the company. Arthur’s widow, Jillian Sackler, released a statement saying in part, “It deeply saddens me to witness Arthur being blamed for actions taken by his brothers and other OxySacklers.”

OxySacklers.  Heh.

Pelosi Backs Down

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After ignoring progressive concerns over her drug price bill Pelosi has cut a deal with the Progressive Caucus to strengthen the bill.

I still do not think that the bill is strong enough, but it’s good that progressives in Congress were sufficiently disciplined force the Speaker to do the right thing:

Speaker Nancy Pelosi (D-Calif.) reached a deal with progressive leaders on Tuesday night to avert a showdown over her signature bill to lower drug prices.

The deal with Reps. Pramila Jayapal (D-Wash.) and Mark Pocan (D-Wis.), the co-chairs of the Congressional Progressive Caucus, will include two changes that progressives have been pushing for over the course of weeks.

Those changes are to increase the minimum number of drugs subject to negotiation under the bill from 35 to 50 and to restore the implementation of Jayapal’s amendment, which would extend protections against drug price spikes to people on employer-sponsored health insurance plans, not just those on Medicare.

The deal prevents a showdown on Thursday when the bill will come to the floor for a vote. Progressive leaders had been contemplating a rare full-scale rebellion against Pelosi, thinking of blocking a vote on the drug pricing bill by trying to vote down a procedural motion.

Oh Snap

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Bernie Sanders, Elizabeth Warren and most of the House Progressive Caucus are trying to replace Nancy Pelosi’s phony baloney prescription drug price bill with something useful.

There is no downside to this effort, except that Nancy Pelosi might lose some street cred with her lobbyist buddies.

Mitch McConnell won’t allow a vote on any version of this bill in the Senate:

Senators Bernie Sanders and Elizabeth Warren have taken the side of the Congressional Progressive Caucus against House Speaker Nancy Pelosi in a dramatic fight over the details of a drug pricing bill that has been a source of intra-caucus sparring all year.

Pelosi is hoping to move quickly to a floor vote to satisfy a major 2018 campaign pledge that Democrats would work to lower drug prices. Progressives, led by Representatives Pramila Jayapal and Mark Pocan, who are advocating for changes to the legislation, are pushing back, arguing the bill is far too modest and would do little if enacted—which, given the makeup of the Senate, it won’t be.

………

 The Warren-Sanders effort has already gained one new ally: Alexandria Ocasio-Cortez (D-NY), whose spokesperson Corbin Trent ripped the bill put together by Pelosi and her staff. “They stripped out everything that looked like progress,” Corbin said.

The bill, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, will not become law, whether Pelosi’s version passes or whether the stronger elements preferred by the Progressive Caucus are included. Senate Majority Leader Mitch McConnell will bury it with the other 400-odd pieces of legislation in his graveyard. But the importance of this House Democratic squabble goes well beyond a single bill. It will indicate whether the 98-member Progressive Caucus, which grew in size this year, is willing and able to fight for policies it believes in. How hard progressives push back against Pelosi will determine whether she will continue to ignore progressives as she pursues her policy framework, or whether she’ll have to respect and include them.

………

 The Rules Committee is expected to vote on the bill Tuesday afternoon, which would then allow it to move to the House floor for a vote. The Progressive Caucus has been surveying members the past several days, encouraging them to vote against the rule for the bill, which would block it from coming to the floor and send it back to the legislative drawing board. A source involved with the whip operation said that so far “the count is excellent,” expressing confidence that enough members of the caucus would stick together. (Before the House votes on a bill, it first votes to approve or reject the “rule” under which it would be considered. Taking down the rule is a way to block the underlying bill from a vote.)

………

 The relative weakness of the bill coming to the House floor makes a mockery of the health care debate unfolding on the presidential campaign trail. While 2020 Democratic hopefuls debate a sweeping, comprehensive reform of the healthcare system, Democrats in the House are having trouble giving authority to the government to negotiate lower prices for more than a mere 25 drugs. The gap between the two debates could hardly be greater, even though Democrats in the House have a free hand policy-wise: After all, the bill has little chance of passing the Senate and becoming law, so it’s largely a messaging exercise.

………

 AS THE PROSPECT documented last Friday, Pelosi and her staff, led by top health policy aide Wendell Primus, have frozen out progressives from deliberations over the Lower Drug Costs Now Act, exercising extreme control over the process. They bypassed legislation written by Representative Lloyd Doggett (D-TX), which, thanks to progressive organizing, had the support of a majority of the caucus. Instead, Pelosi and Primus sought to find a compromise with the Trump White House, only to see Trump savage the bill on Twitter, indicating that it didn’t have his support. Despite that reversal, all the provisions weakened or watered down to gain Trump’s support remain in the bill, leaving open large gaps in who will benefit from the effects.

………

 In addition, the uninsured will not see any benefits from the price negotiations, and will be forced to pay whatever price drug companies can command. Nicole Smith-Holt, the mother of a diabetic who died because he had to go off her insurance at age 26 and could no longer afford insulin, explained to the Prospect last week that “People like my son Alec wouldn’t have benefited. It wouldn’t have saved his life. And a lot of other lives would be at risk too.”

………

After being shut out of a high-priority legislative action—drug prices were one of the top issues in the 2018 midterms—and having the improvements they did get in whittled down to nothing, the Progressive Caucus, co-chaired by Jayapal and Representative Mark Pocan (D-WI), decided to rebel. On Friday afternoon, they began whipping Progressive Caucus member offices on whether they would be willing to vote against the rule for the Lower Drug Costs Now Act.

A Democratic source confirmed that “a substantial number of progressives” would vote against the rule if certain priorities—restoring the Jayapal amendment, increasing the minimum drugs negotiated, striking the non-interference clause, and making sure the uninsured benefit—were not included in the final text.

Pelosi’s team seemed unmoved by this threat, with an aide telling The Hill, “Representatives Pocan and Jayapal are gravely misreading the situation if they try to stand in the way of the overwhelming hunger for HR3 within the House Democratic Caucus and among progressive Members … The Lower Drug Costs Now Act will pass next week.”

………

 Pelosi appears to be banking on progressives’ past failures to follow through on their threats and defy leadership. But with Sanders and Warren siding with Jayapal and the CPC over the weekend, the progressive caucus may finally have the impetus to block the bill in its current form. The senators’ statements also mean that Pelosi now must contend not only with the left-wing elements of her caucus, but the two presidential candidates commanding a substantial chunk of the primary electorate. On the other hand, passing a messaging bill on drug pricing is a high priority for Democrats up for reelection in tight races, no matter the details, and progressive will be under intense pressure to go along on their behalf.


XTC Snowman

Once again, we see that Nancy Pelosi sees Republicans as the opposition, and progressives as the enemy.

Until and unless Pelosi gets handed a loss, she will continue to ignore progressive priorities, because, to quote XTC, “People will always be tempted to wipe their feet, On anything with ‘welcome’ written on it.”

Clearly, the Solution is Stronger and Longer Patents

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It looks like Gilead Sciences delayed the introduction of safer HIV medications because they want to extend the monopoly rents on older drugs.

What’s the destruction of some patients’ bone marrow and kidneys against more profits? Priorities man:

In 2005, Gilead Sciences notified federal regulators that it was suspending development of a potentially safer, more potent HIV-fighting drug than the one on the market. The company did not restart its Food and Drug Administration application until 2010. Now the five-year delay of a promising drug is at the core of accusations by advocates that Gilead improperly exploited the patent system at the expense of patient health.

 An HIV-prevention group called PrEP4All Collaboration filed a petition Wednesday with the U.S. Patent and Trademark Office contending Gilead knew its new, improved drug — approved in 2015 and now part of Gilead’s combination therapies Genvoya and Descovy — was safer. But it alleged Gilead postponed development so it could continue to gain monopoly profits from its older combination HIV drugs, including Viread and Truvada, for a longer period,before those drugs went off patent and faced generic competition.

 Gilead used the delaying tactic even though the older drugs posed more risks to bone and kidney health, PrEP4All alleged.

This is some seriously evil sh%$:

The group is asking the Patent and Trademark Office to reject Gilead’s request for three extra years of patent life on the newer drug, called tenofovir alafenamide, or TAF. Odds of success are steep because the patent office will review such third-party petitions only in “extraordinary’’ circumstances, according to its rules.

“Gilead has not only intentionally delayed clinical development of a drug to artificially manipulate its eligibility for a patent-term extension, but it has done so despite the apparent harm to patients,’’ said Christopher Morten, who is supervising attorney at New York University’s Technology Policy and Law Clinic, who filed the petition on behalf of PrEP4All.

Indeed.

One of the main drivers of inequality in our society is sh%$ like this.

It is a tax on the rest of us that goes into the pockets of companies that would never even consider the public good in their decisions.

I’m not sure that we can thow these guys in jail, but we can fix the system that they exploit to do this.

A Week Ago, I Could Not Find the Evil in This

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I literally wrote, “I Cannot Find the Evil Here,” regarding the Trump Administration’s move against Gilead for violating the CDC’s patent on “Truvada for PrEP,” which used the drug as a prophylactic treatment for HIV.

Well, it turns out that the nature of the CDC patent is such that their attempted enforcement of their claims would allow big Pharma to “Evergreen” (maintain their drug monopoly) basically forever.

It turns out that the patent is not on the drug, but on the fact that taking one pill a day will prevent HIV infection.

This is wrong on a number of levels.

First, the PrEP treatment was not an invention, it was a discovery, which should not be patentable, and second, if upheld, this will provide drug makers with the ability to acquire IP based exclusivity forever:

The Trump administration appeared this month to finally act on a campaign promise to lower drug prices by taking the maker of an HIV drug to court for violating a government patent.

But as with all things Trump, what you see on the surface is not all that’s actually going on.

First, this is only about one drug, a crucial drug to prevent HIV, that was developed with taxpayer money. Its high price has been targeted by well-organized activists for the HIV/AIDS community because it costs more than 300 times as much in the United States as in Africa.

Second, and more importantly, the federal complaint may well help drug companies extend their patents and years of sales at inflated monopoly prices.

“Evergreening” patents and sales exclusivity by the pharmaceutical industry is one of key factors in the high price of prescription drugs in the United States. It keeps cheaper generics medicines off the market.

The specific patent that the U.S. government wants to protect, and get paid for, is one of the controversial group of patents for a process. It covers the prescribed regimen that says the patient must take one pill daily—but not the pill itself.

………

Critics think the government patent is weak. But they also worry that a court decision may validate patents for the regimen, which could create a government-supported precedent allowing drug companies to maintain monopoly prices for decades and possibly forever.

………

Prevention is a secondary use of Truvada. Patents for secondary uses, or for processes—telling patients what pill to take and when—have given drug companies essentially eternal monopolies on sales of those medicines.

“If the government protects this kind of patent, it could ultimately serve drug makers and enable them to keep recycling old patents,” said Love. His non-profit organization has been in the front of efforts to push Congress to force the Bush, Obama and now the Trump administrations to stop giving profitable, semi-permanent patent protection to makers of drugs developed through taxpayer-funded research.

………

The U.S. Government has rarely fought a major pharmaceutical corporation for royalties, though groups such as KEI and Public Citizen have been pushing for aggressive action related to drugs largely funded by American taxpayers.

………

Gilead charges American patients with AIDS about $20,000 per year for the drug Truvada. The same/version of the drug sells in Africa for $60 per year. Truvada for PrEP is the term for applying the drug to prevent AIDS infection. PrEP is an acronym for pre-exposure prophylaxis. This preventive usage is crucial for public health strategies to eradicate HIV and AIDS by 2030, a target announced by Donald Trump this year.

………

Yale University’s Global Health Justice Program leadership, during Congressional hearings in May on PrEP access and costs, slammed Gilead for its refusal to share the proceeds from its sales of Truvada with the government or to significantly lower the price for patients in the United States.

In a letter to the House Oversight Committee, Yale’s health justice team also raised questions about the government’s patent of the secondary use and the treatment process. “We have serious concerns about the value that method of treatment patents like the CDC’s patents for PrEP (and still more other “secondary” patents),” the team wrote.

“Indeed, they are regularly used by the pharmaceutical industry to artificially extend patent protection on expensive brand name drug products, delay generic competition, and keep prices high,” the Yale letter continued.
………

KEI’s Love said the government has been slow to act. “HHS could have exercised march-in rights three years ago on this drug paid for by U.S. taxpayers,” Love said. The government could have applied for a patent that guaranteed the royalty payments to America, not profits to Gilead. “But getting a patent for the procedure is another way of “evergreening” a patent – it makes the United States a patent troll.”

FYI, “March-In Rights” are a provision of Bayh-Dole, the 1980 law that privatized the proceeds of most federally funded research.

The “March-In Rights” allow the federal government to license patents to other entities if the patent holder fails to meet the, “Health and safety needs of consumers.”

Despite the egregious actions of big pharma, “March-In” has never been applied.

I would prefer for the Bayh-Dole to be completely repealed, but the case for “March-In” is incontrovertible.

Canada Concludes that the US Drug Market is Insane

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Canada uses a sophisticated formula to set drug prices.

They have just updated the algorithm to eliminate US drug prices from their calculations because they are completely out of line.

Pharma is unamused, but they can go and Cheney themselves:

The Canadian government on Friday announced final regulations to reduce patented drug prices it said would save Canadians C$13.2 billion ($10 billion) over a decade, overriding heavy opposition from pharmaceutical companies.

………

The new rules, described in a statement by Health Canada, were largely in line with a December 2017 draft. They came after months of delay prompted speculation the government would back down in the face of industry lobbying or simply run out of time before Canada’s October election.

………

Under the new rules, Canada will change the countries the federal drug price regulator, the Patented Medicine Prices Review Board (PMPRB), compares domestic prices to, dropping the United States and Switzerland where prices are highest, and let the agency consider the cost-effectiveness of new medicines.

It will also force drugmakers to disclose some confidential discounts to the PMPRB, which sets maximum prices.

………

Global drugmakers, including Johnson & Johnson, Merck & Co and Amgen Inc, argued against the draft plan.

Petitpas Taylor said the new rules would lay the foundation for a new national pharmaceutical care program. Prime Minister Justin Trudeau’s government is expected to announce a program to cover the cost of prescription drugs for some or all Canadians, but the program’s scope is not yet clear.

Good.

Big pharma needs to be taken down.

Not Enough Bullets

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Generic drug makers conspired to raise the price of their drugs by over 1000%.

Capitalism, you gotta love it, huh?

Leading drug companies including Teva, Pfizer, Novartis and Mylan conspired to inflate the prices of generic drugs by as much as 1,000 percent, according to a far-reaching lawsuit filed on Friday by 44 states.

The industrywide scheme affected the prices of more than 100 generic drugs, according to the complaint, including lamivudine-zidovudine, which treats H.I.V.; budesonide, an asthma medication; fenofibrate, which treats high cholesterol; amphetamine-dextroamphetamine for A.D.H.D.; oral antibiotics; blood thinners; cancer drugs; contraceptives; and antidepressants.

“We all know that prescription drugs can be expensive,” Gurbir S. Grewal, the New Jersey attorney general, said in a statement. “Now we know that high drug prices have been driven in part by an illegal conspiracy among generic drug companies to inflate their prices.”

Can we PLEASE start jailing the executives who do this?

It’s a criminal conspiracy, and should be treated as the crime that it is.