A bombshell report reveals that taxpayers spent billions developing medicines that drugmakers say shouldn’t face Medicare price negotiations

 

As the government begins its first-ever price negotiations for a handful of medicines under Medicare, the pharmaceutical industry has launched an all-out legal and PR assault on this meager attempt to control out-of-control drug prices for the country’s most vulnerable. Big Pharma reasons that the government has no place setting prices for the drugs developed by private companies. 

But the government, and by extension taxpayers, heavily subsidizes the development of drugs in this country. Now a bombshell new report reveals that Americans funded the development of all 10 drugs up for price negotiations, shelling out a total of $11.7 billion on their research. In 2022 alone, Big Pharma made $70 billion selling those same drugs — and now they want to keep their prices sky high.

According to the new study out of the Center for Integration of Science and Industry at Bentley University, which has not yet been published, the 10 selected prescription drugs received anywhere from $227 million to $6.5 billion in funding from the government’s National Institutes of Health (NIH) for crucial, foundational research. 

“When the average taxpayer is paying for the drug, it’s not just what’s being paid at the pharmacy,” said Fred Ledley, professor of natural and applied sciences at Bentley and senior author on the study. 

These drugs, which are covered by Medicare’s prescription drug benefit plan, are taken by 7.7 million enrollees, most of them elderly, to treat conditions including blood clots, heart failure, diabetes, autoimmune conditions, and chronic kidney disease. In 2022, Medicare patients spent $3.4 billion out of pocket on these medications, a number that increased by 116 percent over a four-year span. 

From 2018 to 2022, out-of-pocket costs for Medicare enrollees climbed for nine of the 10 drugs. The average annual out-of-pocket cost for Stelara, an injectable drug that treats autoimmune conditions, rose the most from $709 per enrollee to $2,058. For non-Medicare U.S. patients, Stelara can be considerably more expensive, especially since drugmakers charge far higher prices in this country than they do elsewhere. A 2019 report found that the regular price for Stelara was $16,600 per dose in the United States, compared to $2,900 per dose in the United Kingdom. 

According to the new report from Bentley University, the Johnson & Johnson subsidiary that developed Stelara received $6.5 billion in taxpayer funding for it — by far the most of any of the medicines up for price negotiations.

Total Medicare spending to pay for enrollees’ use of these vital drugs more than doubled from about $20 billion in 2018 to $50.5 billion in 2023. Paying for these particular drugs accounted for roughly 20 percent of all Medicare spending on prescription drugs between summer 2022 and spring 2023.  

Pharmaceutical Research and Manufacturers of America (PhRMA), the pharmaceutical industry’s main lobbying group, said it could not comment on the specifics of a study it has not reviewed. 

Sarah Ryan, PhRMA’s senior manager of public affairs, added in an email to The Lever that “while the NIH plays a crucial role in fostering basic research, private industry contributions, both financial and technical, are instrumental in turning discoveries into fully developed therapies for patients. There is a rich body of research documenting the nature of these complementary roles, which overwhelmingly demonstrates that the private sector invests significantly more and takes on far greater risk in drug development than the government.”

After finalizing negotiations with the drug manufacturers, the Centers for Medicare and Medicaid Services, which oversees all federal health programs, will publish the agreed-upon drug prices by Sept. 1, 2024, and the new prices will go into effect starting Jan. 1, 2026…

 

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Source URL: https://portside.org/2024-02-24/americans-paid-11-billion-drugs-you-cant-afford

Pfizer to Charge $1,390 for Lifesaving Covid Drug That Costs Just $13

"Pfizer treats Paxlovid like a Prada handbag; a luxury for the few rather than a treatment for the many," said one consumer advocate.

U.S. consumer watchdog Public Citizen on Thursday excoriated Pfizer after the pharmaceutical giant announced it would more than double the price of a lifesaving Covid-19 treatment, which will soon sell for an estimated 100 times the cost of production.

Pfizer said Wednesday that it will price its patented Covid treatment nirmatrelvir-ritonavir—sold under the brand name Paxlovid—at $1,390 for a five-day course. Researchers Melissa J. Barber and Dzintars Gotham recently estimated it costs Pfizer $13 to produce five days' worth of the drug, which is taken in three-pill doses.

"Pfizer's new price is an estimated 100 times the cost of production," Peter Maybarduk, director of Public Citizen's Access to Medicines program, said in a statement.

"Pfizer chose to double its U.S. price just as pandemic funding falters and the precarious winter viral season begins."

It's also more than 2.5 times the federal government's purchase price for Paxlovid. The government has bought and distributed the antiviral drug to the public free of charge since December 2021, when the U.S. Food and Drug Administration approved the treatment. Starting next year, Pfizer will sell Paxlovid directly to health insurance companies.

"Pfizer has made tens of billions in Paxlovid sales, largely through major government purchases," Maybarduk noted. "Pfizer could choose now to support the fight against Covid and ease treatment access by lowering its already inflated prices."

"Instead, Pfizer chose to double its U.S. price just as pandemic funding falters and the precarious winter viral season begins," he continued. "This will strain health budgets and contribute to further treatment rationing."

"Pfizer treats Paxlovid like a Prada handbag; a luxury for the few rather than a treatment for the many," Maybarduk added. "For shame."

Medical professionals and patient advocates have voiced concerns that increasing the price of Paxlovid could leave at-risk people without access to the lifesaving drug, which is proven to reduce the risk of death or severe illness from Covid-19 for patients with weakened immune systems or ailments like diabetes and heart conditions.

News of the Paxlovid price hike came a day after Public Citizen and the Health Global Access Project (Health GAP) published an analysis revealing that more than 8 million people with high-risk Covid-19 infections in low- and middle-income nations could not access the drug last year, leaving over 90% of the need for the treatment unmet.

"At a minimum, 10 times more people needed Paxlovid than had any chance to receive it in developing countries, and that almost certainly significantly understates the problem," Maybarduk said on Tuesday.

In addition to Paxlovid, Pfizer manufactures one of the two available mRNA vaccines for Covid-19. The company reported $56 billion in sales of its Covid-19 vaccine and Paxlovid last year. However, projecting a sales slump in 2023, Pfizer late last year announced a plan to significantly hike the price of its publicly funded Covid-19 shot.

Pfizer reported profits of $31.4 billion in 2022, a 43% increase over the previous year. Pfizer CEO Albert Bourla took home $33 million in compensation last year, a 36% raise from 2021. 

-Brett Wilkins, Common Dreams

 

400% Price Hike of COVID Vaccine

 

Moderna’s expected 400% hike for its COVID vaccine sparked outrage on Capitol Hill. The pharmaceutical giant could raise the price of the vaccine from its current $26 per dose to between $110 and $130 per shot, according to The Wall Street Journal.

Sen. Bernie Sanders (I-Vt.) blasted Moderna, noting that the company is getting rich off of a vaccine that was developed with financial aid from taxpayers. “This vaccine was discovered in partnership with the NIH, with a government agency supported by the taxpayers of this country,” Sanders told CNN on Wednesday. “In addition, the government put $1.9 billion into research and development for Moderna and then guaranteed Moderna billions of dollars in sales.”

Last year, Moderna raked in $18.4 billion from sales of its COVID vaccine. “They’re going to charge whatever it is. 110 bucks a vaccine. It costs about $2 to produce that vaccine,” Sanders countered. “So, the taxpayers of this country who put money into the vaccine in order to protect the health and lives of the American people are now creating billionaires in an industry — in a company that it’s going to quadruple prices for the American people,” the senator added. “That is outrageous, that is unacceptable, and we’ve got to do something about that.”

Moderna CEO Stephane Bancel defended the anticipated price hike, telling the Journal: “I would think this type of pricing is consistent with the value.” The move is similar to the one made by Moderna’s rival, Pfizer, which raised the price of its COVID vaccine that was developed jointly with BioNTech by some 400%.

Last month, Senators Elizabeth Warren (D.-Mass.) and Peter Welch (D-Vt.) sent a letter to Pfizer CEO Albert Bourla calling the price hike “pure and deadly greed.” Pfizer, according to the senators, was guilty of “unseemly profiteering.” “We urge you to back off from your proposed price increases and ensure COVID-19 vaccines are reasonably priced and accessible to people across the United States,” they wrote.

Both the Moderna and the Pfizer-BioNTech vaccines, which use mRNA technology, has been made available to Americans for free after the doses were purchased by the federal government. Both companies plan to shift to commercial distribution of the vaccines once their contracts with the federal government expires.

In July, the government reached a deal with Moderna to pay $26 per dose of the updated COVID booster shot. Previously, the government paid between $15 and $16 per dose. This past summer, the government agreed to pay Pfizer a little more than $30 per dose — up from $19.50 per dose in 2020 contracts. “We enter 2023 in a great position, with significant momentum across our clinical pipeline, a highly energized team and a strong balance sheet of over $18 billion of cash and cash equivalents,” Bancel said in a press release Monday.

Moderna said it anticipated making a minimum of $5 billion in vaccine sales this year. 

-Ariel Zilber, NY Post

 

Five Things to Know about the New Alzheimer's Drug, Leqembi

 

On  January 6th, the Food and Drug Administration approved, via the Accelerated Approval pathway, a new treatment for Alzheimer’s disease called Leqembi. While older Alzheimer’s drugs may ease symptoms for a time, they do nothing to stop the relentless downward course of the disease. Leqembi is the second of a new class of drugs that are designed to slow the progression of the disease.  

 “This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease,” said Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. Here are five things to know about the new Alzheimer’s drug, Leqembi. 

How effective is Leqembi? 

The new treatment may slow declines in memory and thinking skills in those in the early stages of Alzheimer’s disease, but it is not a cure. The drug is what’s known as a monoclonal antibody, designed to target the beta-amyloid plaques that build up in the brains of those with Alzheimer’s disease. It is made by the drug companies Esai and Biogen, and was tested under the name lecanamab. (In 2021, the FDA approved another monoclonal antibody for Alzheimer’s called Aduhelm, but in tests it seems that it was not as effective as Leqembi; its efficacy remains controversial and it has some potentially deleterious side effects. As a consequence it is not widely prescribed.) 

In studies in nearly 1,800 patients over 18 months, Leqembi slowed disease progression by 27 percent compared to a placebo – equivalent to about a five-month delay in the disease getting worse. But both groups still showed declines in cognitive skills, and any benefits were modest. On an 18-point scale of memory and thinking skills, those getting the treatment scored about a half-point higher, which experts caution may not be noticeable to patients in their everyday lives. It’s unknown whether the treatment may have benefits over longer periods; continued testing is underway. 

Who might benefit from Leqembi? 

The treatment showed modest benefits in those in the early stages of Alzheimer’s disease and in those with mild cognitive impairment, which often progresses to full-blown Alzheimer’s. But it probably won’t help those with more advanced disease, when damage to the brain has become extensive. Nor would it be expected to help those who have dementia that is not caused by the amyloid plaques of Alzheimer’s. Indeed, patients that are candidates for the treatment must first get a brain scan to confirm that there is evidence of beta-amyloid buildup in the brain.

How is the treatment administered? 

Leqembi is given as an intravenous injection every two weeks, typically at a clinic or hospital. Patients getting the infusions may experience flu-like chills, fever and other side effects.  

Is Leqembi safe? 

The treatment with Leqembi, and with antibodies in general, carries risks. In tests, about 13 percent of people receiving the medication showed evidence of brain swelling, compared to less than 2 percent taking a placebo. About 17 percent had small bleeds in the brain, compared to about 9 percent of those in the placebo group. Several people who were receiving the drug have died of brain hemorrhages, including two who were also taking blood thinning medications, though the drug makers say the deaths were not a result of Leqembi. Still, experts caution that special caution is warranted, especially in anyone taking blood thinners, which doctors commonly prescribe to prevent or treat strokes. Patients may need to be monitored with brain scans to assess brain bleeding and swelling, which may cause symptoms such as headaches or dizziness. 

How much does Leqembi cost? 

The drug is expected to become available in the coming months at an average cost of $26,500 a year. That’s on top of any additional costs for administering the medication and follow-up testing. It is unknown at this time whether Medicare or other health insurance plans will cover some or all of the costs. 

By ALZinfo.org, The Alzheimer’s Information Site. Reviewed by Marc Flajolet, Ph.D., Fisher Center for Alzheimer’s Research Foundation at The Rockefeller University.  

Source:  Food and Drug Administration, Esai, Biogen 

 

“Just a few companies are making millions of dollars in profit every single hour, while just two percent of people in low-income countries have been fully vaccinated against coronavirus” -Jake Johnson, Common Dreams

 

Moderna, Pfizer, and BioNTech—the makers of the two most successful coronavirus vaccines—are raking in a combined $65,000 in profits every minute as they refuse to share their manufacturing recipes with developing countries, where billions of people still lack access to lifesaving shots.

According to a new People's Vaccine Alliance analysis of recent earnings reports, the three pharmaceutical giants have made a total of $34 billion in profits this year, which amounts to roughly $1,083 per second, $64,961 per minute, or $3.9 million per hour.

"It is obscene that just a few companies are making millions of dollars in profit every single hour while just two percent of people in low-income countries have been fully vaccinated against coronavirus," said Maaza Seyoum of the People's Vaccine Alliance Africa. "Pfizer, BioNTech, and Moderna have used their monopolies to prioritize the most profitable contracts with the richest governments, leaving low-income countries out in the cold."

Moderna—a Massachusetts-based company that developed its vaccine with the help of government research and around $10 billion in taxpayer funding—has delivered just 0.2% of its total vaccine supply to low-income countries, the People's Vaccine Alliance estimates. The coronavirus vaccine is Moderna's only product on the market.

Pfizer and its Germany-based partner BioNTech—whose vaccine was also helped along by taxpayer money—haven't done much better than their competitor, sending less than 1% of their supply to poor nations while profiting hugely from sales to rich countries.

"Predominantly, right now, we have already signed orders, and those are with high-income countries," Pfizer CEO Albert Bourla recently said of coronavirus vaccine sales for next year, blaming poor countries for not ordering shots quickly enough. "We are negotiating right now with few middle-income countries, and with even fewer low-income countries," Bourla said.

But public health campaigners argue that bilateral deals and vaccine donations are not sufficient to bring production and distribution into line with global needs. Instead, they say, pharmaceutical giants must relinquish their vaccine recipes and allow qualified manufacturers around the world to produce low-cost generic versions for their populations.

Moderna and Pfizer-BioNTech have thus far refused to do so—and lobbied aggressively against a World Trade Organization proposal to temporarily suspend vaccine patents. Bourla, for his part, has dismissed technology-transfer proposals as "dangerous nonsense."

"Contrary to what Pfizer's CEO says, the real nonsense is claiming the experience and expertise to develop and manufacture lifesaving medicines and vaccines does not exist in developing countries," Anna Marriott, health policy manager at Oxfam International, said in a statement Tuesday. "This is just a false excuse that pharmaceutical companies are hiding behind to protect their astronomical profits."

"It is also a complete failure of government to allow these companies to maintain monopoly control and artificially constrain supply in the midst of a pandemic while so many people in the world are yet to be vaccinated," she added.

Facing backlash for fueling massive inequities in vaccine distribution, Moderna on Tuesday announced a deal that will allow the European Union and European Economic Area countries to donate coronavirus vaccine doses that they purchased from the company to COVAX, the World Health Organization-backed vaccination initiative.

The agreement was met with derision from vaccine equity campaigners. "Goodness, how generous," responded Nick Dearden, director of the U.K.-based advocacy group Global Justice Now. "Most people will simply be astounded that you were stopping them from doing this in the first place. Why don't you, instead, share your publicly funded vaccine recipe with the WHO?" he added. "That might actually help."

In a letter to Moderna's billionaire CEO Stéphane Bancel on Tuesday, a coalition of nearly 90 civil society organizations wrote that "we are in no doubt that most Covid-19 deaths in low-income countries are now avoidable deaths: lives that could be saved were effective vaccines, none more than [Moderna's], widely available to their populations."

The groups called on Moderna to transfer its vaccine technology to qualified manufacturers through the WHO to ramp up global vaccine production and to commit to selling its shot to low-income countries at a not-for-profit price.

"So far, only about one million doses of mRNA-1273 have gone to low-income countries and Moderna has shipped a greater share of doses to wealthy countries than any other Covid-19 vaccine manufacturer," the groups noted. "Our analysis suggests that at scale, a not-for-profit price for mRNA-1273 would be no greater than $3 per dose."

"Moderna, with the [National Institutes of Health], has developed the world's most effective vaccine technology, that is also the world's most exclusive vaccine, out of reach to billions of people," they added. "This can and must change."

Peter Maybarduk, director of the Access to Medicines program at Public Citizen—one of the groups behind the letter—said Tuesday that Moderna "lags behind even its recalcitrant Big Pharma counterparts when it comes to offering a dose of compassion to the world in this time of need."

"The Biden administration and WHO have asked for Moderna's help, and so far Moderna largely has spurned them, despite the U.S. government's essential role developing the NIH-Moderna vaccine and significant contributions to making Moderna executives billionaires," said Maybarduk. "It is past time to share the NIH-Moderna vaccine with the world."   

-Jake Johnson, Common Dreams

"Members of the Sackler family who are at the center of the nation's deadly opioid crisis have won sweeping immunity from opioid lawsuits linked to their privately owned company Purdue Pharma and its OxyContin medication" (NPR)

 

Federal Judge Robert Drain approved a bankruptcy settlement on Wednesday that grants the Sacklers "global peace" from any liability for the opioid epidemic. "This is a bitter result," Drain said. "I believe that at least some of the Sackler parties have liability for those [opioid OxyContin] claims. ... I would have expected a higher settlement."

The complex bankruptcy plan, confirmed by Drain at a hearing in White Plains, N.Y., was negotiated in a series of intense closed-door mediation sessions over the past two years. The deal grants "releases" from liability for harm caused by OxyContin and other opioids to the Sacklers, hundreds of their associates, as well as their remaining empire of companies and trusts. In return, they have agreed to pay roughly $4.3 billion, while also forfeiting ownership of Purdue Pharma.

In his bench ruling, Drain acknowledged the devastating harm caused by Purdue Pharma's opioid products, which he said contributed to a "massive public health crisis." According to Drain, this settlement offers an opportunity to help communities with funding for drug treatment and other opioid abatement programs. "It is clear to me after a lengthy trial that there is now no other reasonably conceivable means to achieve this result," he said.

The Sacklers, who admit no wrongdoing and who by their own reckoning earned more than $10 billion from opioid sales, will remain one of the wealthiest families in the world. Representatives of the Mortimer Sackler branch of the family sent a statement to NPR. "While we dispute the allegations that have been made about our family, we have embraced this path in order to help combat a serious and complex public health crisis."

In his ruling, Judge Drain noted that members of the Sackler family had declined to offer an explicit apology for their role leading Purdue Pharma. "A forced apology is not really an apology," Drain said. "So we will have to live without one."

Critics of this bankruptcy settlement, meanwhile, said they would challenge Drain's confirmation because of the liability releases for the Sacklers. "This order is insulting to victims of the opioid epidemic who had no voice in these proceedings — and must be appealed," said Washington state Attorney General Bob Ferguson on Twitter. The U.S. Trustee Program, a division of the Justice Department that serves as a bankruptcy watchdog, also announced that it would seek a stay of Judge Drain's ruling pending the resolution of appeals.

Activists are outraged

The settlement has incensed opioid activists and many legal scholars, who describe the outcome as a miscarriage of justice. "I've never seen any such abuse of justice," said Nan Goldin, an artist who emerged as a leading opioid activist after becoming addicted to OxyContin. Goldin spoke to NPR ahead of the ruling, when it became clear Drain would approve liability releases for the Sacklers. "It's shocking. It's really shocking. I've been deeply depressed and horrified," she said.

In a series of legal briefs and during a bankruptcy trial over the last two weeks, the Department of Justice urged Drain to reject the settlement. Attorneys general for nine states and the District of Columbia also opposed the plan. They argued the settlement would unfairly deny individuals and governments the right to sue the Sacklers, who themselves never filed for bankruptcy protection. "Due process requires that those with litigation claims have reasonable opportunity to be heard," argued DOJ attorney Paul Schwartzberg during the trial.

Attorneys for Purdue Pharma and the Sacklers argued that without this deal there would be legal chaos as thousands of individuals lawsuits move forward against the company and members of the family. During the trial, Judge Drain seemed to endorse that legal argument.

In his ruling, Drain did narrow the scope of legal protections available for the Sacklers and their associates. Consultants and advisers who worked with Purdue Pharma, including a law firm operated by former Alabama Sen. Luther Strange, will no longer be covered by the liability releases. Attorneys for the family also demanded that family members receive protection from all lawsuits relating to their private company. Drain, however, demanded that most non-opioid claims be excluded from the deal. He also clarified on Wednesday that protection from civil lawsuits granted to members of the Sackler family does not protect them from any criminal charges.

The Sacklers have never been charged and say they did nothing wrong

Critics say the introduction of OxyContin in the late 1990s when members of the Sackler family served on the company's board helped usher in the opioid crisis. More than 500,000 people in the United States have died from drug overdoses involving opioids, and millions more suffer from opioid use disorder.

Purdue Pharma has pleaded guilty twice to criminal wrongdoing in its marketing of OxyContin, first in 2007 and again last year. The Sacklers have never been charged and say they did nothing illegal or unethical. Facing a wave of negative publicity linked to their company, however, the Sacklers have seen their name stripped from buildings and institutions. Many philanthropic and cultural groups around the world have stopped accepting donations from the family.

Supporters of the bankruptcy plan — including most state and local government officials across the U.S. — have voiced unhappiness with liability releases granted to the Sacklers. But they say the deal is expected to distribute more than $5 billion over the next decade to public trusts created to fund drug treatment and health care programs. "Instead of years of value-destructive litigation, including between and among creditors, this plan ensures that billions of dollars will be devoted to helping people and communities who have been hurt by the opioid crisis," said Steve Miller, who chairs Purdue Pharma's board of directors, in a statement sent to NPR.

Even some early critics of the bankruptcy plan, including New York Attorney General Letitia James, said the money contributed by the Sacklers will do real good. "No deal is perfect, and no amount of money will ever make up for the hundreds of thousands who lost their lives, the millions who became addicted, or the countless families torn apart by this crisis, but these funds will be used to prevent future death and destruction as a result of the opioid epidemic," James said in a statement.

The new company that emerges from the ashes of Purdue Pharma will be allowed to continue making and selling opioid products, including OxyContin. But architects of this deal say future opioid profits will go to help fund drug treatment programs. Purdue Pharma itself will re-emerge from bankruptcy as a new company operated as a form of public trust corporation.

An appeal by the DOJ could be the final hurdle

NPR reported on Tuesday that Purdue Pharma and its attorneys launched a behind-the-scenes pressure campaign aimed at convincing the DOJ not to challenge the plan in court. NPR acquired an early draft of a letter distributed by the drug company to groups supportive of the bankruptcy deal. The letter is framed as a direct appeal to DOJ officials and purports to be written by those injured by the company and members of the Sackler family. "We collectively speak for the overwhelming majority of the state and local governments, organizations, and individuals harmed by Purdue and the Sacklers," the letter states.

 

There is no mention in the document of the company's role launching the effort or crafting the message. Ryan Hampton, an opioid activist who served on a key committee negotiating the bankruptcy deal, expressed outrage at Purdue Pharma's effort. "This letter was highly inappropriate. It was wrong," Hampton told NPR. "It was written, proposed and pushed at the eleventh hour at the beckoning of Purdue Pharma." A DOJ spokesperson declined to comment on the drug company's efforts to influence its decision-making and would not disclose the timeline for deciding whether it will file an appeal.

NPR

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease/ Biogen CEO Michel Vounatsos says $56,000 annually for Alzheimer’s drug is "fair," and promises not to hike price for at least 4 years

 

by Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research

Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.

This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.  The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.

We are well-aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With a treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.

At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward. We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway—a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.

What the Data Show

The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint.  In all studies in which it was evaluated, however, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion.  It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline.

We know that the Peripheral and Central Nervous System Drugs Advisory Committee, which convened in November 2020 to review the clinical trial data and discuss the evidence supporting the Aduhelm application, did not agree that it was reasonable to consider the clinical benefit of the one successful trial as the primary evidence supporting approval. The option of Accelerated Approval was not discussed by the Advisory Committee. As mentioned above, treatment with Aduhelm was clearly shown in all trials to substantially reduce amyloid beta plaques. This reduction in plaques is reasonably likely to result in clinical benefit. After the Advisory Committee provided its feedback, our review and deliberations continued, and we decided that the evidence presented in the Aduhelm application met the standard for Accelerated Approval. We thank the Advisory Committee for its independent review of the data and valuable advice.

Accelerated Approval

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need.  Approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain).  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. 

The Devastation of Alzheimer’s Disease

With all this said, we are extremely aware of the gradual and cumulative devastation that Alzheimer’s disease causes, as patients lose their memory and cognitive functioning over time. In late-stage disease, people can no longer hold a conversation or respond to their environment. On average, a person with Alzheimer’s disease lives four to eight years after diagnosis, but some patients can live up to 20 years with the disease. 

The need for treatments is urgent: right now, more than 6 million Americans are living with Alzheimer’s disease and this number is expected to grow as the population ages. Alzheimer's is the sixth leading cause of death in the United States.

Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.  As a result of FDA’s approval of Aduhelm, patients with Alzheimer’s disease have an important and critical new treatment to help combat this disease.  

FDA will continue to monitor Aduhelm as it reaches the market and ultimately the patient’s bedside. Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.

 https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease

An Exorbitantly-Expensive Drug Can Reduce Dementia’s Delusions

“A drug that curbs delusions in Parkinson's patients did the same for people with Alzheimer's disease and other forms of dementia in a study that was stopped early because the benefit seemed clear.

“If regulators agree, the drug could become the first treatment specifically for dementia-related psychosis and the first new medicine for Alzheimer's in nearly two decades. It targets some of the most troubling symptoms that patients and caregivers face - hallucinations that often lead to anxiety, aggression, and physical and verbal abuse. Results were disclosed Wednesday at a conference in San Diego.

“‘This would be a very important advance,’ said one independent expert, Dr. Howard Fillit, chief science officer of the Alzheimer's Drug Discovery Foundation. Although the field is focused on finding a cure for dementia and preventing future cases, ‘there is a huge unmet need for better treatment’ for those who have it now, said Maria Carrillo, the Alzheimer's Association's chief science officer.

“The drug is pimavanserin, a daily pill sold as Nuplazid by Acadia Pharmaceuticals Inc. It was approved for Parkinson's-related psychosis in 2016 and is thought to work by blocking a brain chemical that seems to spur delusions. About 8 million Americans have dementia, and studies suggest that up to 30% of them develop psychosis.

“‘It's terrifying,’ said Dr. Jeffrey Cummings of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. ‘You believe that people might be trying to hurt you. You believe that people are stealing from you. You believe that your spouse is unfaithful to you. Those are the three most common false beliefs.’

“He consults for Acadia and helped lead the study, which included about 400 people with dementia and psychosis. All were given a low dose of the drug for three months, and those who seemed to respond or benefit were then split into two groups. Half continued on the drug and the others were given dummy pills for six months or until they had a relapse or worsening of symptoms. Neither the patients nor their doctors knew who was getting what.

“Independent monitors stopped the study when they saw that those on dummy pills were more than twice as likely as those on the drug to relapse or worsen - 28% versus nearly 13%. There were relatively few serious side effects - 5% in the drug group and 4% in the others. Headaches and urinary tract infections were more common among those on the drug. Two deaths occurred, but study leaders said neither was related to the drug.

“Carrillo said the study was small, but the drug's effect seemed large, and it's not known whether the federal Food and Drug Administration would want more evidence to approve a new use. Current anti-psychotic medicines have some major drawbacks and are not approved for dementia patients. ‘They're often used off label because we have very few other options,’ Fillit said. All carry warnings that they can raise the risk of death in elderly patients, as does Nuplazid.

“Cost could be an issue - about $3,000 a month. What patients pay can vary depending on insurance coverage.”   

For the article, click here.

Walgreens: “By Any Other Name Would [Be Greed]”

Walgreens Will No Longer Provide Health Benefits for Retired Employees:

“Walgreens said in a September letter reviewed by CNBC that it would no longer subsidize medical benefits for its former employees who hadn't turned 64 by March 31, citing ‘rising and unpredictable healthcare costs’…

“Some 550 retirees receive the subsidies from Walgreens before they turn 65 and are eligible for Medicare. Under the age restrictions laid out in the September letter, they won't receive the payments, which vary in amount based on employees' years of service.

“Neither will employees who were eligible for the benefit upon retirement under the old rules, which made it available to employees who had turned 50 by May 2017 and had worked at the company 20 years. (Employees still needed to be at least 55 with at least 25 years of service at the time of retirement to receive the benefit).

“Walgreens tightened the requirements for the subsidies in the past, eliminating eligibility for new hires and younger employees, but until last fall, the company had stopped short of touching the payments of retirees who were already receiving them.

“‘Pre-65, I do think it's unusual to take people who already have a subsidy right now and eliminate that subsidy,’ said Derek Guyton, a partner in the health and benefits business at Mercer, owned by Marsh & McLennan. ‘What's more common is you tell people way ahead of time you're not going to have this subsidy when you get to 55 or what have you. That obviously has happened a lot and continues to happen, but taking it away from people, some employers consider that almost an employment contract.’

“Walgreens has said it is working on a ‘lower-cost, unsubsidized retiree health program starting in 2020,’ according to an October letter it sent to retirees. It has yet to provide details on its plan.

“Walgreens spokesman Phil Caruso said that the company reviewed a host of factors before deciding to change eligibility requirements for the subsidies.

“‘We are continuing to work toward a new retiree healthcare program for 2020, paying particular attention to the transition impact for those with current subsidized coverage,’ he said. ‘We will continue to update our retirees.’

“The drugstore chain employed roughly 354,000 people as of August, according to its annual report…

“Despite its profits [Recent Quarter Earnings Rose 4.6% to $34.53 Billion], the drugstore chain is under pressure from investors to cut costs.

“Pharmacies are getting paid less to fill prescriptions as insurers squeeze them. Prices of the drugs they're dispensing aren't increasing at the same rates they used to as drug makers face pressure from lawmakers. People also aren't buying as much candy and soap at drugstores, instead buying convenience items online on sites like Amazon.

“The company earlier this year ramped up cost-cutting after CEO Stefano Pessina called its second-fiscal quarter the most difficult quarter since Walgreens acquired Boots Alliance in 2015. [Pessina’s Net worth Is $10 Billion. His Net Worth Was $15.3 Billion in 2015. He Earned $14.7 Million in 2017. The Average Hourly Rate for Employees Is $12.33]. Walgreens now expects to save $1.5 billion annually by 2022, executives told Wall Street analysts on a conference call in April.

“In cutting the subsidies for early retirees, Walgreens reduced its benefit plan obligation by $201 million in 2018 from the previous year, the company said in its annual report…” [There Are 13,200 Walgreens Stores in 11 Countries. The Company’s Net Worth Is $47.95 Billion (as of June 21, 2019). The Average Hourly Rate for Pharmacy Technicians Is $12.88; the Average Hourly Rate for Retail Shift Supervisors Is $12.98; the Average Hourly Rate for Customer Service Associates Is $8 - $12].

For the entire article, click here.

"We the public, we the people, developed this drug, we paid for this drug. There's no reason this should be $2,000 a month. People are dying because of it”-Alexandria Ocasio-Cortez

“During a House hearing on Thursday [May 16], Rep. Alexandria Ocasio-Cortez asked the CEO of one of America's largest pharmaceutical companies a simple but crucial question: ‘Why does a life-saving HIV drug that costs $8 a month in Australia have a $2,000 price tag in the U.S.?’

“Gilead chief executive Daniel O'Day declined to comment on the low price of Truvada for PrEP in Australia, but said the reason the cost is close to $2,000—'the current list price is $1,780,’ he said—in the United States is because the drug has ‘patent protection.’

“As the Washington Post reported in March, the development of Truvada as a treatment for HIV was ‘almost fully funded by U.S. taxpayers.’

“The U.S. government patented the treatment in 2015, according to the Post, but has ‘opted not to file an infringement suit to enforce’ the patent even as Gilead—which argues the government patent is invalid—rakes in billions of dollars in profits from Truvada.

“Ocasio-Cortez highlighted these facts during the House Oversight and Reform Committee hearing on Thursday.

“‘I think it's important that we notice here that we the public, we the people, developed this drug, we paid for this drug, we led and developed all of the grounding patents to create PrEP, and then that patent has been privatized despite the fact that that patent is owned by the public,’ said Ocasio-Cortez. ‘We refuse to enforce it.’

“‘There's no reason this should be $2,000 a month,’ Ocasio-Cortez added. ‘People are dying because of it. We own the intellectual property for it. People are dying for no reason. For no reason. We developed this drug.’

“In a tweet following Thursday's hearing, Ocasio Cortez answered her own question on why Truvada's price is $8 in Australia. ‘Spoiler: Because Australia has universal healthcare,’ wrote the New York congresswoman.

“‘The reason the United States hasn't joined the rest of the industrialized world in establishing a universal healthcare system is not individual drug company executives like O'Day,’ said Ocasio-Cortez.

“‘I don't blame you. I blame us. I blame this body,’ Ocasio-Cortez said during the hearing. Because every single developed country in the world guarantees healthcare as a right except us. Except the United States. Because we can't get it together. Because we don't have the fortitude to kick pharmaceutical lobbyists [out of] our congressional offices.’”

Commondreams.org