Burden from Pharmaceutical Industry Drug Patent Monopolies Exceeds Interest Payments on National Debt

The pharmaceutical industry must find it convenient that the financial burden it imposes in general on American society is mentioned a lot less than the much more minor burden imposed by interest payments on the national debt.

The deficit hawks have also never raised any concerns about the burdens created by government-granted patent and copyright monopolies. This is bizarre since these monopolies are an alternative mechanism to direct funding. The government could directly pay for research on drugs, software, and other items, paying for it through taxing or borrowing, or it can tell private companies to do the research and then give them monopolies to allow them to recover their costs.

The deficit hawks hyperventilate endlessly about the former route of paying for things, but completely ignore the latter, even though it poses a much larger burden. In the case of prescription drugs alone, the burden is more than $370 billion a year (we pay more than $450 billion for drugs that would likely cost less than $80 billion in a free market). This sum is just under 2.0 percent of GDP and more than twice the interest burden net of money rebated by the Fed. The total cost from these monopolies, including medical equipment, chemicals, software, and other items would likely be more than three times the cost of drug patents.

Anyone who is seriously concerned about the burden of government debt on future generations must also be concerned about the burden posed by patent and copyright monopolies, if they are consistent. Of course, if their goal is simply to cut Social Security, Medicare, and other social programs then it is understandable they would not want to discuss patent and copyright monopolies.

I’m not linking to the full article, but what’s not referred to is that there’s a different process possible to incentivize pharmaceutical innovation than using patent monopolies and other unjust legal protections for the industry. The pharmaceutical industry’s trade group, PhRMA, says that pharma corporations spend $70 billion a year on research and development. This is also in light of the industry spending more on stock buybacks that mostly benefit the upper class than it spends on R&D.

So the U.S. spends a few hundred billion dollars more a year than it has to on prescription drugs, and instead of giving that taxpayer-directed money away to be misused by the pharma industry, a lesser amount could be spent on direct funding for the NIH (say $90 billion a year) — with much better research outcomes and lower prescription costs for consumers. This isn’t the easiest concept to understand, but it’s valuable if you’re able to see it, and I linked to where I wrote about it in more depth as well.

Study Shows a Bigger Pharmaceutical Industry is Linked to Worse Health Outcomes

The ridiculously extreme profits of pharmaceutical corporations has allowed them to lobby legislatures and enact laws that further boost their profits — while being detrimental to the public interest. Much of this is due to drug patent monopolies, which are regularly equivalent to harmful, regressive tariffs of hundreds or thousands of percent.

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While Americans debate the rising cost of health care, a new study of 30 countries over 27 years found that medical expansion has improved overall health — with one major exception.

Researchers found that increased spending on health care and increases in specialized care were both associated with longer life expectancy and less mortality in the countries studied.

But pharmaceutical industry expansion was linked to negative health effects.

“This study isn’t the first to suggest prescription drugs can pose a health risk. But it is the first to find that the growth of the pharmaceutical industry itself may be associated with worse rather than better health,” said Hui Zheng, lead author of the study and associate professor of sociology at The Ohio State University.

[…]

Two measures of expansion in the pharmaceutical industry — increased sales and more money spent on research and development — were linked to lower life expectancy among women aged 65 and older, and with increased mortality rates. The pharmaceutical measures were not associated with the other health outcomes studied.

The researchers ran tests to confirm that it wasn’t the other way around — that lower life expectancy and increased mortality were causing an expansion of the pharmaceutical industry. But that wasn’t the case.

That wasn’t the only negative finding about the growing drug industry.

“We found that as the pharmaceutical industry expands, there is a decrease in the beneficial impact of medical specialization on population health,” Zheng said.

This study can’t say why expansion in the pharmaceutical industry is leading to negative population health effects, Zheng said.

“It could be due to toxic side effects of drugs, doctors’ prescribing practices, patients’ misuse of prescription drugs, reasons related to pharmaceutical industry’s marketing strategies or some combination of these factors,” he said.

Prozac and Chemical Imbalances in the Brain — The False Narrative

There are admittedly probably a few people with actual chemical imbalances in the brain that cause depression, but for the most part, I think the commonly false chemical imbalance narrative is a ploy pushed by pharmaceutical companies to make profits. I lived years of my life with pretty severe depression and I knew that antidepressants wouldn’t remedy that — if anything, they would have made it worse. I learned that sleeping enough, exercising fairly often, finding some satisfying sex life (ideally finding a lover), limiting or avoiding drug intake, having a healthy diet, having good friends, and doing work that is fulfilling and meaningful are much better types of solutions than relying on a pill. The underlying problem has to be fixed for real happiness — it shouldn’t be artificially made with drugs.

Some 2,000 years ago, the Ancient Greek scholar Hippocrates argued that all ailments, including mental illnesses such as melancholia, could be explained by imbalances in the four bodily fluids, or “humors.” Today, most of us like to think we know better: Depression—our term for melancholia—is caused by an imbalance, sure, but a chemical imbalance, in the brain.

This explanation, widely cited as empirical truth, is false. It was once a tentatively-posed hypothesis in the sciences, but no evidence for it has been found, and so it has been discarded by physicians and researchers. Yet the idea of chemical imbalances has remained stubbornly embedded in the public understanding of depression.

Prozac, approved by the US Food and Drug Administration 30 years ago today, on Dec. 29, 1987, marked the first in a wave of widely prescribed antidepressants that built on and capitalized off this theory. No wonder: Taking a drug to tweak the biological chemical imbalances in the brain makes intuitive sense. But depression isn’t caused by a chemical imbalance, we don’t know how Prozac works, and we don’t even know for sure if it’s an effective treatment for the majority of people with depression.

One reason the theory of chemical imbalances won’t die is that it fits in with psychiatry’s attempt, over the past half century, to portray depression as a disease of the brain, instead of an illness of the mind. This narrative, which depicts depression as a biological condition that afflicts the material substance of the body, much like cancer, divorces depression from the self. It also casts aside the social factors that contribute to depression, such as isolation, poverty, or tragic events, as secondary concerns. Non-pharmaceutical treatments, such as therapy and exercise, often play second fiddle to drugs.

In the three decades since Prozac went on the market, antidepressants have propagated, which has further fed into the myths and false narratives we tell about mental illnesses. In that time, these trends have shifted not just our understanding, but our actual experiences of depression.

[…]

Both the narrative and the use of drugs to treat symptoms of depression transformed after Prozac—the brand name for fluoxetine—was released. “Prozac was unique when it came out in terms of side effects compared to the antidepressants available at the time (tricyclic antidepressants and monoamine oxidase inhibitors),” Anthony Rothschild, psychiatry professor at the University of Massachusetts Medical School, writes in an email. “It was the first of the newer antidepressants with less side effects.”

Even the minimum therapeutic dose of commonly prescribed tricyclics like amitriptyline (Elavil) could cause intolerable side effects, says Hyman. “Also these drugs were potentially lethal in overdose, which terrified prescribers.” The market for early antidepressants, as a result, was small.

Prozac changed everything. It was the first major success in the selective serotonin reuptake inhibitor (SSRI) class of drugs, designed to target serotonin, a neurotransmitter. It was followed by many more SSRIs, which came to dominate the antidepressant market. The variety affords choice, which means that anyone who experiences a problematic side effect from one drug can simply opt for another. (Each antidepressant causes variable and unpredictable side effects in some patients. Deciding which antidepressant to prescribe to which patient has been described as a “flip of a coin.”)

Rothschild notes that all existing antidepressant have similar efficacy. “No drug today is more efficacious that the very first antidepressants such as the tricyclic imipramine,” agrees Hyman. Three decades since Prozac arrived, there are many more antidepressant options, but no improvement in efficacy of treatment.

Meanwhile, as Lacasse and Leo note in a 2005 paper, manufacturers typically marketed these drugs with references to chemical imbalances in the brain. For example, a 2001 television ad for sertraline (another SSRI) said, “While the causes are unknown, depression may be related to an imbalance of natural chemicals between nerve cells in the brain. Prescription Zoloft works to correct this imbalance.”

Another advertisement, this one in 2005, for the drug paroxetine, said, “With continued treatment, Paxil can help restore the balance of serotonin,” a neurotransmitter.

“[T]he serotonin hypothesis is typically presented as a collective scientific belief,” write Lacasse and Leo, though, as they note: “There is not a single peer-reviewed article that can be accurately cited to directly support claims of serotonin deficiency in any mental disorder, while there are many articles that present counterevidence.”

Despite the lack of evidence, the theory has saturated society. In their 2007 paper, Lacasse and Leo point to dozens of articles in mainstream publications that refer to chemical imbalances as the unquestioned cause of depression. One New York Times article on Joseph Schildkraut, the psychiatrist who first put forward the theory in 1965, states that his hypothesis “proved to be right.” When Lacasse and Leo asked the reporter for evidence to support this unfounded claim, they did not get a response. A decade on, there are still dozens of articles published every month in which depression is unquestionably described as the result of a chemical imbalance, and many people explain their own symptoms by referring to the myth.

Meanwhile, 30 years after Prozac was released, rates of depression are higher than ever.

[…]

Depression is now a global health epidemic, affecting one in four people worldwide. Treating it as an individual medical disorder, primarily with drugs, and failing to consider the environmental factors that underlie the epidemic—such as isolation and poverty, bereavement, job loss, long-term unemployment, and sexual abuse—is comparable to asking citizens to live in a smog-ridden city and using medication to treat the diseases that result instead of regulating pollution.

Investing in substantive societal changes could help prevent the onset of widespread mental illness; we could attempt to prevent the depressive health epidemic, rather than treating it once it’s already prevalent. The conditions that engender a higher quality of life—safe and affordable housing, counsellors in schools, meaningful employment, strong local communities to combat loneliness—are not necessarily easy or cheap to create. But all would lead to a population that has fewer mental health issues, and would be, ultimately, far more productive for society.

Inhumane Avarice as Inherited Vision Loss Treatment to Cost $850,000

The extremely high cost means that only the wealthy will be able to afford the vision loss treatment. This is especially pernicious because *inherited* vision loss is something that those affected by the ailment were born with. It isn’t as a result of anything wrong they did themselves.

The $850,000 cost is also pernicious because the development of Luxturna benefited significantly from tax breaks and government research investments. It’s therefore yet another twisted case of public costs and privatized profits.

In December, the FDA approved a treatment from the pharmaceutical company Spark Therapeutics to treat a rare form of inherited vision loss. And January 3rd, the company put a price tag on the groundbreaking treatment. The Luxturna gene therapy will cost $850,000 — or $425,000 per eye.

Originally, the price of the treatment was estimated at $1 million. But even with the slightly lower cost, Luxturna is still one of the priciest treatments in the world.

Luxturna is the first gene therapy approved in the U.S. for an inherited disease, and patients only need to receive the treatment one time. The therapy was created to treat patients with retinal dystrophy, an inherited form of vision loss that causes the destruction of retinal cells. Luxturna works by injecting each eye with a normal copy of the gene responsible for vision loss. Retinal dystrophy affects between 1,000 and 2,000 Americans.

[…]

Medical advancements over the past decade have been amazing, and Luxturna has the potential to benefit thousands of people. But the reality is that most people probably won’t be able to afford this treatment, meaning it will only be accessible to the incredibly wealthy. And for people who can’t access health insurance, regular trips to the doctor are difficult to afford, let alone life-altering medications like Luxturna. We urge pharmaceutical companies to make groundbreaking treatments available for all people — not just the 1 percent.

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Source: Public Citizen

Latest Price Gouging as Cost of Gleostine Drug is Hiked 1400%

Drug patent monopolies have long been detrimental to the general population. In 2017, the U.S. spent over $450 billion (2.4 percent of annual GDP) on prescription drugs, an amount that would probably have been one fifth of that total if there were no government-granted drug patent monopolies. Furthermore, in world history’s richest country, it is absurd that about 20 percent of seniors regularly cannot afford their medication. That happens as the top five biggest pharmaceutical corporations made a combined $50 billion in profits for the year too.

Gleostine, which had its patent expire recently, is the latest example of this systemic pharmaceutical failure. The drug companies must be reined in, or these outrages will keep continuing into the future.

Critics of the pharmaceutical industry have expressed outrage over a Wall Street Journal analysis that found the owner of a 40-year-old cancer drug used to treat brain tumors and Hodgkin’s lymphoma has hiked the cost of the medication by 1,400 percent since acquiring it in 2013.

Lomustine, which was introduced in 1976, “has no generic competition, giving seller NextSource Biotechnology LLC significant pricing power,” the Journal reports, noting that lomustine is just “one of at least 319 drugs for which U.S. patents have expired but which have no generic copies, according to a list the agency published earlier this month.”

While the U.S. Food and Drug Administration is reportedly working to speed up the approval process for generic versions of these drugs, some critics say the report demonstrates a need for a broader overhaul of the nation’s healthcare system, with the Robin Hood Tax campaign citing it as evidence for “why we need” Medicare For All, which has been promoted by Sen. Bernie Sanders (I-Vt.) and a growing number of Democrats in Congress.

[…]

“This is simply price gouging, period,” concluded Henry Friedman, a neuro-oncologist at Duke University who wrote an editorial criticizing the lomustine price hikes earlier this year. “People are not going to be able to afford it, or they’re going to pay a lot of money and have financial liability.”

Atrocious Consequences of Pharmaceutical Price Gouging

The greed of the pharmaceutical industry has caused far too much suffering already, and it is long past time that the industry payed a high price of its own for the damage it has caused.

Particular important to highlight again is the part where — in the wealthiest country in world history — “Shane Patrick Boyle, a founder of Zine Fest Houston, died on March 18 after his GoFundMe campaign to pay for insulin came up $50 short.” What kind of society can that sentence even be written in?

Last year The New York Times published an op-ed urging the break up of the “insulin racket.” But rather than break it up, Trump has nominated one of its architects, Alex Azar, for secretary of Health and Human Services.

From 2007 to 2017, Azar worked for pharmaceutical giant Eli Lilly. While he was a senior VP, Lilly paid a record $1.415 billion to settle a case on its off-label promotion of the antipsychotic Zyprexa. Rising up the ranks, Azar became president of Lilly USA, the largest division of Eli Lilly, in 2012, a position he held until resigning in January of this year.

During Azar’s tenure, Eli Lilly raised the prices on its insulins in the United States by 20.8 percent in 2014, 16.9 percent in 2015, and 7.5 percent in 2016. Eli Lilly’s biggest seller, Humalog insulin, is now off-patent. But rather than becoming cheaper, Humalog costs more now than when it first came to market in 1996. When Azar started working at Eli Lilly in June 2007, the list price for a vial of Humalog was $74. When he quit in January 2017, it was $269.

At T1International we asked people with type 1 diabetes around the world how much they paid each month to stay alive. The United States topped every country, spending on average $571.69 per month on diabetes costs. Even with insurance, some Americans are spending around half their income on insulin and other supplies.

In fact, price gouging from Eli Lilly and other insulin manufacturers has already had deadly consequences. Shane Patrick Boyle, a founder of Zine Fest Houston, died on March 18 after his GoFundMe campaign to pay for insulin came up $50 short. Alec Raeshawn Smith, age 26, was found dead in his apartment on June 27. He was rationing his insulin after he aged out of his parent’s insurance coverage. The sad fact is more people would be alive today if insulin was affordable for all Americans.

Contrary to pharma propaganda, insulin is neither “new” nor “innovative.” It was developed in Toronto in 1921. The discoverers turned down the chance to create for-profit clinics. Instead, they licensed their creation for $1 (Canadian) a piece. Their recorded reason for doing this was to make sure insulin would be available for all who needed it. Eli Lilly’s was tasked with manufacturing insulin for North America. There was an understanding insulin would be sold at a reasonable price until there was a cure for diabetes.

What difference a century makes! Eli Lilly is currently under investigation by multiple state attorneys general for price fixing. It is also named in a class-action lawsuit that alleges that it colluded with Novo Nordisk and Sanofi to keep the prices in the US insulin market rising. These “Big 3” insulin makers control over 90 percent of the global market and maintain their lock on it in many ways. One is “pay-for-delay schemes,” like when Sanofi paid Eli Lilly to delay the launch of an insulin similar to its Lantus brand. Another is to sue potential competitors for intellectual property infringement, such as when Merck attempted to enter the insulin market in 2016. The companies also funnel money into patient-advocacy groups, both big and small. This might explain the inaction or even outright opposition of these groups on measures that may rein in prices.

Financing Prescription Drugs Using a Different System Without Harmful Drug Patent Monopolies

A new study finds that scientific breakthroughs are significantly as a result of collaboration. It used the development of five anti-cancer drugs to show how important researchers sharing information was, and it also strengthened the notion that beneficial scientific research tends to advance fastest when the results are fully open to view.

The study is evidence against the pharmaceutical research financing failure that is drug patent monopolies. Pharmaceutical corporations have an incentive to share as little of their research as possible to be granted their drug patent monopolies, as doing otherwise would risk threats to their profit margins through not receiving the patent. If the research findings are kept hidden from the public in this type of example, there is also a waste of resources to develop another similarly effective drug. This is notably seen with the Hepatitis C drug Sovaldi, which costs $84,000 for a 12 week course of treatment because the Gilead Sciences corporation has a patent monopoly on the drug. This is usefully contrasted with a high quality generic of Sovaldi selling for only $200 for the same three month course of treatment in India.

The U.S. government has the power to arrest people who sell Sovaldi in competition with Gilead Sciences, so the Abbvie corporation developed its own Hepatitis C cure drug known as Mavyret. Sovaldi was already an effective drug at curing Hepatitis C though, so the researchers that developed Mavyret could have been focused on other important research. This is, of course, a phenomenon that is continuously repeated with other drugs, and it prompts the logical conclusion of using a different system to finance pharmaceutical research.

A more ideal system would be to make drug patent monopolies illegal and have the U.S. government directly finance pharmaceutical research. The U.S. public already funds the National Institutes of Health with $30 billion annually, and even the pharmaceutical industry admits that is money well spent. PhRMA, the industry trade group, puts the amount that the pharmaceutical corporations spend on yearly research and development at only a somewhat higher total of $70 billion. This is in light of an important study revealing that pharmaceutical corporations spend more on stock buybacks that benefit the wealthy than they do on research and development. That is in light of the U.S. set to spend $450 billion (2.4 percent of GDP) on prescription drugs in 2017, an amount that would be $370 billion — half of the latest U.S. military budget approval — less if the patents and related unjust protections were removed from the pharmaceutical industry.

These large expenditures are especially significant considering that it’s been estimated that the U.S. will spend an even higher $610 billion a year on prescription drugs by 2021. With the current pharmaceutical system, that will mean that the U.S. could be spending about $120 billion on prescription drugs in 2021 instead of $610 billion.

The $370 billion possible to save currently though could be used in a variety of more productive ways than granting it to the pharmaceutical industry under the current financing system. For one example, the budget of the NIH could easily be boosted by a factor of five, making it $150 billion a year. What money remains is possible to spend on productive investment programs, such as an infrastructure project for clean and renewable energy. The U.S. economy is not doing that well for most of its people, but a significant improvement to that should be well-known — government investment to stimulate more demand.

The research done by the NIH could of course remain fully open for pharmaceutical companies and other organizations to use to develop drugs. Developed drugs could then be sold inexpensively without patent monopolies and the other unjust protections, which is how it should be done considering that prescription drugs are usually cheap to produce after their research process is completed. The firms developing valuable drugs should be rewarded for their innovative efforts, and they could be through the combination of governmental contracting, a publicly-funded prize system, and the demand of markets. That would almost certainly be a more beneficial system for the public interest than the current drug patent monopoly scandal, which is inefficient at advancing vital research and leaves many millions struggling to afford unnecessarily costly prescription drugs.

Thugnificently

In his own (admittedly questionable) way, Thugnificent wasn’t a sucker for the pharmaceutical industry’s tricks. You shouldn’t be a sucker for their tricks either. [Image is from S3E12 of The Boondocks.]

The Billionaire Family Profiting from the Disastrous Opioid Epidemic

Here is another sickening example of profits being earned through cruel corporate activities. The expose of this family is notable in how it digs deeper than most reports to find the original problem.

The descendants of Mortimer and Raymond Sackler, a pair of psychiatrist brothers from Brooklyn, are members of a billionaire clan with homes scattered across Connecticut, London, Utah, Gstaad, the Hamptons, and, especially, New York City. It was not until 2015 that they were noticed by Forbes, which added them to the list of America’s richest families. The magazine pegged their wealth, shared among twenty heirs, at a conservative $14 billion. (Descendants of Arthur Sackler, Mortimer and Raymond’s older brother, split off decades ago and are mere multi-millionaires.) To a remarkable degree, those who share in the billions appear to have abided by an oath of omertà: Never comment publicly on the source of the family’s wealth.

That may be because the greatest part of that $14 billion fortune tallied by Forbes came from OxyContin, the narcotic painkiller regarded by many public-health experts as among the most dangerous products ever sold on a mass scale. Since 1996, when the drug was brought to market by Purdue Pharma, the American branch of the Sacklers’ pharmaceutical empire, more than two hundred thousand people in the United States have died from overdoses of OxyContin and other prescription painkillers. Thousands more have died after starting on a prescription opioid and then switching to a drug with a cheaper street price, such as heroin. Not all of these deaths are related to OxyContin—dozens of other painkillers, including generics, have flooded the market in the past thirty years. Nevertheless, Purdue Pharma was the first to achieve a dominant share of the market for long-acting opioids, accounting for more than half of prescriptions by 2001.

According to the Centers for Disease Control, fifty-three thousand Americans died from opioid overdoses in 2016, more than the thirty-six thousand who died in car crashes in 2015 or the thirty-five thousand who died from gun violence that year. This past July, Donald Trump’s Commission on Combating Drug Addiction and the Opioid Crisis, led by New Jersey governor Chris Christie, declared that opioids were killing roughly 142 Americans each day, a tally vividly described as “September 11th every three weeks.” The epidemic has also exacted a crushing financial toll: According to a study published by the American Public Health Association, using data from 2013—before the epidemic entered its current, more virulent phase—the total economic burden from opioid use stood at about $80 billion, adding together health costs, criminal-justice costs, and GDP loss from drug-dependent Americans leaving the workforce. Tobacco remains, by a significant multiple, the country’s most lethal product, responsible for some 480,000 deaths per year. But although billions have been made from tobacco, cars, and firearms, it’s not clear that any of those enterprises has generated a family fortune from a single product that approaches the Sacklers’ haul from OxyContin.

Democracy Now has coverage of these origins of OxyContin too.

Pharmaceutical Corporation Gilead Again Gouging People With Life-Threatening Illnesses

The Gilead corporation is among the greediest of corporations in the modern era. This is the same firm that abused its patent monopoly on the Hepatitis C drug Sovaldi to set the price at $84,000 for a 12 week course of treatment.

Now Gilead has a new gene therapy that it’s setting at a price near $400,000. This is yet another example of the enormous costs to the general population incurred by Big Pharma and the existence of drug patent monopolies.

U.S. regulators approved on Wednesday a new therapy for a type of lymphoma, which was developed by Gilead Science Inc’s (GILD.O) Kite Pharma, marking the second approval for this potentially revolutionary approach to fighting cancer.

The Food and Drug Administration approved the gene therapy, to be sold under the name Yescarta, to treat adults with large B-cell lymphoma, a type of non-Hodgkin lymphoma, who have failed to respond to other treatments.

Gilead, which recently acquired Kite Pharma, said the list price for Yescarta, which is to be administered just once to each patient, would be $373,000.

The price is well below that of the first drug in this new class – Novartis AG’s (NOVN.S) $475,000 Kymriah. The Novartis gene therapy was approved in August for B-cell acute lymphoblastic leukemia, the most common form of childhood cancer in the United States.

Both are chimeric antigen receptor T-cell therapies, or CAR-Ts, which reprogram the body’s own immune cells to recognize and attack malignant cells.

The high price of CAR-Ts is igniting a new debate over the rising cost of prescription drugs. Novartis said it would charge for Kymriah only if patients responded within a month of the treatment, but Gilead is not following suit.

“We are in ongoing and active discussions with payers, and we have communicated our openness to considering different solutions that improve patient access,” Gilead spokeswoman Amy Flood said in an email.

She said the price was set following extensive research with both government agencies that reimburse for drug costs and private insurers, and cancer centers.

Gilead Sciences shares rose almost 4 percent to $83 in after-the-bell trading.

Jefferies analyst Michael Yee said Yescarta could generate sales of up to $250 million in 2018.

Gilead said about 7,500 lymphoma patients each year in the United States would be eligible for CAR-T therapy.

The American Cancer Society estimates that 72,240 people will be diagnosed with non-Hodgkins lymphoma this year and 20,140 people will die from it. This type of lymphoma accounts for about 4 percent of all cancers in the United States.

Potentially curative CAR-T therapies are poised to revolutionize blood cancer treatment, offering therapies tailored to the individual patient.

The treatments are made from a patient’s own infection-fighting cells. They are extracted, genetically engineered to recognize cancer cells, and infused back into the patient, where they form an army to attack and destroy malignant cells, potentially for years.

“Gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” FDA Commissioner Scott Gottlieb said in a statement.

In a pivotal clinical trial of more than 100 adults, 51 percent of patients treated with Yescarta achieved complete remission, far higher than what is typical with current standard-of-care treatments.

Gilead agreed in August to pay about $12 billion to acquire Kite Pharma, two days before the U.S. approval of Novartis’ Kymriah boosted confidence in the entire CAR-T class.

Similar CAR-T treatments are being developed by Juno Therapeutics Inc (JUNO.O), bluebird bio Inc (BLUE.O) and others.

Low U.S. Public Trust in Drug Companies

The executives at Allergan are currently demonstrating why there’s such low trust in Big Pharma. Organizations in the pharmaceutical industry should ultimately exist to help people, not to profit off their suffering and vulnerabilities. If drug companies regularly fail at working towards public interest value, then their corporate charters should probably be revoked.

BRENT SAUNDERS, THE chief executive of Allergan, one of the largest pharmaceutical firms in the world, is concerned that Americans will become fed up and, in an era of increasing political polarization, come to embrace the single-payer health care plan being unveiled Wednesday by Sen. Bernie Sanders, I-Vt.

The candid thoughts were shared last weekend at the Wells Fargo Healthcare Conference in Boston, a gathering for investors and major pharmaceutical and biotech firms.

Americans have lost trust in drug companies, Saunders said, noting the industry consistently ranks lower than oil and tobacco companies in public trust surveys.

Pharmaceutical Corporation Faked Its Number of Cancer Patients to Sell Drugs

What was this fraud for? It was for selling more powerful opioids, for more corporate profits, even during the ongoing opioid crisis.

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

When Insys Therapeutics got approval to sell an ultra-powerful opioid for cancer patients with acute pain in 2012, it soon discovered a problem: finding enough cancer patients to use the drug.

To boost sales, the company allegedly took patients who didn’t have cancer and made it look like they did.

The drug maker used a combination of tactics, such as falsifying medical records, misleading insurance companies and providing kickbacks to doctors in league with the company, according to a federal indictment and ongoing congressional investigation by Sen. Claire McCaskill, a Democrat from Missouri.

The new report by McCaskill’s office released Wednesday includes allegations about just how far the company went to push prescriptions of its sprayable form of fentanyl, Subsys.

Because of the high cost associated with Subsys, most insurers wouldn’t pay for it unless it was approved in advance. That process, likely familiar to anyone who’s taken an expensive medication, is called “prior-authorization.”

So Insys set up an elaborate charade — with employees that pretended to be doctors’ offices — to fool insurance companies into approving the drug, according to the Senate report.

[…]

Insys is currently in the midst of an avalanche of criminal and civil legal trouble.
In December, federal prosecutors in Boston criminally charged six former Insys executives, including its former CEO, with fraud and racketeering charges related to Subsys. Prosecutors described a “nationwide conspiracy to bribe medical practitioners to unnecessarily prescribe a fentanyl-based pain medication and defraud health care insurers.”

“As alleged, top executives of Insys Therapeutics, Inc. paid kickbacks and committed fraud to sell a highly potent and addictive opioid that can lead to abuse and life threatening respiratory depression,” said Harold H. Shaw, special agent in charge of the Federal Bureau of Investigation’s Boston field office, in a statement in December.

Other federal charges have also subsequently been brought against individuals connected to Subsys, and several state attorneys general have filed lawsuits of their own.

The six executives in the original December case have pled not guilty, and their cases are currently pending. But other former employees have since made guilty pleas.

In May, Motahari, then just weeks into his new job, told analysts on a corporate earnings call that the company hoped to resolve the federal investigation against it with a settlement.

“We continue to engage in discussions with the DOJ and remain highly committed to resolving this matter,” Motahari told the analysts.

Sick Drug Corporation Hiding Behind a Native American Tribe to Protect Its Drug Patent

The failures of the monetary profit motive and the failures of drug patent monopolies merge to form a new absurdity from a pharmaceutical corporation: Exploiting the sovereignty of a Native American tribe. It’s for money, of course. Money, money, money, money, and money. Money for primarily a small number of rich shareholders, who will probably use the corporate profits at public expenses to buy another yacht, or some other materialistic excess. Meanwhile, the weight of suffering continues build, worsened by the wrongful capture of labor value from so many.

And why the hell is a corporation trying to invoke the Fifth Amendment right against double jeopardy? Do large corporations effectively have more legal priveleges than most people do now?

If you thought the pharmaceutical industry couldn’t possibly sink any lower in its pursuit of profits Allergan just proved you wrong. The geniuses at Allergan came up with the brilliant idea of turning over one of its patents on the dry-eye drug Restasis to the Mohawk tribe. The tribe will then lease the patent back to the Allergan.

The reason for this silly trick is that the Mohawk tribe, based on its sovereign status, is disputing the right of generic competitors to pursue a case before the Patent Trial and Appeal Board. This board is supposed to determine whether a patent was appropriately granted in the first place.

The article may have left readers confused about the issues involved when it reported without comment a statement by Allergan’s lawyer, which claimed that they were trying to avoid double jeopardy, since the company also faces a case in federal court. The additional background here is that there is an enormous asymmetry in legal cases involving patents. The patent holder is fighting for the right to sell a drug in a monopoly market, which means monopoly profits. The challenger(s) is fighting for the right to be able to sell the drug in a competitive market, which means normal profits.

In this context, the patent holder has an enormous incentive to delay and run up the cost of litigation, which may quickly prove unprofitable to the generic competitor. The Patent Trial and Appeal Board was created to allow a quicker lower cost process to challenge invalid patents. It is also worth noting that Allergan’s revenue on this drug (more than $1.3 billion annually, according to the article) can be thought of as a tax on the American public. Without this patent, the drug would likely sell for 20 percent or less of its patent protected price.