500 Cities, Counties and Tribes Sue Owners of Oxycontin Manufacturer

Much of the Trump/Pence.GOP agenda has been aimed at slashing regulations that protect the public and creating a new Gilded Age where the wealthy are allowed to make fortunes at the expense of the larger populace and avoid accountability.  Among some of the most greed driven are the pharmaceutical companies which charge obscenely high prices to Americans for drugs that cost a small fraction of the US cost in Europe, Canada and elsewhere.  Previous post have looked at the greed of the manufacturer of PrEP that protects against HIV infection.  The other huge scandal involves the manufactures of opioids who made billions while misleading doctors and fueling the national opiod crisis.  Among such companies are the manufacturers of Oxycontin who have amassed a fortune at the cost and lives of many Americans.  The owners of that company now face a massive lawsuit to hold them responsible.  Here are highlights from The Guardian:

A group made up of more than 500 cities, counties and Native American tribes across the United States has filed a massive lawsuit accusing members of the Sackler family, who own the maker of the opioid painkiller OxyContin, of helping to create “the worst drug crisis in American history”.

The lawsuit represents communities in 26 states and eight tribes and accuses Sackler family members of knowingly breaking laws in order to enrich themselves to the tune of billions of dollars, while hundreds of thousands of Americans died.

“Eight people in a single family made the choices that caused much of the opioid epidemic,” the lawsuit, filed earlier this week in federal court in the southern district of New York, states.

The same eight members of the family had recently been added to a small number of lawsuits that are underway against a string of opioid-makers, including the Connecticut-based pharmaceutical company the Sacklers wholly-own, Purdue Pharma, but they have not been sued as individuals on anything like this scale before.

“This nation is facing an unprecedented opioid addiction epidemic that was initiated and perpetuated by the Sackler Defendants for their own financial gain, to the detriment of each of the Plaintiffs and their residents. The ‘Sackler Defendants’ include Richard Sackler, Beverly Sackler, David Sackler, Ilene Sackler Lefcourt, Jonathan Sackler, Kathe Sackler, Mortimer DA Sackler, and Theresa Sackler,” this week’s lawsuit states.

Court documents accuse the eight family members of purposely playing down the dangers of the prescription painkiller OxyContin, which is more potent than heroin or morphine. They are accused of deceiving doctors and patients and directing sales and marketing techniques that drove huge over-prescribing and ever stronger doses for many patients who should never have been prescribed the pills in the first place.

“The defendants’ actions caused and continue to cause the public health epidemic…caused deaths, serious injuries, and a severe disruption to public peace, order and safety, it is ongoing and it is producing permanent and long-lasting damage,” the court documents allege.

The lawsuit filed in New York on 18 March is extraordinary because it focuses almost entirely on the individual Sacklers.

Richard and Jonathan Sackler are sons of the late Raymond Sackler, one of the founding brothers of Purdue. Beverly is Raymond’s widow and David his grandson.

Ilene, Kathe and Mortimer David Alfons are children of the late Mortimer Sackler, another of the founding brothers of Purdue, and Theresa is his widow.

The only other defendants named in the lawsuit are the family trust connected to Raymond Sackler’s branch of the family and Rhodes Pharmaceuticals, a company owned by the Sacklers that produces generic opioid painkillers.

Other cases focus mostly on Purdue and other well known pharmaceutical giants involved in opioid production, such as Johnson & Johnson and Allergan.

Drug overdoses now kill more than 72,000 people in the US a year, according to government figures from the Centers for Disease Control and Prevention, and 49,000 of those are caused by opioids.

Purdue’s business has attracted a wave of lawsuits alleging deception about the safety of OxyContin, which the company had admitted misbranding in a 2007 criminal case.

Purdue has not ruled out filing for bankruptcy, which would cause a hiatus in the civil cases brought against it, but also indicates it could be short of the kind of funds that would be needed for a massive settlement or a fine at trial in the cases against it, to compensate communities for the cost of the crisis.

But a victory in the latest lawsuit against the Sacklers would give the plaintiffs access to the Sacklers’ personal fortune.

One can only hope the lawsuit is successful.

PrEP Use Increasing, But Too Low Due to Extreme Cost

The United States' health care system remains one of the most inefficient of any developed nation and medications that cost little in Europe and Canada are exorbitantly expensive and out of financial reach of many.  A prime example is so-called PrEP which prevents HIV/AIDS infections.  At a cost of $2,000 -$3,000 per month, even good insurance coverage leaves one with thousands of dollars in out of pocket costs. A generic version sells for $200.00 a year and, as this blog has noted before, the actual production costs is about 6 cents per pill.  Making matters even more outrageous, government programs and charities funded the development research, not Gilead which markets the drug making obscene profits.   As long as insurance companies and pharmaceutical company greed control America's health care, quality health care remain out of the reach of millions. Meanwhile, the rest of us pay the price through astronomical hospital and drug costs.  A piece at NBC News looks at the under usage of PrEP.  Here are excerpts:

Thirty-five percent of gay and bisexual men at high risk of HIV infection were using PrEP, or pre-exposure prophylaxis, the daily pill that prevents HIV infection, in 2017, according to data released Thursday by the Centers for Disease Control and Prevention. In 2014, just 6 percent of these men used PrEP.

However, despite the nearly 500 percent jump in PrEP use among men who have sex with men, the CDC notes “PrEP use remains too low, especially among gay and bisexual men of color.”

The study was presented Thursday in Seattle at the 2019 Conference on Retroviruses and Opportunistic Infections, a major annual HIV/AIDS conference, and was based on more than 8,000 interviews in 20 American cities.

More than 40 percent of white gay and bisexual men at high risk of HIV used PrEP in 2017, while only 30 percent of their Latino counterparts and 26 percent of their African-American counterparts did so. The updated data highlights the fact that minorities access PrEP at lower rates than whites, despite being at higher risk of HIV infection.

The data also found high awareness of PrEP, which is also known by its brand name, Truvada, among all gay and bi men: Eighty-six percent of African-Americans know about it, as do 87 percent of Latinos and 95 percent of whites.

“The study’s findings suggest that efforts to increase PrEP awareness and use among populations at risk is working, but it remains underutilized,” according to a press memo distributed by the CDC.

Many people struggle to access PrEP because of its high cost — a roughly $2,000 per month list price — and complex insurance procedures.

“Of the estimated one million Americans at substantial risk for HIV and who could benefit from PrEP, fewer than 10 percent are actually using this medication,” the CDC noted, referring to low uptake overall among heterosexual and injection-drug-using populations that are also at high risk of HIV infection.

The CDC said it is funding government and private health organizations’ efforts to spread awareness of PrEP, and “developing new ways to connect gay and bisexual men of color and transgender people to PrEP."

Break Gilead's strangle hold on PrEP and allow generic forms and I suspect you would see usage surge.  But that would mean members of Congress would have to vote against their financial overlords. 

HIV Is Reported Cured in a Second Patient

One of the things one encounters as a gay male is the effort of the far right and Christian extremists to depict all gays as diseased and a health care threat.  While HIV/AIDS is no longer the virtual death sentence it was three decades ago, treatment remains expensive.  Likewise, thanks to the greed of American pharmaceutical companies, preventive medications such as PrEP outrageously expensive in the USA - in contrast to Europe and Canada - and out of the financial reach of the majority of those in need of it.  The result is that a permanent cure remains the hope of many, including in the black community where heterosexuals are increasingly at risk of the disease in part due to the lack of access to preventive health care and the continued homophobia of black churches (much of the support for the anti-gay vote in the United Methodist Church came from African delegations).  Now, the New York Times is reporting on a second time where HIV seemingly has been cured. While the treatment regime is not of a nature making it easily replicated on a wide scale basis, it may give rise to future treatments.   Here are article highlights: 

For just the second time since the global epidemic began, a patient appears to have been cured of infection with H.I.V., the virus that causes AIDS.

The news comes nearly 12 years to the day after the first patient known to be cured, a feat that researchers have long tried, and failed, to duplicate. The surprise success now confirms that a cure for H.I.V. infection is possible, if difficult, researchers said.

Publicly, the scientists are describing the case as a long-term remission. In interviews, most experts are calling it a cure, with the caveat that it is hard to know how to define the word when there are only two known instances.

Both milestones resulted from bone-marrow transplants given to infected patients. But the transplants were intended to treat cancer in the patients, not H.I.V.

Bone-marrow transplantation is unlikely to be a realistic treatment option in the near future. Powerful drugs are now available to control H.I.V. infection, while the transplants are risky, with harsh side effects that can last for years.

But rearming the body with immune cells similarly modified to resist H.I.V. might well succeed as a practical treatment, experts said.

“This will inspire people that cure is not a dream,” said Dr. Annemarie Wensing, a virologist at the University Medical Center Utrecht in the Netherlands. “It’s reachable.”

The new patient has chosen to remain anonymous, and the scientists referred to him only as the “London patient.”  “I feel a sense of responsibility to help the doctors understand how it happened so they can develop the science,” he told The New York Times in an email. Learning that he could be cured of both cancer and H.I.V. infection was “surreal” and “overwhelming,” he added. “I never thought that there would be a cure during my lifetime.”

The London patient has answered that question: A near-death experience is not required for the procedure to work. He had Hodgkin’s lymphoma and received a bone-marrow transplant from a donor with the CCR5 mutation in May 2016. He, too, received immunosuppressive drugs, but the treatment was much less intense, in line with current standards for transplant patients.

He quit taking anti-H.I.V. drugs in September 2017, making him the first patient since Mr. Brown known to remain virus-free for more than a year after stopping.

Although the London patient was not as ill as Mr. Brown had been after the transplant, the procedure worked about as well: The transplant destroyed the cancer without harmful side effects. The transplanted immune cells, now resistant to H.I.V., seem to have fully replaced his vulnerable cells.

Most people with the H.I.V.-resistant mutation, called delta 32, are of Northern European descent. IciStem maintains a database of about 22,000 such donors.

Several companies are pursuing gene therapies but have not yet been successful. The modification must target the right number of cells, in the right place — only the bone marrow, for example, and not the brain — and tweak only the genes directing production of CCR5. Several teams are working on all of these obstacles, Dr. McCune said. Eventually, they may be able to develop a viral delivery system that, when injected into the body, seeks out all CCR5 receptors and deletes them, or even a donor stem cell that is resistant to H.I.V. but could be given to any patient. Mr. Brown says he is hopeful that the London patient’s cure proves as durable as his own. “If something has happened once in medical science, it can happen again,” Mr. Brown said. “I’ve been waiting for company for a long time.”

If one looks to Africa, HIV/AIDS is not a gay disease.  It impacts millions of heterosexuals contrary to the propaganda of the far right and Christofascist.  Let's hope for a successful cure available for widespread use in the near term. 

Pharmaceutical Company Greed Impedes Fight Against HIV

The Center for Disease Control and Prevention describes PrEP as follows:

Pre-exposure prophylaxis, or PrEP, is a way for people who do not have HIV but who are at substantial risk of getting it to prevent HIV infection by taking a pill every day. The pill (brand name Truvada) contains two medicines (tenofovir and emtricitabine) that are used in combination with other medicines to treat HIV. When someone is exposed to HIV through sex or injection drug use, these medicines can work to keep the virus from establishing a permanent infection.

When used consistently, PrEP has a very high success rate of preventing HIV infection. So why aren't many more Americans on PrEP if it works so well.  The answer is simple: the cost. In the USA, the cost can be over $20,000.00 per year. In other parts of the world, the cost is $100.00 per year.  Why do Americans pay 200 times what those in other countries?  Simply put, because American's utterly screwed up health care system allows it. Typically, pharmaceutical companies justify shockingly high costs by citing the cost of developing new drugs.  That argument does not work with PeEP because the federal government and charities funded the development costs. So again, why the exorbitantly high cost?  I offer a few other possible factors: (i) the current Trump/Pence regime caters to allowing large corporations to act as the robber barons of old, and (ii) gays and increasingly blacks, including black women, are disliked by the Trump/Pence regime and its extremist supporters.  As reported by the New York Daily News, in New York State, some are beginning to demand that federal government use its existing authority to make PeEP available to the masses, not just the rich.  Here are article highlights:

As the number of people in New York City living with HIV or AIDS continues to rise, local advocates are calling for the federal government to take steps to make the life-saving prevention drug PrEP more affordable.

City Council Speaker Corey Johnson joined other politicians and activists at the city’s AIDS Memorial on Monday to demand that the National Institute of Health “break the patent” on the drug, which dramatically reduces the spread of the HIV virus.

“It’s life or death for people who do not get access to this live-saving medication that they need,” said Johnson, who is HIV-positive. “Other countries pay $100 year for PrEP. Americans end up paying more than $20,000 a year for the same medication.”
 
Advocates say a major barrier between patients and PrEP is the cost of the drug, which is patented by Gilead Sciences and was approved for use by the FDA in 2012.

“Gilead Sciences charged over $2,000 a month for a drug that costs them less than $6 a month to make, and whose research was funded entirely by the fed govt and other charities,” Christian Urrutia, co-founder of the PrEP4All Collaboration, said on Monday.

Because the U.S. government funded the research for PrEP, federal law allows the NIH to exercise “march-in” rights to break its patent and allow other manufacturers to produce it at generic costs.

The legal maneuver dates back to 1980 and the passage of the Bayh-Dole Act, which requires patent holders of federally-backed drugs to allow third party companies to produce the drug when requested by the government.

The advocates are calling on the feds to make such a request for PrEP.  If the price of the drug plummets for New Yorkers, advocates believe the rate of new HIV infections would follow.

People Over 50 Are the Fastest-Growing Group of Cannabis Users

Illustration: George Wylesol for the Guardian.

The push to decriminalize marijuana and expand its medical uses is sweeping the country - even in Virginia.  I support decriminalization since, having been a teen in the 1960's, I am no stranger to marijuana and, in my view, the claim that it is a "gateway drug" is bullshit (pardon my "French"). If someone is trying to lose themselves in drugs, the real solution is decent mental health care that addresses the underlying issues.  Moreover, in my experience, the marijuana laws (especially in Virginia) seem to be aimed at criminalizing blacks with a goal of disenfranchising them.  Hence why the Virginia Republican Party is killing decriminalization efforts in this year's session of the Virginia General Assembly. With the Virginia GOP not being able to win a statewide election in a decade, the desperation to minimize "those people" on the voter rolls has reached new levels of desperation. As a piece in The Guardian indirectly notes, however, the GOP may be about to hit a brick fall in its efforts to retain this tool for criminalizing blacks.  The fastest growing cohort of marijuana users is the older 50 crowd, a key GOP demographic.  Here are article highlights (note the drop in opioid usage where marijuana has been decriminalized): 

As attitudes towards cannabis shift, the fastest-growing group of users is over 50 – and marijuana’s popularity among seniors is beginning to change the American experience of old age.

Why are more seniors getting high? It might make more sense to ask: “Why not?” As adults reach retirement, they age out of drug tests and have far more time on their hands. Some feel liberated to abandon long-held proprieties.

Elegant vape pens and other attractive, discreet products have helped de stigmatize the drug among older Americans. “Legalization seems to make non-users seem a little less scared of it, and perhaps less judgmental,” says Jo, a 56-year-old cannabis user who preferred not to use her real name.

The seniors using cannabis today aren’t your parents’ grandparents. The generation that camped out at Woodstock is now in its seventies. They’ve been around grass long enough to realize it’s not going to kill them, and are more open to the possibility it will come with health benefits.

Seniors’ affinity for weed is beginning to ripple across the US healthcare system. A 2016 study found that in states with access to medical marijuana, those using Medicare part D – a benefit primarily for seniors – received fewer prescriptions for other drugs to treat depression, anxiety, pain, and other chronic issues.

[P]roven or not, a number of seniors evidently prefer it to the medications they would otherwise be taking. A study published last year in in the Journal of the American Medical Association found opioid prescriptions for Medicare part D recipients dropped 14% after a state legalized medical marijuana – a hopeful sign amid the opioids crisis.

While some doctors have expressed concerns about seniors self-medicating with weed, virtually everyone agrees the public health consequences of opioids are far worse. And the most serious health concerns associated with marijuana, such as impaired brain development, tend to affect younger people.

For the industry, seniors’ newfound interest in cannabis is a business opportunity. The Colorado edibles company Wana Brands, among many others, sells cannabis products reminiscent of medicines familiar to seniors. Wana sells extended release capsules as well as products with different ratios of THC and CBD, which intoxicate users to different degrees and can have a variety of effects on ailments.

For someone who hasn’t seen a joint in 40 years, the modern dispensary can be a dizzying experience replete with dozens of products – topicals (lotions), tinctures, sprays – all promising to help you feel better, but also to get you stoned. Whether or not marijuana helps seniors to alleviate their conditions, many may enjoy a sense of control over their own wellbeing. Meanwhile, dispensaries in California and elsewhere cater to older clientele with discounts and shuttle busses.

It hasn’t escaped the pharmaceutical industry that marijuana could soon be seen as a viable replacement for many of its products. Perhaps someday soon it will be normal for seniors to pass their last decades in a cannabis-induced haze.

For those who support decriminalization, there's an easy step to take: vote Democrat in every race possible in November 2019 and flip control of the General Assembly from the GOP. 

America's Insanely High Prescription Drug Prices

As the prior post noted, America continues to have one of the most flawed and expensive health care systems of any developed nation.  Much preventative treatment is not covered and our prescription drug prices are obscenely high compared to drug prices in other developed nations.   Why? Largely, because large pharmaceutical companies have bought and paid for members of Congress, especially Republicans.  The other reason is that programs like Medicaid and Medicare continue to fail to negotiate lower prices, in part because of politicians in the pockets of the pharmaceutical companies.  Imagine if there was a drug that could have a 99% track record of preventing disease but was so expensive - at least in America - that only a tiny percentage of those who would benefit can afford it even if they have "good insurance."  Due to the lack of affordability, many become ill and huge medical costs are incurred - costs that could have been avoided.  The drug exists: Truvada which taken daily and known as PrEP prevents HIV infection.  It cost about $55 to produce a year's supply, yet in America, the cost to patients is $20,000 per year.  I have focused on PrEP, but the same phenomenon applies to countless drugs that drive up medical costs into the stratosphere.  A piece in the New York Times looks at the USA experience versus other developed nations.  Here are highlights:

Last week, the High Court of England and Wales announced a momentous decision: It invalidated the pharmaceutical company Gilead’s patent on Truvada, opening the way to generic competition.

Truvada, a combination of two drugs, is one of the world’s most-used H.I.V. medicines. For treating H.I.V., it’s used along with a third drug. But many H.I.V.-negative people also take Truvada daily as a preventive. That’s called pre-exposure prophylaxis, or PrEP.
In the United States, Truvada is available only as a brand-name drug. It costs $20,000 a year.

Here’s how it will work in Britain’s National Health Service, according to Dr. Andrew Hill, a senior research fellow at Liverpool University who studies the cost of medicines. “The N.H.S. will say to a group of generic companies: ‘We need PrEP for 20,000 people. Give us your best price.’” The cost of making PrEP is $55 per year, Dr. Hill said. He believes that the generic will sell for between $100 and $200.

All over the world, more and more people are taking H.I.V. drugs. These medicines are very good at their job — keeping people healthy and noncontagious — so most patients will take them until they die of something that isn’t H.I.V. Patients are also starting earlier on antiretroviral therapy; the new recommendation is to start immediately upon diagnosis. And now with PrEP, a potentially enormous new group of patients has arisen: H.I.V.-negative people who are at risk for catching the virus.

It’s lucky, then, that Truvada will have generic competition. It should allow the health service to greatly lower costs and offer PrEP to anyone who needs it.

The health service does an admirable job with H.I.V. Around the world, countries measure the percentage of people living with H.I.V. who have no virus detectable in their blood. In the United States, only 49 percent have achieved this. In Britain, the number is 78 percent.

While the National Health Service has a lot of problems, it has some huge advantages over the American system that allow it to provide high-quality H.I.V. care in a cost-efficient manner. So it’s worth looking at what the British health service does right, because some of those strategies could work in America, even though the two systems are structured very differently.

Even when brand-name drugs have no generic equivalents, the medicines in the British system cost a small fraction of what they cost in America. Most brand-name triple therapies cost about $6,500, said Dr. Laura Waters, an H.I.V. physician who is a member of the health service’s H.I.V. Clinical Reference Group, which sets policy. She said that a combination pill that includes some generics would cost between $2,600 and $4,000. Full generics usually cost 70 to 80 percent less than comparable brand names. One completely generic H.I.V. regimen costs $400 per year. If America were to use more generics, much of the savings would stay with insurance companies and pharmacy benefit managers. That doesn’t help people with H.I.V. “The resources saved can and should finance a more aggressive effort to fight AIDS in America,” said Anil Soni, head of global infectious diseases for Mylan.

Could it happen with Medicare or Medicaid? Just a few states — New York, Georgia, Florida, California and Maryland — are responsible for a large share of Medicaid’s spending on H.I.V. drugs. They could lead a drive toward using more generic drugs. These drugs are already available, but doctors don’t prescribe them. Like the National Health Service, Medicaid would have to find ways to encourage (or cajole, entice or force) doctors to prescribe generics. If the generics were more widely used, that would encourage competition that could further drop the price.

Every day, America pays for H.I.V. drugs at higher and higher prices, for more and more people. There is no choice but to reform an unsustainable system.

“I just don’t understand why American payers don’t look up reference prices,” Dr. Hill said. “It’s $150 in England, so why are they spending $10,000? Surely they don’t have unlimited budgets in the U.S. But they behave as if they do.”

 Again, the same phenomenon applies to countless other drugs and is one of the reasons for America's exploding health care costs. 

Politicians Continue to Allow Big Pharma to Screw Americans

Americans pay more for healthcare than residents of any other developed country.  The same goes for drugs.  It is common for American consumers to pay three times (often many times more) the prices paid in Europe, Canada and even Mexico.  The reasons for this rip off of American consumers?  First, the lack of a decent, national health insurance system where managing care, not maximizing prices for private interests, is the goal  Nowhere is the greed and rapaciousness in American healthcare worse than in the area of prescription drugs.  Big Pharma is allowed to hold monopoly power and charge whatever outrageous price it wants and the government refuses to force price negotiations of prices for programs such as Medicare.  The result stems from politicians being bought by pharmaceutical companies.  Indeed, Congress has played a huge role in allowing the opioid epidemic to grow by tying the hands of would be government regulators.  A piece in the New York Times looks at America's broken system.  Here are excerpts: 

So Donald Trump broke another promise: he did not, after all, empower Medicare to negotiate lower drug prices. Instead he (and Michael Cohen, who definitely isn’t his bagman) took money from drug lobbyists, appointed them to key positions, and announced a plan that sent drug stocks soaring. I’m sure you’re shocked.

But promise-breaking aside, would introducing a policy of bargaining drug prices down have been good for America? Actually, yes.

Oddly, I never got around to doing my homework on the economics of drug-price bargaining – partly because I was realistic enough about the political economy to realize that it wasn’t going to happen in America any time soon. Still, the fact that Trump promised to do something makes it somewhat relevant, even if he did predictably break that promise. And it turns out that the economic case for doing what Trump just didn’t do, for putting caps on drug prices, is remarkably strong.

Let’s start with where things are right now. After a drug company gets a patent, it has a temporary monopoly on sales of its drug. So its situation looks like that of a standard monopolist . . . It charges a price that is above the marginal cost of producing the drug – usually well above marginal cost.

[O]verall, society gains from the drug’s existence. However, . . . . society would gain more if someone – regulators, purchasing managers at government agencies, whatever – forced the drug company to charge less than the monopoly price.

[T]he United States would almost certainly be better off with a moderate level of bargaining/price control than it is under the current hands-off regime. Why? I count at least four distinct reasons.

First, a point made by Lackdawalla and Sood is that the profit effects of constraining a monopolist’s price are second-order. . . . . What’s going on here is that the profits lost on existing sales are almost fully offset by the profits on additional sales.

What this means in turn is that the negative effect on innovation is small if prices aren’t pushed down a lot, while the consumer gains are first-order. Some price bargaining is always welfare-improving.

Second . . . . . it’s often argued that pharma companies basically develop too many drugs, wasting resources on what amounts to unnecessary duplication. To the extent that this is true, discouraging some innovation isn’t a bad thing.

Third, the consumer surplus calculation assumes that consumers actually pay for the drug. In fact, many drugs are paid for by insurers – which is necessary, because like much of modern medicine the cost if you need it is far beyond most people’s ability to pay out of pocket. But this means that the price someone is willing to pay may greatly exceed the value to the patient. In general, the interaction of drug insurance with monopoly pricing creates potentially huge distortions in both drug development and drug use, reinforcing the case for bargaining.

Finally, it’s a global market – which means that much of the consumer surplus from drug development accrues to foreigners, not U.S. citizens. Maybe there should be more drug development from the point of view of global welfare. But given the unique unwillingness of the U.S. to bargain over prices, we end up paying a much larger share of the costs of that development than we receive of the benefits. Funny how Trump is America first on everything, except when a nationalist position might be bad for Big Pharma.

Yes, Trump says he wants to force other countries to raise drug prices. Good luck on that.

What this comes down to is that there is a very strong case for doing what Trump promised to do but didn’t. I’m aware that simply saying “let’s bargain over drug prices” isn’t effective unless coupled with a willingness to say no – to tell a drug company that an overpriced drug will be excluded from the formulary. So it wouldn’t be politically easy. But it would be good economics.

The Opioid Crisis: Holding Pharmaceutical Companies Responsible

Tiny Vinton, Ohio, where massive amounts of opioids were shipped.

Much has been said about who is to blame for the opioid crisis impacting America, especially portions of rural America.  Some would blame the users, others would blame physicians, others blame economic distress, but, in my view, the real villains are the pharmaceutical companies, who like gun manufacturers, care nothing about the consequences of their product.  Rather their sole focus is seller ever larger quantities and to make more and more money.  Part of this effort includes wining and dining physicians and other prescribers and pushing them to prescribe more and more product.  Part of it is advertising campaigns to encourage patients to ask their doctors for prescriptions.  Yet another part is turning a blind eye to what even in passing would be insane quantities of opioids being shipped to small communities. Now, as the Washington Post reports, localities and states are seeking to hold pharmaceutical companies for the damage their products and their negligence have done.  Here are article highlights:

Vinton Ohio — The opioid epidemic has affected nearly every aspect of life in Vinton County. Teachers buy shoes for students whose addicted parents send them to school in footwear held together with tape. Overdose deaths have surged. Foster care is overwhelmed. The jail is bursting at the seams.

The expenses related to caring for the children of drug abusers and locking up drug offenders here eat up about 25 percent of the Ohio county’s $4 million annual budget, a hole that it can’t plug. Now, Vinton officials think someone should help foot the bill: Big Pharma.

“It almost feels like Vinton County was preyed upon,” said Lily Niple, who got addicted to prescription opioids here but managed to push through, having been clean for more than two years. “It’s like a huge exploitation of the people here. And it was negligent. Just complete disregard for the future.”

[T]he biggest fight against the opioid epidemic is being waged in a federal courthouse in Cleveland, where hundreds of lawsuits brought by cities, counties, Native American tribes and unions have been brought together into one case with a scope that rivals anything seen in the U.S. legal system. Vinton County and hundreds of other municipalities across the nation are suing companies that manufactured and distributed powerful painkillers and others up and down the supply chain, arguing that they knowingly peddled massive amounts of a highly addictive product that set in motion a public health crisis. The plaintiffs argue that the vast network of opioid businesses should pay for the damage the drugs wrought.

“This is probably the most complex piece of litigation in the history of our country,” said Paul J. Hanly Jr., one of the lead plaintiffs lawyers.

The consolidated case is being compared to the one that led to hundreds of millions of dollars in settlements against tobacco companies and restricted the sale and marketing of cigarettes. Some of the same tobacco lawyers are now working on the opioids trial.

Plaintiffs are making different, but similar, claims and suing various companies in the drug pipeline. Some allege the drug companies created a public nuisance with their products. Others argue that deceptive marketing led to an epidemic. Some say state consumer protection laws were violated. Some of the lawyers allege that the distribution system, which includes wholesalers and distributors of powerful narcotics, amounted to a criminal enterprise. A small group is suing pharmacy benefit managers. Some are suing pharmacies. One lawyer is suing on behalf of children born to mothers who were addicted to opioids.

The Justice Department filed a motion this past week requesting that it be allowed to participate in settlement discussions as a friend of the court. Attorney General Jeff Sessions said the department would seek repayment for the cost of the drug crisis because the federal government has borne substantial expenses. The sheer number of defendants in the case — more than a dozen — also is staggering and unprecedented. And they could start pointing fingers at one another. They include the manufacturers Purdue Pharma and Janssen Pharmaceuticals, the distributors AmerisourceBergen, McKesson and Cardinal Health and pharmacy benefit managers such as Express Scripts. The litigation comes as people at all levels of government have identified opioid abuse as a major public health — and societal — woe, one that thus far has defied solution. And in many ways, lawyers and legal experts say, the opioid lawsuit is different and far larger in scope than efforts such as the action against Big Tobacco.

The opioid epidemic kills hundreds of people each day, akin to the 1918 flu pandemic. The judge overseeing the case, Dan Aaron Polster of the Northern District of Ohio, said during a January hearing that this scourge was man-made and that lawyers need to reach a resolution quickly, because approximately 150 people are dying each day.

 The White House Council of Economic Advisers estimates that the economic cost of the opioid crisis was $504 billion just in 2015, or 2.8 percent of that year’s gross domestic product. Altarum, a nonprofit organization that studies health care, estimates the opioid crisis cost the country more than $1 trillion from 2001 to 2017. Mark Chalos, a lawyer who represents communities in Tennessee and some unions, said the toll is tremendous, “a preventable catastrophe . . . made entirely by an industry that operates in plain view.” [Judge] Polster is taking a unique tack — he is not interested in litigation for the sake of litigation. Instead, he wants to help solve the crisis and do something to “dramatically reduce the quantity” of opioids being disseminated, manufactured and distributed, he said in a January hearing. He also wants to ensure the drugs are being used properly. It is not the first time that some of the companies have been pursued in the courts. In 2003, Hanly sued Purdue Pharma, which makes the powerful synthetic opioid painkiller OxyContin. The company paid out $600 million, and three executives pleaded guilty to criminal charges that they misled doctors, regulators and patients. But the epidemic raged on. The judge also put a protective order on what lawyers say is likely the linchpin of the case: information from a database kept by the Drug Enforcement Administration that monitors the flow of prescription painkillers from manufacturer to distribution point.

After initially resisting, the DEA said it would disclose some of the data, including identifying the manufacturers and distributors that sold 95 percent of the opioids in each state from 2006 to 2014. Lawyers say the full set of data could provide a road map for the crisis, perhaps showing a correlation between where the drugs flooded and where people died. . . . . but some information that has been released and analyzed is staggering: In two instances, millions of pills were shipped to pharmacies in tiny West Virginia towns.

In Vinton County, where 13,000 people live among the rolling hills and creeks, an average of 113.5 doses of opioids were dispensed per resident here in 2012, according to state data.

Despite what Republicans will bloviate, industries cannot be trusted to regulate themselves.  They have only one true god:  money.  Who gets hurt or dies as a consequence all too often is nowhere in the equation.  The quantities of opioids shipped to tiny Vinton, Ohio,  make it clear that manufacturers and suppliers knew something was seriously wrong, but did nothing.  All they cared about was profit.   The GOP effort to create a new Gilded Age is witnessing the same kind of abuses that ultimately were reined in during the first decades of the 20th Century.  It seems Republicans learned nothing. 

Big Pharma - Drug Dealers in Lab Coats

Last weekend the Washington Post and “60 Minutes” did a major public service and reported that pharmaceutical lobbyists had manipulated Congress to hamstring the Drug Enforcement Administration.  Just as frightening, Donald Trump intended to name big Pharma's point man in Congress to be his new drug czar until the scathing coverage derailed that effort and Pennsylvania Republican Tom Marino, withdrew his name from consideration.  The crisis of deaths from opioids is a prime example of why strict government regulation is needed because sadly in too many corporate board rooms the only thing that matters is money - even when it comes from actions that lead to needless deaths. Rather than rail against petty anti dealers and increase the arrests on users of small amounts of marijuana, Trump and the ever despicable Jeff Sessions need to go after big Pharma which not only has become a merchant of death but also overcharges everyday Americans on virtually a daily basis.  A column in the New York Times looks at the underlying cause for the opioid crisis.  Here are highlights:

For decades, America has waged an ineffective war on drug pushers and drug lords, from Bronx street corners to Medellin, Colombia, regarding them as among the most contemptible specimens of humanity.

One reason our efforts have failed is we ignored the biggest drug pushers of all: American pharmaceutical companies.

Our policy was: You get 15 people hooked on opioids, and you’re a thug who deserves to rot in hell; you get 150,000 people hooked, and you’re a marketing genius who deserves a huge bonus.

Big Pharma should be writhing in embarrassment this week after The Washington Post and “60 Minutes” reported that pharmaceutical lobbyists had manipulated Congress to hamstring the Drug Enforcement Administration. But the abuse goes far beyond that: The industry systematically manipulated the entire country for 25 years, and its executives are responsible for many of the 64,000 deaths of Americans last year from drugs — more than the number of Americans who died in the Vietnam and Iraq wars combined.

The opioid crisis unfolded because greedy people — Latin drug lords and American pharma executives alike — lost their humanity when they saw the astounding profits that could be made.

Today, 75 percent of people with opioid addictions began with prescription painkillers. The slide starts not on a street corner, but in a doctor’s office.

That’s because pharmaceutical companies in the 1990s sought to promote opioid painkillers as new blockbuster drugs. Company executives accused doctors of often undertreating pain (there was something to this, but pharma executives contrived to turn it into a crisis that they could monetize). The companies backed front organizations like the American Pain Foundation, which purported to speak on behalf of suffering patients.

The opioid promoters hailed opioids as “safe and effective,” and they particularly encouraged opioids for returning veterans — one reason so many veterans have suffered addictions.

Drug companies employed roughly the same strategy as street-corner pushers: Get somebody hooked and business will take care of itself. So last year, Americans received 236 million opioid prescriptions — that’s about one bottle for every adult.

[T]he Sackler family, owner of the company that makes OxyContin, joined Forbes’s list of richest American families in 2015, with $14 billion.

It’s maddening that the public narrative is still often about an opioid crisis fueled by the personal weakness and irresponsibility of users. No, it’s fueled primarily by the greed and irresponsibility of drug lords — including the kind who inhabit executive suites. The Washington Post quoted a former D.E.A. official as referring to pharmaceutical company representatives as “drug dealers in lab coats.”

Our pattern of opioid addiction points to a tragedy, driven by the greed of some of America’s leading companies and business executives, systematically manipulating doctors and patients and killing people on a scale that terrorists could never dream of.

There’s a lot of talk in the Trump administration about lifting regulations to free up the dynamism of corporations. Really? You want to see the consequences of unfettered pharma? Go visit a cemetery.

Bernie Sanders Releases Plan to Defeat AIDS

If nothing else, as noted in a previous post, Hillary Clinton's disastrous misstatement about Nancy Reagan and the HIV/AIDS crisis has prompted a new and much needed conversation about HIV/AIDS, a disease that continues to wreak havoc, especially in minority populations (it is a huge problem in the Hampton Roads black community).  Now, Bernie Sanders has released his proposed plan on who to defeat the disease, including by taking on “profiteering” pharmaceutical companies" that have keep prices prohibitively high and out of the reach of many in need of HIV/AIDS medications.   A piece in The Advocate looks at Sanders' proposal.  Here are highlights:

 Bernie Sanders has a plan to create an AIDS-free generation.

The Democratic candidate’s campaign released a statement on his website in order to address “the great moral issue of our day”— the affordability of HIV medication

The statement took “profiteering” pharmaceutical companies to task for raising the prices of these treatments, thereby forcing those who live with HIV to pay thousands of dollars each year.

The Centers for Disease Control and Prevention estimates that at least 1.2 million people are living with HIV in the United States. In 2012, over 13,000 people died of an AIDS-related illness. LGBT people and people of color are particularly at risk. A recent CDC report noted that half of black gay men will be diagnosed with HIV in their lifetime.

“In the richest nation in the world, we must not tolerate a health care system that offers the best care to the rich, while leaving everyone else to fend for themselves,” said the Sanders statement. “We must do everything possible to end the greed of the pharmaceutical companies and get people the medicine they need at a price they can afford.”

To this end, the Sanders team proposed creating a “Prize Fund” of more than $3 billion annually that would “incentivize drug development” and “provide virtually universal access to lower-cost life-saving medicines” as they become available.

The plan also seeks to reform patent laws that privilege pharmaceutical companies. Moreover, as president, Sanders would have the secretary of Health and Human Services “negotiate drug prices with pharmaceutical companies and reduce barriers to the importation of lower-cost drugs from Canada and other countries.”

“The United States is the only major country on earth that does not regulate prescription drug prices in some manner,” the plan pointed out, “and the results have been an unmitigated disaster for patients and their families.”

The Sanders plan called for universal health care and the expansion of health services currently in place, including access to mental health care, the Ryan White HIV/AIDS program, the President’s Emergency Plan for AIDS Relief, and Housing Opportunities for Persons With AIDS.

Sanders also stressed the need for civil rights protections for LGBT and HIV-positive people, including safeguards against employment and housing discrimination.

“We all must work together so we can finally realize the goal of an AIDS-free generation,” the statement concluded.

It goes without saying that Sanders' proposals would be vigorously opposed by Republicans and their Christofascist base,

Pharma-Douche Martin Shkreli Arrested By The FBI

Martin Shkreli being taken away in handcuffs

Few individuals personify the epitome of vulture capitalism and pharmaceutical company greed more than Martin Shkreli, a former hedge fund operator and douche bag who purchased a pharmaceutical company and then promptly raised the price of a drug used to treat infections that can be devastating for babies and those with AIDS from $13.50 a pill to $750 a pill.  Today, the lime ball and arrogant bastard (who seems to have studied the art under Donald Trump) got his just deserves and was arrested by the FBI on securities fraud and wire fraud charges.  The New York Times has details.  Here are highlights:

It has been a busy week for Martin Shkreli, the flamboyant businessman at the center of the drug industry’s price-gouging scandals.

He said he would sharply increase the cost of a drug used to treat a potentially deadly parasitic infection. He called himself “the world’s most eligible bachelor” on Twitter and railed against critics in a live-streaming YouTube video.

Then, at 6 a.m. Thursday morning, federal authorities arrested Mr. Shkreli, 32, at his Murray Hill apartment. He was arraigned in Federal District Court in Brooklyn on securities fraud and wire fraud charges.

Mr. Shkreli has emerged as a symbol of pharmaceutical greed for acquiring a decades-old drug used to treat an infection that can be devastating for babies and people with AIDS and, overnight, raised the price to $750 a pill from $13.50. His only mistake, he later conceded, was not raising the price more.

Those price increases combined with Mr. Shkreli’s jeering response has made him a lightning rod for public outrage and fodder for the presidential campaign. His company, Turing Pharmaceuticals, and others, like Valeant Pharmaceuticals, have come under fire from lawmakers and consumers for profiting from steep price increases for old drugs.

But the criminal charges brought against him actually relate to something else entirely — his time as a hedge fund manager and when he ran his first biopharmaceutical company, Retrophin. Federal officials described his crimes as a quasi-Ponzi scheme in which he used money from his company to pay off money-losing investors in his hedge funds. An F.B.I. official called his business schemes a “securities fraud trifecta of lies, deceit and greed.”

Still, for many of his critics, Mr. Shkreli’s arrest was a comeuppance for the brash, irreverent executive who has seemed to enjoy — relish, even — his public notoriety.

“Personally, I think Martin Shkreli has become wealthy at the expense of the public good. I don’t believe for a second that his manipulation of drug prices fuels valuable research as he has claimed,” said Katie Uva, a 2006 alumni of Hunter College High School in Manhattan where Mr. Shkreli attended, in an email response to questions. This fall, Ms. Uva started an online fund-raising campaign to match a $1 million donation from Mr. Shkreli to Hunter in the hope of persuading the school to return the donation.

MSMB’s performance wasn’t nearly as hot as Mr. Shkreli let on. From 2009 through 2012, Mr. Shkreli lost millions of dollars trading in the market, according to the accusations contained in the indictment. But he hid those losses, telling investors instead that the funds had strong double-digit returns.

In 2011, Mr. Shkreli started Retrophin, which quickly adopted a controversial business strategy, acquiring old, neglected drugs used for rare diseases and quickly raising their prices.

Soon, however, Mr. Shkreli was embarking on a plan to use Retrophin assets to pay off MSMB investors. . . . When seven MSMB investors threatened to sue in 2013, Mr. Shkreli and Evan Greebel, the lead outside counsel for Retrophin, used $3.4 million in Retrophin funds and stock to settle the investors’ claims, even though Retrophin had no responsibility, the indictment says.

[W]hen Retrophin’s auditor raised questions about the settlements, Mr. Shkreli and Mr. Greebel created fraudulent consulting agreements for the investors, thinking they could pay the money back without upsetting the auditor, the indictment states. From September 2013 to March 2014, they created fake consulting agreements for four investors, paying $7.6 million in cash and stock. Retrophin’s board did not approve of the consulting agreements, the indictment says.

In September 2014, Retrophin ousted Mr. Shkreli as its chief executive. A lawsuit filed this summer by the company mirrors many of the same accusations contained in the federal charges.

There is more, but the take away is that this guy is disgusting.  I hope he gets convicted and ends up being someone's bitch in prison.  It would be all too sweet of a divine justice.  Of course, if you believe Ben Carson's lunatic theories, Shkreli will be gay when he gets out of prison.

Vulture Capitalism and Pharmaceutical Companies

In the 2012 election cycle Mitt Romney was his own symbol of vulture capitalism - the GOP's god after tax cuts for the wealthy - and it came back to haunt him.  Now, as we begin the 2016 election cycle, Martin Shkreli, the former hedge fund manager known as the “Pharma bro,” has singlehandedly underscored the evils of unfettered capitalism.  Shkreli accomplished this by buying the rights to Daraprim, a drug used to treat severe infections in AIDS patients and infants, and then increasing the price to consumers by 5000%.  Drug prices in America are out of control - one can get the identical drugs in Canada for far less - and perhaps Shkeli's greed will trigger some much needed oversight of the shockingly greedy pharmaceutical industry.  A piece in Think Progress looks at the phenomenon.  Here are highlights:

Is the “Pharma bro” coming to Congress? He will if Rep. Elijah Cummings (D-MD) gets his way.

Cummings, the Ranking Member of the House Committee On Oversight And Government Reform, has requested a hearing next week to question Martin Shkreli, the former hedge fund manager known as the “Pharma bro.”

Shkreli has attracted attention since he hiked the price of Daraprim, a drug used to treat severe infections in AIDS patients and infants, by 5000%. Shkreli is the CEO of Turing Pharmaceuticals.
In an interview, Cummings called Shkreli’s actions “criminal.”

As a member of the Democratic minority, Cummings cannot unilaterally call the hearing. But he wrote a letter to Chairman Jason Chaffetz on Tuesday, requesting a hearing be scheduled.

Cummings notes that the committee had previously “agreed unanimously to investigate the increasing price of certain prescription drugs” but “has held no hearings and has issued no document requests to drug companies this year.”

Tuesday night, Shkreli told ABC News he would reduce the price of Daraprim. He would not specify the new price.

We need a national health care system that would bar sleaze bags like Shkreli from engaging in such vile conduct.