Pharmaceutical Giant Makes Billions from HIV Treatment Funded by Taxpayers

I have touched on this topic before, but it bears addressing again since Donald Trump, a/k/a Der Trumpenführer, has again declared war on the Affordable Health Care Act and seeks to throw the general public at the mercy of greedy insurance carriers and even greedier pharmaceutical companies.  The preferred Trump/GOP health care system is one that maximizes profits to insurance companies, for profit health care providers and greed driven pharmaceutical companies and says to hell with average Americans and taxpayers other than the very wealthy.  A piece in the Washington Post looks at the obscene profits - $3 billion last ear - being raked in by Gilead Sciences on a drug that was developed at taxpayer expense and patented by the federal government  Something is seriously wrong with this picture even before one considers the fact that the high prices charged by Gilead makes the drug unobtainable for many who need it.  While the drug that is the subject of the article is HIV related, the same ridiculous screwing over of American taxpayers/consumers applies to many other drugs as well.  Here are article highlights (Note: (i) Gilead has made $36.2 billion off a government funded drug; and (ii) the same drug which cost $3,000/month in the USA costs $200 in the United Kingdom):

Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex.

Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, ­Truvada’s maker, which earned $3 billion in Truvada sales last year.

Gilead argues that the government’s patents for Truvada for PrEP, as the prevention treatment is called, are invalid. And the government has failed to reach a deal for royalties or other concessions from the company — benefits that could be used to distribute the drug more widely.

The extraordinary standoff between the CDC and a drug company over patent rights raises a big question for the Trump administration: How aggressively should the government attempt to enforce its patents against an industry partner?

The Department of Health and Human Services, which includes the CDC and the National Institutes of Health, has patented more than 2,500 inventions created with taxpayer dollars since 1976, according to the U.S. Patent and Trademark Office.

It routinely licenses new pharmaceutical compounds to private companies that take those publicly financed discoveries into the marketplace.

Gilead, which enjoys a U.S. monopoly on Truvada, charges between $1,600 and $2,000 for a month’s supply of a pill that can be manufactured for a fraction of that amount [actually about $0.6 per pill]. The number of new HIV infections in the United States has barely budged, meanwhile, and is stuck around 40,000 a year, according to CDC estimates.

Activists want the government to take a more aggressive stance against Gilead. Their complaints are part of a broader wave of anger over drug companies reaping hefty financial rewards by capitalizing on taxpayer-funded research.

“The CDC has all these patents, and is allowing Gilead to rip off the American people at the expense of public health,’’ said James Krellenstein, an HIV/AIDS activist and co-founder of the PrEP4All Collaboration, who has spent months digging into the government patents. Instead of enforcing its patent, Krellenstein said, the CDC is “twiddling their thumbs.’’

NIH and CDC officials see their role as encouraging the commercialization of government-financed discoveries, not placing curbs on them, Sukhatme said. That tends to take patent infringement lawsuits off the table. . . . But that stance increasingly is challenged by political anger over high drug prices. Consumer advocates and members of Congress have stepped up demands that the government exercise its rights under existing law to license generic competition or imports during shortages or unwarranted price spikes; several billswould enhance such “compulsory licensing’’ provisions.

The case of Gilead and Truvada for PrEP adds a new twist to these debates, with demands that the government be more aggressive in exercising its own patent to ease the cost effects of a monopoly.

After Truvada was shown to work as a prophylactic in primates, the CDC applied for its patents. That began a nine-year effort, using two outside law firms retained by the CDC, which made their case to U.S. Patent and Trademark Office examiners.

In addition to $50 million in government money, $17 million for the study came from the Bill & Melinda Gates Foundation, Grant said.

Federal officials estimated in 2016 that less than 10 percent of the 1.1 million people who should be on PrEP treatment are receiving the drug. Gilead says that has now improved to about 20 percent. The problem is particularly acute in Southern states, where cultural barriers and lack of education programs are holding back its use.

The CDC waged a successful defense of its patent in Europe, adding strength to its case that its patents are legitimate, Morten said.

“I have no reason to believe that these patents are not valid and enforceable, and moreover, they seem to be infringed [by Gilead] by the use of Truvada for PrEP,’’ Morten said in an interview. “These are public assets that were generated with public money that effectively are going to waste here.’’

In response to complaints about its price, Gilead said it offers discount coupons that reduce the cost to less than $5 for a monthly supply for patients who lack insurance. It says it has spent $138 million since 2012 on community grant programs to raise awareness and educate at-risk people. Gilead has earned $36.2 billion on Truvada since 2004, according to its annual reports.

Obtaining Gilead’s coupons for Truvada for PrEP is a cumbersome process, they said. If the CDC leveraged its patents to get money for Truvada, it could help cash-strapped state Medicaid programs undertake aggressive education and distribution programs. Virginia Medicaid said it pays $54.04 per pill, or $1,621.20 for a monthly course of treatment.

“What we’re seeing is that because city and local governments are spending so much on getting PrEP,’’ said HIV/AIDS activist Christian Urrutia, “they don’t have a lot of money left over to do these kinds of programs.’’ 

For the record, I have what is deemed "excellent" healthcare coverage and when I inquired about PrEP given the current controversy, I was advised that I would have to incur $3,600.00 in out of pocket expense before the coverage would reduce the cost.  Obviously, thousands of individuals do not have $3,600 lying around - and that assumes they have "excellent coverage", something most do not have.

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.

American Pharmaceutical Company Keeps HIV Risk High

One of the reasons for America's sky high health care costs is the daily gauging of consumers by large pharmaceutical companies.  Americans pay in some cases, thousands of times more for crucial drugs that cost a relative pittance in other countries.  A prime example is Truvada, the brand name for a type of HIV pre-exposure prophylaxis, or PrEP, which is up to 99 percent effective at preventing HIV infection.  The cost in America?  Thanks to the monopoly of Gilead Sciences, over $20,000 per year, far outside the reach of even many affluent individuals even with insurance (assuming carriers do not deny coverage).  The cost elsewhere?  In other countries, a one-month supply of generic Truvada costs less than $6.00. If widely administered, PrEP could largely eliminate HIV/AIDS in America.  But just like the opioid manufacturers behind the crisis in many parts of America, money is Gilead Science's god.  Human lives mean little.  A piece in the New York Times looks at this shocking example of corporate greed.  Here are excerpts:

On July 3, 1981, this newspaper wrote about a “rare cancer” killing gay men in New York and California. . . . Today, after 37 years, we finally have a proven pathway to ending the AIDS epidemic in this country.

The only catch? Poor policy and pharmaceutical price-gouging have blocked the way, making critical drugs a luxury rather than an imperative.

The solution comes in a pill: Taken daily, Truvada, the brand name for a type of pre-exposure prophylaxis, or PrEP, is up to 99 percent effective at preventing H.I.V. infection; it also lowers the amount of H.I.V. circulating in infected patients' blood streams. Used as directed, it’s one of the most effective methods of preventing a viral infection ever discovered, as good as the polio vaccine, the miracle of modern medicine. When you combine that protection with the discovery that people with H.I.V. cannot transmit the virus to others once Truvada has suppressed it to undetectable levels, we could be on the verge of a swift end to the epidemic.

Truvada was approved by the Food and Drug Administration in 2012. But over six years later, the United States is failing miserably in expanding its use. Less than 10 percent of the 1.2 million Americans who might benefit from PrEP are actually getting it. The major reason is quite clear: pricing. With a list price over $20,000 a year, Truvada, the only PrEP drug available in the United States, is simply too expensive to become the public health tool it should be. Gilead Sciences, the company that makes Truvada, maintains a monopoly on the drug domestically. In other countries, a one-month supply of generic Truvada costs less than $6, but Gilead charges Americans, on average, more than $1,600, a markup from the generic of 25,000 percent. Infuriatingly, American taxpayers and private charities — not Gilead — paid for almost all of the clinical research used to develop Truvada as PrEP. Yet the price stays out of reach for millions, and will for at least several more years.

The disparities in PrEP access are astounding: Its use in black and Hispanic populations is a small fraction of that among whites. In the South, where a majority of H.I.V. infections occur, use is half what it is in the Northeast. Women use PrEP at drastically lower rates than men . . .

The ability of PrEP to greatly reduce new H.I.V. infections is no longer in question. In New South Wales, Australia, a program providing free access to PrEP led to a drop in H.I.V. diagnoses in the most vulnerable communities by a third in just six months, one of the fastest declines recorded since the global AIDS crisis began.

So how can we import such progress into the United States? Faced with more than half a decade of inaction by the federal government, activists have developed their own national strategy to begin the end of the H.I.V. epidemic. At the International AIDS Conference later this month, our organization, the PrEP4All Collaboration, will release its plan for a national PrEP program to ensure all Americans who need PrEP can get it.

A critical component of this plan is insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly. With low-price, generic Truvada, the cost to cover every American who needs PrEP — including both drug costs and clinical care — would be less than a tenth the amount that the federal government already spends on H.I.V. care. The billions saved could pay for vital services to ensure those who need PrEP the most can get it and those living with H.I.V. can keep the virus suppressed. If the patent on Truvada remains, the plan will cost over $20 billion. Science has delivered answers, but Gilead’s greed and the government’s inaction are keeping it from those who need it most. There’s a pill that stops H.I.V. We can make it possible for everyone who needs that pill to get it.

Gilead's greed is replicated across the medical spectrum and is a prime reason why Americans pay far, far more for healthcare than in any other nation in the world.  We need a single payer system with government negotiation of drug prices. 

A Pill to Prevent HIV Goes Largely Unused

A piece in the New York Times looks at the failure of an effective HIV preventative pill to gain wide traction in the LGBT community.  The article recites a number of possible reasons but I suspect that perhaps the largest is the cost - roughly $1,000 per month.  Even with decent insurance, the out of pocket cost is beyond the reach of many.  The phenomenon is part and parcel with America's ass backwards approach to health care: skimp on preventative care and then have to face huge costs once severe conditions have developed.   It's a kin to never maintaining one's house and then being shocked when suddenly huge repair costs become unavoidable.  There is also the possible fear by many with job derived health care coverage that use of the preventative may cause one to be stigmatized.  Lastly, some HIV/AIDS organizations have opposed use of the drug fearing that it may encourage risky practices - a mindset akin to the Christofascists' opposition to reality based sex education in favor of abstinence only programs.  Just like unwanted pregnancies, risky behavior will continue, so why not prepare for it?  Here are article highlights:

[A] daily pill that studies show is highly effective in protecting people from infection. 

The very existence of that option represents a startling turn in the too-long history of the AIDS epidemic. Many health experts hoped that the medication — Truvada, a combination of two antiviral drugs that has been used to treat H.I.V. since 2004 — would be exuberantly embraced by H.I.V.-negative gay men. Instead, Truvada has been slow to catch on as an H.I.V. preventive in the 18 months since the strategy’s approval by the Food and Drug Administration. In some quarters, the idea that healthy gay men should take a medication to prevent infection — an approach called pre-exposure prophylaxis, or PrEP — has met with hostility or indifference. 

“It’s gotten tons of attention at H.I.V. meetings as a new tool for prevention, and I consider it an important option for the right person,” said Dr. Lisa Capaldini, a primary care doctor here who treats many gay men. “And yet there’s been very little interest among my patients. There’s a fascinating disconnect.”

Many experts hailed Truvada as an opportunity to reduce new infections among high-risk groups like young gay men, people in relationships with H.I.V.-positive partners, and prostitutes. The F.D.A. called for prescriptions to be accompanied by counseling, frequent H.I.V. testing, and continued promotion of safer sex, although research suggests that daily use of the pill alone confers close to full protection. 

For many gay men, and for some public health officials, the new option has brought both hope and confusion. 

“We’ve had several decades of the recommendation to use condoms,” said Dr. Kenneth H. Mayer, a professor of medicine at Harvard University and the medical research director at Fenway Health, a community center in Boston with many lesbian and gay patients. “Now we’re saying, ‘Here’s a pill that might protect you if you don’t use condoms.’ So it’s flying in the face of community norms.”

Certainly, fewer people have tried PrEP than many experts had anticipated. . . . So why haven’t more gay men signed up? 

Some men have reported receiving negative reactions from their health care providers when they brought it up. Use of the drug as a preventive can be stigmatizing among gay men as well: the term “Truvada whore” has been bandied about on some social networks. 

And many simply may not know much about the strategy. 

Potential side effects like kidney damage and a loss of bone density, although rare, are also a concern. And Truvada is expensive: more than $1,000 a month. So far, private and public insurers, including state Medicaid programs, have generally covered the drug for prevention. 

But a generational shift in attitudes toward H.I.V. among gay men may also be playing a role, some experts say. With advances in treatment, many younger men who did not experience the worst years of the epidemic are less fearful of the consequences of infection. Moreover, current medications can lower viral levels in H.I.V.-positive people to the point where the risk of transmission is negligible, further reducing the perceived need for PrEP among H.I.V.-negative partners.

Adherence to the drug regimen is another thorny issue. The major trial that confirmed Truvada as an effective H.I.V. preventive among men who have sex with men, also found that many participants did not take the pill every day, leaving them more vulnerable to infection. 

Michael Weinstein, president of the AIDS Healthcare Foundation, warned that drug adherence will continue to be a problem, likely leading to more infections and the emergence of drug-resistant H.I.V. strains. “If you don’t take the medication every day and you don’t use condoms, and you’re highly sexually active, you’re going to get infected,” Mr. Weinstein said.

In any event, the protocol for pre-exposure prophylaxis is itself likely to undergo significant changes as findings emerge from current and upcoming research into other formulations of Truvada such as gels or injectables, less frequent dosing regimens, and the use of other medications altogether. 

“People are not lining up, but I’m not pessimistic,” said Dr. Mayer of Fenway Health. “It’s going to take time. It’s really early days.”