Trump's Ass Backwards Approach to Stopping the HIV Epidemic

In addition to the scandal of allowing Gilead raking in billions of dollars and imposing astronomical prices for PrEP, a totally government and charity developed drug, the Trump/Pence regime is moving to slash funding to family planning clinics that provide free HIV testing to the poor, including poor women who increasingly make up those being diagnosed with the virus.  The Trump/Pence motivation is simple: attack family planning clinics to please the anti-abortion Christofascists who remain the regime's most loyal base of support.  Never mind that abortion services/referrals are offered by only a small percentage of such clinics which often provide the only means of medical treatment for the poor - a group that Trump despises, especially those who are non-white. Such ass backward actions reveal the disingenuous nature of Trump's claim he wants to end the HIV epidemic by 2030.  A piece in Politico looks at the damage the Trump/Pence approach will do to stopping the rate of HIV infections (which is the worse in the South/Bible Belt).  Here are excerpts:

Last month, the Centers for Disease Control and Prevention released a report detailing the state of the HIV epidemic in the United States. One finding stood out: Nearly 40 percent of new HIV transmissions come from a relatively small group of people who don’t know they have the virus.

In his State of the Union address, President Donald Trump announced an initiative to end the HIV epidemic in our country by 2030. . . . . There’s just one problem: The Trump administration is also cutting funding to many of the safety net medical clinics that do a significant number of these tests.

One reason that some Americans don’t know they have HIV is that they lack access to routine health care. While millions of people have gained access to health care through Obamacare or the expansion of Medicaid that accompanied it, there remains a significant coverage gap in states that decided not to expand Medicaid, and it’s those states, many of them in the South, which have the highest rates of HIV infection.

For the more than 2.5 million poor, uninsured Americans who cannot get Medicaid or any financial support to purchase Obamacare, one of the only remaining places they can get health care, including low-cost or free HIV testing, is at so-called Title X clinics.

The Title X Family Planning Program was enacted by Congress in 1970 and it is the only federal grant program dedicated solely to providing all individuals, regardless of their ability to pay, with family planning and related preventive health services including HIV testing. In establishing Title X, Congress made clear that its major goal was to “decrease adverse health and financial effects on children, women, and their families of inadequately spaced childbearing” by providing information, access to birth control and preventative health services. For nearly 50 years, this government-funded program has greatly improved access to vital medical care for millions of low-income, uninsured people.

Currently, there are nearly 4,000 Title X-funded family planning clinics across the U.S., and they serve approximately 4 million people each year. In addition to providing family planning services like low-cost or free birth control, Title X clinics also provide low-income men and women with services such as free testing for HIV, other sexually transmitted infections, and breast and cervical cancer screening.

[N]early half a million men also receive care in these clinics each year, mostly driven by their need for testing services. In 2017 alone, Title X clinics performed 1,192,119 confidential HIV tests, resulting in 2,195 new HIV diagnoses.

Another key component of Trump’s plan is to focus on geographic HIV hotspots. The Southern U.S. is the current epicenter of the national HIV epidemic; Southern states account for over half of new HIV diagnoses despite having only 37 percent of the population. This is particularly true for women; of all U.S. women recently diagnosed with HIV, 56 percent were living in the South. In fact, my home state of Georgia has the highest rate of new HIV diagnoses in the country.

In states like Georgia that did not expand Medicaid, Title X clinics serve as the sole source of heath care for the majority of their female clients.

Sadly though, the administration announced in February changes to Title X that will result in cutting funding to a sizable portion of family planning clinics. The motivation for these cuts is purely political, with the singular goal of removing Planned Parenthood and other medical clinics that provide abortions or refer patients for abortions out of the Title X network within the coming months. As it happens, only 13 percent of all Title X clinics are operated by Planned Parenthood, and an additional 26 percent are nonprofit, community-based family planning clinics, many of which may be in jeopardy of losing funding as well.

Title X funds have never been allowed to pay for abortions, but the new rule will cut funding to family planning clinics solely because they provide or refer patients elsewhere for abortions. Due to the loss of federal funds, some of these vital safety net clinics may close, others will have to lay off staff and reduce hours, and many may have to reduce services—like HIV testing—in order to offset costs.

Rather than dismantling Title X clinics, the Trump administration should leverage and expand on the important role that this network of family planning clinics has always played in providing HIV testing to the 4 million people they serve each year.

I]t’s time to increase funding to family planning clinics to expand HIV testing, not decrease access to HIV testing through politically motivated efforts that may result in the closing of vital safety net clinics.

As always, actions speak louder than words and Trump's actions send a message to the poorest Americans: just get sick and die.

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.

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.