By Mark S. King | BALTIMORE – A financial crisis that will curtail hundreds of millions of dollars to HIV clinics and the community-based organizations that run them is coming on January 1, 2022. It’s only weeks away. Meanwhile, our national advocacy groups are essentially frozen into inaction, caught like deer in the proverbial headlights.

Spoiler alert: pharma giant Gilead Sciences again plays the villain in this story but there’s plenty of blame to go around. The landscape includes community organizations with a woeful lack of contingency planning, our government’s hypocritical lack of actual investment in “Ending the HIV Epidemic,” and yes, the insidious grip Big Pharma has on the people and organizations we trust to speak up on our behalf.

The situation is a doozy but somewhat murky. Buckle up.

The 340B program is a house of cards that is falling apart

Never heard of 340B? I’m not surprised. Its very complexity has sheltered it from skeptical eyes. My own crash course in 340B intricacies began in the last few months; this article is based on off-the-record interviews with providers, activists, staff within community-based agencies, and leaders from national HIV advocacy coalitions.

Journalist Benjamin Ryan does a great job of explaining how 340B works in his July 7, 2021, story for NBC News. I recommend you read it, but here’s the bottom line: 340B is a federal drug pricing law that makes it possible for certain safety-net community clinics with a pharmacy — let’s just talk about HIV or PrEP clinics here — to purchase name brand medications at rock-bottom prices.

For patients with insurance who receive the medication from those clinics purchased at the discounted price, the insurance company reimburses that pharmacy at a rate based on the undiscounted cost of the medication. If the patient does not have insurance, the pharma giant Gilead, which manufactures 90% of HIV treatment meds and the brand name versions of both approved PrEP drugs, makes a similar reimbursement to the clinic through its patient assistance program.

You read that right. These community clinics get a check for nearly the full retail price of a medication they bought for pennies on the dollar. The difference, the money the clinic is collecting out of thin air, is known as “the 340B spread.”

How much are these community-based programs making off this scheme? Collectively, it’s into the hundreds of millions of dollars per year, according to estimates I’ve received, but no one knows the real numbers because they aren’t reported. The windfall to agencies is perfectly permissible, though, and is considered “unrestricted funding.” Agencies have used the monies to cover other clinical costs in those clinics and to pay for everything from condoms to safe sex counselors to advertising.

Nowhere has 340B been more lucrative than for agencies that have pre-exposure prophylaxis (PrEP) clinics. The two brand-name drugs used for PrEP are both made by Gilead. Truvada, its first PrEP drug, has now gone off patent and there are more than ten cheap generic versions available. Gilead’s newer drug for PrEP, Descovy, is far more expensive.

The yearly cost of Descovy for one ‘PrEP patient can creep towards $20,000, so remember, most of that amount is sent to the agency through Gilead’s patient assistance program if the patient is uninsured, even though the clinic actually paid much less for it. Free money, folks.

If you were a community clinic with a caseload of uninsured patients, which drug would you prescribe for PrEP: the cheap generic drug that won’t bring much 340B money back to your agency, or the Descovy, which will generate an enormous reimbursement check from Gilead?

It’s difficult to fault a struggling community agency for gulping heartily from this spigot of unrestricted funding. Well, unless it is making clinical decisions unduly influenced by money rather than the interests of the patient. For example, Truvada has renal and bone-density side effects that are rare, while Descovy has been shown to contribute to weight gain and bad cholesterol. The choice between them should be a patient-centered decision, not a financial one.

Anyone with common sense would conclude that the 340B gravy train couldn’t possibly last forever. They’re right. In a few weeks, Gilead is derailing the train.

The Gilead gambit to abandon PrEP clinics

Gilead abruptly announced in April that it would change their policy on these 340B disbursements. They will no longer pay the clinics anywhere near the full retail price, only allowing for minimal mark-up and therefore ending the big 340B payday to clinics. After an initial community outcry, they moved the effective date from October, 2021 to January, 2022. Gilead is reportedly firm on this new date.

Does Gilead have the legal right to make this change? Yes. In doing so, though, they will devastate community organizations that rely upon this revenue. As ethicist Kwame Anthony Appiah recently advised in his New York Times column, “When you provide people with ongoing assistance, you tend to assume ongoing obligations… when a helping hand is dependably there, it’s only reasonable that we come to depend on it.”

Gilead is obligated to help solve a problem it helped to create, and not summarily abandon agencies that have come to depend upon Gilead’s funding.

For their part, Gilead claims that it is making this change because it just discovered it was reimbursing the clinics more than the clinics paid for the drugs. Uh huh. This program has been in place for years, folks. Gilead needs a new accountant, at the very least, if the fact it has dispersed hundreds of millions of dollars is somehow new information.

In another insulting statement of feigned ignorance, Gilead further claims that they had no idea that clinics relied upon 340B to fund their services. What does Gilead think agencies have been doing with this money? Maybe they figure everyone keeps a huge slush fund to use for, I don’t know, cozying up to physicians on expensive junkets and conference receptions.

Our community advocacy response has been weak, clearly. With COVID still slowing much of our activist momentum, minimal action has been taken to deal with this impending disaster. Make no mistake, when this change goes into effect clinics will close, programs will end, and preventable HIV transmissions will occur. So much for “Ending the HIV Epidemic.”

Gilead’s wholesale purchase of the HIV community is nearly complete

Aside from 340B reimbursements, Gilead still papers the HIV landscape with checks. There is nary an HIV organization or program in this country totally untouched by Gilead’s financial fingerprints. It makes it hard to publicly criticize Gilead when you’re waiting on its response to your grant request.

When I asked national HIV advocacy leaders what exactly is being done to persuade Gilead to change its decision or at least delay it until alternatives are found, I was met with silences so long that I thought my cell service had failed.

Take AIDS United, the national consortium of HIV organizations with a twenty-million-dollar budget that is tasked with looking out for our interests from a policy and legislative standpoint. After AIDS United’s strongly worded press release opposing Gilead’s change, there has evidently been little further action.  A subgroup of its Public Policy Committee (PPC) considered a scheme to take money away from Ryan White, which funds HIV treatment, to help cover the loss of 340B funds to PrEP clinics. Cooler heads prevailed, fortunately, and that strategy was scrapped. Their current battle plan is, well… I have no idea. They meet this week. Let’s watch to see what they come up with. Gilead’s financial support of AIDS United runs deep, it’s worth noting.

Where is the United States Government?

Nowhere else in the world does a system exist where the provision of health services is dependent upon drug prices remaining high. It’s peculiar and perverse. If the United States had a national program that funded PrEP clinics we wouldn’t be confronting this mess. Sadly, it does not and we are.

This summer, an ad hoc community coalition sent a letter to Harold Phillips, Director of the Office of National AIDS Policy (ONAP) at the White House, asking ONAP to please broker a meeting between the coalition and Gilead to discuss a remedy for all this. Phillips declined. So much for leadership from the White House.

Here’s a fun fact: Douglas Brooks, who was once the Director of the White House Office of National AIDS Policy himself, resigned from it in 2016 after two years and started a new job as a Gilead executive just one month later. I’ll let that story speak for itself.

Then there’s the Presidential Advisory Council on HIV/AIDS (PACHA), made up of dedicated community advocates and clinicians but also littered with pharmaceutical executives and their apologists. What is this auspicious council doing, you might ask, about a crisis that will have a crushing impact on their National AIDS Strategy for “Ending the HIV Epidemic?” The agenda for the council’s meeting this week is public information, and nowhere on it will you find mention of the 340B funding crisis. Not a word.

Perhaps AIDS United could use its strength to work with legislators to create funding for these PrEP clinics, and we could all go back to being at the mercy of politicians rather than the pharmaceutical industry. That sounds quaint at this point, but it’s worth a try.

Some final thoughts

The more you understand 340B, the more you might lose faith in our systems of HIV funding, or doubt the allegiances of our community leadership, or even question the judgment of those who provide HIV clinical services. Being disgusted by the actions of Gilead is a given, but the actions (and inactions) of players within our own community are especially demoralizing.

I remember the activism that forced our government to address the AIDS crisis and to fund research for medications when there were none. You don’t even need a long memory to recall the activism of PrEP4All, leading to congressional hearings just two years ago on the high cost of Gilead’s PrEP drugs.

I never envisioned HIV community clinics would one day become pigs at the trough, gorging on money from a pharma giant we once opposed with righteous clarity, or that the national HIV advocacy coalitions we created would simply shrug in the face of an oncoming financial disaster, or that the National AIDS Strategy our government touted would ignore the structural needs of a true prevention response.

Above all, I worry for the individuals who will be left defenseless against HIV transmission come January, when the clinic that provided their PrEP medication and HIV prevention education closes.

Even if the closings happen without much notice to the people the clinics serve, it will certainly happen after plenty of warning to the rest of us.

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The preceding article was previously published at My Fabulous Disease and is republished with permission.

LONDON — The HPV, or human papillomavirus, vaccine cuts cervical cancer cases in young women by nearly 90%, according to a King’s College London study published in The Lancet. 

The study — which Cancer Research U.K. called “historic” — found that cervical cancer rates in women aged 12-13 vaccinated against HPV were 87% lower than women without the vaccine. In women aged 14-16, rates were 62% lower and 34% lower in women 16-18. 

Nearly all cervical cancers, which are the fourth most common cancer in women worldwide, are caused by viruses. The research fuels hope that vaccination could almost eliminate the disease. 

The King’s College researchers looked at U.K. population-based cancer registry data between January 2006 and June 2019. The women were inoculated with the Cervarix vaccine, which protects against two strains of cancer-causing. New vaccines, sold by Gardasil, protect against even more strains.

The study estimates that by mid-2019, there were 450 fewer cervical cancer cases and 17,200 fewer cases of pre-cancers in the vaccinated population.

“This study provides the first direct evidence of the impact of the UK HPV vaccination campaign on cervical cancer incidence, showing a large reduction in cervical cancer rates in vaccinated cohorts,” study co-author Dr. Kate Soldan from the U.K. Health Security Agency said, per CNN.

“This represents an important step forwards in cervical cancer prevention,” she said. “We hope that these new results encourage uptake as the success of the vaccination program relies not only on the efficacy of the vaccine but also the proportion of the population vaccinated.”

It is still too early to know the full impact that HPV vaccinations have on cervical cancer rates. 

Though all women are at risk of cervical cancers, the disease is uncommon in young women, as it occurs most often in women over the age of 30, according to the Center for Disease Control and Prevention (CDC). The study also collected data from the outdated Cervarix vaccine — the U.K. now uses Gardasil. 

According to the BBC, cervical cancer kills more than 300,000 women worldwide every year. Almost 90% of those deaths come from middle and low-income countries, and the hope is vaccination will have an even bigger impact in those nations. 

The World Health Organization (WHO) started the first-ever global commitment to eliminate cancer called the Global Strategy to Accelerate the Elimination of Cervical Cancer. The goal is to vaccinate 90% of girls against HPV before they turn 15. 

The U.S. Department of Health and Human Services started a campaign to increase HPV vaccination rates, mainly targeting states with low vaccination rates. 

Prof Peter Sasieni, one of the researchers at King’s College London, called the study “just the tip of the iceberg.” He added that the “impact has been huge.”

By Michelangelo Signorile | NEW YORK – I was recently diagnosed with prostate cancer. And I’m going to be fine.

Fortunately, it’s localized, and it’s been detected early — so early that I don’t require treatment right now beyond what is called active surveillance, which means monitoring how fast, or how slowly, it grows. If and when I do require further treatment there are options and it is curable.

All of that said, I can’t tell you that the past few weeks have not been a bit excruciating.

Waiting two weeks for biopsy results is living in a cesspool of anxiety. Finding out the news that you have cancer is a gut punch, particularly before you know many of the details. But learning all the facts is key to feeling in control of the situation.

I want to explain what happened so that maybe it can help other people, particularly with regard to the vital importance of early detection.

Back in February, I went for my annual physical and it turned out my levels of PSA — prostate-specific antigen — were slightly-elevated. For those who don’t know, this is a number determined via a routine blood test. I had no symptoms of prostate cancer. No physical exam showed anything out of the ordinary. Even a sonogram was normal.

Sometimes PSA levels in the blood can spike a little bit from working out a lot, and particularly from riding a bike. And some people just have higher levels at a given point, or develop PSA levels that bounce up and down. I could have been in those categories.

So, my doctors and I waited six months and did another PSA test. The number was slightly more elevated.

Only 25% of people with slightly elevated PSA levels, but no symptoms or indications via a digital rectal exam, turn out to have prostate cancer. There are other less serious health issues — such as a urinary tract infection — that can cause the number to be elevated.

The next step should have been an MRI. But my insurance company wouldn’t pay for it because nothing else beyond my slightly-elevated PSA levels indicated prostate cancer. In other words, I didn’t appear sick enough to find out how sick I was. This is another reason why health insurance is a disaster. In case you needed another reason.

So I had a biopsy. It wasn’t that bad, actually. Fifteen to 20 minutes in the urologists’s office, and done. Local anesthesia and some valium. Slight discomfort but no real pain.

Then the wait. And then the phone call from my urologist, after which my heart sank.

But I felt almost 100% better after my husband David and I went into the office, where my urologist explained it was found early and showed us precisely where it was limited to in the prostate. Finally, he said he fully anticipated a CT scan and a whole-body bone scan would show it had not spread beyond the prostate. (Both scans, performed a week later during a full day in a hospital, confirmed his belief.) My friend Joe had advised me to record the meeting with the doctor because I would be so overwhelmed I’d forget just about everything. My mother thought that was such smart advice, and she was right.

Active surveillance — basically, monitoring the PSA numbers via a blood test every few months — is actually now considered a treatment. If and when I require or would like further treatment, there are choices, different options with excellent outcomes. I have time to research them and weigh them, and get other opinions.

Having that ability can in large part be attributed to early detection.

“Friends” star James Michael Tyler, who famously played Gunther, tragically died this week due to prostate cancer at the age of 59. Tyler appears to have a had a much more aggressive form of prostate cancer. But early detection still would have made a difference. The cancer had already spread to his bones by 2018 when he had his very first PSA test, which showed staggeringly high levels of PSA in his blood. Tyler said he should have “listened to my wonderful wife” and gotten tested sooner:

I would have gone in earlier, and it would have been, hopefully, caught earlier. The next time you go in for just a basic exam or your yearly check-up, please ask your doctor for a PSA test. Caught early, 99 percent treatable.

So I want to take this opportunity to urge everyone who has a prostate and isn’t getting PSA-tested to speak with your doctor about regularly getting a PSA test. I’ve now learned that some doctors advocate regular screening when patients turn 40 while other doctors don’t test at all, even among older patients, unless a patient requests it.

The Prostate Cancer Foundation recommends screening beginning at 40 if you are Black, or have a family history of prostate cancer. And beginning at 45 for everyone else. The American Cancer Society says screening should begin at 50, and at 45 if you’re Black, or there is a family history. The U.S. Preventive Services Task Force recommends talking to your doctor about screening beginning at 55 (and only screening until age 69).

These differences in recommendations have caused confusion. They stem, for the most part, from concerns among medical professionals about too many unnecessary biopsies and over-treatment. So, if your doctor hasn’t already decided to regularly screen you (and I’m thankful that mine did) you have to make the decision for yourself and ask about it. It’s just a blood test. It can’t hurt you. But it can save your life.

You should also be getting a routine digital rectal exam (DRE), which takes just a minute. Some doctors don’t perform it. Some patients don’t like to have it done. Get over it. Sometimes PSA levels will reveal a problem while a DRE doesn’t show it (as in my case). But in other instances a DRE will indicate an issue that a PSA test doesn’t reveal.

Let me repeat: I had —and still have — no symptoms. I feel great, and am in otherwise excellent physical condition. I’m very active and workout at the gym or run outside just about every day. I’ve been vegetarian for over 30 years. So don’t think you’re too healthy, or that you’d feel ill or would have some other indications.

I’m sure many of you have been down this road, or are on it now, and will have a lot to add. I’m grateful for your thoughts and experiences. Certainly queer people of my generation lived through the early HIV epidemic and empowered ourselves, learning that information is power. My experience as an AIDS activist has taught me a lot and I’m confident it’s prepared me for this.

I’ve already come to realize, for example, how straight men and gay men, as well as transgender women, are faced with uniquely different sets of challenges when it comes to prostate cancer treatments, possible side effects affecting sexual health and other issues. And you can guess which group the medical field is often more geared toward focusing on.

I consider myself very lucky. I benefited from early detection. I live in a city with the best doctors and medical technology in the world. And I have comparatively good health insurance, headaches and ridiculousness notwithstanding.

It means very little to tell people to get PSA-tested if they are uninsured and don’t have adequate medical care. And that is the case for millions of Americans. My diagnosis reconfirms my commitment — as an activist, a journalist and a radio host — to fight for access to health care for everyone.

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The preceding article was previously published at The Signorile Report and is republished by permission.