Thursday, March 15, 2018

Shkreli's Cell Block Tango

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In the acclaimed Broadway musical, Chicago, it was the "Cell Block Tango" that yielded the memorable line, "He had it coming." It now fittingly applies to disgraced former pharmaceutical executive, Martin Shkreli. The "Pharma Bro" (as Shkreli was notoriously dubbed) fraudster will be sitting in a cellblock for the next seven years, and most certainly he had it coming!

Martin Shkreli being arrested for securities fraud.
Photo Source: Daily Squat

On Friday, March 9th, U.S. District Judge Kiyo Matsumoto handed Shkreli a seven-year prison term for securities fraud, as well as ordered him to forfeit assets and pay fines. It is unlikely anyone in the HIV/AIDS advocacy community shed any tears about this news, though Shkreli's sentence reportedly brought him to tears (boo, hoo, hoo).

The discussion over drug pricing is nothing new to the HIV/AIDS community. In fact, it is a healthy discussion and one that needs to be had. But what Shkreli pulled several years ago...purchasing the rights to a popular HIV drug and then jacking-up the price more than 5000%...was unconscionable. Whereas Shkreli's sentence to do hard time had nothing to do with his actions on the drug Daraprim (pyrimethamine), it was nonetheless celebrated by our community. In fact, there was even quite a bit of humor at his expense  evidenced by the headline, "Prison commissary increases lube price by 5000% ahead of Martin Shkreli’s arrival."

According to someone who closely followed the case, "...critically, during Judge Matsumoto’s sentencing rationale, she specifically referenced receipt of correspondence from organizations working with HIV/AIDS patients as balancing off letters written in support of Shkreli." The observation was in reference to a community-led effort by Housing Works to send a strong message to Judge Matsumoto that Shkreli should forfeit his remaining shares in Vyera Pharmaceuticals (formerly Turing Pharmaceuticals), which owns the rights to Daraprim.

The community letter argued that allowing Shkreli to maintain ownership of his shares "will have a devastating impact on innocent people — including current Vyera employees, current Vyera shareholders and countless waiting for Vyera's anticipated treatments for certain orphan and rare diseases." Read the letter signed by 22 organizations, including the ADAP Advocacy Association.

Shkreli will undoubtedly appeal, but the HIV/AIDS community sent a message that such behavior moving forward will not go unnoticed, nor will it be tolerated! With respect to the Shkreli, additional advocacy on the issue is underway.

For now, Pharma Bro can be left to do the Cell Block Tango.

Cell Block Tango scene from the movie, Chicago.
Photo Source: Chicago

Thursday, March 8, 2018

Rx Drug Coupon Concerns Pit Prices Against Patients

By: Marcus J. Hopkins, Blogger

Drug manufacturer coupons have increasingly become a popular method of reducing the price consumers pay for their medications. Insurers, Pharmacy Benefits Managers (PBMs), and other payors, however, argue that these cost saving tools actually drive prices upward and result in patients choosing expensive brand name drugs over less expensive generic alternatives, essentially costing the payors more money, in the long run. As a result, some payors are taking the extraordinary step of no longer counting drug coupons toward patients’ out-of-pocket costs and deductibles, meaning that once patients use a coupon, they’ll be left to pay the remaining cost of the drug out-of-pocket.

When looking at how and when these coupons are used, however, Health Affairs = a leading journal in health policy thought and research – found that just 21% of coupons used in the 200 highest expenditure drugs of 2014 had a direct generic substitute, while another 28% had an “imperfect substitute.” The remaining 51% of drug had either no generic substitute or only branded alternatives (Van Nuys et al., 2018).

Januvia Rx Drug Coupon

For patients living with HIV (and, more recently, Hepatitis C), the past decade has been revolutionary in terms of the medications that have been made available to treat the disease. In 2007, most patients began treatment using a two- or three-pill regimen with various storage requirements. A year earlier, the first single-pill regimen, Atripla (Gilead), was approved by the FDA for the treatment of HIV.  In 2017, virtually patients begin HIV treatment with a single-pill regimen. The sad reality, however, is that there are no generic substitutes available in the United States for HIV drugs, and manufacturer coupons that reduce co-pays for them play a vital role in determining whether or not patients can afford the lifesaving medications they need.

“Consumers with life-threatening conditions are caught in the crossfire of an ongoing battle between insurers and drug companies over drug pricing. No matter who wins the battle, the casualties will be the patients, taxpayers, and the general public,” says Eddie Hamilton of the Columbus, Ohio-based ADAP Educational Initiative.

Rx pharmacy receipt
Photo Source: Consumer Reports

He is correct. In the rush to lower expenditures in the post-Affordable Care Act (ACA) market, insurers have increasingly begun weaponizing their drug formularies – the list of drugs payors will cover and for how much – against manufacturers to force lower pricing agreements, all of which are confidential under existing Trade Secrets laws. Placing brand name drugs in higher-cost tiers has been a relatively ineffective weapon when it comes to lowering overall prices, but has been an effective barrier to treatment for many patients living with HIV and other chronic illnesses for which there are few, if any, generic and/or effective alternatives.

This latest salvo against drug manufacturers will ultimately end up hurting consumers more than it will lower expenditures for insurers.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates. 

Thursday, March 1, 2018

Is the Federal "Right to Try" Legislation Righteous, or Rotten?

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Thirty-eight states have laws on it. The U.S. Senate passed a bipartisan bill on it (S. 204). The current occupant at 1600 Pennsylvania Avenue has endorsed it. Many patient rights groups support it. So it begs the question, what is holding-up federal "Right to Try" legislation in the U.S. Congress? Most likely it all depends on your perspective.

According to Wikipedia, "Right-to-try laws are U.S. state laws that were created to let terminally ill patients try experimental therapies (drugs, biologics, devices) that have completed Phase 1 testing but have not been approved by the Food and Drug Administration (FDA)."[1] Simply put, right-to-try laws allow patients and their doctors to bypass the FDA and seek the an investigational therapy directly from the drug manufacturer.

The libertarian-leaning Goldwater Institute touts that the right-to-try laws are already in place in 38 states and counting: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia, Washington and Wyoming. More states are expected to follow suit, too.[2] This effort is supported by numerous national patient advocacy organizations.

Certainly for people living with life-threatening (or potential life-threatening) conditions, right-to-try laws make perfectly good sense to them. In fact, there was a time when living with HIV/AIDS was considered one such condition (and still can be so, if the person is not properly treated or if the person is experiencing treatment failure/resistance). “Dallas Buyers Club” styled arrangements back in the 1980s and early 90s come to mind. Today, it is common to find enthusiasts for right-to-try laws among people living with Alzheimer’s disease, cancer, chronic obstructive pulmonary disease (COPD), or Lou Gehrig’s disease (ALS), among others. People living with HIV/AIDS also appear to support them, at least in theory.

There has been a growing effort to pass a federal right-to-try law, mirrored after what states have already passed. Nathan Nascimento, senior policy adviser at Freedom Partners Chamber of Commerce, previously argued in Forbes Magazine: "The few available remedies for this problem are limited. The agency sometimes issues 'compassionate use' exemptions allowing patients to try certain medicines and treatments still under federal review, but getting those exemptions is easier said than done. Roughly 99% of those seeking compassionate use exemptions never get through their application."[3]

Though there has been increased attention on right-to-try laws, they received a big boost earlier this year. On January 30th during the State of the Union (SOTU), such laws received the unequivocal support from the man delivering the speech:
“We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”
President Trump delivers his State of the Union address
Photo Source: SUSAN WALSH/AP
The remarks were hailed by David Barnes, who serves as the policy director for the millennials advocacy group Generation Opportunity. Barnes penned an Op-Ed in which he argued, "Change to federal policy is needed to ensure that the FDA, or any other federal agency, does not interfere with state-passed laws. And there are terminally ill patients who don’t live in Right to Try states and desperately seek a chance to save their lives."[4]

Not everyone applauded the presidential endorsement.

Alison Bateman-House, assistant professor in the Division of Medical Ethics at NYU School of Medicine, claimed what was extolled in the SOTU would only punish the seriously ill. Writing an opinion piece in Forbes Magazine, Bateman-House summarized, "Rarely has a president spoken so vehemently in favor of a bill that would do so little for the sick. But even allowing for the extemporaneous nature of these remarks, it is clear that the president misunderstands how access to investigational drugs works in the U.S. and how right-to-try legislation, if enacted, would change it."[5]

Ms. Bateman-House was not alone. The Society for Science-Based Medicine (SBM),[6] and the National Organization for Rare Disorders (NORD)[7] vehemently oppose such laws. Other groups have also expressed concerns.

Interestingly enough, an important cancer survivor also has doubts about the pending federal right-to-try law. Scott Gottlieb, who serves as the current FDA Commissioner, testified before Congress, “Adequate policies and processes must be in place to appropriately balance individual patients’ needs for access to investigational therapies while recognizing the importance of maintaining a rigorous clinical trial paradigm for testing investigational products to demonstrate safety and efficacy.[8]

As stated earlier, it is all about perspective. The ADAP Advocacy Association has not taken a position on this policy issue.

Related articles of potential interest:


[1] Wikipedia, the free encyclopedia (2018, January 3). Right-to-try law. Retrieved from
[2] Goldwater Institute (2017). Right to Try. Retrieved from
[3] Nascimento, Nathan (2016, August 31). Right To Try: A Healthcare Reform That Can Save Lives. Forbes Magazine. Retrieved from
[4] Barnes, David (2018, February 15). Congressman Flores should press ‘Right to Try’ bill. Waco Tribune-Herald. Retrieved from
[5] Bateman-House, Alison, Lisa Kearns and Arthur Caplan (2018, February 1). Trump's 'Right To Try' Push Would Only Punish The Seriously Ill. Forbes Magazine. Retrieved from
[6] Ballamy, Jann (2014, March 6). The illusions of “right to try” laws. Science-Based Medicine. Retrieved from
[7] Mullen, Laura (2018, February 13). One-pager from NORD on Opposition to Right to Try Act.  National Organization for Rare Disorders. Retrieved from
[8] Gottlieb, Scott (2017, October 3). Examining Patient Access to Investigational Drugs. Before the Subcommittee on Health, Committee on Energy and Commerce, US House of Representatives. Retrieved from

Thursday, February 22, 2018

Trump & HHS Sanction Healthcare Discrimination

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The ADAP Advocacy Association earlier this week joined with the Community Access National Network (CANN) in issuing a strong rebuttal to the expected approval of new federal rules sanctioning discrimination by healthcare workers. The “Moral Exemptions & Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act” — which was initially published in the Federal Register on October 13, 2017, and subsequently on January 26, 2018  harkens the United States back to the dark, early days of the AIDS epidemic. It is absolutely deplorable!

Photo of an unhappy nurse standing near a patient's bedside
Photo Source:
The impending federal rules are not surprising since the current occupant at 1600 Pennsylvania Avenue has systematically embraced the hateful rhetoric and policy positions of the extreme religious right in this country! In the Oval Office, our beloved Bill of Rights has been replaced with advise from Tony Perkins. In the U.S. Department of Health & Human Services, our sacred Hippocratic Oath has been shoved aside to make room for James Dobson. In the HHS Office for Civil Rights, primum non nocere (first, do no harm) has been flushed down the toilet to make way for the bullsh#t being spewed by Jerry L. Falwell, Jr.

Clearly, most of the anti-gay and anti-AIDS posturing is coming from our esteemed Vice President (pun intended). The buck stops with the (crazy) man at the top, and he is who must be held accountable for sanctioning this discrimination.

In fairness, such laws are nothing new. So-called "Church Amendment" laws date back to the 1970s. Most recently it was the Affordable Care Act (Pub. L. No. 111-148 as amended by Pub. L. No. 111-152) itself that included such conscience protections regarding abortions and assisted suicides. The newly released proposed federal rules go further, though.[1]

The target of the so-called "Conscience Rule" are women seeking abortions, but also an entire group of people who identify as gay, lesbian, bisexual, or transgender (LGBT). Its potential reach has broader implications. And as such the reaction from the medical community, scientific organizations, patient advocacy groups, mainstream religious institutions, and so many others has been overwhelmingly negative.

It was summarized best by our board member and former Registered Nurse, Wanda Brendle-Moss:
"As a practicing nurse in Winston-Salem, North Carolina during the early 1980s, I witnessed firsthand the devastating impact of a new illness that was wreaking havoc on the gay men. What made the circumstances robbing so many lives even harsher was medical professionals refusing to treat these patients because they feared the illness. That illness would soon have a name, and it remains with us today: AIDS. Though we’ve made a lot of progress in fighting this deadly epidemic — which as taken nearly 40 million souls from us globally — that fear remains today. Unfortunately, new guidance issued by our government only makes matters worse."
According to Brendle-Moss, trying to comprehend the long range impact of the changes is incomprehensible. In her estimation the "First, Do No Harm" oath taken by all medical students could now be replaced with the prejudicial refusal to provide care and treatment. As a woman living with HIV/AIDS, she fears for the future of her longtime profession if it is allowed to be held hostage to religious fanaticism. She rhetorically asks, "What will be the standard of care for persons diagnosed with AIDS, or women seeking family planning services?"

It isn't only the LGBT community that is concerned. Women are also rightfully worried, especially those who are battered women or rape victims. We've already seen how people living with HIV/AIDS were treated at the outset of the AIDS epidemic. All of these groups...and others...could be faced with legalized refusal to treat under these new federal regulations.

Read the Joint Statement on Discriminatory Proposed Healthcare "Conscience Rule".

Photo of a broken pill


[1] Mohr, Aaron, and Allison Smith (2018, February 9); How HHS’s New Division in the Office for Civil Rights Will Enforce Rights of Conscience and Religious Freedom; JD SUPRA. Retrieved from

Thursday, February 15, 2018

Advocacy Scholarship Applications Now Being Accepted for 11th Annual ADAP Conference

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

This week via Twitter (@adapadvocacy) the ADAP Advocacy Association announced it is accepting advocacy scholarship applications to attend its 11th Annual AIDS Drug Assistance Program ("ADAP") Conference. The 2018 conference is being held on September 20th & 21st under the theme, "Mapping a New Course to Protect the Public Health Safety Net."

The Annual ADAP Conference is the premier, patient-centric advocacy event on the AIDS Drug Assistance Program held in Washington, DC. It assembles advocates, community organizers, health care professionals, government agencies, patients, pharmaceutical companies, pharmacies, and other stakeholders for two days of advocacy, dialogue, education, and networking.

In 2017, over 50 scholarships were funded for advocates to attend the advocacy and educational events with recipients representing 20 states (including AL, CA, FL, GA, IL, IN, LA, MA, MD, MI, MO, NC, NY, OH, PA, SC, TX, VA, WA, and the District of Columbia). This year, we hope to fund even more.

Advocates interested in submitting an application for a scholarship to attend the conference can do so online at Four different scholarships are offered, and they include:
It includes waived conference registration fee and awards dinner registration, only.
It includes waived conference registration fee and awards dinner registration; and provides two nights hotel accommodation.
It includes waived conference registration fee and awards dinner registration; and provides roundtrip transportation (up to $325.00).
  • SCHOLARSHIP OPTION D (Editor's Note: Applicants for this option must be invited to apply using an invitation code)
It includes waived conference registration fee and awards dinner registration; provides two nights hotel accommodations; and provides roundtrip transportation (up to $325.00).

Applicants seeking a full scholarship (option D) to attend the 11th Annual ADAP Conference must be invited to apply using an invitational code. This represents a new policy for the full scholarship option.

11th Annual ADAP Conference
The scholarship application process has grown increasingly competitive since it was launched six years ago. As such, we look to offer scholarships to advocates who are looking to do more than simply learn; rather we're seeking to assist advocates who will take what they learn and apply it back home in their communities. Scholarship recipients are required to sign a scholarship contract since more scholarship applications are received than can be approved each year, and therefore it is expected that scholarship recipients attend the conference sessions.

Please help to support these advocates by donating online today.

Additional information about the 11th Annual ADAP Conference is available online. Potential scholarship applicants can also obtain additional information about the conference and scholarship process by sending an email to

Thursday, February 8, 2018

Taking a Deeper Dive into the Ryan White HIV/AIDS Program

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

The Health Resources & Services Administration ("HRSA") HIV/AIDS Bureau at the U.S. Department of Health & Human Services ("HHS") has made available state profiles to highlight important client-level data (2015). It includes an interactive web platform, which allows users to compare states, compare states to national data, or compare data by year. The estimated number of clients served by Ryan White HIV/AIDS program providers in the United States in 2015 was 533,0361.[1]

Aside from client characteristics, other key data focuses on grant recipients, client outcomes, oral health programs, and services received. Of particular interest to stakeholders concerned about the AIDS Drug Assistance Program ("ADAP"), users can download how ADAP funds were administered in the United States in 2015. In 2015, an estimated 259,531 clients were served by ADAP in the United States. According to HRSA, new clients were served totaled 34,265.[2]

Map of the United States showing Ryan White HIV/AIDS program clients served, by state, 2015.

The site shares key ADAP-related client demographics on age, gender, race, and income. For example, Florida served 56,677 clients in 2015. Males represented 75.9% of the clients served, and females represented 23.4% of the clients served. Clients who identified as transgender were 0.7%. Vermont served 595 clients, with one in four clients being male.

HRSA sharing the Ryan White program-related data is not only important because it promotes programmatic transparency (and these programs have long demonstrated to be highly effective), but also because it fosters better state-level advocacy. All too often, data on public health programs can often be quite lacking, or delayed (or both). The data included on the site will come in handy as we map a new course to protect the public health safety net!

Explore national-and state-level Ryan White HIV/AIDS Program data.


[1] HRSA. Ryan White HIV/AIDS Program Services Report (RSR) 2015. *RSR data were deduplicated at the national level. Clients receiving services in multiple states were not included in state-specific totals; these clients make up less than 2% of the total RWHAP population.
[2] HRSA. Ryan White HIV/AIDS Program Services Report (RSR) 2015. 

Friday, February 2, 2018

Introduce a Little Anarchy...and Everything Becomes Chaos

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

In the 2008 blockbuster film, The Dark Knight, there is an infamous line by the Joker (played by the late Heath Ledger): "Introduce a little anarchy; upset the established order, and everything becomes chaos." That line by the Clown Prince of Crime pretty much sums up the last twelve months for those of us working to end the HIV/AIDS epidemic. In fact, chaotic would be an understatement.

The Joker in the movie, The Dark Knight
Photo Source: The Dark Knight

The Administration's proposed budget last year was submitted to Congress late (and it will be so again this year), and it was laced with requested funding cuts to vital safety net programs. The Presidential Advisory Committee on HIV/AIDS ("PACHA") is in complete disarray between protest resignations coupled with termination of the remaining members. The Office of National AIDS Policy ("ONAP") — viewed as an important component of the White House Domestic Policy Council since 1993 is seemingly gone. There has been no ONAP Director to coordinate the nation's response to HIV/AIDS at home, and abroad. Proposed regulations allowing healthcare professionals to deny care if it violates their "conscious" and seek to divert limited resources to organizations that refuse comprehensive strategies under the banner of religious objection. And that doesn't even scratch the surface with the countless attacks levied against the patient protections offered to people living with HIV/AIDS under the Affordable Care Act ("ACA").

On February 1st, we fired a shot across the bow at the Administration. We called on the newly minted Secretary of the U.S. Department of Health & Human Services ("HHS") to fill the vacant director position at ONAP. Now to be fair, HHS Secretary Alex Azar has no statutory authority to fill this position but he has the ear of the President who does — and that has to be worth something. Our press release is available online.

Health and Human Services Secretary Alex Azar, left, accompanied by his family, is sworn in during a ceremony in the Roosevelt Room at the White House, Monday, Jan. 29, 2018, in Washington. (AP Photo/Andrew Harnik)
Photo Source: (AP Photo/Andrew Harnik)

It is, after all, a core responsibility of the HHS Secretary to utilize the position of influence with the President in seeking to address the public health needs of the nation. We have added our voice to the calls from numerous other advocates, legislators, and organizations that realize the vital need for this position to be filled immediately.

Since 1993 when ONAP was created the longest time period the director position remained vacant was approximately two months. It has now been twelve months since someone has led our government's response to an epidemic that has taken 35 million souls globally. It is bad public policy. It demonstrates poor leadership. And it is simply wrong!