Friday, March 17, 2017

Pharmaceutical Drug Pricing, According to President Donald J. Trump

By: Marcus J. Hopkins, Blogger

Screenshot of President Donald J. Trump speaking at January 10th press conference about the pharmaceutical industry.
Source: Fox Business News; WATCH CLIP
"I think a lot of industries are going to be coming back. We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don't make them here. To a large extent. And the other thing we have to do is create a new bidding procedures for the drug industry because they're getting away with murder. 
Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there's very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don't bid properly. And were going to start bidding and were going to save billions of dollars over a period of time (National Public Radio, 2017)."
 President Donald J. Trump


Those two paragraphs during then-President-Elect Trump’s first press conference on January 10th, 2017, resulted in the nine biggest pharmaceutical companies (by market cap on the S&P 500) shedding $24.6 billion dollars in just twenty minutes (Shen, 2017). Fox Business Network (FBN) analysts were falling all over themselves to explain what he meant, desperate to make it seem like he wasn’t saying that there needs to be a cap on industry profits and to make it into an issue about taxes, regulations, and the Food and Drug Administration (FDA) approval process (Fox Business Network, 2017). In just two paragraphs, Donald Trump managed to place pharmaceutical companies and lobbyists on the defensive – a position few likely thought they’d be in, after his electoral win in 2016, as market-oriented Republicans have consistently been sympathetic to the industry.

But breaking beyond his rhetoric and getting at the heart of what he’s attempting to say about the way the Federal government in the U.S. deals with pharmaceutical pricing is no simple task, largely because the issue of pricing is cloaked from the public as a result of existing Trade Secrets laws at both the state and Federal levels. These laws allow companies to keep secret how they set the price for their drugs, as well as what and how prices are negotiated with private insurers and government payers, like Medicaid and Ryan White Part B – the AIDS Drug Assistance Program (ADAP). While the Centers for Medicare and Medicaid Services (CMS) are privy to this information, the exact price that each state’s Medicaid program pays is not public information, and releasing that data could result in serious consequences for those programs.

Of the three major public healthcare programs – Medicaid, the Veterans Administration, and Medicare – only the latter is barred by law from negotiating drug prices (Kertscher, 2017). This is a result of a provision inserted into the Medicaid Modernization Act (2003); the act that introduced the controversial Medicare Part D. Medicare Part D is a voluntary insurance program for prescription drugs for people on Medicare that was introduced by former President George W. Bush that has been in place since 2006. It created a market wherein private insurance companies offer various plans (at the county and zip-code-based levels) subsidized by the Federal government. One of the main provisions of the Act states that, “…in order to promote competition,” the Health and Human Services (HHS) Secretary “…may not interfere with the negotiations between drug manufacturers and pharmacies and prescription drug plans.”

There have been various attempts, since 2003, to amend this part of the legislation, as it strictly forbids the Medicare program from using its leverage to essentially force pharmaceutical companies to provide drugs for lower prices. This leverage exists in the form of the 55.3 million Medicare beneficiaries. The 59 state and territorial Medicaid programs have used their numbers – 74.165 million – to successfully negotiate considerably larger rebates from drug manufacturers than the private plans in Medicare Part D “…by a substantial margin” (Department of Health and Human Services, 2015). What differentiates Medicaid from Medicare is that the former is a Federally-funded, state-administered program, where the latter is essentially a model of what other nations refer to as “Universal Coverage.”

Opponents of Medicare drug negotiation argue that allowing the largest government-funded healthcare program to negotiate lower prices will lead pharmaceutical companies to push for higher prices for everyone else (those not enrolled in Medicare). They also argue that the private insurers have greater leverage to negotiate, despite their seeming inability to negotiate better than state governments. Others, still, argue that Medicare negotiation is essentially anti-“Free Market,” and amounts to “price controls” that would serve as a disincentive for drug makers to continue investing in the research and development that produces new drugs (Cubanski & Neuman, 2017).

What makes now-President Trump’s two-paragraph-stock-temblor difficult for pharmaceutical companies – not to mention “Free Market” Republicans – to swallow is that it is entirely heretical to the “small government” line toed by modern Republicans. That a sitting Republican president should dare utter the belief that Big Government should be allowed to use its leverage to “negotiate” (read: “force”) lower drug prices for Medicare is antithetical to everything market-based Republicans and small-government Conservatives have argued for the past forty years. And, let’s be honest: this is the kind of stuff that made and continues to make Trump so troublesome for the Republican Party. He’s unpredictable, often shoots from the hip without a filter, and leaves his mess to be cleaned up by a staff of harried, but loyal adherents who either have to step in and try to translate what he’s said into comprehensible English, or twist themselves into human pretzels to try and convince people that he didn’t actually say what he said, and then, explain what he was supposed to have meant. It’s very unsettling, and often provides political opponents enough artillery to successfully derail his (and thereby their) agenda.

Despite President Trump’s seeming willingness to work with pharmaceutical companies on the issue of FDA approval procedures and regulatory issues (Johnson, 2017), both he and his media surrogates continue to float his argument for Medicare negotiations (Daurat & Olorunnipa, 2017). He also faces considerable opposition from his own party – one that has made no bones about their opposition to the idea.  To their way of thinking, the private sector is better suited to negotiate lower prices, rather than Big Government coming in to tell them what they can charge. His Secretary of Health and Human Services, Tom Price, has, in the past, been consistent in his opposition to Medicare drug negotiations and has repeatedly blocked measures that would allow the HHS to do so. In his confirmation hearings, however, he stated that his “boss will be the President of the United States,” in response to questions on the subject. While not an overt statement in support, it came across as more of a resignation that that’s what Trump wants, despite his own wishes.

Congressional Republicans even have some evidence to back up their claims. The Congressional Budget Office (CBO) has indicated that competition among plan sponsors in Medicare Part D markets has led to lower costs (Congressional Budget Office, 2014). The caveat is that those savings are largely seen only in regions where there are a large number of sponsors – essentially, places where there is a market for their services: areas where retirees have higher incomes. Part of the reason why Medicare Part D has come in at a lower price tag than the CBO initially projected is that enrollment is 12% lower than expected (CBO). Advocates of Medicare negotiation have suggested that this lower enrollment is due to people in smaller markets being unable to afford the monthly expenditure for Part D coverage, as well as the fact that the prices in those smaller markets’ plans simply aren’t low enough to make the plans attractive. Essentially, “Why buy something you can barely afford only to still be unable to afford your medications?”

There’s little question that the coming year is likely to produce many questions about President Trump’s assertion that the drug companies are “getting away with murder,” especially as his positions continue to be amorphous. What this will mean for Medicare has yet to be seen, but you can bet that whatever it is, it will leave critics and proponents, alike, trying to figure out how they got there.


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. 


References:

Thursday, March 2, 2017

What is All the Fuss Over Drug Importation?

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

The rising cost of prescription drugs is on everyone's mind, and the issue is increasingly being scrutinized by the executive and legislative branches inside the Beltway. Even President Donald J. Trump has raised the issue over prescription drugs costs — though it typically ins't a signature Republican issue — and Senator Bernie Sanders (I-VT) has recently introduced legislation to allow drug importation. The debate over drug importation is a complex one, often muddled by talking points by both sides.

Here is how the American Association of Retired Persons (AARP) defines drug importation:
"Drug re-importation refers to the practice of importing back to the United States prescription drugs that were originally manufactured in the U.S. and exported for sale in another country. Most often, Americans re-import drugs for personal use by filling their prescriptions in Canadian or Mexican pharmacies, either in person, or through mail-order or Internet pharmacies."1
Proponents of the drug importation cite the need for consumers to access less expensive prescriptions drugs. According to a relatively recent national survey commissioned by Gallup, "27% of Americans name cost as top health problem."2

The U.S. Food & Drug Administration (FDA) found that one in ten Americans cannot afford their prescription drugs. That same study found approximately 1.6% of consumers have bought prescription drugs from another country.[3]

“There is no reason why drug importation should be a problem for the United States," said Eddie Hamilton of the ADAP Educational Initiative based in Ohio. "Generic Abacavir is already being imported into the U.S. from India  for domestic patients by ADAPs without issue.”

Sen. Bernie Sanders
Photo Source: Huffington Post

The Sanders legislation is only latest attempt by Congress to allow drug importation. It has also gained support from some colleagues — Senators Cory Booker (D-NJ) and Bob Casey (D-PA) — in the Senate who had previously opposed drug importation legislation.

Though AARP hasn't yet endorsed the Sanders legislation (S.469), similar legislation did receive support from the organization. In 2009, AARP Senior Vice President David Sloane argued: “AARP is committed to helping our members and all older Americans have greater access to and reduced costs for the prescription drugs they need, including both through safe importation and other important measures such as closing the dreaded coverage gap in Medicare Part D known as the ‘doughnut hole.’"[3]

Senator Sanders isn't alone in his fight over drug importation, because Senator John McCain (R-AZ) has also introduced similar legislation. The McCain legislation (S.92) has bipartisan support, unlike the Sanders legislation.

Report Cover: "Black Market HIV/AIDS Drugs in the News, 2006-2013" with the AIDS Red Ribbon next to a spoon full of prescription drugs.

Opponents have equally strong arguments against drug importation. Among them, concern over drug safety, including counterfeit or black market drugs. In 2014, a new resource for the HIV/AIDS community and their doctors was made available by the Community Access National Network (CANN) and Partnership for Safe Medicines. The resource, "Black Market HIV Drugs in the News, 2006-2013," sought to increase awareness of the severe health risks posed by counterfeit or black market medicines.[4]

Summarized Bill Arnold, CANN's President & CEO, who continues to have doubts about drug importation: "The importation or re-importation of medications from outlets other than those regulated by the FDA and other U.S. authorities is particularly dangerous for the HIV-positive patient. In the past, anti-retroviral drugs from this grey, or black, market system have turned up in many places. These drugs have turned out to be completely fake, improper potency, contaminated, and worse."

The Pharmaceutical Research and Manufacturers of America (PhRMA), who also opposes drug importation, has been very local about pitfalls over the potential lack of drug safety. The issue is characterized as "unsafe and lead to potentially dangerous outcomes for patients."[5]

PhRMA will host a policy briefing on the issue. The briefing, "Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients," will discuss the important role of the FDA in ensuring the safety of medicines from test tube to patient, the threat of counterfeit drugs to patient safety, the importance of the Drug Supply Chain Security Act and the implications of drug importation proposals. It is open to all interested stakeholders, but advance registration is required.[6]

It appears that Senator Sanders anticipated the pushback over drug safety, because his legislation requires foreign sellers to register with the FDA, as well as other safety measures. The add-ons should alleviate some concerns, but not all of them.

The ADAP Advocacy Association has also traditionally opposed drug importation, but it remains open to dialogue on the issue. Like most public policy issues, there is no easy answer or solutions. To that end, drug importation will be part of the conversation during our 10th Annual Conference later this year.

To register for the 10th Annual Conference, go to our website.
__________
[1] American Association of Retired Persons (AAPR), Prescription Drug Re-Importation Question and Answer Sheet, 2016; available online at http://assets.aarp.org/www.aarp.org_/articles/international/ReimportationQA.pdf.
[2] Gallup, Cost Edges Access as Most Urgent U.S. Health Problem, December 7, 2016; available online at http://www.gallup.com/poll/199169/cost-edges-access-urgent-health-problem.aspx?g_source=prescription+drug+costs&g_medium=search&g_campaign=tiles
[3] Renal & Urology News, Almost 1 in 10 Americans Can't Afford Medications Says CDC, February 4, 2015; available online at http://www.renalandurologynews.com/news/cdc-americans-can-not-afford-medications-eight-percent/article/395374/
[4] American Association of Retired Persons (AAPR), AARP Response to Senate Block on Prescription Drug Importation Legislation, December 11, 2009; available online at http://www.aarp.org/about-aarp/press-center/info-03-2010/aarp_response_tosenateblockonprescriptiondrugimportationlegislat.html.
[4] Partnership for Safe Medicines, Patient Advocates Warn of Dangers of Black Market HIV Medicines, May 21, 2014; available online at http://www.safemedicines.org/2014/05/patient-advocates-warn-of-dangers-of-black-market-hiv-medicines5-22-14.html.
[5] Pharmaceutical Research and Manufacturers of America (PhRMA), Fact Check Friday: The truth about drug importation and patient safety, February 24, 2017; available online at http://catalyst.phrma.org/fact-check-friday-the-truth-about-drug-importation-and-patient-safety.
[6] Pharmaceutical Research and Manufacturers of America (PhRMA), Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients, February 23, 2017.


Thursday, February 16, 2017

Get Ready to "SYNC" to Better Coordinate HIV, HCV, and LGBT Health

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

The ADAP Advocacy Association has collaborated with HealthHIV – which is one of the most respected national HIV organizations – numerous times over the last 5 years to promote access to care and treatment-related issues for people living with HIV/AIDS. This year, we're proud to promote HealthHIV's National Conference for HIV, HCV, and LGBT Health – or as its commonly called: SYNChronicity (SYNC 2017). SYNC 2017 is slated for April 24th-25th, in Arlington, Virginia, at the Renaissance Arlington Capital View Hotel.

SYNChronicity 2017: The National Conference on HIV, HCV, and LGBT Health. April 24-25, 2017. Renaissance Arlington Capital View Hotel. Arlington, VA.




With the rapid changes and challenges in the health care sector, the need to come together and "SYNC" on pressing issues from access to delivery is greater than ever. SYNC 2017 participants will receive training on a variety of HIV, HCV and LGBT-related health topics, and have the unique opportunity to engage with clinicians, service providers, government officials, community-based organization leaders, advocates, and others. Together they will SYNC systems, data, programs, models, interventions and policies to generate targeted solutions and approaches within a dynamic health care environment. Continuing education credits will be offered.

The agenda is expanded to include LGBT health with the National Coalition for LGBT Health co-hosting SYNC 2017. It will feature five (5) plenary sessions and five (5) breakout tracks —Preventative Health, MSM of Color Health, HCV Health, LGBT Health, and Systems Health. Each track will feature three (3) sessions. Various educational offerings will be provided following the conference via webinars and an app with available resources—keeping participants synched throughout the year.

Early registrants qualify for discounts, and a small number of SYNC 2017 scholarships are available. Complete information and registration is available at SYNC2017.org.

For more information, contact Terrence Calhoun, Meetings & Conferences Manager, by email at terrence@healthhiv.org or by phone at (202) 507-4723.

SYNC SOCIAL MEDIA LAB















HealthHIV and AIDS.gov are teaming up to offer a Social Media Lab during the conference. It’s THE place to bring your digital communication questions, big or small. Come in to learn how to set goals for your social media efforts and then measure impact. Do you want to learn what others in the community have done? Looking at how Twitter, Instagram or Snapchat could fit into your communications planning? Plan to visit the lab, and stay tuned for more details in upcoming conference e-mails.

Thursday, February 9, 2017

California has an ADAP Problem

By: Marcus J. Hopkins, Blogger

A contentious switch in contractors approved by the California Department of Health’s Office of AIDS (CDPH/OA) in 2016 has had several negative consequences, including two lawsuits from the previous contractor, lost applications, dropped coverage, a broken application system, and wrongly denied coverage for California ADAP clients. In other words, it is a complete mess in California.

The AIDS Drug Assistance Program (ADAP), Part B of the Ryan White CARE Act (RWCA) is designed to be the “payer of last resort” for patients living with HIV/AIDS whose incomes fall near enough to the Federal Poverty Level (FPL) to make affording the cost of care prohibitive, if not entirely unaffordable. As such, ADAP clients come to rely upon the uninterrupted delivery of those services in order to effectively treat their HIV infection, address co-morbidities, and achieve and maintain the viral suppression that makes transmission of the virus highly unlikely. By those measures the state of California has abjectly failed the charges whose health the ADAP program was intended to address.

California Department of Public Health (CDPH)

The process that resulted in California’s dereliction of duty began in October 2015, when the initial Request for Proposal Process (RFP) was sent out. The initial RFP followed state guidelines using a 1,000-point allocation system to award the bid to contractors. Consistent with government regulations, the actual monetary bid for the contract (“Cost Calculation”) was weighted at 75% (750 points) and “Technical Calculation” requirements were weighted at 25% (250 points), with a contract term of three years with two one-year extensions for a total of a five-year contract (Hews, 2016).

Using this state-mandated RFP, the then-existing contractor, Ramsell Corp (Oakland, CA) submitted a bid of $900,000 per year, with no increases over the five-year period, for a total of $4.5 million for the Enrollment Benefits Management (EMB) part of the program – the process where clients apply for coverage and maintain enrollment in the program. A competing bid was submitted by Michigan-based A.J. Boggs & Co., Inc.: $4,699,585 for the first year, $2,212,563 for the second, $2,208,767 for the third, $2,211,532 for the fourth, and $2,235,012 for the fifth and final year, totaling $13,567,459 – a bid roughly $9.067 million higher than Ramsell’s (Hews).

Under the terms of the RFP, point allocation to the lowest bidder – Ramsell – would have been 750 points, while Boggs would have received 296 points, using the state-mandated formula. That was the case, until CDPH/AO Procurement Officer, Jeffrey Mapes, changed the terms of the RFP on December 03, 2015, reversing the calculations so that the Technical Calculation became weighted 75% and the Cost Calculation, weighted by 25% (Hews). Mapes’ actions, along with simple math miscalculations, led the Boggs being awarded the new contract on March 04, 2016.  Ramsell, unaware of these changes and miscalculations, submitted a Freedom of Information Act (FOIA) request for all documents related to the Boggs bid – a request whose fulfilment was delayed and incomplete. 

Realizing the errors in the process, Ramsell submitted a protest on April 06, 2016, from which the following excerpt comes:
We are concerned that the amount of time that has been allotted for system beta testing and enrollment worker training is not adequate. The Office of AIDS has notified us that the new system is still being developed, beta testing has not yet begun, and enrollment worker training will not begin until just weeks before the July 1st transition.  Further, the system is transitioning from one to three contractors which will require additional coordination to effectively serve clients. In order to ensure a seamless transition, we believe additional time is necessary to adequately beta test the new system, train enrollment workers, and ensure time for feedback on what works properly and what needs improvement (Otiko, 2016).
In June 2016, Ramsell Corp filed two separate suits related to the EBM and the Pharmacy Benefits Management (PBM) contract awarded to Magellan Rx Management, LLC. The EBM suit alleges that:
…after Ramsell complained about major defects in the unfair procurement, CDPH cancelled the award to Boggs, and then gave them an illegal, sole-sourced contract only days later in violation of the requirements of the State Contracting Manual. The lawsuit also notes that the Boggs’ bid was about three times higher ($9 million more) than the Ramsell bid (Allen & Barajas, 2016).
The PBM suit alleges that:
…in procuring the new contracts, CDPH: (1) failed to follow its own rules as set forth in the Request for Proposals (RFP); and (2) conducted the procurement in a biased manner that was slanted in favor of the out-of-state companies (Allen & Barajas).
Despite these lawsuits being filed, CDPH/OA continued the transition to the three new vendors, which also included Pool Administrators Inc. (which covered the Health Insurance Premium Payments (OA-HIPP) and Medicare Part D premium payment programs), effective July 01, 2016 (Grimes, 2016). Since that transition occurred, ADAP clients, healthcare providers, clinics, pharmacies, and AIDS Service Organizations (ASOs) have experienced numerous problems accessing coverage.

Clients have been turned away at pharmacies, forced to postpone medical procedures, and some have been dropped from the program, altogether (Gorman, 2017). Additional complaints from patients and caseworkers allege that reimbursement claims have been repeatedly rejected (Allday, 2017) and patients have been dropped from the health insurance because ADAP failed to send premium payments to the correct address (Gorman). Dr. Karen Smith, director of California’s Public Health Department, stated in a letter to state Senator Scott Wiener (D-San Francisco) that: 
Shortly after [the department switched to new contractors in July 2016], …CDPH received a letter from constituents expressing concerns that there were issues for some clients receiving medications.  …As you note, the ADAP portal was unexpectedly unavailable for ADAP enrollment worker and client use as of November 29, 2016, due to information security vulnerabilities in the system. …To ensure uninterrupted client access to medications, we have extended client eligibility to their next reenrollment or recertification date occurring after June 30, 2017 (Hemmelgarn, 2017). 

Photo of California State Senator Scott Wiener
California State Senator Senator Scott Wiener; Gloss Magazine

Dr. Smith noted that her agency identified two separate breaches of information, and that impacted clients were notified. Those breaches, however, led to the online portal, where patients could register, re-enroll, and re-certify, being taken offline indefinitely on November 29, 2016. As of January 23, 2017 – just seven days short of the January 30 extension deadline – that online portal has not been replaced. This failure on the part of Boggs forced patients and caseworkers to register for ADAP by fax – a process that took weeks, due to a shortage of both fax machines and customer service workers to handle the load (Allday).

In response to patients being unable to access pharmacy services due to complications with PBM contractor, Magellan, the staff at Magellan were authorized by the state 
…to provide real-time, 24 hours a day, seven days a week authorizations to pharmacies for a 30-day supply of medications for ADAP clients with active eligibility who experience access issues at the pharmacy (Hemmelgarn). 
While this step is a nice quarter-way measure to ensure that active patients – those who have not been erroneously dropped or unable to enroll or certify – can gain access to their lifesaving HIV medications, it in no way serves as a long-term solution to address the myriad disasters that this ill-advised contract switch has created. For those patients, providers, and caseworkers who have been unable to successfully register clients, process claims, pay premiums, or be successfully reimbursed, this disastrous transition is entirely unacceptable.

Further frustrating already harried caseworkers and providers is that this transition from one California-based, minority-owned contractor (Ramsell) to three out-of-state contractors, one of which is inexperienced in the arena, could and should have been entirely avoided, had the CDPH/OA complied with the state-mandated RFP process and properly calculated the points, even within the new calculation. That Ramsell Corp, a company that had successfully provided services to California’s ADAP program for nearly twenty years, was summarily dismissed and their bids rejected in what appears to be retaliation for filing a formal protest in response to the procurement process is foolish behavior on the part of the CDPH/OA.


CDPH/OA’s failure to follow even the most basic statutes indicates the need for a new Procurement Officer, as Jeffrey Mapes’ unexplained and potentially illegal (Hews) actions indicates that he is unfit for the position. California’s patients deserve better, and until there is a permanent fix in place, it is incumbent upon all California residents, advocates, caseworkers, and providers to keep the pressure on the CDPH/OA.

According to sources, the Health Resources & Services Administration (HRSA) at the U.S. Department of Health & Human Services is aware of the situation and monitoring it.


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.


References:

Friday, January 27, 2017

Despite Treatment Improvements, Patients Remain Concerned about Lipo

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

In 2016, a lot of attention was devoted to raising awareness about lipodystrophy by the ADAP Advocacy Association — including blogs, webinars, and public comment. Whereas some advocates might see this effort as inconsequential, or even trivial considering the larger ongoing debate about access to care and treatment, it isn't either for the patients living with the condition. HIV-related lipodystrophy is very real, and its impact on the patients living with the condition shouldn't be discounted. In fact, raising awareness about lipodystrophy and treatment for the condition is consistent with our mission to improve access to care for persons living with HIV/AIDS.

HIV-related lipodystrophy can manifest itself as fat loss or fat buildup or both. It isn't uncommon for people living with HIV-infection to express concern about developing facial wasting, belly fat, lipomas, or the dreaded "buffalo hump" on the back of the neck.

Photo of man living with HIV-related lipodystrophy
Photo Source: Boston Globe

Lipodystrophy can also contribute to certain co-morbidities and health risks, such as too much fat gain in the abdominal cavity increasing the risk of heart attack and diabetes.[1] There are also psychological effects, such as depression, feeling socially isolated, and suffering from low self-esteem.[2]

According to the National Alliance of State & Territorial AIDS Directors' (NASTAD) 2016 National ADAP Monitoring Project Annual Report, approximately 50% of clients on the AIDS Drug Assistance Program (ADAP) are age 45 or older.[3] It is safe to assume that many of these ADAP clients are long term survivors, who probably were prescribed some of the older, more toxic antiretroviral medications. Many of these medication, in fact, have been attributed to HIV-related lipodystrophy.

"HIV long-term survivors are primarily impacted by lipodystrophy because it was a side effect of several of the earlier treatments," said Tez Anderson, founder Let’s Kick ASS. "Lipodystrophy is more than cosmetic. Exacerbated by body shape changes, such as facial wasting or the appearance of a distended stomach associated with excess visceral adipose tissue (VAT) is associated with a variety of health concerns, like diabetes and cardiovascular disease."

According to Anderson, lipodystrophy may increase the risk for comorbidities and may worsen a person’s quality of life and body self-image. "Too many HIV long-term survivors, lipodystrophy is like battle scars from decades of living with HIV. Talking to your doctor about it is important," he argued.

Robert Reed, who is 55 years old and HIV-positive for nearly half of his life, summarized how lipodystrophy impacted his life: "I was in very severe depression and refused to leave my house (unless for doctor's appointments) or go anywhere, until last year's ADAP Advocacy Association annual conference in Washington, DC. Lipodystrophy and the subsequent fear someone may say something about my weight led me to live in isolation for eight long years. Fortunately, I'm now on treatment for the condition."

People newly diagnosed with HIV-infection are also concerned about lipodystrophy, evidenced by a recent submission to TheBody.com's "Ask the Experts" forum:[4]
"Dear Dr. Pierone;
If someone started HAART today with one of the 5 recommended first line regimens, and he did everything else by the book ( stay fit, eat healthy, keep his total cholesterol, HDL, LDL, triglycerides and glucose levels within normal limits), what would be the likelihood (in a rough percentage figure, if possible) that he would develop lipodystrophy after 15-20 years on therapy?
Looking forward to your answer. Thanks a lot for you input, John"
The exact cause of lipodystrophy is unknown. It is estimated that between 10-30% of patients will develop the condition. For years, there's been a common misconception that this condition is just a physical cosmetic issue that is a side effect of earlier HIV treatments — something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer antiretroviral medications this condition continues to exist. Thus, we will continue our advocacy efforts in 2017 on HIV-related lipodystrophy.

Read our related blogs on this topic:

__________
[1] National Institutes of Health (NIH); AIDSinfo.gov; "Side Effects of HIV Medicines"; 2016.
[2] POZ Magazine; "Changes to Your Face and Body (Lipodystrophy & Wasting)"; February 14, 2016.
[3] National Alliance of State & Territorial AIDS Directors (NASTAD); "2016 National ADAP Monitoring Project Annual Report"; 2016; page 19.
[4] TheBody.com; Ask The Experts; "Current Regimens and Lipo"; October16, 2016.

Thursday, January 19, 2017

Social Workers & HIV Community Resources

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

The ADAP Advocacy Association prides itself on bringing together ALL stakeholders concerned about improving access to care and treatment for people living with HIV/AIDS, namely through the AIDS Drug Assistance Program (ADAP). To that end, one of the most important — and arguably most under appreciated — stakeholder groups in this fight are social workers. Social workers specializing in HIV/AIDS-related supports and services often facilitate critical linkages to care for their patients.

The National HIV/AIDS Strategy (NHAS) recognizes the critical role being played by social workers because they are uniquely positioned to integrate all facets of the care continuum. In fact, many of the NHAS' key indicators cannot be achieved without social workers on the front lines — mainly increasing the percentage of persons with diagnosed HIV infection who are retained in HIV medical care to at least 90 percent, and reducing the percentage of persons in HIV medical care who are homeless to no more than 5 percent.[1]

Since the dawn of the epidemic, social workers have made the difference between life and death for countless people living with the disease. In fact, Michael Shernoff, MSW summarized it best in 1990 when he penned the following:

"This profession can be justly proud of the often pioneering work done by social workers from the onset of the AIDS health crisis in developing psychosocial services of singular diversity and effectiveness that reach out to people infected and affected by HIV. Even before the significance of HIV was known and complete knowledge of the modes of transmission was verified, social workers began to make important contributions to all professionals' understanding of AIDS."[2]

Linkages to care characterizes where social workers fit within the care continuum.We need to be doing more to support their efforts, too.

The premier event for social workers specializing in the HIV/AIDS treatment area is the National Conference on Social Work and HIV/AIDS. In fact, on May 25—28 in Atlanta, Georgia, social workers will convene annually for the 29th time to participate in discussions focusing on "Ending HIV/AIDS through Social Justice: Health Equity for All!" The Boston College School of Social Work sponsors the conference.

Photo of the Atlanta skyline with the words, "Save The Date: May 25-28,2017"
Photo Source: Collaborative Solutions, LLC

The ADAP Advocacy Association for the last several years has convened its ADAP Regional Summit in the South, in order to call attention to the epidemic's disproportionate impact on the region. We're excited to see that the National Conference on Social Work and HIV/AIDS is convening in the South for that very same reason. According to the conference website, "...the Southern region of the U.S. is experiencing an unprecedented increase in HIV cases; which is why it is fitting for us to convene this year’s conference in the heart of the South."

In 1990, Shernoff lamented the social injustice faced by people living with HIV/AIDS during the previous decade. Nearly twenty years later, his words still ring true evidenced by the chosen theme for the 29th Annual National Conference on Social Work and HIV/AIDS. No matter how much things change, they stay the same.

Learn more about the conference online at http://nationalconferenceonsocialworkandhivaids.com. Questions? Contact them at Info@NationalConferenceOnSocialWorkandHivAids.com.

Additional resources include:
__________
[1] AIDS.gov; U.S. Department of Health & Human Services; "National AIDS Strategy"; 2017.
[2] Shernoff, Michael; The Body Dot Com; "Why Every Social Worker Should Be Challenged by AIDS"; 1990. 

Thursday, January 12, 2017

10 Years of Accomplishment, Advocacy & Access to Care

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

It is hard to believe it is true, but 2017 marks the 10-year anniversary for the ADAP Advocacy Association. What started out as an idea by our founder and co-chair, William "Bill" Arnold, and a small start-up grant from Ramsell Corporation, has bloomed into a national voice for people living with HIV/AIDS who rely on the AIDS Drug Assistance Program (ADAP). Throughout these ten years one thing has remained true, that the voice of people living with HIV/AIDS shall always be at the table and the center of the discussion.

One of our greatest accomplishments was launching the ADAP Directory, which was initially made possible by generous grants from AbbVie, Merck, and Walgreens. The groundbreaking approach provides a one-stop online resource center for the latest ADAP information for better decision-making for HIV/AIDS care, improved quality of HIV/AIDS information, and assistance for advocates and care providers. In 2016, over 21,000 users visited the ADAP Directory. Additionally, last year we added the "ADAP Eligibility Calculator" as a new user-friendly, patient-centric tool — powered by Pill Pack — designed to provide additional information about possible ADAP eligibility.

The ADAP Directory

Years earlier during the ADAP waiting list crisis, we hosted an Emergency ADAP Summit in Fort Lauderdale just as the Florida ADAP was on the verge of kicking nearly 3,000 patients off of the program. The event embodied activism in motion because patients were speaking out against the growing waiting lists. Behind the scenes the former President & CEO of the Heinz Family Philanthropies, Jeffrey Lewis, was bringing together the necessary players to launch the Welvista Solution — which provided life-saving medications to literally thousands of people living with HIV/AIDS on ADAP waiting lists. We were honored to have played a role in making it happen.

Advocates protesting ADAP waiting lists.

That same year, we released Public Service Announcements on ADAPs to raise awareness about ongoing the ADAP waiting list crisis. The 60-second PSA aired over six weeks from February 21, 2011, to April 3, 2011, over 210 media outlets nationwide. The PSAs were produced by Neil Romano of The Romano Group, LLC – who worked on campaigns such as "Just Say No" and "America Responds to AIDS."

Public Service Announcement on ADAP showing patient with the words, "teammate & friend."

2017 is a new year, and with it will undoubtedly come new challenges. There remains much uncertainty over the incoming Trump Administration and its implications for the Affordable Care Act and the Ryan White CARE Act. For now, we are continuing to focus on what has been our stable approach to advocacy: the patients voice! Our 10th Annual Conference — which is slated for September 22-23, 2017 in Washington, DC — is being themed, "Unchartered Water: AIDS Drug Assistance Programs in the Age of Trump." In addition, possible collaborative projects are being planned with the AIDS Healthcare Foundation (AHF), Community Access National Network (CANN), HealthHIV and the Professional Association of Social Workers in HIV & AIDS (PASWHA).

This year, two special education projects are planned to improve access to care among transgender men and women living with HIV/AIDS, as well as linkages to care for incarcerated (and formerly incarcerated) populations. As in years past our Scholarship Fund will ensure that the patients voice remains front and center, and this objective couldn't be achieved without the fund's two chief funders, CANN and Housing Works, as well as the many other supporters.

Access to care has been at the center of our mission, and it will continue to do so. Adherence is key to HIV treatment working, thus promoting a robust AIDS Drug Assistance Program is vital to combatting the disease and ending the epidemic. Though our focus is almost exclusively on ADAPs, we will continue to work with advocates, community, health care, government, patients, pharmaceutical companies, and other stakeholders to raise awareness, offer patient educational program, and foster greater community collaboration.

In closing, we would like to thank our funders because our 10th anniversary couldn't happen without their past and ongoing support. Since 2007, our funders have included: Abbott Laboratories, AbbVie, AIDS Alabama, AIDS Drugs Online, AIDS Healthcare Foundation, Alibi Wilton Manors, American Association for Homecare, Audio Visuals & Computer Services, Bender Consulting Services, Biotechnology Industry Organization, Bristol-Myers Squibb, Broward House, Community (A Walgreens Pharmacy), Community Access National Network, Dab the AIDS Bear Project, DC's Most Fabulous Magazine, Diplomat Specialty Pharmacy, Duane Reade Pharmacy (A Walgreens Pharmacy), EHiM, EMD Serono, Elwyn Specialty Care, Flowers Heritage Foundation, Forthright Strategies, HealthHIV, HMS, Housing Works, Genetech, GettingHired.com, Gilead Sciences, Great Lakes ADA Center, Janssen Therapeutics, Job Accommodation Network, Justin's Cafe, Kellari, Kimptons Hotels & Restaurants, Macsata-Kornegay Group, MedData Services, Merck, MOMS Pharmacy, Morgali Films, Mylan Pharmaceuticals, Napo Pharmaceuticals, Number 9, O.B. Sweet, OraSure Technologies, Patient Access Network Foundation, Patient Advocate Foundation, Pharmaceutical Research and Manufacturers of America, Philadelphia FIGHT, Pill Pack, Public Sector Solutions, Ramsell Corporation, The AIDS Institute, Theratechnologies, Social Security Administration's Ticket-to-Work, Southern AIDS Coalition, Southwest Airlines, Starbucks, SunTrust Bank, Turing Pharmaceuticals, Vertex Pharmaceuticals, ViiV Healthcare, Walgreens, We Movement, Wells Fargo, Women's Institute For A Secure Retirement, and World AIDS Institute.

But most of all, we would like to thank the thousands of individual supporters who joined our organization, attended our educational events, and/or donated to us. We couldn't have reached 10 years without you!