Friday, March 30, 2018

Controversial History with HIV Disqualifies Robert Redfield from CDC Service

Guest Blog By: Marcus J. Hopkins, Blogger

Robert Redfield, a 66-year-old virologist and physician, has been appointed to be the head of the U.S. Centers for Disease Control and Prevention (CDC) by U.S. Health and Human Services (HHS) Secretary Alex Azar (Sun, 2018b).  Redfield has replaced the acting head of the CDC, Principal Deputy Director Anne Schuchat, after the Trump Administration’s first pick, Brenda Fitzgerald, was forced to resign because she failed to divest from her “complex financial interests” “…in a definitive time period” (Sun, 2018).

Fitzgerald’s financial interests were so “complex” that she was essentially permanently recused from participating in the agencies activities and was unable to testify before Congress on public health issues.  Appointed by Trump’s first HHS Secretary, the disgraced Tom Price, Fitzgerald repeatedly dismissed concerns about her financial interests, and yet, had to cancel each appearance before Congress because of said interests.

Under Azar, Redfield is yet another controversial pick to head up the nation’s primary health organization.  Redfield has a long and storied history of controversial positions related to HIV and public health.

Photo Source: Gay Today

Beginning with his tenure within the Defense Department, Redfield helped create a disastrous and non-confidential policy of testing all troops for HIV beginning in October 1985 (Garrett, 2018).  Troops who tested Positive for HIV often found out after their entire chain of command, and anyone found to be HIV+ was immediately barred from service.  In addition, Active Duty personnel were also tested, and if found Positive, were often subjected to mistreatment, including isolating HIV+ personnel in isolated barracks colloquially referred to as “the leper colony,” where they were treated like prisoners until they fully developed AIDS or were dishonorably discharged.  By 1989, 5 million troops were tested, and roughly 6,000 testing Positive (Garrett). 

In the 1990s, Redfield was yet again embroiled in HIV chicanery when internal memos were obtained by Public Citizen, a left-leaning non-profit organization that represents patients, citizens, and consumer rights through advocacy and policy research.  These previously unrelease memoranda demonstrated clear evidence that Redfield led a: 
…systematic pattern of data manipulation, inappropriate statistical analyses, and misleading data presentation by Army researchers in an apparent attempt to promote the usefulness of the GP160 AIDS vaccine…which [was] intended to prevent the progression of disease in persons with HIV infection (Public Citizen, 1994).
In Phases I and II studies, researchers at the Walter Reed Army Institute of Research, led by then-Chief of the Department of Retroviral Research, Robert Redfield, and were published in many scientific fora (plural for “forum”), including the New England Journal of Medicine, AIDS Research and Human Retroviruses, and at the International AIDS Conference in 1992.  The fabricated results were also twice falsely presented before hearings of the House Subcommittee on Health and Environment.

This repeated demonstration of a lack of ethics, moral fortitude, and integrity make him clearly unfit to head that nation’s leading health organization.  Dr. Peter Lurie, President of the Center for Science in the Public Interest (CSPI), goes further in his full-throated opposition to Redfield, stating that, as the head of the CDC, we would get “…a sloppy scientist with a long history of scientific misconduct and an extreme religious agenda” (Lurie, 2018).  We at ADAP Advocacy Association could not agree more with this assessment.

The Trump Administration has repeatedly displayed a unprecedented lack of integrity on several front, but perhaps its worst offenses exist with its appointments – Betsy DeVos, Scott Pruitt, Mick Mulvaney, Tom Price, Mike Pompeo, Rex Tillerson and Ryan Zinke.  Each of these appointments stands on their own in terms of their unpreparedness, lack of candor, and incompetence within their positions, rife with conflicts of interest, unacceptable levels of spending on personal travel and completely unnecessary “security upgrades,” and serving not the interests of the American public, but either the interests of corporations who have long derided the wings of government they now lead, or their own.  Robert Redfield is just the latest example of this failure to understand either the complexities of the positions to which they are appointed, or the roles of this organizations in American governance.

Enough is enough.  Redfield must, as his predecessor before him, be flushed out of the CDC before we become the laughing stock of the world.

  • Garrett, L. (2018, March 23). Meet Trump’s New, Homophobic Public Health Quack. Washington, DC: Foreign Policy. Retrieved from:
  • Lurie, P. (2018, March 21). CSPI Urges Administration Not to Appoint Dr. Robert Redfield, with History of Scientific Misconduct, as CDC Director. Washington, DC: Center for Science in the Public Interest: News. Retrived from:
  • Public Citizen. (1994, June 07). Washington, DC: Public Citizen. Retrieved from:
  • Sun, L.H. (2018a, January 31). CDC director resigns because of conflicts over financial interests. Washington, DC: The Washington Post: News: To Your Health. Retrieved from: 
  • Sun, L.H. (2018b, March 21). Longtime AIDS researcher Robert Redfield picked to lead CDC. Washington, DC: The Washington Post: News: To Your Health. Retrieved from:

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 22, 2018

Kudos to Janssen for its 2017 U.S. Transparency Report

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

On March 20th, Janssen Pharmaceutical Companies of Johnson & Johnson hosted a stakeholder meeting in Washington, DC to unveil its "2017 Janssen U.S. Transparency Report" and also promote a dialogue on value, access, and pricing transparency. It is the second time the company has released the comprehensive report, and as such the ADAP Advocacy Association extends its kudos to them for doing so. Patient advocacy groups are often left out of these conversations, yet patients are the people who have the most to gain from transparency. Numerous disease patient advocacy groups were also in attendance, including groups representing people living with diabetes, rheumatoid arthritis, and various mental health conditions.

(Editor's Note: This blog is not intended to be an endorsement of any product made by Janssen Pharmaceutical Companies of Johnson & Johnson but rather acknowledge their efforts to educate stakeholders on their corporate responsibility)

The transparency report highlights four key areas, including Janssen's ongoing investments in new medicines, value assessments, pricing and patient access, and resources for patients. An increasing amount of the public policy discussion has focused on drug pricing, so the information conveyed by Janssen in the report helps patient advocacy groups like ours (and others) refine their areas of interest. It is also important to gain insight into Janssen's work to develop new medicines considering the complexities of the current health care system.

The purpose behind the transparency report is spelled out in a letter from the company leaders, Jennifer Taubert, company group chairman, and Anastasia G. Daifotis, MD, chief scientific officer:
"We want this information to be useful to all our stakeholders: patients, families, caregivers, and advocates, who are asking questions about out-of-pocket costs for medicines and what resources are available to help them; health care professionals, who are increasingly being asked to consider the overall value of the medicines they prescribe; policymakers, who are working to make policy changes to help their constituents get the care they need; and others in the health care system, like payers, who consider value and price information when they make decisions about coverage and access."
The report can be downloaded online at

Report cover for the "2017 Janssen U.S. Transparency Report" available online at

The stakeholder meeting also featured an interactive panel discussion on Innovation, Pricing & Patient Access, as well as another one on Moving to a Value-Based Approach. Each included representatives from Janssen Pharmaceutical Companies, but also independent experts who were asked to share their insight. The two panels offered good analysis on the oddities of the current health care system, and some tough questions from the audience about what needs to change.

The panels discussed numerous issues, including medication adherence, rebates, insurance discriminatory design, valued-based contracting, importation, among others.

Adam Fein, CEO of the Drug Channels Institute, outlined the problem with the "gross-to-net bubble," as he phrased it. For example, whereas the average net prices offered by Janssen declined by 4.6% last year, it is unlikely the reductions were passed along to consumers. Interestingly too, Fein noted that 9 out of 10 drugs on the market are relatively inexpensive with low-cost generics available. However, it is the 1:10 specialty drugs that are the true cost-drivers.

Dan Leonard, President of the National Pharmaceutical Council, addressed the question over value by noting sick people are currently subsidizing the healthy people. Leonard's analysis echoed the recent remarks by U.S. Food & Drug Administration (FDA) Commissioner Dr. Scott Gottlieb. Leonard also touched on how most insurance benefits are valued from the point of sale, except for drug costs due to the complexities of the existing market (i.e., rebates).

One of the more notable  and troubling  observations was shared by Janssen's own, Dr. Anastasia Daifotis. Upon answering a question from a stakeholder in attendance at the event, she said transparency is important because it sheds light on the rise in non-medical switching and how these patient decisions are being driven by budget and not appropriate patient care.

The ADAP Advocacy Association recognizes that the cost of pharmaceuticals is an important part of the broader conversation about the current health care system. In fact, many of the specialty drugs mentioned earlier in this blog directly impact the HIV/AIDS community, and unfortunately we've witnessed patient cost-sharing for these therapies increase under many insurance exchanges. We encourage more conversations like the one hosted by Janssen, and also to reserve a seat at the table for the patient perspective. It is imperative!

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

Guest Blog 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