A Secure Drug Supply Chain is the Best Anti-Counterfeiting Technology We Have

By: Shabbir J. Safdar, Executive Director, The Partnership for Safe Medicines

There are several technologies that have been developed to identify and weed out counterfeit medicines, from serialization to edible security tags on individual pills, but no anti-counterfeiting technology can take the place of a secure, and well-enforced medication supply chain.

Serialization, a central part of our Track & Trace system, provides unique identifying tags on individual packages of medication at the point of manufacture. It is an effective means of quickly spotting fake medicine. However, if you allow members into your supply chain that aren’t effectively regulated, or that are sloppy, it will not prevent patient harm. Though it will make it easier to find the problem after the fact in a follow up investigation by checking the serial numbers against numbers from the manufacturer.

One of PSM’s board members is fond of saying that no technology can protect you when someone is intent on trading your safety to make a dollar. Missing holograms can be ignored, serialized product can be mixed or repackaged with non-serialized product, and other means of making more money and endangering the patient. Serialization will always find the problem after the fact, but our safety goal is higher: we want to prevent such products from ever reaching patients in the first place.

Edible tags, such as the one’s being developed at Purdue University can make identifying genuine pills easier, but again, vigilance on the part of supply chain members is key to their success. A patient may be very interested indeed to find out if their prescribed medication is genuine but if their doctor does not bother to check, the security of edible tags is pointless.

Patients seldom see the packaging of injectable medications such as Avastin, used in cancer treatment; Prolia and Aclasta, used to treat osteoporosis; and Botox, used in treatments ranging from cosmetic to dental and ocular. Every one of these injectable treatments has been counterfeited and successfully sold in the United States, because no one bothered to the genuineness of the medication by examining the packages or checking lot and serial numbers or they had a financial incentive not to. In the case of counterfeit Avastin, U.S. authorities only discovered that American doctors were treating their patients with it when the United Kingdom’s MHRA alerted the FDA in 2012 to warn them that a fake version was in circulation.

If members of the secure supply chain do not carefully examine medication packaging and pills to verify that they genuine using anti-counterfeiting technology, drug counterfeiters can easily fool them with similar packaging and identical-looking pills and vials. The visual spotting of a fake by its label, box, or pill shape and color is imperfect, at best.

Lastly, there has been a lot of press about using blockchain technology to keep counterfeit drugs out of the supply chain. Manufacturers can use technological tracking of their products throughout the supply chain, but if any member of the supply chain ignores digital footprints for medication or fails to recognize their lack, blockchain falls apart and does nothing to protect patients. The best technology to protect patients from counterfeit medication is strong regulation, a secure supply chain, and clear consequences for manufacturers, wholesalers, distributors, and medical professionals who ignore or sidestep the supply chain. In every case where counterfeit medicine has reached patients, bad actors consciously breaking the supply chain put fake drugs in the hands of doctors, clinics, and pharmacies..

References:

• Lilly Serialization: https://www.lilly.com/products/anti-counterfeiting/serialization
• TC Medical: https://www.safemedicines.org/2015/05/canada-based-company-that-acted-as-drop-shipper-pays-33-million-fine-in-misbranded-drug-smuggling-case.html
• Securing Industry edible tags: https://www.securingindustry.com/pharmaceuticals/purdue-scientists-detail-edible-security-tags-for-medicines/s40/a11237/#.XjryFC2ZO9
• Black Market Cancer: https://www.safemedicines.org/2018/08/imported-black-market-cancer-meds.html
• Black Market Osteoporosis: https://www.safemedicines.org/2013/01/the-us-food-and-drug-administrationfda-has-issued-warning-letters-to-20-us-doctors-that-they.html
• Black Market Botox: https://www.safemedicines.org/2014/10/black-market-injectable-cosmetic-treatments-a-nationwide-problem-10-22-14.html
• PSM Fake Avastin: https://www.safemedicines.org/2012/02/mhra-fda-cooperation-rousts-counterfeit-cancer-drugs.html
• Reuters Blockchain: https://www.insurancejournal.com/news/national/2020/02/21/559057.htm

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.

Barriers Ahead for People Living with HIV on Social Security Disability Insurance?

By: Marcus J. Hopkins, Policy Consultant & Guest Contributor 

It’s been a tough few years for people living with HIV…at least as it relates to the determination of healthcare and disability benefits. After nearly a decade of hard-fought and mostly won battles to increase access to healthcare services and improve the quality of life for people living with HIV, the Trump Administration has spent three years doing its damnedest to roll back every one of those improvements via a death from a thousand cuts.

Those who are reading the ADAP Advocacy Association blog are likely familiar with HIV and the deteriorating effects the disease has on the body, particularly in those who have lived with the disease for a long time, have endured the effects of some of the earliest HIV medication regimens, have allowed the disease to go untreated, or are simply older and living with HIV. This is why most benefits-related decisions involving HIV have, traditionally, been made by or in consultation with infectious disease advocates, healthcare providers, or scientists who can explain to government officials how the disease works and why it is important to ensure that people living with HIV are able to remain productive members of society.

The Trump Administration, however, has openly done away with the antiquated and ridiculous notion that important decisions require expert knowledge and input. Instead, decisions have been made with virtually no notice, catching advocates and experts off guard across every aspect of our national governance. Those working in and around HIV (and virtually every other infectious disease) have spent three years attempting to figure out what move comes next from an administration that is flighty, capricious, unwilling to listen to reason, and unable to forecast next moves any better than anyone else.

In a recent meeting of the Federal AIDS Policy Partnership, this was the common refrain: “We have no idea how to plan for 2020, much less for 2021, because nobody knows what’s going to happen, next.” This sentiment was applied to Medicaid coverage, Social Security Disability Insurance (SSDI), and the President’s much vaunted, but unfunded Ending the HIV Epidemic (EHE) plan designed to decrease the number of new HIV infections in the U.S. by 75% by 2025.

On the SSDI front, since March 1st, 2017, people living with HIV have been subject to a Continuing Disability Review (CDR) to determine whether or not they are “still disabled”. This decision was reached because, rather than acknowledging the long-term impacts of HIV on the human body, this administration has chosen, instead, to look at those who are able to live and work without enduring many of the long-term side-effects of early HIV regimens or the deterioration of the body that people living with HIV face as they age. This is the famous argument of, “Well, you don’t look disabled to ME,” put into cruel effect.

Photo Source: PCT Law Group, PLLC

CDRs generally fall into one of three categories: “Medical Improvement Expected” (six-month to 18-month reviews), “Medical Improvement Possible” (reviews every three years), and “medical improvement not expected” (reviews every seven years). The Trump Administration is proposing a new category called, “Medical Improvement Likely,” which would initiate reviews every two years.

While these changes may seem minute to those living without a disability (HIV-related or otherwise), one of the most onerous barriers to overcome is constant reverification of one’s disability. Each review requires constant and consistent documentation to be kept and maintained, trips to and from offices, and long waits that place a strain on disabled people and on those living in poverty. Moreover, this kind of review process fails to take into account that most cases of disability are not static; they tend to be sporadic in nature, with flares, seasonal peaks, and can vary in length and severity (Cokley, 2020). This is particularly true of people living with chronic illnesses, such as HIV.

There have been times where my ability to work was severely limited by my HIV, even though I was virally suppressed. When I lived in Los Angeles, for whatever reason, I was prone to longer-than-average colds, flus, and bouts of gastrointestinal fireworks that would last for days (the latter of which continues, to this day). At the time, I was waiting tables and attempting to go to school, and instead, I would be laid up in bed, not making money, and unable to attend classes in person (though I attempted to attend class via Skype/web cam as often as possible). This is the reality of living with HIV, and although I have never applied for SSDI coverage, I probably should have.

Photo Source: PDFfiller Blog

It isn’t just SSDI reverification that is burdensome; a change during the Obama Administration requires those of us who rely on the Ryan White Program and ADAP to submit documentation for reverification every six months, rather than once a year. Adding an additional review process is time consuming and, frankly, both exhausting, and unwarranted. The “savings” achieved by these reviews is largely outweighed by the amount of unnecessary administrative costs required to conduct these reviews and re-verifications.

As much as the President and his sycophants talk a good game about how much they’re doing for HIV in the U.S., the truth is that most of his proposals are almost certainly calculated to punish those already living with HIV while instead focusing on (still unfunded) efforts to reduce the number of new HIV transmissions. Worse, still, is that both his and his administration’s tendency to spring new rules and announcements on the country with virtually no notice makes planning for the future a near impossibility. The other common refrain I hear at almost every meeting is, “Hopefully, the next administration won’t be as chaotic.”

Hopefully, indeed.

References:

• Cokley, R. (2020, January 30). The next move in Trump administration's war on the disabled. Atlanta, GA: CNN: Opinion. Retrieved from: https://www.cnn.com/2020/01/30/opinions/trump-administration-social-security-disability-benefits-cokley/index.html

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.

U.S. Court of Appeals Strikes Down Trump Administration's Discriminatory 'Deploy or Get Out' Policy

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

In January 2020, the U.S. Court of Appeals for the fourth circuit upheld a lower court ruling in Roe and Voe v. Esper, which allows the two HIV positive members of the air force to continue their service. This ruling also will prevent the discharge of any other airmen based on HIV status alone (Buhl, 2020).

Previously, the U.S. Air Force has justified the discharge of military service members living with HIV under the ‘Deploy or Get Out’ policy, which was first introduced in February of 2018. This policy stated that any service member who is deemed non-deployable for over a year would be subsequently discharged. This policy unfairly affected service members living with HIV, as the long-standing HIV policies within the Air Force and United States military consider HIV positive members non-deployable (Allen, 2018).

The plaintiffs in the Roe and Voe v. Esper case first requested a preliminary injunction in February 2018 in the district court for eastern Virginia.

The most recent case of Roe and Voe v. Esper was filed in December 2018 by Lambda Legal and the Modern Military Association of America, with pro bono co-counselors Winston and Strawn. After filing in December, the appeals court opinion concluded that since the government didn’t consider the low possibility of transmission of HIV, the Air Force denied the service members of their right as employees able to serve.

“These servicemembers, like other HIV-positive individuals with undetectable viral loads, have no symptoms of HIV. They take daily medication—usually one pill, for some people two—and need a regular, but routine blood test. They cannot transmit the virus through normal daily activities, and their risk of transmitting the virus through battlefield exposure, if the virus can be transmitted at all, is extremely low. Although transmission through blood transfusion is possible, these servicemembers have been ordered not to donate blood,” said the opinion (Lambda Legal).

According to the Center for HIV Law and Policy:

“Military policies and regulations – most of them codified in the Uniform Code of Military Justice – set forth consequences for conduct by service members living with or at risk of HIV,” (HIV Law and Policy).

According to The Body, Roe and Voe v. Esper case is one of three cases challenging military policies against service members living with HIV. Two others are currently being reviewed.

“Even though my commanding officer and doctors wanted me to stay in, the informal board recommended discharge, then a formal board of three members recommended discharge,” Roe said in reference to his experience with the Air Force.

Scott A. Schoettes is the HIV project director at the advocacy group Lambda Legal, who helped represent Roe and Voe in their plea at the court of appeals.

“The military is really the only employer in the United States that’s still allowed to do this. Everybody else you can hold accountable. You can sue under statutory protections for people living with HIV,” said Schoettes.

Roe and Voe will be able to continue serving in the Air Force under the recent court of appeals ruling.

References:

• Buhl, L. (2020, January 16). Federal Court Upholds Injunction Preventing Discharge of HIV-Positive Airmen. The Body dot com. Retrieved from https://www.thebody.com/article/appeals-court-injunction-discharge-hiv-military?ap=2008
• HIV Law and Policy Military. (n.d.). Retrieved from https://www.hivlawandpolicy.org/issues/military
• Allen, S. (2018, September 19). The Danger of 'Deploy or Get Out' Facing HIV-Positive Troops. The Daily Beast. Retrieved from https://www.thedailybeast.com/the-danger-of-deploy-or-get-out-facing-hiv-positive-troops
• Opinion: Roe and Voe v. Esper. (2020, January 10). Retrieved from https://www.lambdalegal.org/in-court/legal-docs/roe_va_20200110_opinion

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.

The Lion of Modern-Day HIV/AIDS Advocacy

By: Jeffrey R. Lewis

HIV/AIDS advocacy has had many champions since the 1980s. Each leader made significant strides in raising awareness, tearing down stigma and building support services to combat the epidemic. Among them are Larry Kramer, Jeanne White-Ginder, Jeffrey Crowley, Mary Fisher, Debra Frazer-Howze, Elizabeth Taylor, Elton John, and Ron Woodroof to name just a few. Mild mannered and stoiac, the lion of modern-day HIV/AIDS advocacy movement is a man who is often overlooked, William “Bill” Arnold.

You won’t find Bill’s face on the cover of Time Magazine or the front page of The New York Times. Neither is he featured in HIV media publications, such as POZ Magazine or TheBody. No segment has aired on CNN’s Heroes or CBS’s 60 Minutes. Bill prefers it that way.

Yet, Bill’s contributions cannot be understated. His behind-the-scenes work changed the course of HIV/AIDS advocacy in the United States saving countless lives. Literally!

Bill with The Honorable Donna Christensen

As founder of the Community Access National Network (formerly the Ryan White CARE Act Title II Community AIDS National Network) and its groundbreaking National ADAP Working Group (“NAWG”), Bill’s efforts solidified the transformative work behind the creation of the AIDS Drug Assistance Program (“ADAP”) and its eventual federal funding. Created in the 1990s, when advocates were mistrustful of the pharmaceutical industry and critical of the government’s slow response to the epidemic. Likewise, the industry was skeptical of some of the advocacy community’s brass-knuckles tactics, however necessary they were at the time. During the mid-1990s, ADAP was receiving zero federal dollars, compared to the roughly $1.3 billion per year allocated today.

Bill Arnold made that happen by bringing three reluctant but vital partners together.

Industry brought its traditional "corporate thinking" business models to the table. Advocates brought a decade’s worth of pain (witnessing 50,000 AIDS-related deaths per year). Government agencies brought an institutional understanding of the political process and “traditional” problem based solutions. The result was one of the most effective community uprisings in our nation’s history. Bill was able to fascilitate a collaborative approach that combined stakeholders’ assets. It saved a generation!

Years later, predicting the “perfect storm” besieging ADAPs forcing thousands of people living with HIV/AIDS onto waiting lists for services. Bill founded the ADAP Advocacy Association and (modeled after NAWG’s stakeholder partnerships). Bringing a second organization into the fold!

Bill ensured that persons living with HIV/AIDS would always be at the center of the discussion. He opened the doors to a new generation of advocates empowered to find their voices in the fight against this devastating epidemic.

But that wasn’t all he did.

In 2011, Florida’s ADAP was on the verge of total collapse which would leave thousands of Floridians without life-saving medications. Unbeknownst to most people, Bill worked with the Heinz Family Philanthropies and Ken Trogdon to broker a solution averting a major public health crisis. More than 11,000 patients in eleven states got the medications they needed as a result.

Few pieces of HIV-specific legislation have passed through Congress without Bill’s fingerprints somewhere on them. It’s rare for community healthcare leaders to remain on the White House Domestic Policy Counsel’s speed dial the way Bill has.

This year, remember Bill Arnold. A healthcare hero whose determination, passion, and relentlessness saved tens of thousands of lives by simply caring.  Bill is not a collector of bones or souls, rather of hearts and minds.

Editor's Note: Jeffrey Lewis is the President of Legacy Health Endowment in Turlock, California.  The views expressed are his own.

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.