Tag Archives: PhRMA

Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

The Community Access National Network (CANN) will be hosting a roundtable at the headquarters of the Pharmaceutical Research and Manufacturers of America (PhRMA) on Thursday, May 11th, 2017, on the topic of Hepatitis C (HCV) in Incarcerated Populations. The roundtable will focus on various aspects of treated HCV in prison and jail settings, including the Constitutional requirement that all inmates receive treatment, as well as various barriers that prevent inmates from receiving screening and treatment.

Invite for the Community Roundtable on Linkages to Care for Current/Former Incarcerated Citizens Living with Hepatitis C

Current estimates indicate that between 10-35% of inmates are infected with HCV, and that roughly half of those inmates don’t know that they’re infected. These estimates are, however, limited by inconsistent or non-existent screening protocols, reporting requirements, and various bureaucratic hurdles that prevent inmates from being screened. Furthermore, there are no penalties in place that hold prison and jail systems accountable for failing to screen inmates, which often results in costly lawsuits.

The Federal Bureau of Prisons released a new set of screening guidelines for HCV in October 2016, which included the recommendation that all prisons and jails adopt an “Opt-Out” screening process (Federal Bureau of Prisons, 2016). This strategy requires that HCV screening becomes part of a routine practice, and that inmates must provide “informed refusal” in order not to be screened. This strategy would be instrumental in combating the HCV epidemic running rampant among inmate populations, as well as for data gathering purposes.

Implementing this strategy across all prisons and jails in the U.S. in a difficult proposal, in no small part because it will be expensive. What makes it so expensive is that screening, itself, isn’t cheap – at least not the confirmatory tests; additionally, if prisons and jails discover that an inmate has HCV, or any other life-threatening illness, they are required under the 8th Amendment of the U.S. Constitution to treat that inmate’s illness (Estelle v. Gamble). That last part can cost prison systems tens of thousands of dollars fear each infected inmate – costs that will explode pharmacy and healthcare budgets in the short-term, but will save money in the long-term.

Furthermore, prisons appear to be extremely inconsistent about what prices they pay for drugs. The Wall Street Journal (WSJ) published a report in September 2016 per-patient cost paid by state prisons to treat HCV using Gilead’s Harvoni: the prices ranged from $46,021 in North Dakota to $91,014 in Georgia (Loftus & Fields, 2016). These numbers indicate the need for more price stabilization in the U.S. prison systems, or at the very least, consolidated price negotiation.

While the roundtable is open to the public, seating is limited. Interested parties can sign up for the event at the following address: http://tiicann.org/events.html

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Lessons Learned About HCV and Aging

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

On Thursday, December 8th, the Community Access National Network (CANN) hosted a community roundtable on Hepatitis C (HCV) and Aging at the Pharmaceutical Research and Manufacturers of America® (PhRMA) headquarters in Washington, D.C. The event featured four presenters – Ambrose Delpino (PharmD, practicing HIV pharmacist [AAHIVP], Senior Manager, Virology, Walgreens), Fabian Ancar (a patient who successfully achieved a Sustained Virologic Response [SVR] while co-infected with HIV and HCV), Marissa Tonelli (Senior Manager of Capacity Building, HealthHIV, and Senior Manager of HealthHCV), and Chris Taylor (Senior Director, Hepatitis, National Alliance of State and Territorial AIDS Directors).

Of the four presenters, Dr. Delpino presented the most statistically pertinent presentation (as the others spoke primarily about their experiences, research, and how their organizations engage in advocacy on the local, state, and Federal levels), and the statistics that we’ll be reporting, here, are from his slides. Some of the issues raised during this panel will be further explored in further posts, so this entry will serve as a summation of his main points.

On the basics of infection, Dr. Delpino’s presentation reported that 2.7–3.9 million Americans are estimated to be infected with HCV, with an estimated 17,000 new infections annually. Both he and HEAL Blog note that this estimation is likely very low, as HCV screening, disease monitoring, tracking, and reporting are notoriously problematic, as capturing certain populations (e.g. – Rural, People Who Inject Drugs (PWIDs), et cetera) is difficult at best. It is also estimated that one in thirty Baby Boomers (people born between 1945-1965) are infected with HCV – five times greater incidence than other adults. The estimated cost to the healthcare system, including HCV-symptom-related hospitalizations and treatments is estimated to be over $80 billion over the next ten years.

The primary reason why Baby Boomers (the “birth cohort”) are so much more likely to be infected is related to the facts that HCV is a relatively new discovery in terms of diseases, blood supplies were not adequately screened for HCV prior to 1992, and universal precautions related to sanitation were not, prior to the discovery of HIV, necessarily the standard of care (SOC). This means that anyone who received a blood transfusion or any other blood product prior to 1992 is at risk of having contracted HCV; this also means that anyone who received transplanted organs or had improperly sterilized equipment used on them prior to universal precautions being in place is also at risk.

Outside of the birth cohort, it is estimated that 60% of all HCV infections are believed to be related to injection drug use (IDU). For every 100 people infected with HCV, 75-85% will develop a chronic infection, 60-70% will develop liver disease, 5-20% will develop liver cirrhosis, and 1-5% will die as a result of their infection. What makes this frustrating for HCV advocates is that the cost per SVR in a single 12-week round of the most popular treatment (Harvoni – $94,500) is far less expensive in the short term than the long-term costs associated with chronic HCV infection.

In future posts, we will be examining the pipeline process that it often takes for patients infected with HCV to receive medications to treat their disease, one of the most compelling slides in Dr. Delpino’s presentation. We will also be sharing some of the personal testimony of the patient, Fabian Ancar, whose story was presented at the panel.

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

 

 

 

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Bayh-Dole Threat Sits Idle

By: Marcus J. Hopkins, Blogger

In January 2016, Rep. Lloyd Doggett (D-Texas) led a group of over 50 House Democrats in asking the Department of Health and Human Services (HHS) to open the door to using “march-in rights” to break patents whenever drug manufacturers set prices for their drugs prohibitively high. HHS Secretary Sylvia Matthews Burwell has, once again, maintained the HHS position that this simply isn’t going to happen.

If the concept of “march-in rights” seems confusing, that’s because it is. Essentially, the “march-in rights” provision of the Bayh-Dole Act allows the government to essentially ignore patent rights if government funding has been used in the creation of the patented product, and then, only if one of four criteria are met: (1) the right-holder “has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in the field of use;” (2) the right-holder has not reasonably satisfied “health or safety needs;” (3) the right-holder has not met public use requirements specified by federal regulations; or (4) the right-holder has not satisfied the Bayh-Dole requirements to give certain preferences to U.S. industry.

Image of a stethoscope wrapped around a $20 bill , laying next to an open medication bottle

Affordable Healthcare

The Bayh-Dole Act came about in response to the economic malaise of the 1970s and to the overly complicated and incredibly bureaucratic process of being granted a patent after using Federal resources to conduct research and development. After World War II, President Roosevelt was dogged in his pursuits of scientific breakthroughs and achievements, and funding was heavily stacked in favor of leading the world in those breakthroughs. However, prior to the Bayh-Dole Act, the government had acquired around 28,000 patents, but only 5% of them were used in commercial applications (General Accounting Office, 1998). The Act was supposed to solve those problems.

The unfortunate consequence of this Act has been that private entities can use endless government funds to create products that are intended to benefit the general public, turn around to file a private patent on said product, and essentially charge whatever they please for public use of said product. As a card-carrying Socialist, myself, I find this most perverse – that taxpayer-funded products should then be sold back to the taxpayers whose money already paid for it at a potentially exorbitant price is, to my way of thinking, capitalism at its absolute worst.

Particularly in the field of medicine, this practice has led to an explosion in two things: fast development in pursuit of higher profits and exponential increases in the price of usage. We went from a system in which children were given vaccines for childhood illnesses for free at public schools, to one in which parents are required to have their children vaccinated on their own dime, even though their dimes – along with everyone else’s – have already paid for those vaccinations.

As of January 2015, no Federal agency has exercised its march-in rights. To date, I believe that is still the case. This marks the sixth petition to the HHS to exercise its march-in rights to address the ever-increase pricing issues related to “specialty” drugs – drugs marketed to specifically address only a single disease or a single aspect of a disease – two of which regarded the use of Norvir (ritonavir). The first came in 2004 after the maker of Norvir, Abbott Laboratories (now AbbVie), raised the price of their drug by roughly 400% in the U.S…but, nowhere else in the world.

That’s right: nowhere else in the world does Norvir cost as much as it does in the U.S. Globally, the wholesale cost of Norvir is between $0.07 and $2.20 a day (Drugs[dot]com, n.d.); in the U.S., that cost is about $9.20 up to $55.00 per day, depending on the dose (International Drug Price Indicator Guide, 2014).

The HHS position on price-related march-in rights has been to essentially say, “It’s Congress’ job to deal with drug prices; not ours.” Sadly, I’m not certain that Congress may ever been in a position where that can be effectively done. Although there is certainly disagreement over the degree to which the Pharmaceutical Research and Manufacturers of America (PhRMA) influences Congressional action related to drug prices, there is little disagreement that the influence is there.

PhRMA is dogged in protecting its right to charge whatever it wants for product that they insist were made using their ingenuity alone, regardless of whose money was used in the making. They’re more than willing to receive billions of dollars in federal funds to create products that are meant to heal the public, but they’re less willing to charge reasonable prices for those taxpayer-funded products. Any suggestion that this practice is either unsavory or unethical receives the “This isn’t Communist Russia!” treatment, so favored by vulture capitalists. Furthermore, any movement to address the issue of drug pricing is met with threats of leaving the country to do business in “more hospitable” climes – basically, extortion – and no member of Congress wants to be seen as a “job killer.”

In the case of drug prices, however, something clearly must be done, whether or not the drug manufacturers like it, and if legislative efforts aren’t going to happen, maybe it’s time to march-in on these territories and start putting the taxpayers’ dollars to work FOR them, rather than against them.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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