Tag Archives: FDA

Who Funds the Opioid Epidemic (and the Subsequent HCV Epidemic)

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

Senator Claire McCaskill (D-MO) is planning to introduce a bill into the Senate that would require drug makers to report payments that are made to nonprofit organizations and patient advocacy groups (Silverman, 2018). This is an issue that HEAL Blog, as well as the Community Access National Network’s HIV/HCV Co-Infection Watch publication, has repeatedly brought up in our reporting.

Sen. Claire McCaskill

Photo Source: The Washington Free Beacon

State and Federal lawmakers have been attempting to place prescribing and use restrictions on prescription opioid drugs for the better part of two decades. There is a natural opposition that state and Federal lawmakers face from opioid manufacturing pharmaceutical companies, such as Purdue Pharma, maker of OxyContin, the first prescription opioid drug made available and marketed to average consumers rather than for use in palliative care and severe injury. But, that’s not where the pressure on lawmakers ends.

Purdue Pharma logo

Photo Source: Purdue Pharma

Where McCaskill’s proposal comes into play goes back much further, with pharmaceutical companies creating and funding nonprofit organizations to advocate for a single issue: Pain. Pain Advocates, since the late-1980s, have been actively lobbying Congress, the U.S. Food & Drug Administration (FDA), and state legislatures to push for easier access to these powerful drugs. Every time a legislator or the FDA attempts to reign in what was once virtually unfettered access to

Opioid drugs work by binding to opioid receptors in the brain, spinal cord, and other areas of the body and reducing the sending of pain messages to the brain, thereby reducing the feeling of pain. For Pain Advocates who claim to represent patients whose levels of daily or regular pain leave them unable to function normally, these drugs have been seen as necessary for their survival. What drug manufacturers who fought for easy access to these drugs failed to mention (despite knowing from their own research) is that opioid drugs are highly addictive.

I’ve personally encountered several pain advocates whose opposition to my advocacy for opioid prescribing restrictions in the state of West Virginia has been boiled down to this line of thinking: “How am I supposed to be a functional human being without these prescriptions?” In a state like West Virginia, which has the highest rate of drug overdose deaths in the nation (52 per 100,000) and potentially the highest rate of Hepatitis C (HCV) in the nation (7.2 per 100,000), this comes across to me as them really saying, “My pain is more important than the preventable spread of disease or others’ lives.”

As the rate of new HCV infections continues to rise, in some states like WV, exponentially, is that opioid drug abuse is directly tied to this meteoric increase. In a report from the National Institutes of Health’s (NIH’s) National Institute on Drug Abuse, data indicate that the incidence of heroin initiation (beginning to use) was 19 times higher among those who reported prior nonmedical pain reliever use than among those who did not. Further, a separate study cited by the NIH found that 86% of young, urban heroin injectors had used opioid pain relievers nonmedically prior to using heroin, and that their introduction into nonmedical use was characterized by three main sources of opioids: family, friends, and personal prescriptions (National Institute on Drug Abuse, 2018).

Next week, we’ll take a deeper look at how opioid diversion from legitimate prescriptions can potentially lead to addictions that can increase the risk of acquiring Hepatitis and HIV as a result of Injection Drug Use.

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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The Kids Aren’t Alright

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

For nearly three years, healthcare officials and epidemiologists have been sounding the alarm: the face of the Hepatitis C (HCV) epidemic is changing – it’s getting younger by the minute. We, here at HEAL Blog, have been beating that drum alongside them, and yet, the U.S. Centers for Disease Control and Prevention (CDC) has yet to formally change the screening recommendations to reflect the new reality. As more evidence piles up that new Acute HCV infections are largely being driven by prescription opioid and heroin Injection Drug Use (IDU) among Americans aged 15-45.

A piece written by the Digestive Health Team out of the Cleveland Clinic – Why Is Hepatitis C on the Rise in 20- to 29-Year-Olds? – explicitly says as much. In addition, while African-Americans share a disproportionate burden in the epidemic (as a percentage of the population), these issues are particularly pronounced in white, non-urban (suburban and rural) populations living primarily in Appalachia, the Midwest, and New England.

So, what is it about these areas that drives people to abuse prescription opioids, heroin, and/or other illicit drugs? There isn’t just one answer. A lot of the areas where these outbreaks and epidemics are so pronounced share several similarities – struggling economic circumstances; higher-than-average unemployment; less access to and utilization of healthcare services; high rates of Social Security Disability Insurance utilization; economies driven by high-intensity labor industries (mining, for example). Any combination of these factors can lead people to develop substance addictions; that these areas are more remote with fewer outlets and opportunities for employment, entertainment, or social engagement essentially creates enclaves where people can all but disappear into a considerably isolated world of addiction.

Where the kids come in often has to do with the friends, relatives, and other adults whose legitimate opioid prescriptions get unknowingly diverted by experimenting teens who inadvertently become addicted to the highly addictive substances. As a young adult living in a small city in Tennessee in the 2000s, virtually all any of my friends and co-workers wanted to do was find “pills” (primarily OxyContin). Whereas I grew up in the cocaine-fueled 80s and ecstasy-addled 90s, parties in the 2000s were, for my generation, comparatively somber affairs, with everyone pilled out on opioids and barely able to function. Once the U.S. Food & Drug Administration (FDA) started to catch on and legislators began tightening prescribing guidelines, they turned to cheaper and more readily available heroin.

With IDU comes a whole host of risks that, for much of the 80s and 90s – particularly as it related to HIV/AIDS – were made explicitly known. Every health and D.A.R.E. (Drug Abuse Resistance Education) I was made to attend as a child, pre-teen, and teenager included a very graphic section on the dangers of injecting drugs. Almost every school in the 90s had a rumor going around about some random person who was dancing at a nearby club and got stabbed with a used needle and got AIDS. While a lot of hyperbole was involved in these stories, the sense of horror we were expected to evince – “WHAT?!?! A DIRTY NEEDLE?!?!” – led a lot of us to become more risk averse, particularly in our younger years.

Twenty years later? A lot of those fears have been forgotten. We no longer see horrific images of people dying from AIDS – the treatments are amazing, tolerable, and don’t kill you. We aren’t afraid of diseases like HIV or viral hepatitis, anymore, because…well, HIV isn’t a death sentence, and HCV is curable. Hepatitis B is still a huge problem, as it has no cure. But, the reality is that neither the fear of becoming addicted, nor the fear of becoming infected are presently palpable enough to prevent people from even starting. What starts out as a way to kick back with your friends and loosen up can quickly turn into a daily habit and morph into a physical dependency. Once you’re dependent and addicted, the risks become less frightening.

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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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HIV/HCV Co-Infected Patients Show Similar Cure Rates As Monoinfected

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

Patients who are co-infected with both HIV and Hepatitis C (HCV) demonstrated similar cure (Sustained Virologic Response – SVR) rates as patients who were monoinfected with HCV, according to research published in Hepatology, a journal published on behalf of The American Association for the Study of Liver Diseases. These findings were gathered using a review of studies dated January 2004 to July 2017, and came to the conclusion that the designation of patients co-infected with HIV/HCV as a “special population” by the U.S. Food & Drug Administration (FDA) should be reconsidered, given the advent and increasing use of Direct Acting Antivirals (DAAs) to treat HCV.

aasld-primary-logo

The special population designation by the FDA is designed to allow physicians and researchers to take into consideration populations who, for a variety of reasons – weight, existing disease morbidity, age, body composition, pregnancy, et cetera – may not respond in a typical fashion to standard treatment regimens. For patients living with HIV, many of the HIV-specific treatment regimens, until the past decade or so, made treating co-morbidities not HIV-related difficult, as other drugs would hamper or have their effects hampered by the medications used to treat patients’ HIV. The advent of newer, more easily tolerated, and more effective HIV medications has allowed for more flexibility.

Thus is the case with HIV/HCV co-infection. Prior to the entry of HCV DAAs to the market in 2013, interferon-based treatments were the only way to actively achieve SVR in HCV-infected patients. Notoriously difficult to tolerate and with a high treatment abandonment rate, interferon-based regimens resulted in very low SVR rates for both mono- and co-infected patients. This, along with the fact that co-infected populations experience accelerated progression of HCV-related liver disease, as well as existing barriers to care, led the FDA to designated HIV/HCV co-infected patients as a specific population with unmet medical needs.

The newer regiments, which are both easier to tolerate and exponentially more effective at achieving SVR, have produced similar SVR rates in both mono- and co-infected populations. This serves as good news to physicians and patients, alike. While these findings are welcome news, physicians must still be certain to determine if HCV regimens will have any counterindications with existing HIV therapies. Current treatment recommendations advise against stopping HIV therapy to pursue HCV treatment.

References:

  • Sikavi, C., Chen, P. H., Lee, A. D., Saab, E. G., Choi, G. & Saab, S. (2017, November 06). Hepatitis C and Human Immunodeficiency Virus Co-Infection in the Era of Direct-Acting Antiviral Agents: No Longer A Difficult to Treat Population. Hepatology. Alexandria, VA: The American Association for the Study of Liver Diseases. Accepted Author Manuscript. doi:10.1002/hep.29642

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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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Mavyret and Vosevi Fire Salvos in HCV Price Wars

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

Over the past month, the U.S. Food and Drug Administration has approved two new Direct Acting Antivirals (DAAs) for use in treating Chronic Hepatitis C (HCV) – Vosevi (Gilead) and Mavyret (AbbVie). Both of these drugs are pan-genotypic, meaning that they can be used to treat HCV Genotypes 1-6, making them the second and third pan-genotypic regimens to be approved by the FDA. What makes Vosevi unique is that it’s the first drug approved by the FDA for patients who have previously been treated with other DAA drugs (Brooks, 2017). That, alone, gives Gilead some leeway when it comes to setting their Wholesale Acquisition Cost (WAC), which they set at $74,760 for twelve weeks of treatment.

That was in July 2017. Then, came Mavyret, from AbbVie. Rather than even bother to hide their intention, AbbVie seriously threw a spanner in the works by pricing their new drug just under 50% lower than Vosevi for a similar regimen length. For twelve weeks of Mavyret, the WAC is $39,600 – roughly 48% the cost of Vosevi. But, that’s not the kicker: Mavyret’s recommend dosage for treatment-naïve patients is an eight-week regimen, coming in at $26,400. Vosevi also has an eight-week regimen option, but at a significantly higher price point. Shots. Fired.

This isn’t the first time that AbbVie has played this pricing game, before, in an attempt to undercut Gilead. In 2014, they released Viekira Pak – a four-tablet regimen for use in treating HCV Genotype 1a & 1b – at a WAC of $83,319. While this is significantly more expensive, at the time, it was something of a blow to Gilead and Janssen (makers of Olysio). Individually, Gilead’s Sovaldi had a WAC $84,000 for twelve weeks; however, the drug was intended to be used in combination with Olysio (Janssen), which boasted a WAC of $66,360, making the total cost of the regimen $150,360. Gilead’s newer product, Harvoni – a single-pill regimen designed to be used without Olysio – came in at $94,500.

Despite the lower price, Viekira Pak never really caught on as the go-to treatment regimen for HCV, for a number of reasons: (1.) Gilead had already established relatively deep market penetration and brand recognition; (2.) the four-pill regimen was/is thought to be too cumbersome to ensure compliance with the regimen; (3.) the price wasn’t low enough to get payers to bite. Of these three issues, AbbVie managed to solve the multi-pill regimen part in 2016 with their single-pill Viekira XR, which is now the preferred regimen over the original formulation.

Chart showing HCV therapies available and their Wholesale Acquisition Costs

But, pricing wars are tricky, particularly in the world of HCV therapies. The first truly significantly lower price point came in 2016 with Zepatier – Merck’s single-pill answer to HCV treatment – with a WAC of $54,600. But, even that price wasn’t enough to overcome the drug’s significant barriers to treatment – it was notoriously difficult to prescribe, as it had several counterindications (negative drug interactions) with drugs used to treat other illnesses. This was particularly true in the case of HIV. In addition to individual pricing concerns, treatment indications often require that the drugs be used in combination with other medications, the most common of which is Ribavirin, which can cost between $550 – $850 for twelve weeks, depending on brand vs. generic pricing.

What Mavyret does that Viekira Pak/XR did/does not is put on the market a single-tablet regimen to treat six genotypes of HCV, making it incredibly versatile. Whether or not they will be able to overcome Gilead’s market dominance, however, is another question.

References:

  • Brooks, M. (2017, July 18). FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C. New York, NY: Medscape, LLC: Medscape: News & Perspective: Medscape Medical News: FDA Approvals. Retrieved from: http://www.medscape.com/viewarticle/883095

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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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National Academies Panel Recommends Rethink on Opioids

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

A new report released by the National Academies of Science, Engineering, and Medicine (NASEM) makes several pointed recommendations about the way the United States Food and Drug Administration (FDA) approaches prescription opioid drugs, a class of pain relievers that are highly addictive and serve as a potential gateway to heroin, once supplies and sources of prescription drugs run dry (NASEM, 2017a). The panel, ordered under the Obama Administration’s FDA head in 2016, spent a year looking at the burgeoning opioid and heroin epidemics in the U.S. in an effort to better address these issues at every level of government (Diep, 2017). Among these recommendations are suggested guidelines for how the FDA considers the approval, regulation, and class scheduling of prescription opioid drugs.

National Academies of Science and Engineering Medicine

Photo Source: NASEM

Throughout the 1990s and early-2000s, pain advocates and pharmaceutical companies successfully lobbied the FDA to expand the indications (approved usage) for various high-powered opioid pain relievers that had previously been reserved for major surgeries, injuries, and palliative care. Purdue Pharma, in particular, scored a big win with its groundbreaking product, OxyContin, one of the first high-powered opioids to become commercially successful. What Purdue failed to mention while they were handing out free 30-day trial coupons for doctors to give to patients was that the drug was highly addictive. By the late-1990s, however, it became abundantly clear that these drugs had a high rate of addiction.

The recommendations put forth by NASEM as the FDA to adopt a position they term “opioid exceptionalism,” where “…the FDA thinks about opioid drugs differently from other products, …taking a public health approach to drug approvals and to other decisions about postmarket (sic) surveillance” (Servick, 2017). This would require the FDA to take into account the following:

  • benefits and risks to individual patients, including pain relief, functional improvement, the impact of off-label use, incident opioid use disorder (OUD), respiratory depression, and death;
  • benefits and risks to members of a patient’s household, as well as community health and welfare, such as effects on family well-being, crime, and unemployment;
  • effects on the overall market for legal opioids and, to the extent possible, impacts on illicit opioid markets;
  • risks associated with existing and potential levels of diversion of all prescription opioids;
  • risks associated with the transition to illicit opioids (e.g., heroin), including unsafe routes of administration, injection-related harms (e.g., HIV and hepatitis C virus), and Opioid Use Disorder (OUD); and
  • specific subpopulations or geographic areas that may present distinct benefit-risk profiles (NASEM, 2017b)

These recommendations come on the heels of a June recommendation by the FDA that pharmaceutical company, Endo, voluntarily remove its product, Opana ER, from the market in response to the public health crisis it says is in part because of illicit use of the drug by Injection Drug Users (IDUs) (Mandal, 2017). Endo recently complied with that request, despite insisting that it believes the drug to be safe when used properly (Ramsey, 2017).

Opana ER (Extended Release) is a reformulation of the drug in an effort to stem abuse by patients who were crushing the drug in order to snort it. This reformulation involved coating it with a plastic coating that Endo promised would make it “abuse deterrent/resistant.” Opana abusers, however, were quick to find a way around this by melting down the drug and its the plastic coating, filtering out the plastic through mesh, and injecting the drug directly into their bloodstream, resulting in a more intense effect (McEvers, 2016). Rather than alleviate abuse, Opana ER ended up creating a deadlier epidemic, as users were sharing needles to inject the drug, fostering the spread of both HIV and Hepatitis C (HCV). Once supplies of Opana ER dried up, those users often moved directly to heroin, as it is both cheaper and more readily available.

The NASEM recommendations will no doubt result in outcry from both pain advocates and pharmaceutical companies desperate to retain profits. Should they be adopted, the U.S. may finally be able to break its near-thirty-year abusive relationship with opioid pain killers.

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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Food and Drug Administration Pulls Opana ER from Shelves

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

In April 2016, HEAL Blog wrote an entry about the fascinating and heartbreaking first episode of National Public Radio’s (NPR) series, Embedded. Host Kelly McEvers found a group of prescription opioid Injection Drug Users (IDUs) who allowed her to record an audio interview about their lives and how they use their drugs. The drug in question was Endo Pharmaceuticals’ powerful prescription opioid, Opana ER (McEvers, 2016). A little over a year after this broadcast, the Food and Drug Administration (FDA) reached the conclusion that the “…benefits of the drug may no longer outweigh the risks,” and have asked Endo to remove Opana ER from the market (Mandal, 2017).

What’s at stake here isn’t just a 4% increase in prescription opioid overdose deaths in 2016 (n=17,536), nor the 23% increase in heroin-related deaths (n=12,989); it’s not even the 73% increase in synthetic opioid-related deaths (n=9,580) (Stobbe, 2016). What’s at stake, at least for Endo Pharmaceuticals, is the $158 million in sales Opana ER brought in for Endo in 2016 – a 10% decrease from 2015 (Mandal). For Endo, pulling one of their most successful products from the market means a huge hit to their bottom line.

Opana ER pill bottle

Photo Source: Medcitynews.com

Opana ER, first introduced by Endo in 2006, was reformulated in 2012, when the manufacturers began adding a plastic coating to the outside of the pill to make it “abuse deterrent.” This move, while initially praised by the FDA and lawmakers as a great step forward to combating prescription drug abuse and addiction, simply shifted how drug users abused the drug. While the initial formulation could be crushed and easily snorted nasally, the plastic coating prevented this practice. Necessity (read: addiction) being the mother of invention, drug users found a way to abuse the drug by melting the plastic coating off, filtering the coating out through mesh, load the liquefied drug into a syringe, and injecting it straight into their bloodstreams. The McEvers Embedded piece literally goes over a step-by-step “How To” guide that is already known by IDUs.

The bottom line for states, counties, and municipalities who are having to cope with the 40,105 opioid drug-related deaths in 2016 comes down to more than just money – the issue is negatively impacting virtually every arena of daily life. Families are rent asunder, children are left orphaned, and emergency personnel are facing their own increased risk of overdose from inhaling or coming into direct contact with the powerful synthetic opioids, fentanyl and carfentanil, during overdose calls and drug busts. The risk of overdose due to exposure is so great that the Drug Enforcement Agency just this month issued a safety guide for first responders who might come into contact (Chanen, 2017).

Pain advocates who have long pushed for easy access to prescription painkillers argue that increasing restrictions places an undue burden upon patients who properly adhere to treatment regimens, using powerful prescription opioids as prescribed. To their way of thinking, regulations and prescribing limits unfairly limits the ability of those who live with chronic pain to function and/or go about their daily lives. Pain advocacy groups (many of which are conveniently funded by the very pharmaceutical companies whose drugs are at risk) have repeatedly, and in many cases successfully, lobbied state and Federal legislators to prevent the passage of any legislation that might hinder their access to these drugs.

I don’t buy it, and apparently, neither does the FDA. Endo Pharmaceuticals have said they’re “…evaluating the options and reviewing the situation to opt for an appropriate path forward.” Should the company refuse to remove the product voluntarily (as the FDA has asked), the agency intends to take steps to formally require its removal by withdrawing approval (Kean, 2017).

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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Treating HCV in Pediatric Patients

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

In April of this year, the Food and Drug Administration (FDA) approved the use of Sovaldi and Harvoni (Gilead) for use in treating Hepatitis C (HCV) in pediatric patients aged 12-17. This is an important step in treating HCV in no small part because children and teenagers are considered a vulnerable population. They are, for the most part, not properly equipped to make well-informed decisions about their health, leaving treatment decisions in the hands of the adults who care for them.

Stamp marked, "Approved" next to the initial, "FDA"

Photo Source: 3Dprint.com

Treating pediatric patients is a much riskier prospect, because people outside of the medical community consider children to just be “small adults;” virtually every treatment regimen for every disease must be modified to achieve commensurate outcomes. There are a variety of reasons why this is so, from bodyweight variances between children and adults, to the various ways that physical and chemical changes that occur during the growth and development process from childhood to adulthood can impact how medications behave in pediatric patients. Essentially, “results may vary.”

The new FDA ruling that expands treatment to pediatric patients allows patients weighing at least 77 lbs. to take an unmodified regimen. While access to treatment in adults has proven fraught with hurdles to overcome before being approved by payers, children covered by Medicaid may, in fact, face fewer hurdles than adults. This is due to the following provision: under Federal law, state Medicaid programs must cover “…early and pediatric screening, diagnostic, and treatment services” for children under age 21 that are necessary to correct or ameliorate physical and mental illnesses (Andrews, 2017). While that’s great for patients covered by Medicaid, those covered by private insurers may have a tougher road to hoe, as most within the industry expect the latter payers to largely maintain similar restrictions in pediatric clients as adults.

One of the reason pediatric patients are so vulnerable is that the majority of HCV-infected patients acquire the disease in the womb; only about 20% acquire it through drug use (Andrews). That said, the likelihood is very low – only a 6% chance that babies will acquire HCV if the mother has it.

Hopefully, pediatric patients will face an easier time gaining access to Sovaldi and Harvoni than adults, but only time will tell.

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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