Spike in Monkeypox Disease Among MSM Causes Alarm, Too

By: Ranier Simons, ADAP Blog Guest Contributor

On Saturday, July 23, 2022, the World Health Organization (WHO) declared monkeypox a PHEIC, public health emergency of international concern.[1] Internationally, the number of cases has reached over 16,000 in over 75 European countries, North and South America, the Middle East, South Asia, Australia, and other parts of Africa not previously exposed.[1] In the United States, there have been roughly 2,900 cases. 

It is important to note that anyone can contract monkeypox. Monkeypox was first identified in 1958 in a colony of research monkeys.[2] Since 1970 human outbreaks have been reported in 11 African countries. The first outbreak outside of Africa was in 2003 in the United States. It occurred in several midwestern states and was linked to infected prairie dogs that people had as pets. Those pets likely contracted the disease from being housed with infected rats and door mice shipped from Ghana.

Photo Source: National Institute for Communicable Diseases

Although anyone can contract the disease, the recent outbreak disproportionately affects gay, bisexual, and men who have sex with men (MSM).[2] The U.S. Centers for Disease Control & Prevention (CDC), the media, and health professionals have consciously not labeled monkeypox a gay disease. It indeed is not a gay disease. However, given that the current outbreak mainly affects gay men, it is essential to clarify that explicitly. The award-winning blogger Mark S. King points out, "Gay men are getting monkeypox and suffering greatly. When gay men understand the threat, we are more likely to take precautions, get vaccinated, or be informed about treatment”.[3]

Concerns about stigma are valid. Gay men historically have and continue to face stigma and apathy in the healthcare arena and public opinion regarding healthcare issues. But, King also points out that it is dangerous to bury facts with vague and evasive messaging.[3] Vague messaging leads the general public to think that their present odds of contracting the disease are higher than the reality of the numbers. Conversely, labeling monkeypox a gay illness would make the public complacent about being mindful of their activities and being tested when they should be. 

The Washington Post’s Benjamin Ryan points out that “…public health experts know well, epidemiology is less concerned with whether someone could contract an infection; instead, the much more vital questions focus on which groups of people are most likely to be exposed to a pathogen, to contract it and why.”[4] There need to be targeted education and prevention efforts aimed at gay men to emphasize the specifics that make them more susceptible to the spread of monkeypox. Facts show that the sexual and social networks of gay men are why it is hitting the population hard. There have been clusters of infections traced back to events such as large circuit parties, nightclub events, and pool parties. Bathhouses are the settings of some clustered outbreaks, as well. Gay men need to be informed of the statistical fact of gay men having an increased incidence of multiple sex partners, especially in combination with certain events and travel, which also increases the likelihood of the spread of monkeypox amidst their demographic.

Monkeypox is contracted through close skin-to-skin contact. Transmission comes from exposure to broken skin, mucus membranes, respiratory droplets, infected bodily fluids, and even contact with contaminated linens. It is not airborne like Covid-19. Rubbing, kissing, and physical contact are enough to cause infection. Sexual intercourse is not necessary. Seven to fourteen days after infection is when symptoms usually appear. Fever, chills, exhaustion, headaches, and muscle weakness are typically initial signs.[2] Progression includes the swelling of lymph nodes and widespread body rash that can include the mouth, hands, and feet. Then fluid-filled painful pox can appear on the body, surrounded by red circles. There is increased reporting that some infected individuals only see some rash and painful pox sores in the genital and anal regions instead of all over the body.

Photo Source: PBS

Over 190,000 doses of the two-dose Jynneos vaccine have been pulled from the Strategic National Stockpile. Jynneos is used for the prevention of monkeypox and smallpox. There is still not enough in circulation to meet the demand for vaccination nor to vaccinate all those in the highest risk categories. There is also an antiretroviral effective against monkeypox named TPOXX (tecovirimat), approved by the U.S. Food & Drug Administration (FDA) for use against smallpox in 2018.[5] Unfortunately, TPOXX was only authorized for smallpox because it is deadly and can be considered a possible bioterrorism weapon. Monkeypox is not fatal like smallpox. Thus obtaining TPOXX requires many pages of paperwork to get it from the Strategic National Stockpile. Additionally, protocol requires doctors to submit pictures of a patient's lesions to the local health department or CDC and a folio of pages of detailed information to get TPOXX. After getting the drug, patients are required to keep a daily journal while they are taking it.[5]

Presently, monkeypox prevention is paramount as vaccination and treatment options are scarce. Effectively educating gay, bisexual, and men who have sex with men with the unadulterated details of their demographics’ statistically documented behaviors put them at high risk is the best weapon against the spread of the disease. Targeted explicit information delivered with respect and dignity is the best way to avoid stigma while undergirding the importance of the information.

[1] Branswell, H. (2022, July 23). WHO declares monkeypox outbreak a public health emergency. Retrieved from https://www.statnews.com/2022/07/23/who-declares-monkeypox-outbreak-a-public-health-emergency/
[2] Howard, J. (2022, July 21). Monkeypox spreading in 'cluster events,' but vaccines can help stop it, local health officials say. Retrieved from https://www.cnn.com/2022/07/21/health/monkeypox-clusters-local-officials/index.html
[3] King, M. (2022, July 19). Monkeypox is a gay thing. We must say it. Retrieved from https://marksking.com/my-fabulous-disease/monkeypox-is-a-gay-thing-we-must-say-it/
[4] Ryan, B. (2022, July 18). You are being misled about monkeypox. Retrieved from https://www.washingtonpost.com/opinions/2022/07/18/monkeypox-gay-men-deserve-unvarnished-truth/
[5] Walsh, D. (2022, July 21). There Is a monkeypox antiviral. But try getting it. Retrieved from https://nymag.com/intelligencer/2022/07/tpoxx-is-a-monkeypox-antiviral-but-try-getting-it.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.   

New Study Demonstrates Value of Tesamorelin for Non-Alcoholic Fatty Liver Disease

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

The ADAP Advocacy Association since its inception has advocated for more open drug formularies under the AIDS Drug Assistance Program ("ADAP") because they promote greater access to care and treatment for people living with HIV/AIDS. By omitting therapies that are approved by the U.S. Food & Drug Administration ("FDA") for the treatment of HIV-infection and related co-morbidities, some State ADAPs are being counter-productive to the needs of the people they're intended to serve. One example is the unfair limitation often put on the drug tesamorelin for the treatment of lipodystrophy. A new study published online in The Lancet shows promise for non-alcoholic fatty liver disease, and as such it might finally change some opinions about adding it to drug formularies.

Photo Source: Drugs.com

Current restrictions on the use of tesamorelin do a disservice to the needs of people living with HIV/AIDS, and diagnosed with HIV-related abnormal accumulation of visceral adipose tissue (VAT) by concluding that the potential discontinued use of tesamorelin and its “expense” is limited its use. Yet, research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there's been a common misconception that this belly fat 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 anti-retro viral regimens this condition continues to exist.

Some states, such as Massachusetts, have long recognized the value of tesamorelin - not only within its ADAP drug formulary, but by also mandating treatment for HIV-related lipodystrophy for private insurance. The Massachusetts model was largely based on the FDA's findings: “The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy. The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”[1]

The new study - "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" - yielded positive results, such as demonstrating tesamorelin can reduce liver fat and prevent scarring of the liver.[2]

According to the study, "Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD."[3]

The study's findings concluded:

"61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of −4·1% (95% CI −7·6 to −0·7, p=0·018), corresponding to a −37% (95% CI −67 to −7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localized injection site complaints than those in the placebo group, though none were judged to be serious."[4]

These findings bode well for people living with HIV/AIDS, especially as it relates to co-morbidities such as cardiovascular and type 2 diabetes risks. Now it is time for more State ADAPs to take notice.



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[1] U.S. Food & Drug Administration (2010, November 10). FDA approves Egrifta to treat Lipodystrophy in HIV patients. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/news/889/fda-approves-egrifta-to-treat-lipodystrophy-in-hiv-patients---november-10--2010.
[2] Brokaw, Sommer (2019, October 15). NIH: Drug reverses liver fat, slows fibrosis in HIV-positive people. UPI. Retrieved online at https://www.upi.com/Health_News/2019/10/15/NIH-Drug-reverses-liver-fat-slows-fibrosis-in-HIV-positive-people/8621571156412/?sl=3.
[3] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.
[4] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.

How Americans could unknowingly end up taking black market drugs

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

Senators Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) recently introduced a bill that would permit Americans to import pharmaceuticals from Canada. The two lawmakers believe their bill will reduce drug costs.[1] But their effort begs the question: at what cost?

The bill would instead expose patients to potentially dangerous counterfeit drugs. Lawmakers would be wise to vote against it.

Photo Source: impactlab.net

Americans currently have the safest pharmaceutical supply chain in the world. In large part, that's thanks to the Food and Drug Administration, which strictly supervises the manufacturing and transport of medicines. About 60 percent of our drugs are manufactured at high-tech, ultra-safe facilities right here in the United States.[2] The remainder are made in foreign factories but shipped into the United States through trusted vendors, who never allow the medicines to leave their control.

Sens. Grassley and Klobuchar's bill would allow people to purchase drugs that didn't go through this tightly controlled supply chain. That's worrying. No matter its rigorous safety precautions at home, the FDA can't vouch for the safety and efficacy of foreign-made and supervised drugs. That’s a pretty high price to pay for cheaper drugs.

This is particularly concerning when it comes to drugs coming in from Canadian pharmacies, which often resell drugs imported from India, Turkey, and other countries with subpar safety standards.[3][4]  In fact, one FDA investigation found that 85 percent of packages imported to the United States from online Canadian pharmacies contained potentially counterfeit drugs.[5] One in 10 drugs from low and middle-income countries is fake or substandard, according to the World Health Organization.[6] Some are laced with deadly ingredients, like boric acid and fentanyl.[7]

I've experienced firsthand the dangers of foreign drug imports. I was diagnosed with HIV just shy of my 30th birthday.[8] That day, I found out I was destined to undergo antiretroviral therapy for the rest of my life.[9]

But when my out-of-pocket costs hit $1,300 in just my second month of treatment, I started looking for a cheaper option. I began ordering my medicine from an online pharmacy in Canada.[10]

It never crossed my mind that I might have been taking counterfeit medicine, or that the medicines meant to control my HIV could be compromising my immune system. So when my doctor found out, she told me to stop immediately. She warned me that online pharmacies often sell counterfeit drugs.

Government officials have long opposed importation policies for the same reason.

Photo Source: The Partnership for Safe Medicines

Former FBI Director Louis J. Freeh warns that "importation proposals would do nothing but shift the costs and burden to law enforcement and open up the U.S. drug supply to adulterated and counterfeit drugs."[11]

Former FDA associate commissioner Peter Pitts, meanwhile, opposes the Grassley-Klobuchar proposal for the same reason. He adds that the bill "could endanger American lives by opening the floodgates to harmful counterfeit drugs."[12]

Four other past FDA commissioners penned a letter to Congress explaining that importation would "harm patients" and "compromise" the United States' "carefully constructed system."[13]

And former HHS Secretary Mike Leavitt echoed similar concerns, writing that, while in office, it was "impossible… to certify that importation of medicines from unregulated sellers is safe."[14]

They're all right.

For nearly two decades, liberal and conservative officials have warned against the dangers of drug importation. Not a single FDA commissioner or HHS secretary has been able to verify that it's safe.  Let's listen to the experts -- importation is not a risk worth taking.

This opinion piece was also published in the March 6th edition of the Times of Northwest Indiana.

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[1] https://www.grassley.senate.gov/news/news-releases/grassley-klobuchar-introduce-legislation-permit-personal-importation-rx-drugs 
[2] https://www.consumerreports.org/cro/news/2014/04/are-generic-drugs-made-in-india-safe/index.htm:  "About 40 percent of the medications Americans use everyday are made outside the U.S."
[3] https://www.safemedicines.org/2015/10/5-secrets-canadian-pharmacies-dont-want-you-to-know.html 
[4] http://www.safemedicines.org/wp-content/uploads/FDA-Operation-Reveals-Many-Drugs-Promoted-as-_Canadian_-Products-Really-Originate-From-Other-Countries-captured-January-2017.pdf 
[5] https://www.hivplusmag.com/treatment/2016/7/01/how-avoid-black-market-hiv-drugs 
[6] https://www.reuters.com/article/us-pharmaceuticals-fakes/tens-of-thousands-dying-from-30-billion-fake-drugs-trade-who-says-idUSKBN1DS1XJ 
[7] https://www.safemedicines.org/2015/11/poisons.html 
[8] https://www.washingtonblade.com/2017/08/11/opinion-buying-medicines-online/ 
[9] https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/51/hiv-treatment--the-basics 
[10] https://www.washingtonblade.com/2017/08/11/opinion-buying-medicines-online/ 

[11] https://storage.googleapis.com/m1738/20170605_Report%20on%20Counterfeit%20Drugs.pdf (page 5)

[12] https://www.safemedicines.org/2019/01/importation-is-too-risky-warns-former-fda-associate-commissioner.html and https://thehill.com/opinion/healthcare/426615-proposed-drug-importation-bill-would-expose-americans-to-counterfeit-meds

[13] https://www.washingtonpost.com/news/to-your-health/wp/2017/03/17/four-former-fda-commissioners-denounce-drug-importation-citing-dangers-to-consumers/?utm_term=.c21f7b053dab 

[14] https://morningconsult.com/opinions/drug-importation-flawed-policy/ 

[15] https://www.safemedicines.org/2018/07/who-opposes-drug-importation-every-head-of-the-fda-and-hhs-since-2000.html 

Could New Research Pave Way for Official Guidelines for the Treatment of Lipohypertrophy

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

There purports to be an "obesity epidemic" in the United States,[1] though strong evidence suggests that people can be healthy at every size.[2] Data shows from 1960-2002, in the United States the average male weighed 25 pounds more and average female weighed 24 pounds more. Putting the debate over obesity aside, undesirable weight gain for many people living with HIV/AIDS is often grudgingly accepted as normal. This paradigm could soon be changing because new research could pave the way for better guidelines for treating HIV-related weight gain — namely, Lipohypertrophy.

Photo Source: myclickfine.com

Research published in the Clinical Infectious Diseases by a panel of international authors (U.S., Canada, Europe) from 12 universities represents a consensus opinion on the diagnosis, clinical consequences and treatment of excess fat in adults with treated HIV infection. The groundbreaking study offers some hope to people living with HIV-infection concerned about facial wasting, belly fat, lipomas, or the dreaded "buffalo hump" on the back of the neck.

The publication, "Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection," concludes, "Both generalized obesity and lipohypertrophy are prevalent among HIV-infected persons on ART. Aggressive diagnosis and management are key to the prevention and treatment of end-organ disease in this population, and critical to the present and future health of HIV-infected persons."

Among the research findings, management of HIV-related weight gain includes lifestyle changes in diet and exercise, though there was "insufficient data to support any specific dietary or exercise strategy in patients with HIV and abdominal obesity."[3] Changes in anti-retroviral therapy is also suggested, since some of the new medications have less side-effects.[4] Medical interventions are also identified as viable options — including Growth Hormone (GH) Axis Therapy and Metformin.[5] Finally, surgical interventions are also included in the options identified by the authors.[6]

The research findings are already gaining attention in respected HIV news publications, too.

The ADAP Advocacy Association sees promise in the report findings for patients suffering from a condition for which treating physicians are paying little attention, and in many cases where payors — including many State ADAPs — are excluding coverage for treatment options approved by the U.S. Food & Drug Administration. In late 2016, we urged the Health Resources and Services Administration ("HRSA") to update to the Guide for HIV/AIDS Clinical Care. The national sign-on letter wasn't an endorsement of a specific product or treatment, but rather an attempt to afford patients suffering from HIV-associated lipodystrophy syndrome the opportunity to access the available treatment options (all of which were identified in the aforementioned research).

HRSA now has a template for updating its treatment guidelines. It is up to the federal agency to respond to the needs to the patients!



Read our related blogs on this topic:

• Despite Treatment Improvements, Patients Remain Concerned about Lipo (published January 27, 2017)
• Why HIV Medical Treatment Guidelines Matter (published on October 28, 2016)
• Mandating Treatment for HIV-Related Lipodystrophy: The Massachusetts experience and a call for national action (published on August 25, 2016)
• HIV-Related Belly Fat: More Than Just an Appearance Issue (published on June 23, 2016)

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[1] Rauh, Sherry (2010); Is Fat the New Normal? A rise in average body weight may be changing how we see ourselves. WebMD. Retrieved from http://www.webmd.com/diet/obesity/features/is-fat-the-new-normal#1.
[2] Bacon, Linda (2010, May 4); Health At Every Size: The Surprising Truth About Your Weight; BenBella Books. Retrieved from https://lindabacon.org/health-at-every-size-book/.
[3] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[4] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[5] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[6] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.

Pharmaceutical Drug Pricing, According to President Donald J. Trump

By: Marcus J. Hopkins, Blogger

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:

• Congressional Budget Office. (2014, July). Competition and the Cost of Medicare’s Prescription Drug Program. Washington, DC: Congress of the United States: Congressional Budget Office. Retrieved from: https://www.cbo.gov/sites/default/files/113th-congress-2013-2014/reports/45552-PartD.pdf
• Cubanski, J. & Neuman, T. (2017, January 23). Searching for Savings in Medicare Drug Price Negotiations. Menlo Park, CA: The Henry J. Kaiser Family Foundation: Medicare. Retrieved from: http://kff.org/medicare/issue-brief/searching-for-savings-in-medicare-drug-price-negotiations/
• Daurat, C. & Olorunnipa, T. (2017, February 07). Trump Sinks Pharma Stocks on Medicare Drug Price Negotiation. New York, NY: Bloomberg L.P.: Bloomberg: Markets. Retrieved from: https://www.bloomberg.com/news/articles/2017-02-07/trump-backs-medicare-drug-price-negotiating-spicer-says
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