Jamaica Observer

Heart Institute's Save a Life programme

CARDIOVASCULAR disease (CVD) prevalence has risen remarkably over the past 30 years, from 271 million in 1990 to 523 million in 2019, and CVD deaths have increased from 12.1 million in 1990 to 18.5 million in 2019. About 30 per cent of deaths from CVD are premature deaths affecting individuals between the ages of 30 and 70.

Even though CVD prevalence has risen globally, a disproportionate rise in CVD has been noted in low- and middle-income countries like Jamaica. While paying attention to prevention and maintaining ideal cardiovascular health is essential, we must now design proactive mechanisms for prompt response to acute and critical cardiovascular events that often lead to catastrophic outcomes in the absence of timely and proper intervention.

When individuals present with chest pain or similar symptoms it may signify underlying CVD and, possibly, an evolving acute event. While chest pain may not always be life-threatening, it is impossible to know without comprehensive evaluation by trained professionals. It would be unwise, therefore, to assume otherwise until a thorough assessment is performed. Comprehensive evaluation must be done urgently. Many individuals with chest pain, including those with heart attacks, are still delaying seeking care that could save their lives because of difficulties in accessing necessary care, either due to logistical or financial challenges. It is time to put an end to the unnecessary deaths and disabilities that result from delayed and inappropriate responses to cardiovascular disease and its complications. Delays in treatment can be very costly in money and life, but early intervention saves lives.

Are you at risk for a heart attack?

Key risk factors for heart diseases, including heart attacks, are: being of an age greater than 55, hypertension, diabetes, high cholesterol, smoking, a sedentary lifestyle, obesity, and family history. While individuals with multiple risk factors are at a higher risk for a heart attack, most individuals presenting with their first heart attack do not have multiple risk factors at the time of presentation. This means that you can also have a heart attack even if you are not aware of having risks such an episode. Therefore, it is essential to remain vigilant and respond appropriately if you or your loved ones experience symptoms suggesting the possibility of an acute cardiac event.

Where do you go for medical evaluation of chest pain or potential heart attack?

Home remedy is ineffective for chest pains or an acute cardiac event. All patients with chest pain or acute cardiac complaints should seek care from competent health-care professionals, preferably in facilities with adequate personnel and infrastructure for heart care and with a sense of urgency in addressing cardiovascular complaints. The choice of provider and facility for evaluating and treating your chest pain or cardiac complaint must be intentional as it may be the most critical decision that will determine the outcome of your care. Why? Because time is vital when chest pain has to do with the heart or major vessels. Delays could lead to death or severe complications, while a speedy and appropriate response will save lives and, most likely, avert significant complications.

Cost concerns impede universal access and timely intervention in heart care. Access and affordability are major barriers to timely and appropriate cardiovascular care delivery, especially for patients with acute coronary or other cardiac syndromes for whom timely intervention and comprehensive care are imperative.

Suppose we accept the universal doctrine that all lives are sacred and should be preserved at all costs? In that case, we must evolve mechanisms to align with this doctrine despite the cost and logistical challenges that impede access to care.

Health-care access is the ability to obtain needed care in a timely manner. This is critical in patients with acutely life-threatening conditions like heart attacks, especially in developing countries like Jamaica. Given the rise in chronic diseases, the increasing use of technology, and the ageing of our population, the economic cost of appropriate care is a huge problem. About 7,500 heart attacks occur each year in Jamaica, and many will not survive unless timely intervention is initiated. Our public hospitals receive many heart attack patients, and most of these facilities lack the infrastructure, resources, or human capital to respond to heart attack patients effectively.

For the private sector to play a meaningful role in improving access to care, critical factors that impede access must be eliminated. Any structure that delays or denies access to care is an impediment to care. The centrepiece of what we do as physicians must be the patient, which means all patients — not just a few. This is the basis of inclusive care and health equity.

Current health-care financing mechanisms in Jamaica do not offer adequate protection for patients faced with cardiovascular emergencies. In light of this, the Heart Institute of the Caribbean wishes to embark on a bold HIC Save A Life Programme initiative to fill the gap and ensure that most patients with acute cardiovascular emergencies have timely access to appropriate care.

The HIC Save a Life Programme is sponsored by the HIC Foundation to assist patients with acute coronary syndromes (including heart attack and unstable chest pain or angina) who urgently need life-saving treatment. This comprehensive heart care package is offered at a low, all-inclusive cost to ensure that patients with heart attacks and acute coronary syndromes get immediate access and timely intervention to save lives and avert complications.

Package includes:

Free ambulance pick-up from Kingston and St Andrew, Portmore and Spanish Town

Initial cardiology consultation

Electrocardiogram

Continuous cardiac monitoring

Cardiac catheterisation and coronary angiogram

Coronary angioplasty with drug-eluting stent

All surgeon's and technical fees

All operating room charges

All nursing and technical fees

All surgical consumables and medications

Two to three days' admission in the ICU or telemetry at no cost

All patient meals and medications while admitted

Free, unlimited cardiology consultations for 60 days after discharge

Availability 24/7.

To learn more or to take advantage of this offer, we encourage individuals to call the Heart Institute of the Caribbean at 876-906-2105 to 2108.

Today's key takeaway message in our article is that chest pain or other acute cardiac complaints can and will kill if proper and timely intervention is not initiated. Furthermore, we have now taken a bold step to open access to individuals with acute cardiac complaints so as to minimise the logistical and financial challenges.

Dr Ernest Madu, MD, FACC and Dr Paul Edwards, MD, FACC are consultant cardiologists for the Heart Institute of the Caribbean (HIC) and HIC Heart Hospital. HIC is the regional centre of excellence for cardiovascular care in the English-speaking Caribbean and has pioneered a transformation in the way cardiovascular care is delivered in the region. HIC Heart Hospital is registered by the Ministry of Health and Wellness and is the only heart hospital in Jamaica. Send correspondence to
info@caribbeanheart.com
or call 876-906-2107.

2 years 2 months ago

Health Archives - Barbados Today

Bajans in New York lend a helping hand


The Paediatric Department and the Obstetrics and Gynaecology Clinic of the QEH are benefitting from a donation of US$5,000 by Trinity Church Wall Street, Manhattan, New York.


The Paediatric Department and the Obstetrics and Gynaecology Clinic of the QEH are benefitting from a donation of US$5,000 by Trinity Church Wall Street, Manhattan, New York.

The cheque was recently presented to Dr Angela Jennings, Head of Paediatrics, by Earl Phillips of the Barbados Support Group, NY.

Both departments will use the money for IT support. Psychologists in Paediatrics will utilise items to assist in the evaluation of children with a variety of psychological disorders, while the OG clinic will purchase computers to improve health information management and communication workflows.

The money was channelled in these areas following requests from the respective departments from Dr. Jennings and former QEH employee, Acting Operations Manager Terri-Anne Moore-Knowles.

 

Barbara Inniss

The idea for a donation from Trinity to aid health care in Barbados came from parishioner Barbadian Barbara Inniss. It was coordinated by Consul General of Barbados Mackie Holder and facilitated by Dr. Oneall Parris of Barbados Diaspora Collaborative USA (BDC USA) Inc.

CG Holder said the effort by Ms. Inniss was yet another example of Barbadians looking out for their country and praised her tenacity in making sure Barbados benefitted from the charitable donations of her church.

He said that, due to church regulations, it took some time to finalise the contribution, which involved three different players, but the end result underscored what collaboration in the Barbadian community can deliver. 

The post Bajans in New York lend a helping hand appeared first on Barbados Today.

2 years 2 months ago

A Slider, Features, Health

Health – Dominican Today

Ruta de la Salud: 75% of Santiago’s population is overweight

The 21st edition of “La Ruta de la Salud: Cambia tu estilo de vida” (Health Route: Change your lifestyle) arrived this Friday at the Polideportivo Ambiorix Rodríguez, in the Cienfuegos sector, Santiago Oeste, to instruct the population on how to change their lifestyles and to offer medical services in different specialties.

The Minister of Health, Daniel Rivera, said: “Health is happiness, what is sadness is illness. This day comes to celebrate a change of lifestyle, here there are more than 30 services available to the community so that they can take advantage, approach and know how their health is, because prevention is paramount”.

The official said that in this province, the study on Overweight, Obesity, Diabetes, and Hypertension (Sodhip) showed as a result 33.2% in hypertension, overweight and obesity 75.1% (above the national average of 72%), and 10.4% in hyperglycemia.

He said this demarcation has high indicators. Therefore, they must work to change and care for their health, avoiding diseases.

Rivera urged citizens to practice sports or physical activities, eat healthy foods, fruits, and vegetables, and reduce sugar, salt, and saturated fat consumption so that, in the long term, they can avoid chronic diseases such as diabetes, hypertension, and obesity.

From the early morning hours, the minister offered general consultation, cardiometabolic evaluation, orientations, and referrals to those seeking medical attention.

“Prevention, promotion and education is what can benefit a country the most and lead it to be healthy. We want everyone to participate in the Health Route, here there are more than 35 services, thanks to the people who have come from all over West Santiago and for joining us,” he said.

On his side, the president of the Senate of the Republic, Eduardo Estrella, congratulated this action and highlighted the importance of the investment in the Health sector that the Government is making.

“It is an honor to be in this activity, the 21st, precisely in Santiago Oeste, where President Abinader has put his eyes, he has put them on the health sector in the Dominican Republic. The proof is the investment in medicines that is being made, more than 7 million 200 thousand Dominicans affiliated to the Health Insurance, the investment in repair and reconstruction of hospitals, which were left in neglect, that is called investing in the people, in the lowest, that is to defend the Dominican people, that is why this day is not only palliative but preventive,” said Estrella.

Meanwhile, the Civil Governor of Santiago, Rosa Santos, said that changing habits is a complex but necessary act.

“This activity is to change our physical condition and to be able to perform daily activities, which aims to strengthen the health of the Dominican people, so, I call for them to support and take advantage of these services that are here for their improvement, because today health is in our territory,” she said.

Among the authorities who gave support to this version are: the executive director of the National Health Insurance (Senasa), Santiago Hazim; Adolfo Pérez, director of Promese; Marieta Díaz, regional director of Education; Ulises Rodríguez, general director of Proindustria; Samuel Azcona, regional director of the Cibao Central National Police; Andrés Cueto, general manager of Edenorte, among other personalities.

According to Public Health, more than 170,000 Dominican families have been impacted through the different editions of the Health Routes and their services, which include: pediatrics, dentistry, general medicine, gynecology, ophthalmology, as well as clinical laboratory, electrocardiogram, echocardiogram, glycemia, mammography, sonomammography, sonography, prostate evaluation, and PSA tests, blood typing and donation, Senasa carding and delivery of medicines.

2 years 2 months ago

Health

Health – Dominican Today

World Chagas Disease Day: The facts you need to know

Yesterday, April 14, was World Chagas Disease Day, a disease transmitted by the Trypanosoma cruzi parasite mainly affecting poor Latin American populations.

Facts and figures
According to the World Health Organization, Chagas disease, also called American trypanosomiasis, is a potentially fatal disease caused by the protozoan parasite Trypanosoma cruzi (T. cruzi).

Yesterday, April 14, was World Chagas Disease Day, a disease transmitted by the Trypanosoma cruzi parasite mainly affecting poor Latin American populations.

Facts and figures
According to the World Health Organization, Chagas disease, also called American trypanosomiasis, is a potentially fatal disease caused by the protozoan parasite Trypanosoma cruzi (T. cruzi).

The disease occurs mainly in endemic areas of 21 countries in Latin America, where it is transmitted to humans and other mammals mainly by the feces or urine of triatomines (vectorial route), known as vinchucas, bedbugs, or by many different names, depending on the geographic area.

Initially, Chagas disease was confined to rural areas of the Region of the Americas (except for the Caribbean islands). However, due mainly to increased population mobility in recent decades, most infected persons now live in urban settings, and cases have been increasingly detected in the United States of America and Canada, in many countries in Europe, and in some countries in Africa, the Eastern Mediterranean, and the Western Pacific.

Transmission
In Latin America, the T. cruzi parasite is transmitted mainly by contact with the infected feces or urine of blood-feeding triatomine bugs. In rural and suburban areas, these insects usually live in cracks and holes in the walls and roofs of houses and outdoor structures, such as chicken coops, corrals, and warehouses. They typically remain hidden during the day and become active at night to feed on the blood of mammals, including humans. They generally bite on exposed areas of the skin, such as the face, and defecate/urinate near the bite. The parasites enter the body when the person bitten instinctively rubs, causing feces or urine to come into contact with the bite, eyes, mouth, or an open skin lesion.

The T. cruzi parasite can also be transmitted:

Chagas
By consuming food contaminated by the parasite through contact with, for example, infected triatomine, marsupial feces, or urine. This type of transmission usually results in outbreaks with more severe morbidity and higher mortality;
by transmission from the infected mother to her child during pregnancy or childbirth;
by transfusion of blood or blood products from infected donors;
organ transplantation from an infected person; and
laboratory accidents.

Signs and symptoms
Chagas disease has two phases. Initially, the acute phase lasts about two months after infection. During this critical phase, although a large number of parasites circulate in the bloodstream, in most cases, there are no symptoms or symptoms that are mild and non-specific. In less than 50% of people bitten by a triatomine bug, a characteristic initial sign may be a skin lesion or a purplish swelling of an eyelid. In addition, such persons may present with fever, headache, enlarged lymph nodes, pallor, muscle aches, breathing difficulties, swelling, and abdominal or chest pain.

During the chronic phase, the parasites remain hidden mainly in the heart and digestive muscles. One to three decades later, up to one-third of patients suffer from cardiac disorders, and one in ten have digestive (typically, enlargement of the esophagus or colon), neurological, or mixed disorders. Over the years, the infection may cause sudden death from cardiac arrhythmias or progressive heart failure due to the destruction of the innervations of the heart muscle and the muscle itself.

Treatment
Chagas disease can be treated with benznidazole or nifurtimox, which kills the parasite. Both drugs are fully effective in curing the disease if given at the onset of infection in the acute stage, including cases of congenital transmission. However, their efficacy decreases with time, and adverse reactions are more frequent at older ages. Therefore, treatment with these drugs is also indicated in case of reactivation of infection (e.g., due to immunosuppression) and in patients at the beginning of the chronic phase, including girls and women of childbearing age (before or after pregnancy) to prevent congenital transmission.

Treatment should be offered to infected adults, especially those without symptoms, as deworming may prevent or slow disease progression. In other cases, the potential benefits of medication in preventing or delaying the progression of Chagas disease must be weighed against the prolonged duration of treatment (up to two months) and possible adverse reactions (which occur in up to 40% of treated patients). Benznidazole and nifurtimox should not be administered to pregnant women or persons with renal or hepatic insufficiency. Nifurtimox is also contraindicated in persons with a history of neurological or psychiatric disorders. In addition, specific treatment for cardiac, digestive, or neurological manifestations may be necessary.

Control and prevention
Because of the large number of wild animals that serve as reservoirs for the T. cruzi parasite in the Americas, the infection cannot be eradicated. Instead, control objectives are to eliminate transmission and to ensure that the infected and sick population has early access to health care.

There is no vaccine against Chagas disease. The T. cruzi parasite can infect many species of triatomines, most of which are found in the Region of the Americas. Vector control has been the most effective method of prevention in this region. Blood screening is necessary to prevent infection through blood transfusion and organ transplantation and to improve the detection and care of the affected population worldwide.

Depending on the geographical area, WHO recommends the following prevention and control methods:

spraying of houses and their surroundings with residual insecticides;
improvement of houses and their cleanliness to prevent vector infestation;
personal preventive measures, such as the use of mosquito nets, good hygienic practices in the preparation, transport, storage, and consumption of food;
development of contextualized information, education, and communication activities for the different actors and scenarios on preventive measures and surveillance tools;
screening of donated blood;
screening tests on donated organs, tissues, or cells and their recipients;
access to diagnosis and treatment for those for whom deworming is indicated or recommended, especially children and women of childbearing age before pregnancy; and
screening of newborns and children of infected mothers who have not previously received deworming treatment for early diagnosis and treatment.

2 years 2 months ago

Health

Health | NOW Grenada

Raising minimum wage to alleviate food insecurity

Factors that affect food security include the high food import bill and the increase in chronic non-communicable diseases influenced by lifestyle factors, of which diet is one component

2 years 2 months ago

Agriculture/Fisheries, Business, Community, Health, lifestyle, curlan campbell, food and agriculture organisation, food import bill, marcia cameron, minimum wage, national food and nutrition security policy, united nations

MedCity News

Acelyrin Plans IPO to Fund Pivotal Tests of Drug That Could Rival AbbVie’s Humira

Biotech IPOs continues to be almost non-existent, but Acelyrin wants to see if the public markets have an appetite for its lead drug candidate. The small protein drug could match up favorably against blockbuster biologics and it has reached pivotal testing in three inflammatory disorders.

2 years 2 months ago

BioPharma, Pharma, SYN, Top Story, Acelyrin, biotech IPO, Clinical Trials, inflammatory diseases, izokibep, Los Angeles

PAHO/WHO | Pan American Health Organization

New transatlantic partnership to address post-pandemic global health priorities and challenges

New transatlantic partnership to address post-pandemic global health priorities and challenges

Cristina Mitchell

14 Apr 2023

New transatlantic partnership to address post-pandemic global health priorities and challenges

Cristina Mitchell

14 Apr 2023

2 years 2 months ago

MedCity News

What Do Payers Need to Help Value-Based Contracting Deals for Novel Therapies Succeed? [Sponsored]

A panel discussion at the annual Abarca Forward conference in Puerto Rico last month sought to identify some of the innovative financial approaches that can be applied to managing the high price of novel therapies. Conversations also addressed what payers need for these financing models to be sustainable.

2 years 2 months ago

BioPharma, Daily, News, Payers, Pharma, sponsored content, Sponsored Post, Top Story, Abarca, Abarca Forward 2023, cell therapy, gene therapy, Payers, Presented by Abarca, Reimbursement, sponsored content

Medical News, Health News Latest, Medical News Today - Medical Dialogues |

Teva, Viatris win US appeal in patent fight over Parkinson's drug

New Delhi: Belgian biopharmaceutical company UCB on Wednesday lost its U.S. court appeal seeking to revive a patent covering its Parkinson's disease drug Neupro, clearing an obstacle for Teva's Actavis Laboratories UT Inc and Viatris' Mylan Technologies Inc to sell generic versions of the drug.

The U.S. Court of Appeals for the Federal Circuit agreed with a Delaware federal court that UCB's patent on Neupro patches was invalid. A ruling for UCB could have delayed U.S. Food and Drug Administration approval of a Neupro generic until it expired in December 2030, the court said.An earlier court order based on a separate patent had blocked Actavis' proposed generic until 2021.A Teva spokesperson said the company was pleased with the decision. Representatives for UCB and Viatris did not immediately respond to requests for comment.The FDA first approved Neupro in 2007 to treat Parkinson's disease, a neurodegenerative disorder. It was removed from the market in 2008 over dosing concerns and reapproved with a different formula in 2012.UCB sold over 300 million Euros worth of the drug worldwide last year, according to a company report.UCB and LTS Lohmann Therapie-Systeme AG sued Actavis and Mylan for patent infringement in 2019 over their planned Neupro generics. A Delaware court invalidated UCB and LTS' patent in 2021 based on their earlier patents for the original version of Neupro that the court said covered the same invention.Read also: Biocon partner Viatris gets Complete Response Letter from USFDA for Bevacizumab license applicationThe Federal Circuit affirmed Wednesday that the patent UCB accused Actavis and Mylan of infringing was obvious and unpatentable.The case is UCB Inc v. Actavis Laboratories UT Inc, U.S. Court of Appeals for the Federal Circuit, No. 21-1924Read also: Cipla, Aurobindo, Viatris in licensing pact with MPP to produce generic versions of ViiV Healthcare HIV drug

2 years 2 months ago

News,Industry,Pharma News,Latest Industry News

STAT

Demand for home health aides is soaring. So why are they still so undervalued?

On most days around 2 p.m., home health aide Duane Crichlow can be found in an apartment in Sunset Park, Brooklyn, playing catch with his client — a man in his 30s with a developmental disability who is quick to give Crichlow hugs and kisses.

If it’s nice outside, Crichlow will walk his client, who is nonverbal and in a wheelchair half the time, down three flights of stairs, hauling the wheelchair back and forth separately.

A 49-year-old Trinidadian who lives in Bed-Stuy, Brooklyn, Crichlow works for St. Nicholas Alliance Home Care, where he earns between $17-$18 per hour. His client likes it when Crichlow imitates Mojo Jojo, a character from the TV series “The Powerpuff Girls,” or tries out Cardi B’s signature catchphrase, “Okurr.” “I do different characters that make him laugh. As long as he’s happy, I’m happy,” Crichlow said.

Read the rest…

2 years 2 months ago

Health, Aging, caregiving, health care workers, Mental Health

Medical News, Health News Latest, Medical News Today - Medical Dialogues |

Eli Lilly bowel disease drug Mirikizumab rejected by USFDA

United States: Eli Lilly and Co said on Thursday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug to treat a type of chronic inflammatory bowel disease in adults.

The agency's decision puts Lilly further behind in its quest to enter the nearly $20 billion market, which already has drugs for the disease from rivals such as Abbvie Inc, Pfizer Inc and Johnson & Johnson.

The health regulator cited issues related to the proposed manufacturing of the drug, mirikizumab, although it did not express concerns about the clinical data package, safety, or label for the medicine, Lilly said.

The company also said it was confident in the late-stage data of the drug, which was pegged among Lilly's potential growth drivers for this decade, and was working with the FDA to address the issue.

"The setback is fairly minor from the context of what a great portfolio Eli Lilly has and even within the drug itself, it sounds like it's manufacturing issues, so I don't think that's going to be overly problematic," Morningstar analyst Damien Conover told Reuters.

Eli Lilly was seeking approval for the drug as a treatment for ulcerative colitis, which is a condition where abnormal reactions of the immune system cause inflammation and ulcers on the inner lining of the colon, possibly leading to diarrhea, passing of blood with stool and abdominal pain.

"There is still possibility this product can exceed $2 billion peak sales," Wells Fargo analyst Mohit Bansal said in a note.

Earlier this year, the health regulator had declined an accelerated nod for Lilly's Alzheimer's disease drug, donanemab, potentially preventing the company from expediting the launch.

Read also: USFDA rejects accelerated approval for Eli Lilly Alzheimer's drug Donanemab

The drugmaker's other anticipated launches in 2023 include tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema, and cancer drug pirtobrutinib.

2 years 2 months ago

News,Industry,Pharma News,Latest Industry News

Health | NOW Grenada

Cellular phone services activated for Princess Alice Hospital

“The public can call +1 (473) 417-4747 to report any threat to life or health, where an immediate response is needed from the Princess Alice Hospital”

2 years 2 months ago

Health, PRESS RELEASE, gis, Ministry of Health, princess alice hospital

PAHO/WHO | Pan American Health Organization

Strengthening primary care, harnessing new health technologies key to better pandemic recovery and preparedness, PAHO Director says

Strengthening primary care, harnessing new health technologies key to better pandemic recovery and preparedness, PAHO Director says

Cristina Mitchell

13 Apr 2023

Strengthening primary care, harnessing new health technologies key to better pandemic recovery and preparedness, PAHO Director says

Cristina Mitchell

13 Apr 2023

2 years 2 months ago

KFF Health News

The Confusing Fate of the Abortion Pill

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

The Host

Julie Rovner
KFF Health News


@jrovner


Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News’ weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

The abortion pill mifepristone is now ground zero in the abortion debate. Late Wednesday night, the 5th Circuit Court of Appeals said the drug should remain on the market but under restrictions on distribution that were in effect before 2016, which ban prescribing by mail or by telemedicine. The restrictions would make it even more difficult for patients in states where abortion is illegal or widely unavailable.

The decision comes in response to a ruling last week out of Texas, where a federal judge, as was widely expected, found that the FDA should not have approved the drug more than 22 years ago and ordered it, effectively, unapproved.

Complicating matters further still, in a separate case filed by 18 attorneys general in states where abortion is largely legal, last week a federal district judge in Washington state ordered the FDA not to reinstate any of the old restrictions.

This week’s panelists are Julie Rovner of KFF Health News, Victoria Knight of Axios, Shefali Luthra of The 19th, and Sarah Karlin-Smith of the Pink Sheet.

Panelists

Sarah Karlin-Smith
Pink Sheet


@SarahKarlin


Read Sarah's stories

Victoria Knight
Axios


@victoriaregisk


Read Victoria's stories

Shefali Luthra
The 19th


@Shefalil


Read Shefali's stories

Among the takeaways from this week’s episode:

  • A late-night decision by the appeals court preserves access to mifepristone while the legal battle continues. But it also resurrects outdated limitations on the drug, meaning mifepristone can be used only up to seven weeks into a pregnancy, among other restrictions.
  • While it is expected that the U.S. Supreme Court will ultimately decide the drug’s fate, some providers and state officials are rushing to stockpile it. Cutting off access to the abortion pill puts extra pressure on clinics in states where abortion remains legal, which are also serving women from so-called prohibition states and could see an influx of patients as mifepristone becomes difficult — or impossible — to get.
  • Republicans largely have remained quiet about the ruling overturning mifepristone’s FDA approval. While many in the party support banning the drug, they likely recognize the political risks of broadcasting that stance. Meanwhile, the Biden administration moved to strengthen privacy protections for patients and providers related to abortion, offering some reassurance to those who fear they could be prosecuted under their home state laws for seeking abortions elsewhere.
  • As Southern states have whittled away at abortion access, Florida, with its 15-week abortion ban, had emerged as a hub for patients across the region. This week the state moved to restrict the procedure to six weeks, a change that could send many patients scrambling north to states like Virginia and New York for care. And in Idaho, a new law makes “abortion trafficking” — or transporting a minor to have an abortion without parental consent — a crime.
  • Congress is exploring new drug pricing measures, particularly aimed at increasing transparency around pharmacy benefit managers and capping insulin costs. Lawmakers are also watching the approach of the debt ceiling threshold; in the mix of budgetary pressure valves are Medicaid and, potentially, work requirements to receive Supplemental Nutrition Assistance Program benefits.
  • Congress continues to show little appetite for addressing a different, intensifying public health crisis: gun violence. A new poll from KFF shows startlingly high numbers of Americans — especially people of color — have directly experienced gun violence and live with that threat every day.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too:

Julie Rovner: The Washington Post’s “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese.

Shefali Luthra: KFF Health News’ “For Uninsured People With Cancer, Securing Care Can Be Like Spinning a Roulette Wheel,” by Charlotte Huff.

Victoria Knight: The Washington Post’s “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn,” by David Willman and Joby Warrick.

Sarah Karlin-Smith: NBC News’ “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It,” by Brandy Zadrozny.

Click to open the transcript

Transcript: The Confusing Fate of the Abortion Pill

KFF Health News’ ‘What the Health?’Episode Title: The Confusing Fate of the Abortion PillEpisode Number: 293Published: April 13, 2023

[Editor’s note: This transcript, generated using transcription software, has been edited for style and clarity.]

Julie Rovner: Hello and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent at KFF Health News. And I’m joined by some of the best and smartest health reporters in Washington. We are taping this week on Thursday, April 13, at 10 a.m. As always, news happens fast —really fast this week — and things might have changed by the time you hear this. So here we go. We are joined today by video conference by Victoria Knight of Axios.

Victoria Knight: Good morning.

Rovner: Sarah Karlin-Smith of the Pink Sheet.

Sarah Karlin-Smith: Hi, Julie.

Rovner: And Shefali Luthra of The 19th.

Shefali Luthra: Hello.

Rovner: Well, no interview this week, but spring is busting out all over with health news, so we will get right to it. We will begin in Texas with that court case that we’ve been saying for the last few weeks we hadn’t gotten a decision in. Well, we got a decision last Friday night around dinnertime and then very early this morning — that’s Thursday — we got an appeals court decision, too. But let’s take them one at a time. Last Friday night, in an opinion that was shocking but not surprising, as many people put it, Trump-appointed federal District Judge Matthew Kacsmaryk effectively rolled back the Food and Drug Administration’s 22-plus-year-old approval of mifepristone; that’s the first of two pills used for medication abortion early in pregnancy. Literally within the hour, federal District Judge Thomas Rice in Spokane, Washington, ruled in a separate case — brought by a group of about a dozen and a half state attorneys general — basically the opposite, ordering the FDA not to alter the current availability of the drug. Judge Kacsmaryk in Texas very kindly stayed his stay until this Friday to allow the Biden administration to appeal to the also very conservative 5th Circuit Court of Appeals. And in the wee hours of today, Thursday, an appeals court panel ruled that, while this lawsuit proceeds, mifepristone can continue to be sold, but only under the extremely onerous restrictions that were in effect until 2016. Shefali, where does that leave us? It’s kind of a mess, isn’t it?

Luthra: It is a huge mess, and the implications will be really significant. In particular, the 2016 restrictions on mifepristone don’t allow telemedicine. You have to go in person to a doctor to get the medication, and you can only use it up to seven weeks of pregnancy, when all of the evidence we have, including from the World Health Organization, says 10 weeks, sometimes maybe even 11. And I mean, we know realistically that people are taking mifepristone far later in pregnancy now because they can’t access legal abortion. And what this is going to do if it takes effect is it’s going to put a real strain on abortion clinics in states that have become destinations, right? The ones that are seeing so many out-of-state patients that largely do medication abortions because it’s easier, it’s faster, it pays a little bit better — all of these reasons that you do it —and that have really come to rely on telemedicine: Either they will have to take much longer to do this process and only do it for a handful of the patients they’re seeing, or they’ll switch to what we’ve talked about before, the misoprostol-only regimen, which is more painful, which is less effective. Still very good at terminating a pregnancy, but has a higher failure rate. And what clinics have told me is very often they expect that patients, when they hear that these are their options, will opt for a procedural abortion instead because that they know will absolutely work and they have to go home. They don’t worry about coming back to the clinic and worrying that they need an abortion again.

Karlin-Smith: I just want to put in the caveat that, you know, off-label use, which is where doctors prescribe a drug for use not approved for FDA, is something they do have sort of the discretion to do in practice of medicine once the product’s available. So the rollback is significant, but practically a lot of doctors will have the flexibility to still treat patients up to the longer timeframe. And people have pointed out this morning that, actually, many doctors were doing that prior to FDA formally expanding the approval.

Luthra: And to your point, many states have been stocking up on mifepristone in particular, and so have many abortion clinics, and they plan to use it as long as they can. The real challenge, I think, will be if there are supply issues at some point or other sorts of decisions from the Supreme Court, etc., or enforcement actions that essentially don’t allow telemedicine anymore.

Rovner: What it looks like the 5th Circuit has done is made it much harder for people in states where there are abortion bans to go to other states or to not go to another state but get the abortion pill, because they’ve banned it by mail; they’ve basically stopped in its tracks what we’ve been talking about for weeks — the ability of pharmacies to start to distribute it — because until 2016 you had to go — the doctor had to physically hand you the pill, which is what we are back to, and there have to be three visits in order to complete a medication abortion. These were all sort of the pre-2016 requirements. And the big question, though, is in Washington state, the requirement was that the FDA not change any of the relaxed restrictions. And now the 5th Circuit has said, yes, you will. So this still is on a fast track to the Supreme Court, right?

Luthra: It feels very like this is going to be decided by the Supreme Court. I mean, I wouldn’t be surprised if we hear about an appeal today. I wouldn’t be surprised if we hear about it tomorrow. It feels like really this could have changed between us taping and the podcast releasing.

Rovner: I think that’s entirely possible. So one of the things we thought Judge Kacsmaryk might do was order the FDA to basically restart its approval process for mifepristone, since his reasoning for rescinding essentially the drug’s approval is that the FDA violated its own procedures. Ironically, this decision came in a week when the FDA did withdraw the approval of a drug, a medication to prevent preterm birth called Makena. Sarah, what’s this drug and why is the FDA pulling it off the market? And this is how it’s supposed to work, right?

Karlin-Smith: Yes — supposed to work maybe is a stretch, depending on how some people felt about Makena; they felt it took way too long for FDA to withdraw it. So two sides of a coin, I suppose. But after a very long process, FDA finally pulled a drug that is given to women with the idea that it might help them deliver later, once their baby was full term, and prevent complications that come from having a premature birth. Unfortunately, over the years, as more clinical research was done on the drug, it appeared that it was not actually doing that. And as like all drugs, there are some side effects. And FDA basically ended up deciding, you know, absent any benefit, all you have is risk and this drug should not be pulled off the market. So it was finally pulled off the market after quite a lengthy process this week, right? It was still this week, or was it — no, it was last week.

Rovner: I think it was last week.

Karlin-Smith: Time. Time —

Rovner: Time is a very flat circle right now.

Karlin-Smith: Yeah, and so unfortunately it was really the only approved product that could possibly prevent preterm birth. And FDA really tried to recognize that and understand that people would be frustrated without options. But they tried to really emphasize the point that having an ineffective option is not the answer to that problem. The answer there is sort of push for more research on other products or even on this product to figure out if there’s a population of women it might benefit.

Rovner: So I wanted to mention that, because obviously the mifepristone ruling has the impact to affect much, much more than just abortion drugs. Individual drug companies are, to use the vernacular, freaking out about the idea that they could spend millions of dollars to shepherd a drug through clinical trials and the FDA approval process, only to see it banned because some small group of people object to it for some non-medical reason. Sarah, you cover the FDA. Is this freakout warranted right now?

Karlin-Smith: I do think most people think it is. And, you know, even in my preliminary look at what the 5th Circuit did this morning, I think that freakout is still going to continue because they seem to still give like this wide breadth that would allow many people to have the ability to challenge FDA approval decisions for any drug and then let judges weigh in who may not have the expertise and based on the science and all that other stuff that FDA has. So I think as this case has proceeded there’s still this underlying threat to the FDA’s authority and how they make decisions. Again, in the Texas case, he wasn’t trying to push it back to FDA and say, “OK, FDA, you go review this drug and decide again whether it needs to do it,” and then, you know, set them up for a Makena-like process where they would have to go through it. You know, they were trying to fast-track and overrule FDA’s authority. And if you read some of the details of the brief, you can really understand why it freaks out pharma and the FDA so much, because you can just tell how little the judge gets about how drugs are approved, the science, the regulatory process, and so forth.

Rovner: And basically that you have judges who are making medical and scientific decisions for which they are observably not qualified.

Karlin-Smith: Right, and I mean if nothing else industries likes stability, they like predictability, so there’s just this element of incredible unpredictability when you would have all these judges and potential legal cases throughout the country that would make it hard for them to deal with — and figuring out how to defend their products.

Rovner: So the FDA is obviously in an impossible situation here. They cannot satisfy both the Washington decision and the Court of Appeals decision because one says you can’t roll it back and one says you have to roll it back. Do we have any idea what the FDA is going to do here?

Luthra: I don’t know that we do. I mean, the Biden administration has said that they will follow the court orders, but the court orders are in conflict. So it seems like there should be some more clarity, perhaps, that we get. We, as of taping, haven’t gotten any statement from the president or the vice president or HHS, so we’ll keep an eye out and see if they have even just words of wisdom to offer about what this means or how they feel about the decision. But at this point, a lot is still quite confusing.

Rovner: So the Biden administration did take other action on abortion this week, in some separate steps. It announced Wednesday a series of new privacy protections for women and providers seeking or giving reproductive health care. How big a deal are these new rules, which sort of expand the HIPAA privacy rules? And why did it take them almost a year to do this? Hadn’t they been talking about this like right after the Dobbs ruling?

Luthra: They had been talking about this for a while. And what they said was that they believed that the guidance they had given to providers was sufficient to protect patient privacy. That has clearly not been the case, because we have continued to hear from people seeking abortions and from the health care providers giving them that they do not feel safe, right? They constantly have this fear that if I put something in someone’s medical record about an abortion, someone else might see it and it could get reported. So this should make that very clear beyond the guidance that was given out last summer — should make very clear that if you get an abortion, your doctor does not have to and should not tell any law enforcement about what happened. I think this has the potential to be really significant because one thing that we hear constantly from the people who are traveling out of state is they are terrified that they are breaking the law and that someone is going to find them, even though —

Rovner: That they’re breaking the law of their home state.

Luthra: Mm-hmm. Even though, of course, the home state laws do not criminalize the people who are seeking abortion.

Rovner: Yes. Well, I want to turn to the politics before we leave all of this. Democrats at all level of government were quick to decry this decision as wrong, anti-democratic, small d, and various other things. Republicans were a lot slower to react. How big a problem is abortion becoming for the Republican Party? They seem to be getting even more split on, “Gee, we thought that maybe overturning Roe was what we wanted and we were going to leave it at that.” And apparently anti-abortion activists are not leaving it at that.

Luthra: I mean, I think a great example of how Republicans are trying to navigate this problem is Congresswoman Nancy Mace, who, we may all recall, the day that Roe was overturned, put out a statement, like so many Republicans, saying that this was a great decision, very good for the country, the right step forward — and has since then tried very deliberately to walk away from that and to recalibrate her image on abortion and was one of the ones to come out this week and denounce the opinion from the District Court in Texas. Republicans who are willing to praise the decision in particular to take medication abortion off the market or to further restrict it, which is so unpopular, are finding themselves in a really tough spot. This is a winning issue for them and all they can really hope, and what we saw in the midterms, is to not talk about and to try and change the subject to something else.

Knight: I think important to note also that there were a good number of Republicans in Congress — think it was 69 — that signed on to an amicus brief both supporting the original lawsuit, this Texas lawsuit, and then also this decision when it came out.

Rovner: Right. This is an amicus brief to the Court of Appeals urging them to uphold the original decision.

Knight: Yeah. There were two amicus briefs , and a good number of congressional Republicans. — yeah, first for the original court case and then for the Appeals. But it was very noticeable that most of the Republican offices did not issue any kind of statement when this decision came out last week. So they’re fine supporting, putting documentation forward, supporting it, but they’re not broadcasting it, if that makes sense. And so I think that was very telling. It really was only Sen. Cindy Hyde-Smith, who is the Senate lead of the Pro-Life Caucus, that put something out. But it was very quiet among the rest of the Republicans, yeah.

Rovner: I noticed with that amicus brief, it’s like, OK, they’re going to say on the down-low to the anti-abortion activists, “We’re with you, but we really don’t want to publicize this because it’s not terribly popular with a lot of people.”

Luthra: To build on that, one example of someone who is really trying to walk that line and seems like is maybe facing challenges is Ron DeSantis, right? The person who did this compromise ban last year, the 15-week abortion ban, and now has clearly realized that if you want to be a nationally prominent Republican with support from the very powerful anti-abortion movement, you can’t do that; you need to be more overt in your disapproval of abortion and willingness to restrict access. But at the same time —

Rovner: Well, you’re anticipating my next question, which is that there is other abortion news this week. And in Florida, the legislature seems like it’s on the cusp of approving a six-week abortion ban to supplant the 15-week abortion ban it passed last year. And the aforementioned governor DeSantis says he will sign that if it comes to him. But Shefali, you’ve written about this. This could impact a lot more than just the people of Florida, right?

Luthra: I think it’s really important to note that Florida is the third-biggest state in the country and currently the biggest state in the eastern south part of the country where abortion is legal, even if it is only available up to 15 weeks. I have been to the clinics in Florida. It is stunning how crowded they are. There are people coming from all over the South. People are working until midnight to try and see every patient they can. And without Florida, the options are North Carolina and South Carolina. South Carolina clinics, there are very few of them, and they don’t go very far, not because of current state laws, but just because of the providers in the state. North Carolina is also looking likely to have some kind of abortion ban passed this year and again has way fewer clinics than Florida. If Florida is banning abortion after six weeks, a very, very large chunk of the country is going to be almost entirely displaced. The math just doesn’t really work. And we don’t know where people will be able to get abortions other than traveling, frankly, to Virginia, to D.C., to New York, and to all the places that so far, data shows, haven’t been as affected by out-of-state travelers.

Rovner: And of course, with the Court of Appeals decision basically saying that you can’t mail the abortion pills and that you can’t do it by telemedicine, I mean — which is not to say that people aren’t going to continue to get them by mail. It’s just that it won’t be FDA-sanctioned the way it was going to be. So Idaho is also making abortion news. This this feels like an afterthought, even though last week it seemed like a big deal. They have enacted a bill there creating the crime of abortion trafficking, which is the act of any adult transporting a minor for an abortion without her parent’s consent. Now, in the late 1990s and the early aughts, Republicans in the U.S. Congress tried unsuccessfully to pass something called the Child Custody Protection Act, which would have criminalized taking a minor across state lines for an abortion. But Idaho can’t do that. Only the federal government can regulate interstate travel. So this Idaho law just applies to the in-state portion of the trip. But it could still be a big deterrent, right? Unless you live right on the border. If you’re trying to take somebody out of state, you’re going to have to do part of it in state.

Luthra: I mean, of course. And I mean, Julie, I wanted to ask you about this because this is not actually a new kind of restriction. There are a bunch of states that have passed these, quote-unquote, “child trafficking laws” that restrict minors traveling out of state for abortion. Idaho is the first one to do it post-Dobbs. But for some reason, the anti-abortion movement has always had far more success in restricting access to minors. I think we’re all paying more attention now because we realize that this could in fact be the first step toward that thing that Justice Kavanaugh said would not happen, right? The larger-scale restriction of travel out of state for abortions.

Rovner: Yes. Restricting abortion for minors has been sort of the soft spot for the anti-abortion movement, really from the very beginning, because even people who consider themselves in favor of abortion rights, as we’ve seen this year with books — you know, parents are really like, “We want to be in charge of our daughters, and if my daughter needs my permission to get her ears pierced, she should need my permission to get an abortion or, God forbid, travel out of state or get contraception.” This is actually — it’s the minor issue that’s the reason that the Title X, the Family Planning Program, has not been reauthorized by Congress since 1984, which was before I started covering it. Oh, it’s my favorite piece of reproductive health trivia, because every time Congress tried to do it they got hung up over this question of should minors be able to get contraception without their parents’ approval. It is a continuing thing, but I think Idaho probably got more attention because they call this “abortion trafficking,” so we have a new law. All right. Well, there actually is other news this week that does not have to do with abortion. Congress next week will return from its two-week Easter/Passover break. And apparently at the top of the agenda in the Senate is a bill focusing on drug prices and particularly on pharmacy benefit managers. Even the Republican-led House is looking at PBM legislation. Sarah, remind us, what are PBMs and why are they so very unpopular among both Democrats and Republicans?

Karlin-Smith: So PBMs are companies contracted by your health insurance company or now, at this point, often owned by your health insurance company, that administer your pharmacy benefits, and they create the formularies that decide what drugs are covered and how much you are going to pay for them. And then they negotiate deals with pharmaceutical companies to try and lower the prices of drugs. And they also have to work with the pharmacies. So they’re called middlemen, often in a not very nice way. The drug industry has definitely tried to paint them as the key reason prices are too high, saying they give them discounts but they’re not passing them on to patients. It’s a bit more complicated than that. PBMs essentially say they do pass on that money to patients in the U.S. system but it ends up lowering everybody’s premiums, so not necessarily the person who’s paying for the high-cost drug. Of course, it’s a lot more complicated, because this is an industry, I think, surrounded by a lack of transparency. So it’s been hard for people, I think, to verify who’s getting that money and is it all really going to patients? And then, like I mentioned, this consolidation with health insurance companies, with parts of the pharmacy system as well, has started to raise a lot of kind of antitrust concerns and, again, that they may not be working in patients’ best interests.

Rovner: And a lot of this legislation is about transparency, right? It’s about sort of opening the black box of how PBMs set drug prices and negotiate with drug companies and pass these things along to insurers. I see you nodding, Victoria.

Knight: Yeah, and there’s a lot of different bills floating out there. There’s some that have passed out of committee in previous Congress that passed out of committee again, most notably a Senate Commerce bill — Chuck Grassley and Maria Cantwell — and that just passed out of committee, and that would implement some transparency measures, also ban the practice of spread pricing. There is some talk that Schumer may put a health package on the floor sometime soon, and so PBMs are going to potentially be a big part of that. There’s also supposed to be a markup sometime this month out of the Health, Education, Labor, Pensions Committee, where they also are talking about PBMs. So it’s interesting that there is a real movement on both sides of the aisle, also in the House, on PBMs. So they want to put some blame on high drug prices on someone. And right now it seems to be PBMs.

Rovner: And it looks like they’re going to go after insulin again, too, right? In the bill that passed last year they managed to cap insulin costs at $35 a month, but only for people on Medicare. So I guess this is the attempt to come back and require lower insulin prices for others. We will point out that many of the companies have voluntarily lowered some insulin prices, but looks like Congress not done with this yet, right?

Knight: No, it’s not done with it yet. Bernie Sanders is apparently going to haul some insulin execs in to have to testify, even though some of them have committed to lowering prices. And it’s also mentioned in the potential Schumer package, that $35 cap for everyone is supposed to be a part of it. And there’s also a lot of insulin $35-cap bills floating around. There is some Republican support in the Senate for that. There were some Republicans last year that voted for that. But I think the House will be the bigger issue, because there doesn’t seem to be as much Republican support in the House for a cap that extends to everyone.

Rovner: Yeah, but I mean, when we said sort of back in January that there might be some things that they could do on a bipartisan basis, it sounds like we’re starting to see some of them — now that it’s spring — blooming. So anything else that you are looking for this next session between, you know, Easter and Memorial Day?

Knight: I think also, I don’t know how much people are paying attention to this, but there is going to be one of those select subcommittee covid hearings next week and they’re bringing in some intelligence officials to talk about covid origins. So I think this is the first hearing with actual, like, intelligence officials. So I think it’ll be interesting to see what comes out of that. And obviously, there’s a lot of talk around, like, that practical policy implications are that Congress could kind of restrict NIH [National Institutes of Health] funding or how NIH gives out research funding because of all this talk around gain-of-function research in regards to covid origins. So I think that’s what we’re watching for rather than just the rhetoric around it, like what are the actual — how could it play out in regards to NIH funding? And then of course, can’t forget debt ceiling negotiations and work requirements are still very much being talked about.

Rovner: For Medicaid.

Knight: For Medicaid and also SNAP [Supplemental Nutrition Assistance Program] potentially. So there was reporting this morning from Punchbowl saying that work requirements are very much still in the proposals that are being kicked around. So, another thing to watch.

Rovner: May is traditionally a very busy month on Capitol Hill, particularly May of the odd-numbered year, the first year of a Congress, so I imagine we’ll see a lot. One last thing I want to talk about this week, and we haven’t talked about it for a while, but the toll of gun injuries just continues to mount. In the past three weeks, we’ve had mass shootings with multiple fatalities in Tennessee, Kentucky, and Florida. In Louisville, in fact, the mayor, who himself survived a mass shooting last year, lost a close friend in the shooting this week. So it’s not all that surprising that a new poll from my colleagues over the editorial firewall at KFF found that gun violence is so common that more than one in five Americans say they have personally been threatened by a gun. Nearly as many say a family member has been killed by a gun; 17% say they have personally witnessed someone being shot. The numbers are even worse for people of color. Nearly a third of Black adults have witnessed someone being shot, and more than a third have lost a family member to gun violence. We seem to have acknowledged finally that gun violence is a public health problem. Yet that hasn’t brought us any closer as a society to solving it. I mean, we were just talking about the things that Congress might be looking at in terms of health care in the spring. But gun violence isn’t really one of them, is it?

Knight: Yeah. I think you’ve seen from the Biden administration and acknowledgment from both sides of the aisle in Congress that the bipartisan bill that passed last year, which gave a lot of money towards mental health funding and also allowed states the option to implement red flag laws and some other smaller gun safety things. They kind of acknowledged that’s as far as they’re going to be able to go in the current makeup of this Congress. So it seems like a stalemate and it’s kind of like now on a state level. And there was some talk from Tennessee’s governor about doing some small things, perhaps after the shooting in Nashville, but it doesn’t seem like there is much movement.

Rovner: And of course, in Tennessee, it was fighting about not doing anything about guns that erupted in that whole conflagration with people getting —

Knight: — expelled —

Rovner: —evicted from the Tennessee state legislature and then reappointed and yeah, I mean, that — people may not remember, that’s actually over a gun demonstration or a lack-of-gun-legislation demonstration. So who knows whether anyone will find something to do about it. All right. That is the news for this week. Now it’s time for our extra credit segment. That’s when we each recommend a story we read this week we think you should read too. As always, don’t worry if you miss it. We will post the links on the podcast page at khn.org and in our show notes on your phone or other mobile device. Sarah, why don’t you go first this week?

Karlin-Smith: Sure. I looked at an NBC News story called “Conspiracy Theorists Made Tiffany Dover Into an Anti-Vaccine Icon. She’s Finally Ready to Talk About It.” This was a nurse who was one of the first people to receive a covid vaccine when it first became available. And apparently, I guess, this is something that’s been a problem for her, she says, throughout her whole life. Sometimes with certain pain reactions she faints. And the story also talks about how she hadn’t really eaten lunch that day. But basically it was filmed and shared quite widely, including all over social media, and anti-vaccine activists basically took it and were using it sort of as proof of the harm caused by the vaccines. And the reaction to that from the hospital, and herself to some degree, was basically to just kind of keep quiet and not respond. There was very little pushback, yet — the idea was kind of if we ignore it, it will go away. But that just kept fueling everything. And basically people thought she might have even been dead and no one was telling. They thought the hospital was using her co-worker as sort of a body double to show proof of life. And a couple of years later, she’s finally trying to talk about what that experience was like and make clear again: She was fine, she was healthy, you know, she was more than happy to get the vaccine, you know, would do it again and stuff. But it’s a really interesting story because I think the journalists sort of go through again how we’ve been sort of grappling as a society with how to respond to this type of misinformation and how some of the normal kind of PR playbook strategies are actually hurting, not helping, public health. So we need to kind of shift to figure out how to handle that.

Rovner: And there are lots and lots and lots of these stories about people who, you know, quote-unquote, “died” when they got the vaccine, who are perfectly fine and walking around. It was — it was a really well done story. It’s just — it’s really kind of scary. Victoria.

Knight: Victoria, my extra credit this week is a story in The Washington Post by David Willman and Joby Warrick. It’s called “Research With Exotic Viruses Risks a Deadly Outbreak, Scientists Warn.” And so it’s basically kind of an in-depth look at how, over the years, the U.S. has funded virus research where — in other countries — where people go out into like forests and wildlife areas and collect bat samples, collect samples from different animals to try to kind of predict the next pandemic. And it profiles this one team in Thailand who has said, “We’re not accepting U.S. funds anymore.” They told the U.S. in 2021 after covid, “This feels too risky for us.” And we — they have been doing this research funded by the U.S. for four years, and they really felt like they hadn’t found much tangible benefit out of it either. So they’re kind of like, “It’s not worth the risk to our employees and potentially creating another pandemic on our own.”

Rovner: And and just to be clear, this isn’t gain-of-function research.

Knight: This is not even gain-of-function research.

Rovner: This is a different kind of potentially dangerous research.

Knight: Yeah, this is really just going out in the wild and collecting samples from animals that are out there already. But yeah, it’s not doing research in a lab that’s like altering a virus necessarily. So yeah, and so the story is kind of reckoning — like what is the balance between wanting to do scientific research and needing that knowledge for the future and the safety of employees and the general public. So, and it talked about how there is like — the U.S. does fund quite a bit of this kind of research around the world, and the pace of that has not always kept up with regulation and oversight. And so just kind of probing questions, especially as I talked about earlier — Congress does look into this issue of gain-of-function research and just the NIH funding research around the world in general.

Rovner: I feel like this whole week has been, where do government and science cross? Shefali.

Luthra: My story is from the well-named KFF Health News. It is called “For Uninsured People With Cancer, Securing Care Can Be Like Spinning A Roulette Wheel.” It’s by Charlotte Huff. It’s a really, really great look at what happens when you get cancer and in particular live in a state that didn’t expand Medicaid. Charlotte just does a really great job looking at the experiences that this woman has when she develops skin cancer and is recommended all these treatments that she can’t afford. She lives in South Carolina. She’s not eligible for Medicaid because they didn’t expand eligibility. And what it really gets into is the idea that there are a couple of cancers where you will get treatment, but for most of them, you will not get coverage; you have to pay thousands, sometimes tens of thousands out-of-pocket. And it’s a really well done, devastating look at what health care costs mean in our system and how much access really is for so much of health care based on where you happen to live.

Rovner: Yeah, it really is — really wonderful story. Well, my story, it’s also from The Washington Post, and it’s called “To Comply With a New Sesame Allergy Law, Some Businesses Add — Sesame,” by Karen Weese. So back in 2004, I covered the deliberation and passage of the Food Allergen Labeling and Consumer Protection Act, which for the first time required companies to put on the label in plain English if their products contained any of the eight major food allergens, which are milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. It was an enormous relief, particularly to parents of young children with allergies and to anyone with a food allergy that could be fatal. So, the law also required food companies to label whether there was a chance that the product could have been cross-contaminated with one of those allergens. That’s why you sometimes see on a label, you know, quote, “This product was produced in a facility that also makes milk products or that uses nuts” or some such thing. The law has worked pretty well, say those who fought for it, and in 2021 Congress added sesame to the list of allergens that had to be labeled. Except that this time something weird happened. Many food companies, rather than carefully cleaning and monitoring their plants to ensure there would be no cross-contamination with sesame, instead are basically evading the law’s intent by adding small amounts of sesame flour to their products and then putting on the label that “This product contains sesame.” It’s dangerous for a lot of reasons but mainly because for people with sesame allergies who have eaten certain products without problems for years, they may not realize that, to them at least, a poison has been added to their favorite bread or roll or whatever kind of product. So this is something that I imagine Congress is going to want to go back and take a look at. All right. Before we go this week, you may have noticed that the introduction to the podcast has been tweaked. That’s because we have a new name. Kaiser Health News has been retired as of this week. We are KFF Health News to reflect that we are an editorially independent program of KFF, also a new name, and that neither of us is connected in any way to that big HMO [health maintenance organization] Kaiser Permanente. I hope you will bear with us as we all get used to the change. OK, that is our show. As always, if you enjoyed the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review; that helps other people find us too. Special thanks, as always, to our ever-patient producer, Francis Ying. Also, as always, you can email us your comments or questions. We’re at whatthehealth@kff.org. Or you can tweet me, at least for the moment. I am still @jrovner. Victoria?

Knight: @victoriaregisk.

Rovner: Sarah?

Karlin-Smith: @SarahKarlin.

Rovner: Shefali.

Luthra: @shefalil.

Rovner: We will be back in your feed next week. Until then, be healthy.

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2 years 2 months ago

Courts, Multimedia, Pharmaceuticals, States, Abortion, diabetes, Drug Costs, FDA, Guns, KFF, KFF Health News' 'What The Health?', Podcasts, Polls, U.S. Congress

PAHO/WHO | Pan American Health Organization

Menos del 10% de las personas con Chagas han sido diagnosticadas

Less than 10% of people with Chagas receive a diagnosis

Cristina Mitchell

13 Apr 2023

Less than 10% of people with Chagas receive a diagnosis

Cristina Mitchell

13 Apr 2023

2 years 2 months ago

Health Archives - Barbados Today

Child care needed for mothers seeking help for addiction


Women with mental health and addiction issues are knocking on the doors of the Substance Abuse Foundation Inc.’s (SAF) Marina House treatment facility for help.


Women with mental health and addiction issues are knocking on the doors of the Substance Abuse Foundation Inc.’s (SAF) Marina House treatment facility for help.

However, many of them have had to delay the start of treatment because they do not have a support system to adequately care for their children while they are at the New Castle, St John residential facility, according to Senior Mental Health and Addiction Counsellor with SAF, Letitia Wiltshire.

“There is a 100 per cent huge demand for our services and that has actually increased post-COVID. The issues are still there with regards to our women and the child care challenges a lot of them have. Yes, they may need the help with their addiction but they also do not want to leave their children,” said Wiltshire who explained this was why Marina House has previously partnered with the Women of Purpose organisation to provide the resources to allow a mother to have her child with her while accessing treatment.

She appealed to other agencies and charitable organisations to assist women in this position who were seeking to beat drug, sex and gambling addictions.

The counsellor stressed that a significant aspect of the healing process for mothers seeking addiction counselling was having the peace of mind that their children were being well taken care of.

“The women also need the assistance of their family members and those community members who are open to fostering a child for a period of time. We know that it is a big ask of the community; a lot of people would not feel comfortable engaging children who are not their own. But at the end of the day, it takes a village to raise a child and if one of us is sick then, unfortunately, the child can also eventually be sick. When one person with an addiction is sick, it impacts several other persons within that family, so you can do the maths.

“We have a facility that houses 16 women, so if you do the maths and you multiply that by seven, you see how many people are impacted by just one woman not being able to get the help that she needs,” she said.

Wiltshire spoke about the issue during an interview with the media on Tuesday, following the launch of the Rotary Club of Barbados’ Save, Spend, Thrive: Empowering Women Through Financial Wellness initiative, at the Christies Conference Room at the Barbados Light & Power Company, Garrison, St Michael.

“We have dealt with women who have substance abuse issues, women who have challenges with sex addiction, there are women who have challenges with gambling,” she said, noting many women had reached out during the COVID-19 pandemic when they were going through “a depressive phase” and “coming out of COVID, it is still there”.

“So we also deal with self-esteem issues and we are also helping persons with depression. Whatever the need is in terms of mental health we are there to provide that assistance,” the SAF counsellor said.

Wiltshire also noted that given the reported increase in domestic violence cases during the COVID-19 pandemic, Marina House had housed several women waiting to be admitted to the shelter for battered women.

“We would never turn our backs on someone who needs assistance, regardless of what the challenges are. We are going to try to help them to fill that gap until they can get to where they need,” she said.

anestahenry@barbadostoday.bb

The post Child care needed for mothers seeking help for addiction appeared first on Barbados Today.

2 years 2 months ago

A Slider, Health, Local News

KFF Health News

The Drug Company That Prospered Without Creating Any Drugs

[UPDATED on April 18]

The new drug looked so promising — except for that one warning sign.

[UPDATED on April 18]

The new drug looked so promising — except for that one warning sign.

At the American College of Rheumatology’s annual meeting in 2008, Duke University’s Dr. John Sundy proudly announced that pegloticase, a drug he’d helped develop, was astoundingly effective at treating severe gout, which affects perhaps 50,000 Americans. In about half of those who had taken it, the drug melted away the crystalline uric acid deposits that encrusted their joints to cause years of pain, immobility, or disfigurement.

But Sundy also disclosed an unsettling detail: In one clinical trial, patients who got the drug were more likely to develop heart problems than those who didn’t. The day after Sundy’s talk, the stock price of Savient Pharmaceuticals, which developed the drug with Duke scientists, plunged 75%.

That danger signal would disappear in later studies, and the FDA approved pegloticase, under the trade name Krystexxa, two years later. But the small biotech company never recovered. In 2013, Savient was sold at auction to Crealta, a private equity venture created for the purpose, for $120 million.

Two years later, a young company now called Horizon Therapeutics bought Crealta and its drug portfolio for $510 million.

Even at that price, it proved a good deal. Krystexxa brought in $716 million in 2022 and was expected to earn $1 billion annually in coming years.

Although Horizon says it now has 20 drugs under development, in its 15 years of existence it has yet to license a product it invented. Yet the company has managed to assemble a war chest of lucrative drugs, in the process writing a playbook for how to build a modern pharmaceutical colossus.

As the White House and both parties in Congress grapple with reining in prescription drug prices, Horizon’s approach reveals just how difficult this may be.

Horizon’s strategy has paid off handsomely. Krystexxa was just one of the many shiny objects that attracted Amgen, a pharmaceutical giant. Amgen announced in December that it intends to buy Horizon for $27.8 billion, in the biggest pharmaceutical industry deal announced in 2022.

Horizon’s CEO, Tim Walbert, who will reportedly get around $135 million when the deal closes, has mastered a particular kind of industry expertise: taking drugs invented and tested by other people, wrapping them expertly in hard-nosed marketing and warm-hued patient relations, raising their prices, and enjoying astounding revenues.

He’s done this with unusual finesse — courting patients with concierge-like attention and engaging specialist clinicians with lunches, conferences, and research projects, all while touting his own experience as a patient with a rare inflammatory disease. Walbert’s company has been particularly adept at ensuring that insurers, rather than patients, bear the costly burdens of his drugs.

A federal prosecutor in 2015 began examining allegations that Horizon’s patient assistance program had worked with specialty pharmacies to evade insurers’ efforts to shun Horizon’s expensive drugs. A separate probe opened in 2019 over alleged kickbacks to pharmacy benefit managers, companies that negotiate to get Horizon’s drugs covered by insurers. Those investigations appear to be no longer active, Horizon spokesperson Catherine Riedel said. The company this year disclosed a third probe, concerning methods the company allegedly used to get prior authorization of its drugs. Justice officials did not respond to requests for comment on the investigations.

An Injection of Marketing

To help sell its drugs, Horizon blankets specialist physicians with marketing and peer-to-peer appeals. Its payments to physicians for things like consulting, speeches, and meals totaled $8.7 million in 2021, compared with the $10 million it paid them for research, federal records show. By contrast, Seagen, a biotech company of roughly the same size, paid doctors a total of $116 million, with nearly $112 million of that pegged for research. Riedel said Horizon’s marketing and educational approaches were “necessarily unique” because of the challenges of treating rare and neglected diseases.

Walbert launched Horizon in 2008 in the Chicago area by combining and refashioning generic drugs into single pills. Duexis, Horizon’s first drug, is a mixture of generic Motrin and Pepcid. Its Vimovo combines generic Aleve and Nexium. In a 2017 article, a ProPublica reporter described being prescribed Vimovo for a shoulder injury. It cost him nothing, but his insurer was billed $3,252 for pills that together cost about $40 for a month’s supply in generic form. Horizon sold more than $57 million worth of Vimovo that year.

In 2014 and 2015, respectively, Horizon picked up two relatively new drugs that had no generic versions: the immunosuppressant Actimmune and Ravicti, which treats a rare genetic disorder. Soon Horizon was charging more than $50,000 a month for each, placing Actimmmune fourth and Ravicti second on GoodRx’s 2020 list of the most expensive U.S. drugs.

Horizon’s net sales soared from $20 million in 2012 to $981 million in 2016; Walbert’s pay package followed suit, topping an astronomical $93.4 million in 2015 in salary and stock. Stock analysts questioned the long-term soundness of a strategy of simply selling old drugs for mind-boggling prices, but Walbert was using the cash to refashion the company as a rare-diseases franchise.

His approach would make Walbert a darling of pharmaceutical investors and his board, which lavished him with over $20 million in compensation each of the past three years. While most biotechs and startups borrow heavily from venture capital to do science and have no idea how to develop and market a drug, Walbert got cash coming in quickly. “He did it backwards,” said Annabel Samimy, an analyst at Stifel Financial Corp. “Horizon built commercial platforms before they got into drug development.”

Generating “robust sales of what sounded like not very interesting drugs” allowed Walbert “to start a company on not very much,” said Oppenheimer analyst Leland Gershell. All the while, Horizon funded and cultivated the patient advocacy groups that can help lobby for a drug to be approved by the FDA and placed on insurers’ formularies, the lists of drugs health plans cover for patients.

Speaking From Experience

As Walbert and his spokespeople often point out, Walbert and his youngest son suffer from a rare disease, and Walbert also has an autoimmune disease. Walbert won’t name the diseases, but has said he’s taken the anti-inflammatory injectable Humira since 2003 — the year he led that drug’s commercial launch as a vice president at Abbott Laboratories. Humira has become the bestselling drug in history, with about $200 billion in all-time global sales.

In 2014, Walbert moved Horizon’s headquarters to Ireland, which nearly halved its tax rate. A year later it gained control of Krystexxa, and in 2017 it bought, for $145 million, a failing company that produced Tepezza, a drug for thyroid eye disease, which causes unsightly eye bulging and pain.

Tepezza quickly became a blockbuster, with $3.6 billion in total sales in 2021 and 2022. The company conducted additional clinical research on both Tepezza and Krystexxa, but it also spent heavily promoting these and other drugs to specialists who could prescribe them.

All the while it steadily raised prices. Savient put Krystexxa on the market in 2011 at $2,300 per injection. Horizon charges roughly 10 times as much. Six months of Tepezza treatment can run more than $400,000.

Horizon’s publicity emphasized the company’s sensitivity to patients, and its constant contact with disease advocates.

“Our scientists are attuned to the unmet needs of patients, their diagnostic and therapeutic journey,” Bill Rees, Horizon’s vice president for translational sciences, told KFF Health News. “It’s the marrying of the basic clinical science with a focus on the needs of the patient that differentiates us.”

To make sure patients keep using its drugs, clinicians say, Horizon staffers negotiate with insurance carriers, and the company offers drug discounts to lower-income patients while swaddling them with attention from its medical staff.

“Horizon has a nurse talk to each and every patient before every appointment,” said Dr. Brigid Freyne, who treats around half a dozen patients each year with Krystexxa at her Murrieta, California, rheumatology clinic. “The patients who come in here are highly motivated to get their IV. They get the message that it’s very important and they are fortunate to get the medicine.”

None of the manufacturers of her other infusion drugs shower patients with this kind of attention, she said.

While at Abbott, Walbert pioneered direct-to-consumer advertising for specialty drugs like Humira, a trend that aggravated insurers, who anticipated, correctly, that they would soon be shelling out billions for expensive drugs.

Horizon’s marketing plan for Krystexxa includes direct-to-consumer ads aimed at driving patients to specialists. The drug is designed for recalcitrant gout patients, who often have large lumps on their fingers, feet, and kidneys. Many, though not all, are heavy drinkers of beer or soda sweetened with high-fructose corn syrup, which can increase the buildup of uric acid, the cause of gout, said Dr. Robert McLean of Yale University.

While Krystexxa can help patients with advanced gout, the American College of Rheumatology views it as a drug of last resort, with plenty of cheaper, early intervention alternatives available.

“I prescribe it maybe once a year,” McLean said. “From a cost-effectiveness standpoint, it warrants questioning.”

Horizon recently started a publicity campaign addressed to all gout sufferers, urging them to see a rheumatologist or a nephrologist — the specialists it has targeted with Krystexxa educational materials — before the disease does too much harm.

“Horizon would like you to say, ‘Everyone with serious gout should be started on Krystexxa,’” said Dr. James O’Dell, a rheumatologist at the University of Nebraska Medical Center. The Horizon pitchmen he deals with are “nice guys, but we don’t believe that’s the best way.”

The company defends its marketing practices. “We learn what matters most to patient communities and act. This approach has been validated by independent third-party research,” said Riedel.

The Federal Trade Commission said in January it was seeking more information on the Amgen-Horizon merger. Sen. Elizabeth Warren (D-Mass.), citing high prices for Horizon and Amgen drugs, urged the agency to nix the deal.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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This story can be republished for free (details).

2 years 2 months ago

Health Care Costs, Health Industry, Pharmaceuticals, Drug Costs, Prescription Drugs

Health & Wellness | Toronto Caribbean Newspaper

The system is going through a transformation of death, rebirth and transformation

BY AKUA GARCIA Greetings star family! I pray you are all doing well. We are in a new cycle, a new month filled with new opportunities for healing and growth. March was an intense month, with major shifts in the cosmos and here down below. On the global scale we have witnessed bank crashes, mass […]

2 years 2 months ago

Spirituality, #LatestPost

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