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National pharmacare – might it be a pig in a poke?

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From the Macdonald Laurier Institute

By Nigel Rawson and John Adams for Inside Policy

No Canadian should have to choose between paying for medicines and paying for rent or food. National pharmacare has been proposed as a remedy to this situation.

“When will Canada have national pharmacare?” asks the author of a recent article in the British Medical Journal (BMJ). Better questions are: will Canadian pharmacare be the system many Canadians hope for? Or, might it turn out to be skimpy coverage akin to minimum wage laws?

In its 2024 budget document, the federal government proposed providing $1.5 billion over five years to support the launch of national pharmacare for “universal, single-payer coverage for a number of contraception and diabetes medications.” This has been hailed as a “big day for pharmacare” by some labour unions, patients and others, including the author of the BMJ article who said that national pharmacare should be expanded to cover all medication needs beginning with the most commonly-prescribed, clinically-important “essential medicines.”

In its budget, the government stated “coverage of contraceptives will mean that nine million women in Canada will have better access to contraception” and “improving access to diabetes medications will help improve the health of 3.7 million Canadians with diabetes.” Why not salute such affable, motherhood and apple pie, sentiments? The devil is in the details.

The plan does not cover new drugs for diabetes, such as Ozempic, Rybelsus, Wegovy, Mounjaro or Zepbound, all based on innovative GLP-1 agonists, where evidence is building for cardiovascular and weight loss benefits. This limited rollout seems based on cheap, older medicines, which can be less effective for some with diabetes.

The federal government has also consistently under-estimated the cost of national proposals such as pharmacare – not to mention other promises. In their 2019 election platform, the Liberals promised $6 billion for national pharmacare (the NDP promised $10 billion). Keen analysis shows that even these expansive amounts would be woefully inadequate to fund a full national pharmacare plan. This makes the $300 million a year actually proposed by the Liberals’ look like the skimpy window-dressing that it is.

National pharmacare, based on the most comprehensive existing public drug plan (Quebec’s), would cost much more. In 2017, using optimistic assumptions, the Parliamentary Budget Officer (PBO) estimated the cost for a national plan based on Quebec’s experience to be $19.3 billion a year. With more appropriate assumptions, the Canadian Health Policy Institute estimated $26.2 billion. In June 2019, the federal government’s own Advisory Council on the Implementation of National Pharmacare put the cost at $40 billion, while a few months later, the tax consulting company RSM Canada projected $48.3 to $52.5 billion per year. Five years later, costs no doubt have soared.

Even with these staggering cost a program based on matching Quebec’s drug plan at the national level would fail to provide anywhere near the level of coverage already provided to the almost two-thirds of Canadians who have private drug insurance, including many in unionized jobs. Are they willing to sacrifice their superior coverage, especially of innovative brand-name medicines, for a program covering only “essential medicines”? Put another way, are Canadians and their unions prepared to settle for the equivalent of a minimum wage or minimum benefits?

The PBO has estimated the cost of coverage of a range of contraceptives and diabetes medicines as $1.9 billion over five years, which is more than the $1.5 billion provided in the budget. However, this figure is based on an assumption that the new program would only cover Canadians who currently do not have public or private drug plan insurance, those who currently do not fill their prescriptions due to cost related reasons, and the out-of-pocket part of prescription costs for Canadians who have public or private drug plan coverage. This is major guesswork because existing public and private drug plans may see the new federal program as an opportunity to reduce their costs by requiring their beneficiaries to use the new program. If this occurs, the national pharmacare costs to the federal government, even for the limited role out of diabetes and contraceptives, would soar to an estimated $5.7 billion, according to the PBO.

Our governments are not known for accurate estimates of the costs of new programs. One has only to remember the Phoenix pay system and the ArriveCAN costs. In 2017, the Government of Ontario estimated $465 million per year to extend drug coverage to every resident under the age of 25 years. What happened? Introduced in 2018, prescriptions rose by 290% and drug expenditure increased to $839 million – almost double the guesstimate. In 2019, the provincial government back peddled and modified the program to cover only people not already insured by a private plan.

Although we believe governments should facilitate access to necessary medicines for Canadians who cannot afford their medicines, this does not require national pharmacare and a growing bureaucracy. Exempting lower-income Canadians from copayments and premiums required by provincial programs, as British Columbia has done, and removing the requirement to pay for all drugs up to a deductible would allow these Canadians access sooner, more simply, and more effectively.

Moreover, it isn’t just lower-income Canadians who want help with unmet medicine needs. Canadians who need access to drugs for diseases that are difficult to treat and can cost hundreds of thousands of dollars per year also require assistance. Few Canadians whether they have low, medium or high incomes can afford these prices without government or private insurance. Private insurers often refuse to cover these drugs.

The Liberals provided a separate $1.5 billion over three years for drugs for rare disorders, but no province or territory has signed a bilateral agreement with the federal government for these drugs and no patient has received benefit through this program. Even if they did, the $500 million per year would not go far towards the actual costs. There is at least a zero missing in the federal contribution, as the projected cost of public spending on rare disease medicines by 2025 is more than threefold what Ottawa has budgeted.

Expensive drugs for cancer and rare disorders are just as essential as basic medicines for cardiovascular diseases, diabetes, birth control, and many other common conditions. If a costly medicine will allow a person with a life-shortening disease to live longer or one with a disorder that will be severely disabling left untreated to have an improved quality of life and be a productive taxpayer, it too should be regarded as essential.

The Liberals and NDP are working to stampede the bill to introduce the pharmacare program (Bill C-64) through the legislative process. This includes inviting witnesses over the first long weekend of summer, when many Canadians are away, to appear before the parliamentary Standing Committee on Health three days later.

Too much is unknown about what will be covered (will newer drugs be covered or only older, cheaper medicines?), who will be eligible for coverage (all appropriate Canadians regardless of existing coverage or only those with no present coverage?), and what the real cost will be, including whether a new program focusing on older, cheaper drugs will deter drug developers from launching novel medicines for unmet needs in Canada.

This Bill as it stands is such a power grab that, if passed, the federal Health Minister never has to come back to Parliament for review, oversight or another tranche of legal authority, it would empower the Cabinet to make rules and regulations without parliamentary scrutiny.

A lot is at stake for Canadians, especially for patients and their doctors. Prescription medicines are of critical importance to treating many diseases. National pharmacare must not only allow low-income residents to access purported “essential medicines” but also ensure that patients who need specialized drugs, especially higher-cost innovative cell and genetic therapies that may be the only effective treatment for their disorder, are not ignored. Canadians should be careful what they wish for. They may receive less than they anticipate, and, in fact, many Canadians may be worse off despite the increase in public spending. Time to look under the hood and kick the tires.

Nigel Rawson is a senior fellow with the Macdonald-Laurier Institute.

John Adams is co-founder and CEO of Canadian PKU and Allied Disorders Inc., a senior fellow with the Macdonald-Laurier Institute and volunteer board chair of Best Medicines Coalition.

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RFK Jr. purges CDC vaccine panel, citing decades of ‘skewed science’

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From LifeSiteNews

By Robert Jones

Health and Human Services Secretary Robert F. Kennedy Jr. has dismissed every member of the CDC’s top vaccine advisory panel, citing what he described as a “decades” of “conflicts of interest” and “skewed science” in the vaccine regulatory system.

RFK Jr.’s abrupt decision to “retire” all 17 members of the Advisory Committee on Immunization Practices (ACIP) was announced in a Wall Street Journal op-ed Monday and confirmed by HHS shortly thereafter.

The move marks the most sweeping reform to federal vaccine policy in years and follows months of internal reviews and mounting public skepticism.

Kennedy accused the ACIP of being “little more than a rubber stamp for any vaccine,” claiming “it has never recommended against a vaccine.”

“The public must know that unbiased science guides the recommendations from our health agencies,” Kennedy wrote. “This will ensure the American people receive the safest vaccines possible.”

ACIP holds the power to influence which vaccines are recommended by the CDC and covered by insurers. But according to Kennedy, it has failed in its duty to protect the public.

He cited multiple government investigations—dating back to 2000 and 2009—finding that ACIP members were routinely advising on products from pharmaceutical firms with which they had financial ties. Committee members were also issued conflict-of-interest waivers from the CDC.

Kennedy pointed to the 1997 vote approving the Rotashield vaccine – later withdrawn for causing severe bowel obstructions in infants – as a case study in regulatory failure. Four of the eight members who voted for it had financial stakes in rotavirus vaccines under development.

He explained “retiring” the 17 members, “some of whom were last-minute appointees of the Biden administration,” by saying that without such a move, “the Trump administration would not have been able to appoint a majority” until 2028.

Under Kennedy’s leadership, HHS has already halted recommendations for routine COVID-19 shots for healthy children and pregnant women and cancelled COVID-era programs to fast-track new vaccines.

It remains unclear who will replace the outgoing ACIP members, though HHS confirmed the committee will still meet later this month, now under new leadership.

“The new members won’t directly work for the vaccine industry,” he promised. “They will exercise independent judgment, refuse to serve as a rubber stamp, and foster a culture of critical inquiry—unafraid to ask hard questions.”

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Police are charging parents with felonies for not placing infants who died in sleep on their backs

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From LifeSiteNews

By Dr. Brenda Baletti, The Defender

Pennsylvania authorities brought felony charges against the parents of two different babies after police said the infants died because the parents placed them in unsafe sleeping positions.

Parents of two different babies are being charged with felonies in Pennsylvania after police say their babies died because the parents placed them in unsafe sleeping positions, SpotlightPA reported.

In both cases, police allege that the parents failed to follow guidance, including handouts given to them at doctor’s visits, stating that babies should be put to sleep on their backs.

Gina and David Strause of Lebanon County are accused of putting their 3-month-old infant son, Gavin, to sleep on his stomach and allowing him to sleep with stuffed animals in the crib.

They are charged with involuntary manslaughter, recklessly endangering another person, and endangering the welfare of children.

Natalee Rasmus of Luzerne County is accused of putting her 1-month-old daughter, Avaya Jade Rasmus-Alberto, to sleep on her stomach on a boppy pillow, often used for nursing. She is charged with third-degree murder, involuntary manslaughter, and endangering the welfare of children.

Rasmus was a 17-year-old mother when her daughter died in 2022. Court records show that she continues to be held at the Luzerne County Correctional Facility with bail set at $25,000 pending resolution of her case.

In both cases, autopsies concluded the babies died of accidental death from asphyxiation. Law enforcement argued in both cases that parents should have known that putting the babies to sleep on their stomachs was unsafe, because they had received paperwork at wellness visits informing them of safe sleeping practices.

The law requires hospitals, birthing centers, and medical providers to give parents educational materials from the national Safe to Sleep campaign, and ask them to certify that they received them.

Signing the statement is voluntary. The statement doesn’t indicate that parents can be charged with a criminal offense if they don’t follow the campaign advice.

Advocates from national organizations that educate parents about safe sleep practices found the charges shocking. Nancy Maruyama, the executive director of Sudden Infant Death Services of Illinois, told Spotlight PA, “To charge them criminally is a crime, because they have already suffered the worst loss.”

Alison Jacobson, executive director of First Candle, a non-profit that also educates parents about safe sleep practices, told Pennlive, “There is no law against placing a baby on his or her stomach to sleep. How they can charge this family with involuntary manslaughter is completely baffling to me.”

Researcher Neil Z. Miller, an expert on SIDS and the Safe to Sleep campaign, told The Defender, “Parents of a sleeping baby who dies in the middle of the night should never be charged with murder. That’s just cruel.”

Miller, author of “Vaccines: Are They Really Safe and Effective?” added:

Should parents be obligated to follow every “recommendation” made by their doctor or the Safe to Sleep campaign? Would we as a society prefer that doctors raise our babies instead of the parents? Have other possible causes of death been considered, such as vaccinations? As a society, we can, and must, do much better.

Does placing infants on their backs make a difference? 

The handouts shared with new Pennsylvania parents are based on the National Institutes of Health “Safe to Sleep” campaign, which institutionalized a program initiated by the American Academy of Pediatrics (AAP) in 1992 to inform parents to put children to sleep on their backs rather than on their stomachs.

The campaign is based on the premise that babies who sleep on their backs or sides are less likely to die in their sleep. Until that time, it was common for babies to sleep on their stomachs.

The program was launched in the wake of a rising number of SIDS deaths – and growing concern among some parents that the deaths were linked to vaccination.

In a 2021 article in the peer-reviewed journal Toxicology Reports, vaccine researcher Neil Z. Miller provides a history of the SIDS diagnosis, noting that the rise of SIDS coincided with the first mass immunization campaigns.

Between 1992, when the Safe to Sleep program launched, and 2001, SIDS deaths reportedly declined a whopping 55 percent – a number touted in articles celebrating the program, making it appear that babies sleeping on their stomachs was the cause of SIDS, not vaccines.

However, at the same time deaths from SIDS decreased, the rate of mortality from “suffocation in bed,” “suffocation other,” “unknown and unspecified causes,” and “intent unknown” all increased significantly.

Why? The classification system had changed. SIDS deaths were being reclassified by medical certifiers, usually coroners, as one of the other similar categories, not SIDS.

Research published in the journal Pediatrics, the AAP’s flagship journal, concluded that deaths previously certified as SIDS were simply being certified as other non-SIDS causes, such as suffocation – but the deaths were still essentially SIDS deaths.

That change in classification accounted for more than 90 percent of the drop in SIDS rates.

The Pediatrics paper showed no decline in overall postneonatal mortality after the Safe to Sleep campaign was launched, despite the program’s – and the AAP’s – claims to the contrary.

Others verified the Pediatrics paper’s findings, and the trend continued, as reported by multiple studies in top journals. Miller reported that, for example, “From 1999 through 2015, the U.S. SIDS rate declined 35.8% while infant deaths due to accidental suffocation increased 183.8%.”

Research shows that almost 80 percent of SIDS deaths reported to the Vaccine Adverse Event Reporting System (VAERS) happen within seven days of vaccination.

Theories linking vaccines to SIDS suggest that, in some cases, underdeveloped liver enzyme pathways may make it harder for some infants to process toxic ingredients in vaccines. Others argue that other, multiple, complex factors can make some infants vulnerable to toxic ingredients in vaccines.

Baby Gavin was ‘a dream come true’

On April 30, Gina and David Strause were charged with involuntary manslaughter, which carries a sentence of up to 10 years, and other lesser charges in the death of their son, Gavin.

According to the police report, Gina found her son unresponsive, cold, and blue in his crib when she woke up to feed him on the morning of May 8, 2024. She immediately called 911 and performed CPR until the police arrived.

The baby was pronounced dead at the hospital. The autopsy report found the cause of death to be “complications of asphyxia.”

Police said they observed loose items in the crib, “such as blankets and stuffed animals.”

Gina said that after feeding her baby at about 11:30 p.m. the night before he died, she placed him in his crib on his belly, because he was a “belly sleeper,” and covered him with a blanket. She said that she had received the recommendation that he should sleep on his back, but that he preferred to sleep on his stomach.

In an interview with Pennlive, Gina said that she typically put Gavin to sleep on his back, but he had gotten into the daily habit of rolling onto his belly.

Davis Stause told police that when he left for work at 5:30 a.m., he checked on Gavin, who was sleeping on his stomach and moving around a little bit. David said he “patted his butt” to put him back to sleep.

The police reported that they also obtained medical records from birth through death that showed that on the discharge paperwork that the parents received information about safe sleep practices, which included putting the baby on its back, having it sleep in the same room as the parents, and keeping the crib clear of bumper pads and stuffed animals.

They said this paperwork explained how parents could create a safe sleeping environment for their babies to reduce the risk of SIDS.

Baby Gavin also went to the pediatrician for well-child visits on February 7 and 14, March 5, and April 9, a month before he died.

Gina told Pennlive that Gavin, who was born when she was almost 40, was “a dream come true.” She had taken 10 weeks of maternity leave and largely worked at home to spend as much time with him as possible. She said that after she gave birth, she was “overwhelmed” and didn’t remember receiving any paperwork or instructions about sleep.

Gina also said that at the hospital, police treated her and her husband with immediate suspicion, separating and questioning them. They were not allowed to see their baby again before he was taken by the coroner’s office.

The parents created a GoFundMe page, where they shared a copy of the police report, to help cover their legal costs, because they said they do not qualify for a public defender.

The Defender attempted to contact the parents to inquire about the baby’s overall health, if he had any medical conditions, was born prematurely, or had recently received any vaccines, but the parents did not respond by deadline.

The district attorney’s office also did not respond to requests for comment.

‘Tragic accident with no criminal intent to harm or kill the baby’

The forensic pathologist who performed the autopsy for Natalee Rasmus’ baby listed the cause of death as accidental. According to the report, the baby died from asphyxiation, the Times Leader reported.

Rasmus discovered her baby had died on the morning of October 23, 2022, when she picked her up to get her ready for a doctor’s appointment.

Pennsylvania State Police in December charged Rasmus, alleging that she placed her baby face down to sleep against the recommendations of medical personnel and prenatal classes at Geisinger Wyoming Valley Medical Center.

At a preliminary hearing on the case in February, a state trooper testified that Rasmus ignored safe sleeping practices because she had placed her baby face down in her bassinet with a Boppy pillow, which has a tag warning, “Do not use for sleeping.”

The trooper, Caroline Rayeski, also testified that a search of Rasmus’ cell phone found that she had searched the internet to see whether it was ok to allow newborns to sleep on their stomachs. The trooper also seized literature from the prenatal classes stating it is “recommended” to put newborns to sleep on their backs.

“Yeah, she wouldn’t sleep, she’ll just scream, so she has to be like propped up,” Rasmus told the investigating officer, according to Spotlight PA, which reported the story.

Assistant attorneys argued in a preliminary hearing that she disregarded safe sleeping practices, and a judge forwarded the criminal case to county court.

Rasmus is being represented by public defenders Joseph Yeager and Melissa Ann Sulima, who told the Times Leader the baby’s death was “a tragic accident with no criminal intent to harm or kill the baby.”

Yeager said the prenatal literature referring to newborn sleep positions are “recommendations,” not mandates.

“As the death certificate says, it was an accident. Clearly, there was no malice in this accidental death,” said Yeager, who also said the case should be dismissed.

Rasmus’ most serious charge, third-degree murder, is a homicide that involves killing someone without intent to kill, but with reckless disregard for human life. In Pennsylvania, it can carry a prison sentence of up to 40 years.

Court documents indicate that Rasmus remains in jail with a $25,000 bail, pending the outcome of her case. Neither the district attorney nor Rasmus’ attorneys responded to The Defender’s request for comment.

How common is it to bring criminal charges against parents in infant deaths?

Attorney Daniel Nevins told SpotlightPA it is extremely rare for parents to be criminally charged when infants die after sleeping on their stomachs, and that the burden of proof on the prosecutors will be high.

In 2014, Virginia resident Candice Christa Semidey, age 25, was charged with murder after she swaddled her baby and put it to sleep on its stomach, the Washington Post reported. In that case, police similarly did not think that she intended for the baby to die.

She pleaded guilty to involuntary manslaughter and child neglect. She was ordered to serve three years of probation to avoid the five-year prison term she was sentenced to.

Some charges have also been brought against parents in deaths of infants sleeping with Boppy pillows. There have also been several cases of parents charged for sleeping in the same bed as their child.

The Defender recently reported on three SIDS deaths that occurred shortly after vaccination. Police are still investigating the parents of 18-month-old twins who died together a week after receiving three vaccines. Authorities have not yet charged the parents, but initially said they were investigating the deaths as homicides.

Blessings Myrical Jean Simmons, age 6 months, received six routine vaccines at a well-baby visit on January 13. The next morning, her parents found the baby dead in her bassinet. The autopsy lists SIDS as the infant’s cause of death, and no charges were filed against the parents.

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.

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