It was the subject of a Reuters wire story that broke last Tuesday that many may have missed or overlooked. It contained an official statement from Pfizer confirming the death of a toddler due to cardiac arrest after gene therapy treatment for a muscle-wasting disorder trial involving babies and toddlers from the ages of six months to 4 years old. The announcement was sadly reminiscent of a Dec. 2021 statement when Pfizer paused screening and dosing in a Phase Ib trial after the death of a young man.
Approximately 20 years ago, as revealed in a National Library of Medicine search, the Institute of Medicine (US) Committee on Clinical Research Involving Children issued a warning regarding research involving children. "Notwithstanding the expected benefits of these efforts, some caution is appropriate," the committee writes. "Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections."
My wife, Gena, and I are alarmed at how Big Pharma and our federal government seem to be so lacking in oversight and accountability when the health and welfare of infants and other children are on the line. If interested, a more detailed version of my response to this issue can be found here.
Children and young people are not the only ones negatively affected by the power of Big Pharma and the lack of needed controls and intervention when it comes to securing public health for the young, the old and all those in between.
In 2021, the U.S. House Committee on Oversight and Reform detailed what, at the time, it called "Big Pharma's egregious pricing and anti-competitive practices." As a Campaign for Sustainable Rx Pricing report states, "The report is the culmination of a nearly three-year investigation during which the Committee reviewed more than 1.5 million pages of internal documents from pharmaceutical companies.
"Upon reviewing price histories of 12 of the best-selling drugs in Medicare, the committee found prices were raised more than 250 times by Big Pharma companies using strategies that game the system and suppress competition to maintain product monopolies. ... These tactics include 'product hopping' and 'shadow pricing' — techniques deliberately used to shield profits from generic competition — and employing price hikes in concert with other drug manufacturers." The committee found that these 12 drugs now priced 'at a median of almost 500 percent higher than when they were brought to market.'"
According to a report by The Hill, the committee determined the companies responsible for these 12 drugs obtained more than 600 patents for these medications, "effectively blocking competition from more affordable alternatives for decades. In fact, the committee report states that the patents already secured for these 12 drugs 'could potentially extend their monopoly periods to a combined total of nearly 300 years.'"
It appears that not much has been done to rectify this situation. At a time when one out of four Americans cannot afford the medicine their doctors prescribe, it's reported that 10 large pharmaceutical companies made over $112 billion in profits in 2022 alone.
While 2023 was a strong year for innovative new drugs, who will be able to afford them? Writes Alice Park in a January report for Time magazine, "As exciting as the possible new medications are, they also raise questions about affordability and accessibility." As more therapies reach the market, "they could change the reimbursement structure as insurers will likely feel increasing pressure to cover treatments that could be not just life-changing but also potentially curative — and save millions in long-term health care costs."
According to Health News Florida, a Kaiser Family Foundation tracking poll release in March states that "health care tops the list of basic expenses Americans worry about — more than gas, food, and rent. Nearly 3 in 4 adults — and majorities of both parties — say they're concerned about paying for unexpected medical bills and other health costs."
Health care issues might just determine who wins in November's presidential election; as Health News Florida reports, "more than half (of people polled) — 55% — said they were very worried about being able to afford prescription drugs." This comes as health care costs continue to rise for many Americans. "Both Medicaid and Medicare, the government health insurance programs that cover tens of millions of low-income, disabled, and older people, remain broadly popular with voters, said the Democratic pollster Celinda Lake."
We shall see where these issues go. But it reminds me of the late Nelson Mandela, South Africa's first post-apartheid president, who once said: "Safety and security don't just happen, they are the result of collective consensus and public investment."
Follow Chuck Norris through his official social media sites, on Twitter @chucknorris and Facebook's "Official Chuck Norris Page." He blogs at http://chucknorrisnews.blogspot.com. To find out more about Chuck Norris and read features by other Creators Syndicate writers and cartoonists, visit the Creators Syndicate webpage at www.creators.com.
Photo credit: Hal Gatewood at Unsplash
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