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We should stop acting as if Big Pharma is the big villain in American health care

We should stop acting as if Big Pharma is the big villain in American health care

Boston Globe17-03-2025
tPA is a regular staple of medicine, given to people within hours of suffering a stroke. Scientists discovered tPA's existence in animals in 1947. Over the course of four decades, through continued research, the pharmaceutical industry turned tPA into a life-saving drug for stroke victims.
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In 2016, after a massive influx of blood clots into my lungs, doctors gave me tPA. The results were rapid and life saving. Having been given 24 hours to live, I am still here, now taking Xarelto, a pill that daily thins my blood without the bruising associated with Coumadin, the most common blood-thinning medication.
Tagrisso received expedited approval from the Food and Drug Administration in 2015, just months before doctors confirmed my wife had epidermal growth factor receptor mutations that caused her to have a genetic form of lung cancer. Her doctor, who also helped develop Tagrisso, fought to get my wife on the medicine. At the time, he concluded, backed by research, that my wife would have two years before the cancer started growing again. She is still here, one of the longest surviving patients on Tagrisso. Researchers have used her case as evidence to expand the drug's availability.
It is easy to vilify the industry. Americans get expensive medical bills and regularly battle insurance companies for drug approvals. Sometimes drugs are approved, then declined. Some have embraced the conspiracy that doctors and drug makers collude to put people on medicines. In reality, virtually every doctor wants patients to make lifestyle changes, but many patients just want the pill. This is not the fault of drug makers. We are the problem when we would rather take the injection or the pill than make the lifestyle change.
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I am fortunate that I have really good insurance. But even with good insurance, my wife and I experience the frustrations so many Americans share. When the new year turns over, the headaches return. This year, my Xarelto went from $10 to $580 per month for 30 pills. It will be that much the next few months until I have met a deductible.
My wife's Tagrisso is roughly $22,000 a month. With her quarterly cancer scans, just recently adjusted to every four months, we meet her and our family deductible quickly, and insurance has never charged us more than $100 in a month for her Tagrisso. Normally, we pay $20 a month.
But every year, as soon as January rolls around, my wife struggles to renew her prescription with the specialist pharmacy that has a contract with our insurance company. Every year, my wife's anxiety builds as she gets denied the medicine she needs to live and then has someone find an error in her claim, before she finally receives the medicine. For eight years, she has fought this battle annually.
Health insurance likewise causes me anxiety. We need it and, as a result, my job is important. As a conservative talk radio host known to openly criticize the president, I have faced organized mobs of online activists that have tried to get me fired, at the cost of my health insurance. The mobs have not deterred me, but I do understand the anxiety others have over losing their insurance. Every few years, as my job contract is up for renewal, my family's anxiety goes up. I am, to a degree, deprived of negotiating flexibility with my job because without it, our access to life-saving drugs would become vastly more costly.
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Americans tend to pay more for prescription drugs than people in other countries. Those countries often subsidize drug costs. To Americans this is unfair. Big Pharma gets blamed. Newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr. has, in part, gained traction among many Americans for capitalizing on and advancing attacks against the industry, building on American distrust of the health care system. The problem, however, is not really Big Pharma but the convoluted mess of American public and private insurance systems.
Many Americans cheered for
A free-market system could and should provide a saner, more streamlined, and affordable system. But the public, like the political parties, is divided over more or less government control and fewer or more mandates. The government cannot provide clarity or direction for private insurance and medical and pharmaceutical costs because Americans themselves cannot agree.
Government should at least be willing to provide multiple avenues that could, through each path, provide simplicity and more humanity to a system that is too often needlessly faceless and Byzantine.
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ImmunityBio Announces Phase 2 Study of ANKTIVA ® in Patients with Long COVID
ImmunityBio Announces Phase 2 Study of ANKTIVA ® in Patients with Long COVID

Business Wire

time2 hours ago

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ImmunityBio Announces Phase 2 Study of ANKTIVA ® in Patients with Long COVID

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the opening of a new Phase 2 study to assess the BioShield™ platform, anchored by ANKTIVA ® (nogapendekin alfa inbakicept-pmln), in patients with long COVID. An estimated one in five Americans with a previous COVID-19 infection has long COVID, which is comprised of a broad range of symptoms that can substantially impact a patient's quality of life. Long COVID remains a significant public health challenge with no currently available established therapies. The new study, called COVID-4.019-Long, further expands the company's clinical research efforts to assess ANKTIVA's potential beyond cancer or cancer-related diseases. 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'We are excited to study ANKTIVA for the treatment of long COVID, a substantial public health concern,' said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. 'Early in the pandemic, the common assumption was SARS-CoV-2 would prove to be a transient infection, as is the case with coronaviruses in general. But we now know viral nucleic acid and proteins can be in the gut mucosa months after infection. As such, an antiviral strategy looks insufficient to treat or cure long COVID. Based on clinical insights to date, we believe ANKTIVA may be a new therapeutic option for this chronic and potentially disabling condition by enhancing immune function, facilitating viral clearance, and addressing underlying contributions to long COVID.' The study, which is being conducted by ImmunityBio and aims to recruit up to 40 participants who meet the long COVID criteria, as established by the World Health Organization (WHO), is now accepting patients for initial screening to determine study eligibility. The safety and tolerability of ANKTIVA for long COVID is also being assessed in a separate Phase 2 study conducted at the University of California – San Francisco. Both studies are supported by ImmunityBio. To learn more, visit ANKTIVA is currently approved by the U.S. Food and Drug Administration with Bacillus Calmette-Guérin (BCG) for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. About Long COVID Long COVID is a serious illness that can cause chronic health conditions requiring comprehensive care. 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IMPORTANT SAFETY INFORMATION INDICATION AND USAGE: ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy. DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes. Please see the complete Prescribing Information for ANKTIVA ® at References: Robertson MM, Qasmieh SA, Kulkarni SG, et al. The Epidemiology of Long Coronavirus Disease in US Adults. Clin Infect Dis. May 3 2023;76(9):1636-1645. U.S. Centers for Disease Control and Prevention. Long COVID Basics. July 2025. Available at U.S. Centers for Disease Control and Prevention. Long COVID Signs and Symptoms. July 2025. Available at About ImmunityBio ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. 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U.S. pediatricians' new COVID-19 shot recommendations differ from CDC advice
U.S. pediatricians' new COVID-19 shot recommendations differ from CDC advice

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U.S. pediatricians' new COVID-19 shot recommendations differ from CDC advice

For the first time in 30 years, the American Academy of Pediatrics is substantially diverging from U.S. government vaccine recommendations. The group's new COVID-19 recommendations — released Tuesday — come amid a tumultuous year for public health, as vaccine skeptics have come into power in the new Trump administration and government guidance has become increasingly confusing. This isn't going to help, acknowledged Dr. James Campbell, vice chair of the AAP infectious disease committee. 'It is going to be somewhat confusing. But our opinion is we need to make the right choices for children to protect them,' he added. The AAP is strongly recommending COVID-19 shots for children ages 6 months to 2 years. Shots also are advised for older children if parents want their kids vaccinated, the AAP said. That differs from guidance established under U.S. Health Secretary Robert F. Kennedy Jr., which doesn't recommend the shots for healthy children of any age but says kids may get the shots in consultation with physicians. Children ages 6 months to 2 years are at high risk for severe illness from COVID-19, and it was important that recommendations continue to emphasize the need for them to get vaccinated, said Campbell, a University of Maryland infectious diseases expert. Vaccinations also are recommended for older children who have chronic lung diseases or other conditions that put them at higher risk for severe disease, the AAP said. The 95-year-old Itasca, Illinois-based organization has issued vaccination recommendations for children since the 1930s. In 1995, it synced its advice with recommendations made by the federal government's Centers for Disease Control and Prevention. There have been a few small differences between AAP and CDC recommendations since then. For example, the AAP has advised that children get HPV vaccinations starting at age 9; the CDC says that's OK but has emphasized vaccinations at ages 11 and 12. But in 30 years, this is the first time the recommendations have differed 'in a significant or substantial way,' Campbell said. Until recently, the CDC — following recommendations by infectious disease experts — has been urging annual COVID-19 boosters for all Americans ages 6 months and older. But in May, U.S. Health Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines are no longer recommended for healthy children and pregnant women. A few days later, the CDC issued language that healthy children may get the shots, but that there was no longer a 'should' recommendation. The idea that healthy older kids may be able to skip COVID-19 boosters has been brewing for some time among public health experts. As the COVID-19 pandemic has waned, experts have increasingly discussed the possibility of focusing vaccination efforts on people 65 and older — who are among those most as risk for death and hospitalization. A CDC expert panel in June was set to make recommendations about the fall shots. Among the options the panel was considering was whether suggest shots for high-risk groups but still giving lower-risk people the choice to get vaccinated. But Kennedy bypassed the group, and also decided to dismiss the 17-member panel and appoint his own, smaller panel, that included vaccine skeptics. Kennedy also later excluded the AAP, the American Medical Association and other top medical organizations from working with the advisers to establish vaccination recommendations. Kennedy's new vaccine panel has yet to vote on COVID-19 shot recommendations. The panel did endorse continuing to recommend fall flu vaccinations, but also made a decision that led to another notable difference with the AAP. The new advisory panel voted that people should only get flu vaccines that are packaged as single doses and do not contain the preservative thimerosal. The AAP said there is no evidence of harm from the preservative, and recommended doctors use any licensed flu vaccine product that's appropriate for the patient.

US pediatricians' new COVID-19 shot recommendations differ from CDC advice

time3 hours ago

US pediatricians' new COVID-19 shot recommendations differ from CDC advice

NEW YORK -- For the first time in 30 years, the American Academy of Pediatrics is substantially diverging from U.S. government vaccine recommendations. The group's new COVID-19 recommendations — released Tuesday — come amid a tumultuous year for public health, as vaccine skeptics have come into power in the new Trump administration and government guidance has become increasingly confusing. This isn't going to help, acknowledged Dr. James Campbell, vice chair of the AAP infectious disease committee. 'It is going to be somewhat confusing. But our opinion is we need to make the right choices for children to protect them,' he added. The AAP is strongly recommending COVID-19 shots for children ages 6 months to 2 years. Shots also are advised for older children if parents want their kids vaccinated, the AAP said. That differs from guidance established under U.S. Health Secretary Robert F. Kennedy Jr., which doesn't recommend the shots for healthy children of any age but says kids may get the shots in consultation with physicians. Children ages 6 months to 2 years are at high risk for severe illness from COVID-19, and it was important that recommendations continue to emphasize the need for them to get vaccinated, said Campbell, a University of Maryland infectious diseases expert. Vaccinations also are recommended for older children who have chronic lung diseases or other conditions that put them at higher risk for severe disease, the AAP said. The 95-year-old Itasca, Illinois-based organization has issued vaccination recommendations for children since the 1930s. In 1995, it synced its advice with recommendations made by the federal government's Centers for Disease Control and Prevention. There have been a few small differences between AAP and CDC recommendations since then. For example, the AAP has advised that children get HPV vaccinations starting at age 9; the CDC says that's OK but has emphasized vaccinations at ages 11 and 12. But in 30 years, this is the first time the recommendations have differed 'in a significant or substantial way,' Campbell said. Until recently, the CDC — following recommendations by infectious disease experts — has been urging annual COVID-19 boosters for all Americans ages 6 months and older. But in May, U.S. Health Secretary Robert F. Kennedy Jr. announced that COVID-19 vaccines are no longer recommended for healthy children and pregnant women. A few days later, the CDC issued language that healthy children may get the shots, but that there was no longer a 'should' recommendation. The idea that healthy older kids may be able to skip COVID-19 boosters has been brewing for some time among public health experts. As the COVID-19 pandemic has waned, experts have increasingly discussed the possibility of focusing vaccination efforts on people 65 and older — who are among those most as risk for death and hospitalization. A CDC expert panel in June was set to make recommendations about the fall shots. Among the options the panel was considering was whether suggest shots for high-risk groups but still giving lower-risk people the choice to get vaccinated. But Kennedy bypassed the group, and also decided to dismiss the 17-member panel and appoint his own, smaller panel, that included vaccine skeptics. Kennedy also later excluded the AAP, the American Medical Association and other top medical organizations from working with the advisers to establish vaccination recommendations. Kennedy's new vaccine panel has yet to vote on COVID-19 shot recommendations. The panel did endorse continuing to recommend fall flu vaccinations, but also made a decision that led to another notable difference with the AAP. The new advisory panel voted that people should only get flu vaccines that are packaged as single doses and do not contain the preservative thimerosal. The AAP said there is no evidence of harm from the preservative, and recommended doctors use any licensed flu vaccine product that's appropriate for the patient. ___

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