Tag: iab-pharmaceutical industry

‘Am I dreaming?’: Double lung transplants save two people with late-stage cancer | CNN

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CNN
 — 

Two people with stage IV lung cancer who had been told that they had only weeks or months to live are breathing freely after receiving double lung transplants, Northwestern Medicine in Chicago said Wednesday.

Lung cancer is the leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that over 127,000 Americans will die from the disease this year.

It is considered stage IV once additional tumors have developed in the lungs, aside from the primary tumor, or the cancer has spread to more organs.

Someone diagnosed with stage IV lung cancer has limited treatment options, Northwestern Medicine says. A double lung transplantation offers a potentially lifesaving option for some people with a poor prognosis, but doctors say there are specific criteria a lung cancer patient must meet, including that the cancer is contained within the lungs and the person has tried all other treatment options.

In 2020, 54-year-old Albert Khoury of Chicago received a devastating lung cancer diagnosis.

Khoury, a cement finisher for the Chicago Department of Transportation, began to have back pain, sneezing and chills, along with coughing up blood, according to Northwestern Medicine. It was near the start of the Covid-19 pandemic, so at first, he thought he had coronavirus-related symptoms.

He was diagnosed with stage I lung cancer soon after.

Because of the pandemic, Khoury did not begin treatment until July 2020. At that point, the cancer had progressed to stage II and was continuing to grow, eventually reaching stage IV. He was told to consider hospice, special care for people near the end of their lives that focuses on comfort and support.

“I had a couple weeks to live,” Khoury said in a video released by the hospital. “Not that much time.”

His sister suggested that he reach out to Northwestern Medicine about the possibility of a double lung transplant.

“I need new lungs. That is the only hope to live,” Khoury said he told his doctor.

He met with an oncologist at Northwestern Medicine, who told him he should try additional treatments first. But not too long after, he was admitted to the intensive care unit with pneumonia and sepsis.

As his health declined, the oncologists began considering the rarely used procedure.

“His lungs were filled with cancer cells, and day by day, his oxygen was dropping,” said Dr. Young Chae, a medical oncologist at Northwestern Medicine who helped treat Khoury.

Transplant is typically considered for people with some form of lung cancer that has not spread to other parts of the body and for those who have tried all other treatment options and have limited time to live, according to Dr. Ankit Bharat, chief of thoracic surgery at the Northwestern Medicine Canning Thoracic Institute, who helped treat Khoury.

William Dahut, chief scientific officer at the American Cancer Society, also noted the importance of ensuring that cancer has not spread to other parts of the body before doing a transplant.

“There would need to be as much certainty as possible that the cancer is limited to the lungs, so whatever sort of extensive screening tests should be done … to ensure that there are no cancer cells outside of the lungs,” said Dahut, who was not involved in the care of either Northwestern patient.

The oncologists decided Khoury was eligible for the procedure. In September 2021, he spent about seven hours in surgery.

“Surgeons had to be extremely meticulous to not let trillions of cancer cells from the old lungs spill out into Khoury’s chest cavity or into his blood stream,” Northwestern Medicine noted in a news release.

The surgery is not without risk, Bharat said. In people with late-stage cancers, there is always a chance of it returning after the procedure.

“There is certainly the risk of potentially being in a worse off situation than they were,” he said. “So you go through a big surgery, and then you could very quickly have the cancer come back.”

Another risk is the treatment needed after a transplant, Dahut said.

All lung transplant recipients have to take medications to weaken their immune systems, which helps reduce the possibility of their body rejecting the organ – but also decreases its ability to fight off infection, according to the National Cancer Institute.

“Drugs that actually suppress your immune system put you at risk for infection afterwards but could even potentially put you at risk for second cancers afterwards,” Dahut said.

However, 18 months later, Khoury has not had any complications and is back to work.

His doctor showed him an X-ray of his chest with no signs of cancer. “When I saw that X-ray, I believed him,” Khoury said. “My body is in my hands now.”

The procedure was put to the test again last year, this time in a 64-year-old Minnesota woman.

Tannaz Ameli, a retired nurse from Minneapolis, had a persistent cough for several months. Her doctors did a chest X-ray and diagnosed her with pneumonia.

The illness lingered until she was told she had stage IV lung cancer in January 2022.

“There was no hope for my life at that point. They gave me … three months,” Ameli said in a video released by Northwestern Medicine.

She went through unsuccessful chemotherapy treatments and was told to consider hospice.

“I had no hope. I was ready for my life to end,” she said.

But her husband reached out to Northwestern Medicine about the option of a transplant. The oncologists found that Ameli fit their criteria, and she received a double lung transplant in July.

When she was told the procedure had made her cancer-free, she wondered, ” ‘Am I dreaming, sitting here? Can it happen?’ And it did happen.”

Ameli hasn’t had any complications, and she said the procedure has given her a new perspective on life.

“Every morning when I open my eyes, I just can’t believe it,” Ameli said. “Life has a different meaning now.”

Double lung transplants for cancer are rare due to the concern that the cancer may come back, Bharat said.

Historically, the surgery required sequential transplantations, but they are looking to alter the approach to lower the risk of recurrence, he said.

“Typically, what happens in a double lung transplant procedure is, we take one lung out, put the new one in, then take the second lung out and put the second lung in,” he said. “The concern is that when you take one lung out and put a new lung, the other lung is still attached, and they could cross-contaminate. … You could inadvertently have the cancer cells spread into the bloodstream.”

If cancer cells cross-contaminate or enter the bloodstream, there is a higher risk of cancer coming back.

Bharat and his team took a different approach with Khoury and Ameli: They opened the chest cavity and did a full heart and lung bypass.

“Essentially, what that means is, we don’t let any blood go through the heart and the lungs and bypass all of that,” Bharat said. “That allows us to then stop the blood flow to the lungs, which will prevent any cancer cells from going from the lung into the bloodstream.”

The surgeons gave Khoury and Ameli lung-shaped friendship necklaces Wednesday to mark their success.

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What is the painful condition called shingles? | CNN

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CNN
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Sen. Dianne Feinstein, the 89-year-old California Democrat, recently announced she is out of the hospital and recovering at home from shingles, a painful viral inflammation in the skin’s nerves that causes a blistering rash lasting for two to four weeks. Feinstein was diagnosed in February and hospitalized in San Francisco last week.

Shingles, also called herpes zoster, is caused by the varicella-zoster virus — which is the same virus responsible for chickenpox. Varicella zoster is also responsible for a rare condition called Ramsay Hunt syndrome that caused pop star Justin Bieber’s face to become partially paralyzed in June 2022.

“As you can see, this eye is not blinking. I can’t smile on this side of my face. This nostril will not move,” Bieber said at the time in answer to fans who wondered why he had canceled performances.

Painful skin is one of first signs of shingles, and for some people, the pain is intense. It can create a burning sensation, or the skin can tingle or be sensitive to touch, according to the Mayo Clinic. Shingles can occur at other places on the body, such as the face and scalp, but the most common presentation is on the torso on one side of the body.

A red rash will begin to develop at the site of the pain within a few days. The rash often begins as a small, painful patch, which then spreads like “a stripe of blisters that wraps around either the left or right side of the torso,” the Mayo Clinic said.

In rare cases, the rash may become more widespread and look similar to a chickenpox rash, typically in people with weakened immune systems, according to the US Centers of Disease Control and Prevention.

In addition to pain, some people may develop chills, fatigue, fever, headache, upset stomach and sensitivity to light. See a doctor if you are over 50, have a weakened immune system, the rash is widespread and painful, or the pain and rash occur near an eye.

“If left untreated, this infection may lead to permanent eye damage,” according to the Mayo Clinic.

The varicella-zoster virus is highly contagious when in the blister stage, spreading through direct contact with the fluid from blisters and via viral particles in the air.

However, you cannot get shingles from someone who has shingles. If you aren’t vaccinated for chickenpox or haven’t previously had it and are infected by that person, you will develop chickenpox, which then puts you at risk for shingles later in life, the CDC said.

If you have shingles, you can prevent the spread of the virus by covering the rash and not touching or scratching the raised vesicles that form the rash, the CDC stated. Wash your hands often.

“People with shingles cannot spread the virus before their rash blisters appear or after the rash crusts,” the CDC said.

If the rash is covered, the risk of transmission “is low,” the CDC said. “People with chickenpox are more likely to spread (the virus) than people with shingles.”

If you think you have shingles, call a doctor as soon as you can, the CDC recommended. If caught early, there are antiviral medications, including acyclovir, valacyclovir and famciclovir, that can shorten the length and severity of the illness.

“These medicines are most effective if you start taking them as soon as possible after the rash appears,” the CDC said.

Doctors may also suggest over-the-counter or prescription pain medication for the burning and pain, while calamine lotion, wet compresses and oatmeal baths may ease itching.

For older adults, the population most likely to develop shingles, the best treatment is prevention. The US Food and Drug Administration approved a two-dose vaccine called Shingrix in 2017 for people 50 and older.

“Shingrix is also recommended for adults 19 years and older who have weakened immune systems because of disease or therapy,” the CDC said.

Shingrix, which is not based on a live virus, is more than 90% effective in encouraging the aging immune system to recognize and be ready to fight the virus, according to its manufacturer, GlaxoSmithKline.

Anyone who has had a severe allergic reaction to a dose of Shingrix or is allergic to any of the components of the vaccine should avoid it, the CDC said.

“People who currently have shingles, and women who are pregnant or breastfeeding, should wait to get Shingrix,” the CDC said.

Another vaccine called Zostavax, which the FDA approved for people over 50 in 2006, is 51% effective in preventing shingles, according to the CDC. Zostavax is based on a live virus, the same approach used for the chickenpox vaccine recommended in childhood. It has not been sold in the United States since November 2020.

If you have never had chickenpox, you can’t get shingles. However, once you’ve had chickenpox, the virus remains inactive in the spine’s sensory neurons, possibly erupting years later as shingles.

Two doses of a chickenpox vaccine for children, teens and adults, introduced in 1995, is 100% effective at preventing a severe case of chickenpox, according to the CDC. Immunity lasts 10 to 20 years, the CDC noted.

In the small number of people who still get chickenpox after vaccination, the illness is typically milder, with few or no blisters.

The CDC recommends the vaccine be given to children in two doses, the first between 12 and 15 months and a second one between 4 and 6 years. Anyone 13 years old and older who has no evidence of immunity can get two doses four to eight weeks apart, the CDC said.

Some people should not get the vaccine, including pregnant women, people with certain blood disorders or those on prolonged immunosuppressive therapy, and those with a moderate or severe illness, among others.

About 1 in 10 people will develop a painful and possibly debilitating condition called postherpetic neuralgia, or long-term nerve pain. All other signs of the rash can be gone, but the area is extremely painful to touch. Less often, itching or numbness can occur.

The condition rarely affects people under 40, the CDC said. Older adults are most likely to have more severe pain that lasts longer than a younger person with shingles. For some, the nerve pain can be devastating.

“Five years later, I still take prescription medication for pain,” said a 63-year-old harpist who shared his story on the CDC website. “My shingles rash quickly developed into open, oozing sores that in only a few days required me to be hospitalized.

“I could not eat, sleep, or perform even the most minor tasks. It was totally debilitating. The pain still limits my activity levels to this day,” said the musician, who has been unable to continue playing the harp due to pain.

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Asthma, cancer, erectile drugs sent from abroad make up are most confiscations, despite opioid claims | CNN

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For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments. In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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Older people with anxiety frequently don’t get help. Here’s why | CNN

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CNN
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Anxiety is the most common psychological disorder affecting adults in the United States. In older people, it’s associated with considerable distress as well as ill health, diminished quality of life and elevated rates of disability.

Yet when the US Preventive Services Task Force, an independent, influential panel of experts, suggested last year that adults be screened for anxiety, it left out one group — people 65 and older.

The major reason the task force cited in draft recommendations issued in September: “(T)he current evidence is insufficient to assess the balance of benefits and harms of screening for anxiety” in all older adults. (Final recommendations are expected later this year.)

The task force noted that questionnaires used to screen for anxiety may be unreliable for older adults. Screening entails evaluating people who don’t have obvious symptoms of worrisome medical or psychological conditions.

“We recognize that many older adults experience mental health conditions like anxiety,” and “we are calling urgently for more research,” said Lori Pbert, associate chief of the preventive and behavioral medicine division at the University of Massachusetts Chan Medical School and a former task force member who worked on the anxiety recommendations.

This “we don’t know enough yet” stance doesn’t sit well with some experts who study and treat older people with anxiety. Dr. Carmen Andreescu, an associate professor of psychiatry at the University of Pittsburgh, called the task force’s position baffling because “it’s well-established that anxiety isn’t uncommon in older adults and effective treatments exist.”

“I cannot think of any danger in identifying anxiety in older adults, especially because doing so has no harm and we can do things to reduce it,” said Dr. Helen Lavretsky, a psychology professor at UCLA.

In a recent editorial in JAMA Psychiatry, Andreescu and Lavretsky noted that only about one-third of seniors with generalized anxiety disorder — intense, persistent worry about everyday matters — receive treatment. That’s concerning, they said, considering evidence of links between anxiety and stroke, heart failure, coronary artery disease, autoimmune illness and neurodegenerative disorders such as dementia.

Other forms of anxiety commonly undetected and untreated in older adults include phobias (such as a fear of dogs), obsessive-compulsive disorder, panic disorder, social anxiety disorder (a fear of being assessed and judged by others) and post-traumatic stress disorder.

The smoldering disagreement over screening calls attention to the significance of anxiety in later life — a concern heightened during the Covid-19 pandemic, which magnified stress and worry among older people. Here’s what you should know.

According to a book chapter published in 2020, authored by Andreescu and a colleague, up to 15% of people 65 and older who live outside nursing homes or other facilities have a diagnosable anxiety condition.

As many as half have symptoms of anxiety — irritability, worry, restlessness, decreased concentration, sleep changes, fatigue, avoidant behaviors — that can be distressing but don’t justify a diagnosis, the study noted.

Most senior citizens with anxiety have struggled with this condition since earlier in life, but the way it manifests may change over time. Specifically, older adults tend to be more anxious about issues such as illness, the loss of family and friends, retirement and cognitive declines, experts said. Only a fraction develop anxiety after turning 65.

Older adults often minimize symptoms of anxiety, thinking “this is what getting older is like” rather than “this is a problem that I should do something about,” Andreescu said.

Also, they are more likely than younger adults to report “somatic” complaints — physical symptoms such as dizziness, fatigue, headaches, chest pain, shortness of breath and gastrointestinal problems — that can be difficult to distinguish from underlying medical conditions, according to Gretchen Brenes, a professor of gerontology and geriatric medicine at Wake Forest University School of Medicine.

Some types of anxiety or anxious behaviors — notably, hoarding and fear of falling — are much more common in older adults, but questionnaires meant to identify anxiety don’t typically ask about those issues, said Dr. Jordan Karp, chair of psychiatry at the University of Arizona College of Medicine in Tucson.

When older adults voice concerns, medical providers too often dismiss them as normal, given the challenges of aging, said Dr. Eric Lenze, head of psychiatry at Washington University School of Medicine in St. Louis and the third author of the recent JAMA Psychiatry editorial.

Simple questions can help identify whether an older adult needs to be evaluated for anxiety, he and other experts suggested: Do you have recurrent worries that are hard to control? Are you having trouble sleeping? Have you been feeling more irritable, stressed or nervous? Are you having trouble with concentration or thinking? Are you avoiding things you normally like to do because you’re wrapped up in your worries?

Stephen Snyder, 67, who lives in Zelienople, Pennsylvania, and was diagnosed with generalized anxiety disorder in March 2019, would answer “yes” to many of these queries. “I’m a Type A personality and I worry a lot about a lot of things — my family, my finances, the future,” he told me. “Also, I’ve tended to dwell on things that happened in the past and get all worked up.”

Psychotherapy — particularly cognitive behavioral therapy, which helps people address persistent negative thoughts — is generally considered the first line of anxiety treatment in older adults. In an evidence review for the task force, researchers noted that this type of therapy helps reduce anxiety in older people seen in primary care settings.

Also recommended, Lenze noted, is relaxation therapy, which can involve deep breathing exercises, massage or music therapy, yoga and progressive muscle relaxation.

Because mental health practitioners, especially those who specialize in geriatric mental health, are extremely difficult to find, primary care physicians often recommend medications to ease anxiety.

Two categories of drugs — antidepressants known as SSRIs (selective serotonin reuptake inhibitors) and SNRIs (serotonin-norepinephrine reuptake inhibitors) — are typically prescribed, and both appear to help to older adults, experts said.

Frequently prescribed to older adults, but to be avoided by them, are benzodiazepines, a class of sedating medications such as Valium, Ativan, Xanax, and Klonopin. The American Geriatrics Society has warned medical providers not to use these in older adults, except when other therapies have failed, because they are addictive and significantly increase the risk of hip fractures, falls and other accidents, and short-term cognitive impairments.

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Bempedoic acid improved heart health in patients who can’t tolerate statins, study finds | CNN

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CNN
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Bempedoic acid may be an alternative for people who need to lower their cholesterol but can’t or won’t take statins, according to a large study published Saturday in the New England Journal of Medicine.

Statins are the most commonly prescribed cholesterol-lowering drugs that help lower what’s known as the “bad” cholesterol, or low-density lipoprotein (LDL) cholesterol in the blood; more than 90% of adults who take a cholesterol-lowering medicine use a statin, according to the US Centers for Disease Control and Prevention.

Statins are considered safe and effective, but there are millions of people who cannot or will not take them. For some people it causes intense muscle pain. Past research has shown anywhere between 7% and 29% of patients who need to lower cholesterol do not tolerate statins, according Dr. Steven Nissen, a cardiologist and researcher at the Cleveland Clinic and co-author of the new study.

“I see heart patients that come in with terrible histories, multiple myocardial infarction, sometimes bypass surgery, many stents and they say, ‘Doctor, I’ve tried multiple statins, but whenever I take a statin, my muscles hurt, or they’re weak. I can’t walk upstairs. I just can’t tolerate these drugs,’ ” Nissen said. “We do need alternatives for these patients.”

Doctors have a few options, including ezetimibe and a monoclonal antibody called a proprotein convertase subtilisin/kexin type 9, or PCSK9 inhibitors for short.

Bempedoic acid, sold under the name Nexletol, was designed specifically to treat statin-intolerant patients. The FDA approved it for this purpose in 2020, but the effects of the drug on heart health had not been fully assessed until this large trial. The new study was funded in part by Esperion Therapeutics, the maker of Nexletol.

For the study, which was presented Saturday at the American College of Cardiology’s Annual Scientific Session with the World Congress of Cardiology, Nissen and his colleagues enrolled 13,970 patients from 32 countries.

All of the patients were statin intolerant, typically due to musculoskeletal adverse effects. Patients had to sign an agreement that they couldn’t tolerate statins “even though I know they would reduce my risk of a heart attack or stroke or death,” and providers signed a similar statement.

The patients were then randomized into two groups. One was treated with bempedoic acid, the other was given a placebo, which does nothing. Researchers then followed up with those patients for up to nearly five years. The number of men and women in the trial were mostly evenly divided, and most participants, some 91%, were White, and 17% were Hispanic or Latino.

The drug works in a similar way that statins do, by drawing cholesterol out of a waxy substance called plaque that can build up in the walls of the arteries and interfere with the blood flow to the heart. If there is too much plaque buildup, it can lead to a heart attack or stroke.

But bempedoic acid is only activated in the liver, unlike a statin, so it is unlikely to cause muscle aches, Nissen said.

In the trial, investigators found that bempedoic acid was well-tolerated and the percent reduction in the “bad” cholesterol was greater with bempedoic acid than placebo by 21.7%.

The risk of cardiovascular events – including death, stroke, heart attack and coronary revascularization, a procedure or surgery to improve blood flow to the heart – was 13% lower with bempedoic acid than with placebo over a median of 3.4 years.

“The drug worked in primary and secondary prevention patients – that is, patients that had had event and patients who were very high risk for a first event. There were a lot of diabetics. These were very high risk people,” Nissen said. “So the drug met its expectations and probably did a lot better than a lot of people thought it would do.”

In the group that took bempedoic acid, there were a few more cases of gout and gallstones, compared with people who took a placebo.

“The number is small, and weighing that against a heart attack, I think most people would say, ‘OK I’d rather have a little gout attack,’ ” Nissen said.

Bempedoic acid had no observed effect on mortality, but that may be because the observation period was too short to tell if it had that kind of impact. Earlier trials on statins showed the same; it was only after there were multiple studies on statins that scientists were able to show an impact on mortality.

Dr. Howard Weintraub, a cardiologist at NYU Langone Health who did not work on this study, said that while he knows some people will not consider a medication successful unless it reduces mortality, he thinks that is short-sighted.

“I think there’s more to doing medicine then counting body bags,” Weintraub said.”Preventing things that can be life changing, crippling, and certainly change your quality of life forever going forward, and your cost of doing things going forward, I think is a good thing.”

He was pleased to see the results of this trial, especially since the people in this study are often what he called “forgotten individuals” – the millions who could benefit from lowering their cholesterol, but can’t take statins.

“It’s not like their LDL was 180 or 190 or 230, their LDL was 139. This is about average in our country,” Weintraub said. He said often doctors will just tell those patients to watch their diet, but he thinks this suggests they would benefit from medication.

“Both groups primary and secondary prevention got benefit, which I think is impressive with the modest amount of LDL reduction,” Weintraub said.

There are some limitations to this trial. It was narrowly focused on patients with a known statin intolerance. Nissen said the trial was not designed to determine whether bempedoic acid could be an alternative to statins.

“Statins are the gold standard. They are the cornerstone. The purpose of this study was not to replace statins, but to allow an alternative therapy for people who simply cannot take them,” Nissen said.

Bempedoic acid is a much more expensive drug than a statin. There are generic versions of statins and some cost only a few dollars. Bempedoic acid, on the other hand, has no generic alternative and a 30-day supply can cost more than $400, according to GoodRx.

“I think what insurance companies need to recognize that even though this drug is going to cost more than statins, having a heart attack or a stroke or needing a stent is expensive. A 23% reduction in (myocardial infarctions) is a considerable reduction,” Weintraub said.

In an editorial in the New England Journal of Medicine that accompanied the study, Dr. John H. Alexander, who works in the division of cardiology at Duke Clinical Research Institute, Duke Health, Durham said that doctors should take these results into consideration when treating patients with high cholesterol who can’t take statins.

“The benefits of bempedoic acid are now clearer, and it is now our responsibility to translate this information into better primary and secondary prevention for more at-risk patients, who will, as a result, benefit from fewer cardiovascular events,” Alexander wrote.

Dr. Manesh Patel, a cardiologist and volunteer with the American Heart Association who was not a part of the study, said that providers are already prescribing bempedoic acid for some patients, but with this new research, he thinks they will quickly be used with more statin-intolerant patients.

“We continue to see that if we can lower your LDL significantly, we improve people’s cardiovascular health. And so we need as many different arrows in our quiver to try to get that done,” Patel said.

Heart disease is the No. 1 killer for men and women in the world. One person dies every 34 seconds in the US from cardiovascular disease, according to the CDC. About 697,000 people in the US died from heart disease in 2020 alone – about the same number as the population of Oklahoma City.

“Given the number of people that are eligible for statins, which are tens of millions of patients already, the number of people who cannot tolerate statins is in the millions,” Nissen said. “This is a big public health problem and I think we’ve come up with something that directly addresses this.”

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Naloxone nasal spray may soon be in your pharmacy. Our medical analyst explains what it is and who can use it | CNN

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CNN
 — 

Two advisory committees to the US Food and Drug Administration have voted unanimously to recommend that a nasal spray version of the opioid overdose antidote, naloxone (also called Narcan), be made available over the counter.

If the FDA agrees with this recommendation, naloxone may soon be sold without a prescription in pharmacies and made available in grocery stores, big-box stores, gas stations, and corner stores around the country.

This development comes at a time when opioid overdoses are at a record high, rising more than 15% in one year. Deaths attributed to opioids rose from around 70,000 in 2020 to 80,800 in 2021, according to the US Centers for Disease Control and Prevention. The highly potent and lethal opioid, fentanyl, is implicated in the majority of these deaths.

What is naloxone, and how does it work to save lives from opioid overdose? How do you know if someone is overdosing, and how can bystanders administer the antidote? How can people get access to it now, and what will it mean if the FDA approves it for over-the-counter use? What more needs to be done to reduce overdose deaths?

To guide us through these questions, I spoke with CNN Medical Analyst Dr. Leana Wen, an emergency physician and professor of health policy and management at the George Washington University Milken Institute School of Public Health. She is also the chair of the advisory board for Behavioral Health Group, a network of outpatient opioid treatment and recovery centers around the United States. Previously, she was Baltimore’s health commissioner, where she led the city’s overdose prevention strategy.

CNN: How does naloxone work to save people overdosing on opioids?

Dr. Leana Wen: Naloxone is a medicine that rapidly reverses the effect of an opioid overdose. It is an antagonist to opioids, meaning that it attaches to the opioid receptors in the brain, and in doing so, reverses and blocks the effects of opioids.

Someone who has taken too large of a quantity of opioids can become unconscious and stop breathing. This is deadly — a person can die within minutes after they stop breathing. Naloxone reverses the effect of the opioid overdose and can restore normal breathing within a couple of minutes.

CNN: What are the different versions of naloxone? Does it work against illicit drugs like heroin and fentanyl as well as prescription drugs?

Wen: Naloxone comes in two main forms. There is the nasal spray version, with one manufacturer calling its product Narcan Nasal Spray. This version is sprayed into the nostril, similar to some allergy medications.

Naloxone also comes as a liquid. This form can be injected either intravenously through an IV, if a patient already has an IV inserted, or intramuscularly, usually as a shot through the quadriceps muscle in the leg.

Several years ago, there was another version of naloxone that was in an autoinjector, similar to an EpiPen that’s given to people with life-threatening allergic reactions. In 2019, the manufacturer made a business decision to stop making that version available to the public. (An autoinjector is still approved for use by the military and for chemical incident responders.)

The nasal spray, intravenous and intramuscular versions all work very well, and they all work against various versions of opioids. That includes not only heroin and fentanyl but also common opioid medications like oxycodone, hydrocodone, codeine and morphine. It’s important to note that one dose may not be enough, depending on how potent and how much opioid was taken. Often, several doses are needed to revive someone.

CNN: How do you know if someone is overdosing, and how can bystanders administer the antidote?

Wen: Signs of overdose include being unable to be awakened, breathing slowly or not breathing at all, and fingernails and lips taking on a blue or purple color while the skin becomes pale and clammy to the touch. Their pupils are often described as “pinpoint,” or very small.

Someone can overdose from taking too much of an opioid by accident. This often happens when fentanyl, an extremely potent opioid, is mixed with whatever the person is taking without their knowledge. Also, if an opioid is mixed with alcohol or benzodiazepines or other opioids, they can also become unresponsive. And there are instances when someone may not realize they are taking opioids, but the pill they obtained is contaminated with fentanyl.

If someone is overdosing, you or someone who is with you must call 911 immediately. In the meantime, administer naloxone. Naloxone reverses an overdose for up to about 90 minutes, but opioids can stay in the system for longer, so it’s still important for the person to receive medical attention after receiving the drug. Depending on the opioid the person took, they may need to be monitored in the hospital for hours after in case naloxone wears off while the opioid continues to have an effect.

If you have the nasal spray version, insert the tip of the device into the nostril and squeeze. Another spray may be given in the other nostril in two to three minutes if the patient remains unresponsive, and another one in another two to three minutes until either the patient responds or emergency help arrives. If you are trained to perform CPR, and the person isn’t breathing, you should administer CPR as well, in between giving naloxone.

CNN: Is naloxone safe to use? What if you’re not sure if someone is overdosing from opioids?

Wen: Yes, naloxone is extremely safe. If someone is not on opioids and is unresponsive, say, because they drank too much alcohol or has had a stroke, naloxone will have no adverse effect for them. That’s why emergency medical personnel routinely administer naloxone to patients who are found to be unresponsive; there is no harm to people who are unresponsive from non-opioid-related reasons.

If someone overdosed on opioids, naloxone reversal will send them into withdrawal. This could be unpleasant for the individual and could lead to vomiting, agitation, shivering, tearing up and having a runny nose. These aren’t desirable side effects, of course, but in cases when naloxone must be given, the alternative is death.

CNN: How can people get access to naloxone now? What will it mean if the FDA approves it for over-the-counter use?

Wen: As an emergency physician, I’ve given naloxone many times. First responders like paramedics and emergency medical technicians also routinely administer naloxone. When I served as Baltimore’s health commissioner, I felt strongly that everyone should be able to save someone else’s life.

Nonmedical personnel may already obtain and carry naloxone with them, but specific requirements and regulations vary by the state. Health departments and some community nonprofit groups have low-priced or free naloxone that they distribute to community members. Often, the naloxone is distributed to individuals who use drugs, because they are most likely to be around others who are overdosing. Also, their family members can use naloxone to revive them.

If the FDA approves the nasal spray naloxone for over-the-counter use, that means it will be more accessible. People should be able to purchase the spray from pharmacies, grocery stores, gas stations and perhaps even vending machines.

The problem is cost. We don’t yet know how the over-the-counter naloxone spray will be priced, and whether and how much insurance companies cover it will probably vary.

CNN: What more needs to be done to reduce overdose deaths?

Wen: Naloxone access is an important step. Someone who is overdosing has no chance for a better tomorrow if they are dead today. I would encourage everyone with a family member who is on opioids for chronic pain or has an opioid addiction to carry naloxone with them, so that they could save their loved one’s life.

Longer-term, a person who has an opioid use disorder needs treatment with a combination of medications and psychosocial supports. Much more needs to be done to expand treatment access, as well as to reduce the supply of illicitly manufactured drugs like fentanyl that are worsening the overdose crisis.

Finally, I want to remind everyone of 988, a new 24/7 phone and chat hotline that provides suicide counseling, crisis supports and referral for people in need of mental health and addiction support.

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A shortage of albuterol is about to get worse, especially in hospitals | CNN

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CNN
 — 

An ongoing shortage of a medicine commonly used to treat people with breathing problems is expected to get worse after a major supplier to US hospitals shut down last week.

Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. It has been on the US Food and Drug Administration’s shortages list since October. The news of the plant shutdown worries some doctors who work with patients with breathing problems such as asthma.

“This is definitely concerning, especially as we are coming out of the respiratory season where we had a big demand with RSV, Covid-19 and flu, and are now heading into spring allergy season when a lot of kids and adults experience asthma symptoms,” said Dr. Juanita Mora, a national volunteer medical spokesperson for the American Lung Association and an allergist/immunologist based in Chicago. “This is a life-saving drug and being able to breathe is vital for everyone.”

The manufacturer that recently shut down, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.

It was the only company to make certain albuterol products used for continuous nebulizer treatment. It’s a staple in children’s hospitals, but had been out of stock since last fall. Without that particular form of the product, hospitals have had to scramble to find alternatives.

“Members are either forced to compound it themselves to make the product or go to an outside third party source who is compounding the product,” said Paula Gurz, senior director of pharmacy contracting with Premier Inc., a major group purchasing company for hospitals.

With the Akorn shutdown, Gurz said products from the one remaining major domestic source of liquid albuterol, Nephron Pharmacuticals, have been on back order. Nephron just started shipping albuterol last Friday, Gurz said, but to get back on track, “it’s going to be an uphill climb.”

Hospitals around the country said they’re watching the supply chain – and their current stock – closely. There’s concern they might have to delay discharging patients because they don’t have enough medicine, or that they may see more ER visits for people with breathing problems who don’t have access to medicine.

Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital has been largely unaffected so far, but for months she has heard about retail pharmacies and other health systems that have had issues with albuterol shortages.

“The big problem we’ve been hearing about is inhalation solutions, not really the inhalers, it’s more like the solutions that go into the nebulizer machines for inhalation that the patients breath in,” said Piper.

Without the larger Akorn product, staff at Lurie Children’s Hospital in Chicago had to squeeze out the albuterol contents from smaller packages.

It’s “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day),” said hospital spokesperson Julianne Bardele in an email.

When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different concentration and use an alternative liquid bronchodilator, levalbuterol.

Most hospital pharmacies are aware of supply issues for many medicines, particularly pediatric medicines, said T.J. Grimm, the director of retail and ambulatory services at University Hospitals Cleveland Medical Center, and they try to keep a higher stock – especially of the less expensive medicines like albuterol.

“Just so we can cover situations like this,” Grimm said.

Grimm said his system has albuterol supply for a couple of months still, but he’s frustrated and concerned about the supply chain.

“When you have supply chains that are just-in-time, it can create some issues with when something goes off,” Grimm added. “There’s the short-term crisis we all have to get through and then there’s a longer term. We need to think about these things a little more strategically, especially with our kids.”

Jerrod Milton, the chief clinical officer at Children’s Hospital Colorado, said they’ve been paying close attention to the albuterol shortages for many months. The hospital has experienced shortages in the past, and has continued to implement protocols to conserve doses.

“Challenges are what we deal with when it comes to pediatric medicine. We consider most of the kids that we take care of as somewhat therapeutic orphans,” Milton said. “It’s just another one of the myriad of shortages that we have to deal with, I guess.”

Jessica Daley, the group vice president of strategic sourcing for Premier, said that she doesn’t anticipate that the albuterol shortage will be an ongoing problem for years, but when the market has only a handful of suppliers, “it makes for a very tight market, a very concerning market right now.”

Daley said there are things hospitals can do to help, such as protocol changes, making products on site and finding different suppliers.

The Children’s Hospital Association stepped in to help when it heard from members having difficulty finding enough supply. The association worked with STAQ Pharma, a facility that provides compounded pediatric medication, to start production on batches of albuterol for children’s hospitals in the sizes they needed.

“We’ve been creative and trying to work proactively. So when we think there’s going to be a problem, we’re trying to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.

STAQ should be at full production by May, so hospitals will have a steady, stable supply ahead of the next season in which respiratory viruses are in wide circulation, the association says.

Daley at Premier said that in an ideal world, there would be more suppliers of these products, particularly with generic drugs, so that when there is a problem with one, the market could handle it. When there is a concentration of manufacturing with a small number of suppliers, it is very hard to recover, she said.

“We really advocate for diversity and supply to prevent types these types of issues,” Daley said. “Meaning at least three globally, geographically diverse suppliers that are supplying the market with sufficient products.”

For patients, Piper at Children’s Hospital of New Orleans said they are encouraging patients with breathing problems to take precautions and avoid asthma triggers if possible. She said if a patient’s usual pharmacy runs out, it’s also good to check with a doctor to see if there is another medication that’s available.

Inhalers don’t seem to be impacted by the shortage so far, but Daley said if people panic about the lack of albuterol for hospitals, that could change.

“Albuterol is one of those things that if there’s a patient who needs it, you want to have it all the time. So there’s always that potential for the market to respond and react in a way that that will then create downstream shortages of other sizes or presentations of a product,” Daley said.

To avoid that problem, Milton at Children’s Hospital Colorado said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”

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Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes | CNN

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CNN
 — 

Eli Lilly announced Wednesday a series of price cuts that would lower the price of the most commonly used forms of its insulin 70% and said it will automatically cap out-of-pocket insulin costs at $35 for people who have private insurance and use participating pharmacies.

Lilly says it will also expand its Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured.

President Joe Biden heralded the announcement as “a big deal.”

“For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It’s flat wrong,” Biden said in a statement on Wednesday.

The President also urged other pharmaceutical companies to cut insulin prices.

“Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that. It’s a big deal, and it’s time for other manufacturers to follow,” Biden said.

Eli Lilly says it will cut the list price of its nonbranded insulin to $25 a vial as of May 1, making it the lowest list-priced mealtime insulin available. Its current list price is $82.41 for a vial.

Lilly will also lower the list price of Humulin and its most commonly prescribed insulin, Humalog, in the fourth quarter of 2023. The current list price of a Humalog vial is $274.70, and the new list price will be $66.40. For people with commercial insurance who use participating pharmacies, the out-of-pocket costs will now be capped at $35.

Although insulin is relatively inexpensive to manufacture, the cost has been a problem for many Americans for years. At least 16.5% of people in the US who use it report rationing it because of cost.

The average price of insulin nearly tripled between 2002 and 2013, the American Diabetes Association says. GoodRx research shows that the trend has continued, with the average retail price of insulin rising 54% between 2014 and 2019.

Demand for insulin has grown significantly as diabetes has become the fastest-growing chronic disease in the world, a 2022 study found.

In the US alone, the number of adults with diabetes has doubled over the past 20 years, and more than 37.3 million people now have it, according to the US Centers for Disease Control and Prevention. Another 96 million Americans – 38% of the population – have prediabetes, a condition in which blood sugar levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. This can often lead to diabetes.

People with diabetes rely on insulin because their bodies have stopped producing enough of this hormone or aren’t using it efficiently to convert food into energy.

When a person eats, their body breaks down food, mostly into sugar. This sugar enters the bloodstream, and that signals the pancreas to release insulin, which works like a key that allows the sugar to energize cells. But if diabetes keeps sugar in the bloodstream for too long, it can lead to serious problems like kidney disease, heart problems and blindness. In 2019, diabetes was the seventh leading cause of death in the US, according to the American Diabetes Association.

This year’s Inflation Reduction Act capped insulin costs for seniors who get their health coverage through Medicare Part D at $35 a month. Congressional Democrats pushed to extend that price cap to people covered by private insurance, but Republicans stripped that measure from the bill.

The US Food and Drug Administration’s approvals of generic insulin and biosimilars – drugs similar to original versions that can be made differently or with slightly different substances – have driven down the price at least somewhat, according to GoodRx.

Some states have taken matters into their own hands. Twenty-two states and the District of Columbia have price caps ranging from $25 to $100 for insulin as well as diabetes supplies and devices – but that’s only for people covered by insurance plans regulated by those states.

“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap.”

Lilly has been one of the biggest players in the US insulin market since it became the first company to commercialize the lifesaving drug 100 years ago. The company said that its price changes should make a difference, but more is needed to help all Americans with diabetes – 7 out of 10 don’t use the company’s insulin.

The Medicare Part D cap “should be the new standard in America,” Ricks said on CNN This Morning on Wednesday.

He called on the insurance industry, policymakers and other manufacturers to join them in making insulin more affordable.

“We call on everyone to meet us at this point and take this issue away from a disease that’s stressful and difficult to manage already – to take away the affordability challenges,” Ricks told CNN’s Don Lemon.

Other companies have cut insulin costs over the years.

In 2019, Sanofi created the Insulin Valyou Savings Program, which charged patients $99 a month for insulin, regardless of income. In 2021, Novo Nordisk created a similar program called My$99Insulin.

Also that year, Novo Nordisk collaborated with Walmart to sell private-label analog insulin at a deep discount. Walmart said its ReliOn NovoLog vials and FlexPens save customers 58% to 75% off the cash price for branded insulin.

For Eli Lilly insulin, the new price cap will automatically apply at most pharmacies with no additional action from the patient. Otherwise, a coupon will be available for patients to use at the remaining 15% of pharmacies where the electronic system does not allow for the automatic price drop, Ricks said.

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Adderall users struggle with ongoing shortage while reason — and resolution — remain uncertain | CNN

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CNN
 — 

Clara Pitts has always strived for perfection.

The 17-year-old Utah native has been named a 2023 National Merit Scholarship finalist. And she heads to Brigham Young University as a freshman this fall.

But despite all of her achievements, Clara has one thing weighing on her mind: What if she fails?

Clara was diagnosed with attention-deficit/hyperactivity disorder (ADHD) in 10th grade, during the summer of 2020, after months of digital schooling had started to take its toll.

“For the first time, I started struggling with getting my homework done [and] having a set schedule that I had to do myself,” Clara said. “It was because of online school.”

So along with her mother, Rebekah, she made the decision to try medication.

“I didn’t realize just how much my ADHD was inhibiting me from acting the same way as all of my friends until I had that experience of leveling the playing field,” Clara said.

By December 2020, Clara was prescribed 10 milligrams of Adderall, a formulation of amphetamine mixed salts, to be taken twice a day. Immediately, she noticed a difference.

“It seemed like the logical course of action, like something that shouldn’t have been happening in my brain was being fixed,” Clara said. “Naturally, my brain goes really, really fast, and I don’t even notice it because it’s what I’ve grown up with, and it’s the only mind I’ve ever experienced. But once I started having a different experience mentally, I felt a lot calmer.”

For the two years that followed, Clara was finally able to lead what she called a normal life, managing school, extracurricular activities and social life – all with the help of Adderall.

But in October 2022, Clara’s sense of calm was stripped away when the US Food and Drug Administration announced a shortage of Adderall and its generic counterparts.

“I hadn’t heard anything about a shortage,” she said. “I didn’t really take it seriously at first until later that week – maybe three or four days later – when I started to hear news about the shortage, and it really started to sink in.”

CNN first spoke with Clara and her mother, Rebekah, about a month after the FDA’s announcement. At the time, Clara had eight Adderall pills left in her prescription bottle – enough to last her four days.

“Initially, I was just very surprised when I tried to refill the prescription and they would not [refill it],” Rebekah says. “Very quickly, I went from surprised to afraid.”

On October 24, Rebekah texted Clara the bad news. The shortage had finally affected them, and their pharmacy could not refill Clara’s medication due to the shortage.

“They wouldn’t put you on a waiting list,” Rebekah texted her daughter. “I’m just sitting here crying because I can’t get you these meds.”

Rebekah says she called eight local pharmacies, and each one turned up empty.

“I felt really emotional about it in that first week or two … like I had failed my child, even though it wasn’t my fault,” Rebekah said. “I felt scared for what that would mean for her as a senior.”

The FDA announced a shortage of Adderall on October 12. The agency noted that it was in communication with all manufacturers of amphetamine mixed salts and that one of those companies, Teva, was “experiencing ongoing intermittent manufacturing delays.” Although other manufacturers continued to produce the drug, the agency said, “there is not sufficient supply to continue to meet U.S. market demand through those producers.”

Jim McKinney, a spokesperson for the agency, told CNN that the manufacturing delay has been resolved and that the shortage is now “demand-driven.”

Data from the analytics and research company IQVIA shows that the demand for Adderall has risen nearly 27% in recent years, with prescriptions jumping from 35.5 million in 2019 to 45 million last year.

On its website, the FDA lists eight manufacturers that have reported Adderall shortages to the agency. The website lists the shortage reason for some versions of the drug, such as “demand increase” or “shortage of active ingredient,” but for other versions, it just says “other” or lists no reason at all.

Each year, the Drug Enforcement Administration tracks and sets a limit on production of amphetamine, one of the key ingredients in Adderall. It says that for the past three years, manufacturers didn’t expend all of the ingredients that were available for their use.

“DEA is committed to ensuring that all Americans can readily access needed medications,” an agency spokesperson told CNN in a statement. “We are aware that the pharmaceutical industry is claiming that there is a quota shortage for the active ingredients in ADHD drugs. Based on DEA’s information – which is provided by drug manufacturers – this is not true.”

CNN reached out to the eight manufacturers that reported shortages to the FDA.

Teva Pharmaceuticals, Epic Pharma and Rhodes Pharmaceuticals did not respond. Alvogen, SpecGX and Sunrise Pharmaceutical declined to comment.

Sandoz said it had enough product to meet current customer orders. Lannett also said it had enough to meet current customer orders but added that it did not have enough to fulfill increased demand.

McKinney, the FDA spokesperson, said supply is increasing.

“The FDA recognizes the potential impact that reduced availability of certain products may have on health care providers and patients and is working closely with numerous manufacturers and others in the supply chain to understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products,” he said.

McKinney clarified that although the FDA is working with manufacturers, the agency does not make drugs and “cannot require a pharmaceutical company to make a drug, make more of a drug, or change the distribution of a drug.”

Dr. Yoram Unguru, a pediatric hematologist and oncologist with joint faculty appointments at the Herman & Walter Samuelson Children’s Hospital at Sinai and the Johns Hopkins Berman Institute of Bioethics, studies drug shortages.

He says a lack of transparency about details – how big the shortage is and how much drug each company is making – is hindering solutions.

“Pharmaceutical manufacturers are not required to disclose the reason for disrupted supply. Knowing the exact reason for a given shortage is always challenging,” Unguru said. “It’s really difficult to be able to anticipate and let alone come up with meaningful solutions if you don’t know what the problem is.”

Clara ultimately went without Adderall for two and half months as she coped with the stresses of senior year. She began taking a different ADHD medication, Vyvanse, in mid-January.

Rebekah says she hopes Adderall will be an option for Clara again one day, adding that she doesn’t have the emotional stamina to keep searching for the medication.

“I would like her to have medication as an option and for it to be reliable, because college will probably be the hardest journey for her with ADHD.”

Clara says that life without Adderall is like trying to see the world vividly while wearing smudged glasses.

“You go around with dirty glasses. You get used to it, and you don’t realize that they’re dirty. But when you clean them off, having that extra bit of clarity makes a world of difference.”

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Best medications for low back pain, according to new research | CNN

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CNN
 — 

Ouch, that aching back! Perhaps it’s from sitting too long, picking up a heavy object, a sudden slip or fall, or an aging spine — whatever the cause, sudden pain in the lower back is a common complaint.

In fact, low back pain is the leading cause of years lived with disability globally, with neck pain coming in at No. 4, according to the 2016 Global Burden of Disease Study. Low back pain is called “acute” when symptoms last between one and 12 weeks and “chronic” when the pain lasts three months or longer.

People often reach for over-the-counter pain medication to help. But which type of pain med is most effective?

A new study, published Wednesday in the Journal of Orthopaedic Research, attempted to find out. Researchers culled through mountains of published studies and found 18 randomized clinical trials that focused specifically on lower back pain that lasted no more than 12 weeks.

The study looked at the following types of analgesics: aspirin; acetaminophen (Tylenol, Paracetamol and Panadol); and nonsteroidal anti-inflammatory drugs, called NSAIDs for short, of which there are many.

Some common NSAIDs are ibuprofen (Advil, Motrin, PediaCare); naproxen (Aleve, Naxen, Naprosyn, Stirlescent); and celecoxib (Celebrex, Elyxyb), which is not available over the counter.

Researchers also included muscle relaxers in the study, which are not available without a prescription.

The study found the very best medication for acute lower back pain was a combination of an NSAID combined with a prescription muscle relaxer — that combo was effective in reducing pain and disability by the end of one week.

However, muscle relaxers don’t work in quite the way you might think, said Dr. Eliana Cardozo, assistant professor of rehabilitation medicine at the Icahn School of Medicine at Mount Sinai in New York City.

“They don’t go to the muscle and relax it. Instead, they work centrally in our brain where they make us sleepy and that kind of relaxes our body,” said Cardozo, who was not involved in the study.

“It’s hard to use them during the day for pain,” she added. “Personally I like to use muscle relaxers for people having pain at night.”

Combining an NSAID with acetaminophen was associated with a greater improvement than taking an NSAID alone, the study found.

“But when I looked at the actual data in the study, I can’t say that it really makes enough of a difference to add the two medicines — it was only a very small benefit,” Cardozo said.

Taking acetaminophen alone did not reduce pain significantly, the study found.

The results of the study only apply to lower back pain that isn’t ongoing and chronic, stressed the study’s corresponding author, Dr. Filippo Migliorini of the department of orthopedic, trauma, and reconstructive surgery, Universitätsklinikum Aachen in Germany.

Before any such intervention is recommended, the physician should be sure to rule out any “possible specific cause of pain that may require specific actions or diagnostics, for example, a history of cancer or recent trauma,” Migliorini and his coauthors wrote.

Another issue with using pain medications is they have potentially serious side effects. Acetaminophen is not recommended during pregnancy, and it can cause rash, hives and breathing difficulties. Only 4,000 milligrams of acetaminophen can be taken per day. An overdose can lead to liver damage or liver failure, according to the National Library of Medicine.

Side effects from NSAIDs can include indigestion, diarrhea, headaches, dizziness, allergic reactions, and “in rare cases, problems with your liver, kidneys or heart and circulation, such as heart failure, heart attacks and strokes,” the UK National Health Service noted.

Using NSAIDs for some time can lead to stomach ulcers, which can cause internal bleeding and anemia, the NHS said.

“If someone’s perfectly healthy and they have no other issues, then it’s fine to take NSAIDs around the clock for a week — but only a week,” Cardozo said. “And if someone has high blood pressure, asthma, heart disease or a peptic ulcer, those people should not be taking NSAIDs constantly.”

It’s estimated 4 out of 5 people will experience low back pain in their lives, according to the Cleveland Clinic. Due to ongoing deterioration of the spongy disks between back vertebrae, anyone older than 30 is at higher risk for low back pain.

So are people with excess weight due to the increase in pressure on joints and disks, along with people who smoke, drink a lot of alcohol or have a sedentary lifestyle, according to the Cleveland Clinic. Even people with depression and anxiety are at greater risk.

People with prior episodes of acute low back pain are at risk for ongoing, chronic symptoms, according to the North American Spine Society.

Antidepressants are not recommended for the treatment of low back pain, according to clinical guidelines developed by the society. Nor are oral or intravenous steroids. “Opioid pain medications should be cautiously limited and restricted to short duration for the treatment of low back pain,” the guidelines state.

However, over-the-counter gels and creams containing capsicum, or chile peppers, are recommended, and it’s possible that spinal manipulative therapy may help, although studies are mixed.

Exercise is highly recommended: “Remaining active is preferred and likely results in better short-term outcomes than does bed rest,” the guidelines said.

“People can start some exercises right away, such as gentle stretching and core stabilizing exercises, which can strengthen the back,” Cardozo said. “Now these are not sit ups or crunches — so seeing a physical therapist to get some starting exercises can be very helpful.”

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