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How the Shortage of a $15 Cancer Drug Is Upending Treatment

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How the Shortage of a $15 Cancer Drug Is Upending Treatment

Tony Shepard learned he had vocal cord cancer this spring, but he was encouraged when his doctor said he had an 88 percent chance at a cure with chemotherapy and radiation.

That outlook began to dim in recent weeks, though, after the oncology practice he goes to in Central California began to sporadically run out of the critical medication he needs.

Since Mr. Shepard’s doctor informed him of the shortage, each treatment session has felt like a game of “Russian roulette,” he said, knowing that failure would mean the removal of his vocal cords and the disappearing of his voice.

“I try not to even think about it,” said Mr. Shepard, 62, a manager of a gas station in Madera, a town in California’s Central Valley. “It’s something scary that you don’t really want to think about — but you know it’s a reality.”

The nation’s monthslong shortage of highly potent cancer drugs is grinding on, forcing patients and their doctors to face even grimmer realities than those cancer typically presents. Thousands of patients like Mr. Shepard have been confronting gut-wrenching options, delays in treatment and potentially bleaker futures.

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Oncologists are concerned that the alternatives to two crucial chemotherapy drugs are far less effective in treating certain cancers, and are sometimes more toxic. The backup therapies or lack thereof, they say, pose particularly troubling prospects for patients with ovarian, testicular, breast, lung and head and neck cancers.

There are few, if any, signs that the shortage will ease anytime soon. A plant that was a main producer of the more popular drugs shut down late last year and has not reopened, depleting its stock. The easing of restrictions on imported drugs from China this month has provided some relief, but doctors said the influx has yet to make much of a dent. Some companies that sell the medications are projecting that the shortage will last through the fall or later.

So far, neither a group of experts organized by the Biden administration nor prominent medical organizations have found a way to avoid rationing the crucial chemo drugs.

To bridge the gaps, some doctors are extending care intervals and skimming precious milliliters to stretch doses. Others are turning to a strategy of surgery first and chemo later, banking on a resumption of supplies.

One of the nation’s top cancer care groups, the American Society of Clinical Oncology, is now advising doctors with low quantities of the medications to administer them to patients with a shot at a cure — and to deny them to patients with recurrent or widely spread disease.

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​​ “We’re in a situation where patients are being left behind, and we’re really worried survival could be affected by the chemotherapy shortage,” said Dr. Angeles Alvarez Secord, president of the Society of Gynecologic Oncology and a professor at Duke University School of Medicine.

Two main chemotherapy drugs, cisplatin and carboplatin, are deployed as frontline medicines in cocktails used to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply, as well as hundreds of other medications, including antibiotics and sterile injectable fluids. Still, doctors predict that the absence of the powerful chemotherapies may hurt patients most.

Cisplatin and carboplatin are inexpensive: They cost $15 and $23 per vial, according to the U.S. Pharmacopeia, a nonprofit aimed at medication safety and supply. But manufacturing the drugs requires a reliable supply of platinum, a metal used, as well as a sterile plant and special controls to protect workers from the drugs’ toxic effects. As a result, few companies make them.

The most recent shortages of these widely used drugs occurred when a leading manufacturer, Intas Pharmaceuticals, shut down production in December after the Food and Drug Administration had performed a surprise inspection at its plant in Ahmedabad, India. The U.S. agency issued a report that said employees were shredding, tearing and pouring acid on quality control records and noted a “cascade of failure” at the site.

The company’s subsidiary, Accord Healthcare, in Durham, North Carolina, said recently that it was still making improvements at the plant that were needed to restart production.

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By this spring, the effects of the Intas shutdown were deeply felt. A survey by the National Comprehensive Cancer Network of academic treatment centers released earlier this month found that 93 percent of the 27 centers that responded were experiencing a carboplatin shortage. As a result, 36 percent of them reported altering treatments for their patients, resorting to lower doses and longer intervals between therapies.

At cCare Cancer Center in Fresno, Calif., where Mr. Shepard receives care for his vocal cord cancer, efforts to stretch supply have given way to sporadic availability. For the last six weeks, vials of the platinum drugs have been unavailable roughly half of the time, an oncologist, Dr. Ravi Rao, said.

He said Mr. Shepard’s odds of a cure without the drugs would fall from roughly 90 percent to about 45 percent. Fortunately, Mr. Shepard said, the drugs have been available for the first two of seven treatments.

Patients with ovarian cancer are facing the worst outlook, Dr. Rao said, because of how common the disease is and how central the platinum drugs have been in tackling it for decades. Without those drugs, one patient with extensive ovarian cancer has odds of survival that fall to the single digits from about 30 percent, he said.

“This shortage will lead to people dying,” said Dr. Rao, who is also a board member of the Community Oncology Alliance. “There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”

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Others who face heightened threats are patients with testicular cancer, because cisplatin has a known record of curing even advanced cases, said Dr. Julie Gralow, the ASCO chief medical officer, in her testimony to a House subcommittee earlier this month.

“This is critical, impacting maybe as many as half a million Americans with just these two drugs,” Dr. Gralow said.

For Florida Cancer Specialists, with more than 90 sites, the shortage initially meant conserving 10 to 15 percent of a patient’s dose to stretch stock, said Dr. Lucio Gordan, president of the practice.

That was not enough, so doctors began to only give the drugs to patients with a chance at a cure or those enrolled in clinical trials. The practice found some products at vastly inflated prices — apparent price gouging — but bought them anyway.

Still, by May, the practice was without carboplatin for 12 days and cisplatin for eight days, Dr. Gordan said.

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Arias Pitts, 33, who was diagnosed with an aggressive breast cancer in April, encountered the shortage when she arrived to begin treatment on May 16. The carboplatin her doctor had ordered for the first of six rounds of chemotherapy was not available.

“Of course I had questions and concerns,” said Ms. Pitts, an academic adviser at the University of South Florida and a single mother of a 4-year-old. She added: “It’s stressful.”

The F.D.A. has taken steps to ease the shortage. It oversaw the testing and release of batches of the platinum drugs manufactured by Intas in India that were made before the shutdown, but that stock has now been exhausted.

It is also temporarily allowing Qilu Pharmaceuticals, based in China, to ship its cisplatin to the United States.

Jordan Berman, a vice president of Apotex Pharmaceuticals, a Toronto company importing the Qilu drugs, said it received shipments of cisplatin on June 6 and began routing them through major U.S. distributors.

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Oncologists and supply chain experts said there was little data so far to gauge the effect the imports would have. About 600 vials of cisplatin from China arrived at Florida Cancer Specialists earlier this month, Dr. Gordan said. But that was not enough for the practice to resume offering the drugs to patients with advanced or recurrent cancers.

“It’s about six days of treatment for us,” Dr. Gordan said. “We’re scrambling.”

Studies in the 1980s and 90s showed that the platinum drugs were a vast improvement over existing treatments, performing best in combination with other drugs and doubling the response rates for ovarian and head and neck cancer. The platinum drugs pushed the five-year survival rate for testicular cancer to 95 percent from roughly 10 percent.

While newer immunotherapy treatments have improved the outcome for patients with certain types of cancer, like melanoma, oncologists also include them in cocktails with the platinum drugs to extend their lives and enhance the potential for survival.

“In general, we haven’t seen these home runs in cancer” in recent years, said Dr. Mikkael Sekeres, a University of Miami oncologist and former F.D.A. oncology adviser.

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Oncologists advising the field amid the current shortages have urged those treating early-stage lung cancer patients to send them to a center that has the drugs, noting, “there are no equally effective alternatives.”

Dr. Evan Myers, a Duke University researcher in the obstetrics and gynecology department, said he was planning to measure the effects of the shortages. One study of a different medication shortage affecting children and adolescents with Hodgkin’s lymphoma found that the substitute drug was “significantly less effective,” and reduced the survival rate for the young people who received the backup treatment.

Dr. Myers said this year’s shortages would, at a minimum, likely have an effect on the quality of life for people undergoing treatment. “They’re going to be waiting for the other shoe to drop,” he said.

Doctors are also struggling with how to convey such devastating news, said Dr. Prasanthi Ganesa, medical director of The Center for Cancer and Blood Disorders in Fort Worth. Her practice is looking at each case individually, but is also prioritizing crucial doses for patients who could potentially be cured.

“I can imagine a patient listening to this and saying, ‘You know, I am trying to live longer, that is my priority. So I need that drug, doc,’” she said. “We feel really helpless.”

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The situation demands action, said Dr. Karen Knudsen, chief executive of the American Cancer Society. The White House and Congress, which have discussed the problem, have advanced few concrete solutions.

“The necessity for a durable solution is growing greater by the day,” Dr. Knudsen said, adding, “Patients are left hanging.”

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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For diabetes patients, inhaled insulin is shown just as effective as injections and pumps

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Most of the 38 million people living with diabetes in the U.S. use daily injections or insulin pumps to keep glucose at safe levels — but new research suggests that a third option could be just as effective.

In a study led by Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, an inhaled form of insulin — similar to an asthma inhaler — worked just as well as injections or pumps to control type 1 diabetes.

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The research was presented last week at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, Florida.

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The clinical trial tested a product called Afrezza, an inhaled insulin made by MannKind Corporation in California. 

Afrezza, the only inhaled insulin on the market, has been available since getting FDA approval in June 2014.

An inhaled form of insulin worked just as well as injections or pumps to control type 1 diabetes in a recent study. (iStock/MannKind)

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Benefits of a third option

“In those with type 1 diabetes, insulin is required for survival,” Hirsch told Fox News Digital in an interview. 

“With continuous glucose sensing, glucose control has been dramatically improved — but not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” he said.

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With pumps, people must wear the device, which can lead to skin problems

They also have to purchase extra accessories.

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Blood glucose levels can also drop with exercise, Hirsch warned, which can be problematic. 

Afrezza inhaler

Afrezza, an inhaled insulin pictured here, is made by MannKind Corporation in California.  (MannKind)

“Injections overall can be more convenient for some, but they don’t do as well as pump patients,” he said.

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, Hirsch noted.

“Patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice.”

During the 17-week study, researchers evaluated the results of 141 adults who were assigned to either use the Afrezza inhaler or continue with traditional methods of injection or pump delivery.

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At the 17-week mark, all participants switched to the inhaler for another 13 weeks.

Dr. Irl B. Hirsch

Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, led the new study. (MannKind)

All groups were assessed with continuous glucose monitoring at the start of the study, at 17 weeks and again at 30 weeks.

Among the inhaled insulin group, 30% of participants reached their target glucose levels (less than 7% blood sugar) compared to 17% of the people using injections and pumps.

There was no difference in hypoglycemia (low blood sugar) between the groups.

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“In general, there was no difference in our primary endpoint, HbA1c, a reflection of average blood sugar,” Hirsch said. 

“But that alone is misleading — many patients did better with their glucose control, while others did worse.”

Afrezza inhaler

With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, a doctor said. (MannKind)

“The point is, inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

The people who saw the best results inhaled insulin between meals and at bedtime, Hirsch added.

                             

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At the end of the study, more than half of the participants said they would opt to stay on the inhaled insulin therapy.

“The biggest takeaway is that patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice,” he recommended.

‘Adds value’

The American Diabetes Association acknowledged the promise of the study findings in an email to Fox News Digital.

“We look forward to our Scientific Sessions every year to see data like the INHALE-3 study’s findings, which have the potential to expand diabetes care,” Raveendhara Bannuru, M.D., PhD, the ADA’s vice president of medical affairs and quality improvement outcomes in Boston, Massachusetts, told Fox News Digital via email.

diabetes CGM

“With continuous glucose sensing, glucose control has been dramatically improved,” a doctor told Fox News Digital. (iStock)

“We are hopeful for the continuous development of alternative insulin delivery methods that could offer options for people living with diabetes,” the group also said in the statement.

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“The INHALE-3 trial demonstrated that inhaled insulin, combined with insulin degludec, effectively reduces A1c levels without increasing hypoglycemia or weight gain in people with type 1 diabetes. This adds value to the options in insulin therapy.”

Potential risks and limitations

While more people met their glycemic targets with Afrezza, some subjects saw worse readings when switching from usual methods to inhaled insulin — “potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime,” the researchers wrote.

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“We didn’t see any concerns,” Hirsch said when asked about side effects. 

“As expected, a few people coughed immediately when dosing their insulin, but no major concerns were seen and everyone continued on their inhaled insulin.”

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Insulin injection

“Not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” a doctor said. (iStock)

The most common side effects noted in the study were hypoglycemia, cough and throat pain or irritation. 

Afrezza has been linked to a risk of acute bronchospasm in patients with chronic lung disease, such as asthma or COPD, according to the manufacturer.

“Inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”

Before starting Afrezza, patients should see a doctor for a physical examination and testing to measure lung function.

Patients who smoke or who recently quit smoking should not take the inhaled medication.

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For more Health articles, visit www.foxnews/health 

Fox News Digital reached out to MannKind requesting additional comment.

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Surgeon general declares firearm violence in America a public health crisis

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Surgeon general declares firearm violence in America a public health crisis

The United States surgeon general is declaring gun violence a national public health crisis. 

Surgeon General Vivek Murthy issued an advisory on Tuesday stating that firearm-related violence and its immediate psychological ramifications on victims and bystanders has severely compromised public health.

“Today, for the first time in the history of our office, I am issuing a Surgeon General’s Advisory on firearm violence,” Murthy said in a video announcement. “It outlines the urgent threat firearm violence poses to the health and well-being of our country.”

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U.S. Surgeon General Dr. Vivek Murthy released a special advisory on firearm violence on Tuesday, calling gun-related incidents a public health crisis. (Nathan Congleton/NBC via Getty Images)

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“As a doctor, I’ve seen the consequences of firearm violence up close and the lives of the patients that cared for over the years,” the surgeon general continued. “These are moms and dads, sons and daughters, all of whom were robbed of their physical and mental health by senseless acts of violence.”

The advisory states that 54% of adults in America have experienced a firearm-related incident. These experiences with firearm violence include individuals who have been threatened with a gun (21%), lost a family member in a gun-related death (19%), witnessed a shooting (17%), and been wounded by a firearm (4%).

The 54% figure also includes adults who have fired a gun in self-defense (4%). The gun-related death statistic includes those who committed suicide via firearm.

The report noted different demographics are affected in different ways by gun violence. 

Black individuals suffer the highest rate of gun deaths. American Indians, Alaskan Natives, elderly white people, and military veterans are at the highest risk suicide by firearm.

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“Beyond these precious lives that are lost to firearm violence, there are wider ripples of harm to those who are injured, who witnessed the incidents, who live in urban and rural communities where such violence takes place, and who constantly read and hear about firearm violence,” Murthy stated.

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Vivek Murthy

Murthy wrote in the report that the direct casualties of gun violence are compounded by psychological ramifications inflicted on victims and bystanders. (Tom Williams/CQ-Roll Call, Inc via Getty Images)

He added, “The collective trauma and fear that Americans are experiencing is contributing to the mental health challenges that we are facing today. Nearly 6 in 10 U.S. adults say they worry about a loved one being a victim of firearm violence.”

The public advisory on firearm-related violence is the first document of its kind released by the Surgeon General’s Office.

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