Scarcity of drugs against cancer harms treatment – 07/04/2023 – Health

Tony Shepard recently found out he had cancer of the vocal cords, but was heartened when his doctor told him there was an 88% chance of cure with chemotherapy and radiotherapy. However, that outlook has begun to wane in recent weeks after the critical medication he needs began to sporadically run out of the oncology office he attends in central California.

Since his doctor informed him of the shortage, each treatment session has been like a game of “Russian roulette”, he commented, knowing that failure would mean the removal of his vocal cords and the loss of his voice. “I try not to think about it. It’s a scary thing that you don’t even want to think about, but you know it’s a reality,” said Shepard, 62, a gas station manager in Madera, a town in California’s Central Valley.

The country’s lack of potent cancer drugs has persisted for months, forcing patients and their doctors to face situations even more dire than what cancer normally presents. Thousands of patients like Shepard are faced with harrowing options, treatment delays and a potentially bleak future.

Oncologists are concerned that alternatives to two crucial chemotherapy drugs are much less effective at treating certain cancers and, at times, more toxic. According to them, supportive therapies, or the lack thereof, present particularly worrying prospects for patients with ovarian, testicular, breast, lung, head and neck cancer.

There are few signs that the shortage will ease. A factory that was one of the main producers of the most popular drugs closed at the end of last year and has not reopened, running out of stock. The easing of restrictions on drugs imported from China this month has provided some relief, but doctors say it has not yet made much difference. Some companies that sell the drugs are predicting that shortages will last until the end of the year.

So far, neither the Biden administration’s expert group nor medical organizations have found a way to avoid rationing crucial chemotherapy drugs.

To make up for the shortage, some doctors are extending service intervals and saving precious milliliters so that the drugs last longer. Others are resorting to a strategy of surgery first and chemotherapy later, betting on the resumption of supply.

One of the nation’s leading cancer treatment groups, the American Society of Clinical Oncology (Asco), is now advising doctors running low on the drugs to give them to patients who have a chance of a cure—and deny it. them to patients with recurrent or widely disseminated disease.

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

Two main chemotherapy drugs, cisplatin and carboplatin, are used on the front lines to shrink or eliminate tumors. More than a dozen cancer drugs are also officially in short supply, along with hundreds more, including antibiotics and sterile injectable fluids. Still, doctors predict that the lack of powerful chemotherapeutics could harm patients more.

Cisplatin and carboplatin are cheap: $15 and $23 a bottle, according to the US Pharmacopeia, a nonprofit organization focused on drug safety and delivery. But its manufacture requires a reliable supply of platinum, as well as sterile factories and special controls to protect workers from the toxic effects of the substances. As a result, few companies produce them.

The most recent shortage of these widely used drugs came when a leading manufacturer, Intas Pharmaceuticals, halted production in December after the FDA, the US food and drug control agency, made a surprise inspection of its factory in Ahmadabad, India. The FDA released a report noting a “series of failures” in place.

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

Now, the effects of the Intas stoppage are being deeply felt. A National Comprehensive Cancer Network survey released this month showed that 93% of 27 participating physicians were experiencing a carboplatin shortage. As a result, 36% of them reported having changed their patients’ treatments, resorting to lower doses and longer intervals between cycles.

At the cCare Cancer Center in Fresno, Calif., where Shepard is being treated for his vocal cord cancer, efforts to make the drugs last longer have given way to sporadic availability. Over the past six weeks, vials of platinum drugs were unavailable about half the time, reports an oncologist, Dr. Ravi Rao. He explained that the chances of a cure for Shepard without the drugs would drop from around 90% to approximately 45%. Shepard commented that, fortunately, drugs are available for the first two of seven treatments.

Ovarian cancer patients are facing the worst prospects, Rao said, because the disease is more common and platinum drugs have been central to fighting it for decades. He added that without these drugs, the chances of survival for a patient with extensive ovarian cancer drop from about 30% to single digits. “This shortage is going to lead to people dying. There’s no way around it. You can’t remove these life-saving drugs and not have bad results,” said Rao, who is also a board member of the Community Alliance on Oncology.

Others who face heightened threats are patients with testicular cancer, because cisplatin has a known history of curing even advanced cases, explained Julie Gralow, Asco’s chief medical officer, in her testimony to a House subcommittee this month: “This is critical, impacting perhaps as many as half a million Americans on those two drugs alone.”

For Florida Cancer Specialists, which has more than 90 locations, the shortage initially meant keeping 10% to 15% of a patient’s dose to make supplies last longer, said Lucio Gordan, the president of the clinic chain. As that wasn’t enough, doctors started giving the drugs only to patients with a chance of being cured or enrolled in clinical trials. The clinic found some products with very inflated values ​​- apparently price manipulation – but bought them anyway. Despite that, in May he went without carboplatin for 12 days and cisplatin for eight, according to Gòrdan.

Arias Pitts, 33, who was diagnosed with aggressive breast cancer in April, faced shortages when she arrived for treatment on May 16. The carboplatin her doctor had prescribed for the first of six rounds of chemotherapy was not available.

Studies done in the 1980s and 90s showed that platinum drugs were a huge improvement over existing treatments, performing better in combination with other drugs and doubling response rates for ovarian, head and neck cancers. These drugs raised the five-year survival rate for testicular cancer from about 10% to 95%.

While newer immunotherapy treatments have improved outcomes for patients with certain types of cancer, such as melanoma, oncologists also give them cocktails of platinum drugs to extend their lives and increase their potential for survival. “Overall, in the case of cancer, we haven’t seen great success in recent years,” said Mikkael Sekeres, an oncologist at the University of Miami and a former FDA oncology adviser.

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

The situation calls for action, said Karen Knudsen, executive director of the American Cancer Society. The White House and Congress, which discussed the problem, came up with few concrete solutions. “The need for a durable solution grows every day. Patients are waiting,” she added.