Facing Chemo Shortage, Biden Admin Taps Chinese Company That Made Drugs With Toxic Sludge

[mystery-ak]

 Facing Chemo Shortage, Biden Admin Taps Chinese Company That Made Drugs With Toxic Sludge
Supply chain snafu threatens to derail Biden's pledge to 'end cancer as we know it'


Chuck Ross   
June 7, 2023

The Biden administration has outsourced production of cancer drugs to a Chinese pharmaceutical giant that was once investigated for using a toxic sludge called gutter oil to make antibiotics.

The Food and Drug Administration announced last week it will purchase the chemotherapy drug cisplatin from China's Qilu Pharmaceutical in a bid to alleviate what one expert called "one of the worst chemotherapy drug shortages in history." Chinese authorities investigated Qilu, one of the country's largest drugmakers, in 2012 for using discarded cooking oil from restaurants to make antibiotics. The FDA has not approved cisplatin for use in the United States but has granted a temporary waiver to combat a chemotherapy supply chain crisis that has caused widespread delays in treatment for lung, cervical, and other cancers.

The supply chain snafu threatens to derail President Joe Biden's pledge to "end cancer as we know it." Congress has appropriated $1.8 billion since then-vice president Biden launched his "Cancer Moonshot" in 2016. The president in 2022 "reignited" the moonshot and this March asked Congress for an additional $2.8 billion in funding. Researchers say a cure for cancer is still far off.

more
https://freebeacon.com/biden-administration/biden-admin-imports-cancer-drugs-from-chinese-company-that-put-toxic-sludge-in-medicines/

[Kamaji]

[mystery-ak]

 Chemotherapy shortages push cancer centers toward crisis
by Joseph Choi - 06/10/23 6:00 AM ET

Cancer centers are contending with shortages of key chemotherapy drugs, with potentially dire consequences once the scarcity starts hitting patients.

A new survey released this week by the National Comprehensive Cancer Network (NCCN) found that 93 percent of cancer centers are reporting shortages of carboplatin and 70 percent are reporting shortages of cisplatin. These two drugs are commonly used together to treat a wide variety of cancers — including breast, lung, prostate and many types of leukemias — often with the aim of curing them.

The survey conducted in May found that cancer centers were still able to treat patients with cisplatin without delays or claim denials, but only 64 percent of centers were able to keep patients on a regime of carboplatin. A fifth of cancer centers said they were able to continue prescribing carboplatin for some but not all of their patients.

According to Mike Ganio, director of pharmacy practice and quality for the American Society of Health-System Pharmacists (ASHP), the U.S. is seeing “a near-10 year high in active ongoing shortages”

more
https://thehill.com/policy/healthcare/4043094-chemotherapy-shortages-push-cancer-centers-toward-crisis/

[mountaineer]

The FDA claims it's trying to bring in more drugs. Why the hell do we have to rely on China or India for life-saving pharmaceuticals?

Dr. Robert M. Califf
@DrCaliff_FDA
The FDA recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations.

Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.

That was June 2. On June 9, my sister was advised that she no longer may be able to get the carboplatin she needs. The story above notes that the FDA played a role in creating the "shortage."

... Much of the current shortages stem from a major interruption in manufacturing that occurred when a facility in India, run by Intas Pharmaceuticals, halted production in March after the Food and Drug Administration (FDA) discovered a “cascade of failures” in the plant’s quality control.

The FDA issued an import alert to the facility last week, stating all future shipments originating from the facility would be denied admission into the U.S. except for 24 drugs that are in short supply, including carboplatin and cisplatin.  ...

There's no "except ... carboplatin and cisplatin" to it. Those drugs aren't coming into the US.

Meanwhile, the FDA celebrates Pride Month.

Dr. Robert M. Califf
@DrCaliff_FDA
FDA celebrates #PrideMonth by raising the Progressive Pride flag at the FDA headquarters. This flag is a visual reminder that we stand in solidarity with the LGBTQIA+ community during a time when human rights for this community are under attack

[sneakypete]

HOW and WHY  did this happen?

Is there now  a new market for those drugs  that pays more for them?

[libertybele]

A pharmaceutical company was shut down for awhile in India. All the more reason to have pharma manufacturing restricted to the U.S.

I find it appalling that now there is a shortage because the FDA shut down a plant yet they are still pushing and producing experimental drugs for COVID!

[PeteS in CA]

Demonizing Big Bogey-Pharma and chasing Big Bogey-Pharma out of the US has consequences? Who'd athunk it? Attacking Big Bogey-Pharma profitability opens US marketplace doors to companies that cut corners on quality? Who'd athunk it? And Big Bogey-Pharma is shrugging? How Ayn-Randian of them! Who'd athunk it?

Editorial commentary aside, pharmaceuticals production facilities are not backyard-sized. They are huge and hugely expensive. With insurance companies and Medicare squeezing drug prices, pharmaceuticals cannot afford to have much idle capacity. So shutting down just one facility will, predictably, have a significant impact on supply. The same happens when an oil refinery or a meat packing plant or a food processing plant closes down.

I wonder about the demand side of the Supply & Demand equation. Was one of the consequences of partially shutting down medical care providers and facilities and large surge in cancer (and coronary, and etc.) diagnoses and demand for treatments? Delayed diagnoses result, later on, in the need for more serious and sudden demand for treatments and even deaths.

[mountaineer]

The problem is much more the FDA and various other government alphabet soup entities than American pharmaceutical companies, especially in this instance.

[Smokin Joe]

Ia this due to a surge in cases (need), the reduction in production, or both?

[mountaineer]

Ia this due to a surge in cases (need), the reduction in production, or both?

Probably much more the restrictions on shipping imposed by the FDA.

[PeteS in CA]

Ia this due to a surge in cases (need), the reduction in production, or both?

My guess is both, though without the shutdown of the production plant in India the post-C0vid-shutdown surge would have been handled. IOW, I think the plant shutdown is the principle cause. Pretty much any facility producing anything in high volume has a large capacity and is expensive to build and equip. Thus, they are planned and built so that they will be operated at near full volume (idle capacity = investment not paying for itself). Consequently, shutting down an entire facility has a significant impact on available supply, and other facilities have limited available capacity to fill in that hole. My guess is that supply-demand balance will be restored in about a year, no comfort to people whose treatment is being compromised.