Chemo can be brutal. This FDA efforts aims to make it less so

Amgen Plows Ahead With Costly, Highly Toxic Cancer Dosing Despite FDA Challenge

What is Optimal Cancer Care and How Do We Get There?

The Optimal Cancer Care Alliance (OCCA) believes it is a clinical, financial, and ethical imperative to replace current oncology overdosing with optimal dosing. The right amount of medication at the right time reduces toxic side effects, provides the best clinical outcomes and lowers costs.

OCCA - Optimal Cancer Care AllianceWhy is there overdosing?

Historically, doctors used toxic chemotherapy to attack cancer in humans – the more of it, the better. The earliest drug developers focused on one question: “How much of this toxic chemical can we give to treat the cancer without killing the patient or causing other unacceptable side effects?”

We now know better. Lower doses can have the same impact with fewer or no side effects. And newly developed precision medicines do not require overdosing the patient to be fully effective. Given the dramatic changes in science and drug development, clinicians and regulators should be asking: “How little of this stuff do we need to give to effectively to treat the cancer?”

Why is this question important?

Optimal dosing would improve the quality of hundreds of thousands of patients’ lives – fewer pills, fewer side effects, less frequent doctor’s visits – all without sacrificing the effectiveness of cancer care.

Optimal dosing can also save patients and payers billions of dollars. Cancer drugs are almost always expensive, causing massive out-of-pocket expenses. They result in financial insolvency for nearly 40% of oncology patients. People fighting cancer often skip doses of drugs, skimp on other expenses to pay for medicines, or forgo treatment altogether because of high costs or severe side effects. Optimal dosing can help solve these problems.

Has optimal dosing been studied?

A clinical trial of optimal dosing for abiraterone, a type of hormone therapy used to treat men with advanced prostate cancer, demonstrated that taking just one abiraterone pill with food works just as well as four abiraterone pills taken on an empty stomach! The Medicare program alone spends about $1.2 billion per year on abiraterone. If we switched to optimal dosing, nearly $700 million could be saved every year and used for other pressing healthcare needs. Patients would avoid the inconvenience of taking multiple pills and would also save money.

Optimal cancer care. Optimal outcomes.

OCCA has identified numerous examples of cancer drugs that appear to be overdosed. Switching to optimal dosing for these drugs will improve cancer patients’ lives, save them money, and free up Medicare funding so it can be used for other health care needs.

What are the next steps?

Information is power. For drugs currently on the market, we need to fund more optimal dosing studies. For newly approved drugs, pharmaceutical companies should be required to conduct routine dose-optimization studies.

Optimal cancer care requires optimal drug dosing.

OCCA is a tax-exempt charitable organization.