News

An end to faster approvals for cancer drugs? (Morning Read)

Among today’s current medical news: an ugly view of accelerated approvals; Novo Nordisk continues to grow; hospitals’ challenges with Baby Boomers; further state Medicare cuts and the path to genomics breakthroughs.

Current medical news and unique business news for anyone who cares about the healthcare industry.

FDA’s ‘ignorant’ accelerated drug plan. An advisory panel said the FDA should require further trials for companies to receive accelerated approval for cancer drugs. Many drugmakers don’t complete follow-up trials required to get accelerated approval, leaving only one single-arm trial as evidence for the drug’s effectiveness.

Big ambitions from Novo Nordisk. Via Forbes:

presented by

Novo’s next move is to take on Sanofi-aventis, the other heavyweight in the diabetes business. Its Lantus dominates the market for long-acting insulin. To fight back Novo has come up with an even longer-acting insulin called degludec. It claims that degludec avoids the insulin “spikes” seen with Lantus. In one big trial patients on degludec had 35% fewer occurrences of nighttime low blood sugar, a known insulin side effect, than those on Lantus. “It is absolutely hands down a better profile than Lantus,” says Sørensen. Degludec could hit the market by 2012. Sanofi says it is “too early to draw any conclusions” about degludec.

When Baby Boomers attack. 2.8 million Baby Boomers will qualify for Medicare this year alone. Hospitals have at least three concerns: declining access to care, inefficient focus on chronic care issues, and need to see adjustments Medicare reimbursements to fit Baby Boomers’ needs. Three tactics may help as Baby Boomers continue to age: continued cutting of “waste,” even more intense pursuits of accountable care organizations, and an increased reliance on hospital associations.

State cuts rundown. Bracing for a cut in federal aid, states are cutting some of the following benefits from Medicaid: no more organ transplants (Arizona), no more hospice care (South Carolina), a limit of 10 doctor visits a year (California).

Five keys to genomics research. The National Human Genome Research Institute outlined a new path for genomics research. They predict major breakthroughs are “years away,” but also outlines necessary steps to assist genomics research:

  1. Making genomics-based diagnostics routine, much like a blood panel is now.
  2. Defining the genetic components of diseases of all types through study of “upwards of a million patients.”
  3. Comprehensively characterizing cancer genomes to understand what molecular pathways are altered in different subtypes of cancer.
  4. Creating practical ways to keep physicians and patients up to date on the latest knowledge about genetic variants and their association with disease or treatment response.
  5. Investigating the role of the human microbiome to see what role the bacteria in our gut and elsewhere play in our health and disease.

Big salaries = no tax breaks. Washington state officials have reacted to news of hospital executives’ pay by saying the hospitals may no longer be eligible for tax breaks and considering requiring further executive pay disclosures.

Drug-seeking nurse: “Man up.” A nurse told a patient in for kidney stones to “man up” before injecting herself with some of his painkillers.

Topics