Six weeks after Sanofi-Aventis coughed up $500 million for a company with 18 employees, the deal already smells like roses.

When Sanofi reeled in San Francisco-based BiPar Sciences, the prize was an investigational drug known as BSI-201, the furthest along of a new breed of cancer fighters known as PARP inhibitors.

That drug—it was revealed at the recently concluded meetings of the American Society of Clinical Oncology—prolonged survival in women with a particularly nasty form of breast cancer by 61%, to 9.2 months, when added to standard chemotherapy.

That result was hailed as “a huge bombshell” by Powel Brown, director of Baylor’s Breast Center. He predicted the FDA would approve the drug within 2 years.

In commenting on Paris-based Sanofi’s shrewd acquisition, Chief Executive Officer Chris Viehbacher told Bloomberg, “the size of teams and the size of their budget do not correlate to research and development success.”

After chemotherapy or radiation damages the DNA of cancer cells, they typically mobilize PARP enzymes to repair the damage. PARP inhibitors block these enzymes, thereby enhancing the efficacy of the initial treatment.

The ASCO study focused on 116 patients with triple-negative breast cancer, an aggressive form of the disease that is usually unresponsive to treatment because it lacks all 3 genetic targets which have become the focus of modern treatments. About 15% of breast cancer cases are triple-negative.

Nearly 60% of the patients randomized to receive BSI-201 experienced tumor shrinkage or at least slowed progression. That was 3 times more than those receiving standard chemotherapy.
 
Sanofi ‘s next step is to begin a larger trial designed to confirm the findings. That could be completed within a year and then, assuming results hold, they’re off to see the wizards at FDA.

The FDA has warned General Mills that claims about heart benefits appearing on Cheerios boxes violate federal laws.

In particular, the company’s assertion that the iconic breakfast cereal has been “clinically proven to help lower cholesterol” effectively renders the product a drug, according to federal law.

Stephen Sundlof, the director of the FDA’s food-safety center, added that General Mills needs to file a new-drug application for Cheerios if it intends to leave the box labeling as it is.

Tom Forsythe, a gobsmacked GM spokesperson responded that Cheerios’ claim it can “lower your cholesterol 4% in 6 weeks” has been posted for 2 years, and that the labeling references a study in which Cheerios was factored into a low saturated fat, low cholesterol diet.

“The clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong,” Forsythe told the Wall Street Journal.

An unimpressed Sundlof shot back that “we try to make a bright line between what can be said about a drug and what can be said about a food.”

A less specific claim that consuming whole-grain foods can reduce the risk of heart disease risk would be permissible in certain circumstances, he added.

In a letter to General Mills, the FDA said the food-maker must “promptly” correct the violations or else it would be forced to take action, which might include seizing products.

Apparently, the FDA’s intervention was prompted by a tip from the National Consumers League.

The FDA’s love letter follows by one month a case in which the Federal Trade Commission settled a dispute with Kellogg Co. regarding claims that Frosted Mini-Wheats improved children’s attentiveness by 20%.

In 2001, Foundation Coal Holdings Inc. and Peabody Energy Corp. asked retired surgeon Derrell Crowder to help reduce their health care expenditures.

Crowder set out to negotiate price reductions with local providers in Wyoming, where most employees lived. He figured the providers would listen to a pitch from two companies that employed nearly 20% of the population in their towns.

The providers blew him off. They thought they had a monopoly on medical services in the area.

Crowder was unfazed. “Even if I got a discount” he told Bloomberg, “Bad care at a discount is still bad care and it’ll be more expensive in the long run” due to costs associated with avoidable complications, unnecessary tests and longer hospital stays.

Crowder then prepared a list of the top hospitals based on national quality indicators and determined how they stacked up on costs. He found among other things that the Mayo Clinic received very high quality ratings and charged approximately $67,000 for coronary bypass surgery, whereas the coal companies’ local hospital received low ratings and charged $98,000 for the same.

Now mine workers at the two companies can choose to undergo certain elective procedures at a national center of excellence. Their employers pay all travel and lodging costs, and reduce co-payments as well.

In the 3 years since the mining companies instituted Crowder’s plan, their health care costs have dropped 5% per year. Nationally, corporate spending on health rose 7% per year during the same period.