Ted Kennedy’s diagnosis of incurable brain cancer raises seemingly simple question: How long does he have to live? But as WSJ Numbers Guy Carl Bialik reports this morning, there’s no clear answer.

Experts told the Health Blog Kennedy most likely has a disease where survival is typically a little over a year. There’s a smaller chance that he has a less aggressive form of cancer where survival is typically somewhere in the two- to four-year range.

But as Bialik rightly points out, these are mere estimates. Some patients survive for shorter periods of time, some much longer.

“It is lies, damned lies and statistics,” Lynne Taylor, director of neuro-oncology at the Virginia Mason Medical Center in Seattle, told him. “What everyone cares about is what’s going to happen to Ted Kennedy, and that’s the one thing statistics can’t tell.”

In a 2005 study of patients who received radiation treatments and Schering-Plough’s chemotherapy drug Temodar — both of which will likely be given to Kennedy — 27% of patients lived more than two years and nearly 20% lived past three years.

In general, younger brain cancer patients tend to have longer survival times than older patients. And those who are functioning well at the time of diagnosis tend to survive longer than those who are diagnosed after functional problems emerge. Kennedy is 76, and he is functioning well, but translating these variables into a precise life expectancy is impossible.

We’ve all heard stories of patients who are given months to live and, defying the odds, are alive a decade later. But these cases are the exceptions: Studies suggest doctors tend to overestimate, rather than underestimate, life expectancy for the dying.

The body is phenomenally complex, and it’s ultimately impossible to predict how long any single patient will live. Fewer than half of doctors’ predictions are within 33% of the correct survival time.

In what’s likely to be the biggest court case of the year for the drug industry, the federal government has filed a brief with the Supreme Court backing Wyeth.

The case, Wyeth v. Levine, asks whether a patient who has been harmed by a drug can sue under state law if the drug was produced and marketed under terms approved by the FDA. The broader legal question here is called “preemption,” and refers to the question of whether federal law preempts state law.

The lawyers over at the Drug and Device Law blog hash out the brief in some detail. They emphasize the feds’ argument that the FDA considers the balance of risks and benefits when approving a drug’s label, and that there are only very narrow circumstances in which a drugmaker can change a drug’s label without prior approval from the agency.

The balance of risks and benefits weighed by the FDA is central to the feds’ argument. Filing on behalf of the FDA, the Department of Justice wrote in its brief: “Because FDA�s approval strikes a balance between competing considerations, state laws that strike a different balance conflict with FDA’s determination and are impliedly preempted.”

The Supremes will hear the case later this year.

Photo by dbking via Flickr

The FDA is about to tell drug makers to add warnings about suicidal behavior to the labels of 11 epilepsy drug, the WSJ reports.

“We are working on the labeling changes that we want to get to the companies,” Russell Katz, director the FDA’s neuropharmacological drug division, told the paper.

“Everything points in the direction of an increase in what we call suicidality” he said, referring to the FDA’s combined analysis of 199 clinical trials that included 43,892 patients. (For more on the data, see this Health Blog post from earlier this week.)

Pfizer’s Lyrica, GlaxoSmithKline’s Lamictal, Abbott Lab’s Depakote and UCB’s Keppra would be among the drugs affected by the change.

Pfizer has said that its drug is different than others in the class, and the company has not seen signs of increased suicidal behavior in its data. But the label change, which could take effect before a July 12 advisory committee meeting, is likely to apply to the entire class of drugs.

The end of the Clinton campaign tomorrow means we’ll be hearing a lot less about requiring all Americans to buy health insurance, at least for the time being.

A broad health insurance mandate was one of the main tenets of Hillary Clinton’s latest plan for health reform, and the most substantive health policy difference between Clinton and Obama.

So the idea of making everyone buy health insurance came in for lots of discussion. At a February debate, for example, the candidates spent more than 15 minutes hashing things out, with Clinton arguing that a mandate was the only solution to uninsured free-riders. Obama pointed to problems in Massachusetts, which has a universal mandate, fining those who don’t buy insurance. Some, he said, “choose to accept the fine because they still can�t afford it, even with the subsidies.”

Indeed, Massachusetts’s adoption of the mandate at the beginning of ‘07 has been something of a high-water mark for universal health insurance in this country. That plan has indeed significantly cut the percentage of state residents without health insurance — but at a higher than expected cost, as the state subsidizes those who can’t afford insurance at market rates.

Arnold Schwarzenegger’s ambitious plan to create a mandate in California failed earlier this year, largely because of worries over costs. The weak economic climate nationwide, combined with the high cost Massachusetts’s program, mean other states aren’t likely to create their own mandates any time soon.

“We’re moving into a period where state resources are strained,” Robert Reischauer, president of the Urban Institute and health policy guru, told the Health Blog. “Few feel in a position to take on an open-ended entitlement.”

Still, mandates aren’t likely to vanish altogether from the debate. For one thing, Obama does support a mandate for all children to have health insurance. McCain, who has focused on cutting costs and reforming the tax code for health insurance, doesn’t support health insurance mandates for anybody.

Photo: Associated Press

With stents and anemia drugs under pressure, Johnson & Johnson is looking for growth wherever it can find it. Are your kids ready for contact lenses? J&J’s Vistakon division sure thinks so.

J&J thinks she’d look better in contacts (Getty Images)

A recent company-sponsored study showed that kids as young as 8 can wear and properly care for their contacts, said Michael Sneed, the head of J&J’s vision unit, during a J&J review of its medical devices, diagnostics and consumer health businesses yesterday in New Brunswick, N.J.

The typical bespectacled kid who switches to contacts does so around 15, Sneed said. “Our goal is to get contact lens wearers in earlier and staying longer,” he said. “In the future we believe contact lens wearers will range from 8 to 60 years of age. Dropping the entry-level age is integral to growing the category.”

Getting 8-year-olds and up to wear lenses wouldn’t just help the company. The kids would be better able to participate in sports and their self-esteem might also improve, Sneed said. “The belief from optometrists, and from parents, is they would like to put kids in contacts,” he told the Health Blog.

The company has been talking up the contact-lens study with eye doctors in hopes of making them more comfortable with prescribing contacts to youngsters. No further approval from FDA is necessary, and J&J already makes the right sizes.

But parents should use caution in deciding whether their child is ready for contacts because of the risk of infection, Assumpta Madu, an ophthalmologist at Montefiore Medical Center in New York, told the Health Blog. “There will always be some children who are extremely mature for their age who can handle it, but the fear is that there is always possibility of sight-threatening infection,” she said. Because of that risk, the average 8-year-old probably shouldn’t use them, she says.

J&J isn’t ignoring the other end of the age spectrum, either. For older adults who have to stop wearing contacts because they start to have a hard time seeing up close — usually after the age of 45 — the company has products in development to solve the problem. J&J remained mum on exactly what products were coming down the line to address the condition, called presbyopia, but says it has cutting-edge technology and the company is “optimizing it now,” according to Sneed.

Double Vision: You can hear Sneed’s presentation on J&J’s vision business by downloading this podcast from the company’s Web site.

The drug industry has been grumbling over how tough on safety the FDA is these days, but by one measure the agency has fallen off significantly a few years ago. The number of warning letters the FDA sends out has been cut in half in recent years, Dow Jones Newswires’ Jared Favole reports.

FDA is mailing fewer of these to regulated companies

In fiscal 2001, the FDA sent out 1,032 of the letters. That fell to 538 in 2006 and 471 in 2007. The decline followed a policy shift in 2002, when the agency started sending all warning letters through its office of chief counsel. As Dow Jones reports, the letters can be over anything from “the mislabeling of chocolate chip cookies to the improper manufacturing of blood bags.”

FDA Commissioner Andrew von Eschenbach said the agency now focuses the letters on bigger issues. “You may see a change in the number, but you�re seeing a focus on a grain size,” he told DJ. He also said the agency uses alternatives to individual warning letters.

But David Kessler, who ran the FDA during the Clinton years, said the decline is something of a flag. “The number of warning letters has always been one of the surrogate measures of FDA’s enforcement performance,” he said. “It’s not the only measure, but any significant drop raises significant questions of what�s going on.”

Video Bonus: See Jared Favole explain the change in FDA’s enforcement approach by clicking here.

Two diabetes studies released this afternoon are just the latest evidence that lowering key risk factors isn’t enough to improve health. If patients (and their doctors) use the wrong strategies, they may lower risk factors but raise the chances of serious health problems.

That’s the argument from Harlan Krumholz, a Yale cardiologist whose Perspective piece accompanies the studies published today in the New England Journal of Medicine.

One of the studies, dubbed Accord, found that an unusually aggressive approach to lowering glycated hemoglobin, a key risk factor in diabetics, actually increased the risk of death.

The other, called Advance, found that an aggressive approach failed to lower the risk of heart attack or death compared with a more typical treatment approach (though researchers did see less kidney damage in the patients treated aggressively).

Krumholz cites other recent studies that showed that a strategy that should theoretically improve outcomes made no difference or made things worse.