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.”

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 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

People generally need to die in the hospital to become organ donors, because organs have to be harvested almost immediately after death. New York City may change that with a special “organ-recovery ambulance” that will travel to the homes of people who die suddenly.

Yes, it sounds a little creepy. But organ donation always has a touch of the creepy. And thousands of people die every year waiting for transplants, so a program that adds organ donors could save lives.

The city’s organ ambulance, still in the planning stages, is funded by a $1.5 million federal grant.

It would arrive shortly after regular paramedics stopped trying to resuscitate a patient, the Associated Press reports. The team would administer drugs and perform chest compressions in an effort to keep the organs viable. Organ removal would only be done after taking the patient back to the hospital, and only if the family gave consent, or if the deceased had agreed to be an organ donor.

But the organ ambulance might sometimes arrive before the family gave consent. And a recent Washington Post story cited concerns by several bioethicists over the issues raised by the program.

“I think it’s disgusting,” said Michael A. Grodin, director of bioethics at Boston University. “People are going to worry when the ambulance comes out to their house whether they are there to care for them or to take their organs.”

Such programs are apparently already common in parts of Europe, the WaPo said, but haven’t been tested in this country.

Health Blog Poll: What do you think of an organ-recovery ambulance?

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Photo by Wikimedia Commons

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

Pfizer invited a bunch of folks, including the Health Blog, to a media roundtable about Chantix at the company’s 42nd Street HQ this morning.

Chantix, if you’re just tuning in, has weathered a lot of safety questions recently. The label for the drug has been beefed-up to warn about suicidal thinking, and a recent report linked the medicine to a range of possible side effects from seizures to accidents.

By way of introduction at today’s meeting, Pfizer’s VP for media relations Ray Kerins explained to the group that Pfizer wanted to openly correct misunderstandings and misinterpretations in the marketplace.

Here’s a summary of Pfizer’s main points:

#1 Smoking is a serious health problem that kills people.
#2 Most of the adverse events that have been reported recently are already in the Chantix label.
#3 Smokers who are trying to quit can be depressed and irritable.
#4 Paying close attention to adverse-event reports helps the FDA and Pfizer enhance drug safety.

On that last point, Pfizer cautions that real-world, post-market reports aren’t the gold standard of clinical research and shouldn?t be interpreted as such. Still, Joe Feczko, Pfizer?s chief medical officer, acknowledged that the suicide issue appeared largely in the spontaneous reports that trickle in from the real world as opposed to in clinical tests.

Pfizer did say that smoking is associated with suicide -? one of the main reasons Pfizer worked with the FDA to change the drug’s label three times since last November. That way, even if Pfizer and the FDA never figure out if Chantix is changing the risk, at least smokers will have been forewarned.

Barack Obama’s got a solution for dealing with members of Congress who won’t pass his health-care plan, reports the WSJ’s Amy Chozick. It boils down to two words: “Whup them.”

Obama greets supporters after speaking in Bristol, Va. (Photo: Reuters)

At a town hall meeting on health care at Virginia High School, a 95-year-old voter gave the expected Democratic nominee a maple walking stick.

Obama thanked the man, who’d carved the stick himself, and then, admiring his gift, said, “If members of Congress don?t pass my health care plan, I’ll whup them, I’ll whup them. That’s right, don’t mess with me, I’ll have my stick.”

On a more serious note, Obama said he would have an open conversation about health care with the American people, going so far as to promise that negotiations over his reform plan would be aired on cable TV’s C-SPAN, Newsday reported.

He said health-care lobbyists would have a seat at the negotiating table, but that they “wouldn’t take up all the chairs,” according to Newsday.

Also in his speech, Obama told voters there would be at least one thing his health plan wouldn’t pay for. “Liposuction isn?t going to be covered,” he said. “You can still get there but you?ll have to get there yourself,” he said, sparking laughter from the audience and confused looks from his traveling press corps.

The Bristol rally was Obama’s first public campaign event since he passed the delegate threshold of 2,118 needed to secure the nomination.

Bob and Carmen Pack. Photo: AP

In 2003, Bob Pack’s son and daughter were killed by a driver who was abusing prescription drugs. Pack started looking into the issue of prescription drug abuse, and launched a foundation named for his children.

He wound up offering to raise over $3 million to fund a state database that would allow California doctors and pharmacists to see if patients are “doctor shopping” to get prescriptions for drugs of choice. Yesterday, California Attorney General Gerry Brown took Pack up on his offer.

“Every year thousands of doctors try to check their patient’s prescription history information but California’s current database is difficult to access,” Brown said in a statement yesterday. ?If California puts this information online, with real-time access, it will give authorized doctors and pharmacies the technology they need to fight prescription drug abuse which is burdening our healthcare system.?

The existing database has millions of entries for commonly abused drugs such as Vicodin, and receives 60,000 queries a year, the statement said. But responses come by phone or fax, and can take days. Pack, who worked with Kaiser Permanente on a feasibility study, told the Los Angeles Times that the online database could be up and running in 10 months, and offer instant results.

The director of the Privacy Rights Clearinghouse in San Diego said there is a good reason for a system such as this one, but said it could also lead to abuses if people gain access to the data without authorization. She also said patients should be able to review their own drug histories to ensure accuracy.

Goldman Sachs’ pharmaceuticals analyst Jim Kelly pulled back on Pfizer shares today, lowering his rating of the company to neutral from buy.

Kelly always struck us a glass-half-full kind of guy, so it’s not exactly salutary for Pfizer that he’s downgraded the company.

Right now, Kelly wrote in a report, Pfizer’s principal problem is the deterioration of launches of three relatively new drugs: Chantix for smokers, Lyrica for pain and epilepsy, and Sutent for cancer. Safety worries have emerged for Sutent and Chantix, and lately FDA has started looking at suicide risks from epilepsy meds, including Lyrica. The company’s pipeline isn’t likely to contribute significant new products anytime soon, either.

Pfizer had been on Goldman’s “conviction buy list” since Jan. 4, 2007. How’s the stock done since then? Not well, as you probably knew. Pfizer’s down 28.7% compared with a 2.9% decline in the S&P 500 and a 20.4% drop in the value of other companies covered by Kelly’s team.

All is not lost for Pfizer, but it may take a while before things turn up. “We continue to find Pfizer?s valuation attractive, but do not find the near catalysts to drive valuation,” Kelly wrote. That’s where the company’s fat dividend has proved helpful, but even that may come under pressure, as the WSJ reported this week.

Pfizer shares have been trading at lows they haven’t seen since 1997. And the stock keeps on truckin’ downward. In early trading this morning, Pfizer was off 20 cents to $18.60.

Bonus Bets: Kelly replaced Pfizer on the buy list with Eli Lilly, citing the company’s pipeline. He also upgraded Schering-Plough to buy from neutral. Within Big Pharma, Kelly’s picks in descending order are now: Lilly, Schering-Plough, Pfizer, Wyeth, Merck and Bristol-Myers Squibb.

Photo by desi.italy via Flickr