The second time’s a charm for Vivus’s experimental obesity drug Qnexa, at least when it comes to FDA advisory panel votes.

As the WSJ reports, one of the agency’s advisory panels today backed approval of the drug by a decisive 20-2 vote. The FDA — which often but not always follows the advice of its outside panels — is due to make its decision by April 17.

If the drug is approved, it would be the first new prescription weight-loss drug in over a decade. Qnexa combines low doses of two existing drugs: phentermine, which cuts appetite, and topiramate, now used to combat seizures and migraines.

Back in July 2010, FDA advisors voted against approving Qnexa by a margin of 10-6. The FDA itself nixed the drug later in the year, requesting more safety information.

Vivus submitted additional clinical data to the FDA in an attempt to allay its concerns. It’s not clear whether that will be enough to satisfy the agency, though. In briefing documents released ahead of today’s meeting, the FDA raised concerns about possible effects on the heart and about birth defects.

But it also noted that Qnexa produced “significant” weight loss in the first year of treatment, with some regain in the second year.

Qnexa wasn’t the only obesity drug to stumble with the FDA in recent years. The agency said in October 2010 that Arena’s lorcaserin couldn’t be approved without additional data. And in February 2011 the FDA said that it wouldn’t consider approving Orexigen’s Contrave without another clinical trial. (Contrave, unlike lorcaserin, had actually gotten a thumbs-up vote in its first go-round with the advisory panel.)

The Health Blog wondered in September whether some of the rejected drugs might eventually rise from the ashes.

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The Department of Health and Human Services unveiled Wednesday the first draft of a national action plan against Alzheimer’s disease, which aims to come up with effective treatment and prevention strategies by 2025.

The plan, much anticipated by many in the Alzheimer’s community, also targets goals of improving care, expanding support for caregivers and heightening public awareness, in addition to tracking the government’s progress in tackling Alzheimer’s.

To reach these objectives, proposed strategies include coming up with better ways to research the disease, train health-care professionals and coordinate collaboration between private and public stakeholders.

However the devil is in the details — and how they play out, some experts say.

“For me, it’s about implementation,” Eric Hall, a plan advisory council member and chief executive of the Alzheimer’s Foundation of America, an advocacy group, tells the Health Blog.

One major obstacle is funding. Earlier this month, the administration announced $80 million in new funding for Alzheimer’s research in fiscal year 2013, but how much additional money is needed to carry out the plan remains to be seen.

“This is a great jump start, but clearly to get to that huge goal of prevention, treatment, delaying the onset [of disease] … it’s going to take a large investment,” Ronald Petersen, another committee member and head of the Mayo Alzheimer’s Disease Research Center, tells us.

Apart from funding, there are still ways to make progress, such as increasing public-private partnerships and by improving coordination between health agencies to minimize redundancy, according to Zaven Khachaturian, head of a non-profit called PAD2020 – The Campaign to Prevent Alzheimer’s Disease by 2020 and another committee member.

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Fructose has been accused of all sorts of health-related sins, from high blood pressure to diabetes to obesity.

“Classical biochemistry teaching” that shows fructose is metabolized differently than glucose as well as rodent studies showing that a high-fructose diet can spur obesity and other cardiac and metabolic problems have led some to hypothesize that the same thing holds true for humans, says John Sievenpiper, a research fellow at St. Michael’s Hospital in Toronto.

But Sievenpiper and other researchers wanted to investigate whether boosting fructose consumption actually leads to weight gain in humans, as opposed to rats or hamsters. So they reviewed and analyzed the results of 41 previously published feeding trials, where subjects’ intake is very strictly controlled in a laboratory setting. In most of the trials, calories were held steady while pure fructose was substituted for another form of carbohydrate. (It was sprinkled into drinks or processed into foods.)

An analysis of those results showed no effect on body weight, according to the review, published earlier this week in the Annals of Internal Medicine.

When researchers crunched the data behind the 10 trials that added fructose on top of the usual diet to provide additional calories, there was weight gain. It looks like that was due to the extra calories alone, says Sievenpiper.

He says there are limitations to the underlying studies. They didn’t directly simulate real-world consumption: Fructose consumption in the controlled trials was between 1.5 and six times higher than the U.S. average, says Sievenpiper. And the studies were small and fairly short, he says. “We need larger, longer and higher-quality studies,” he says.

That said, “this still represents the best estimate of the impact of fructose on body weight with the best study design that we have,” he says.

The review was primarily funded by the Canadian Institutes of Health Research, with an additional grant from the Calorie Control Council, which represents the low-cal food and beverage industry. Some investigators on the study, including Sievenpiper, have unrestricted grants from Coca-Cola for other research, but that company had no role in this study, he says.

Sievenpiper was an author of a similar review — published online last week by Hypertension –  of previously published feeding studies looking at fructose and high blood pressure. It found “no evidence” to support that swapping in fructose for other carbs increases blood pressure, he says.

Again, longer and larger studies need to be done on this point, he says. And researchers need to figure out what effects the fructose that naturally occurs in fruit may have on the body. (Criticism usually focuses on the added fructose that goes into processed foods.)

Earlier this month, researchers from UCSF cited links to hypertension and diabetes when they argued in a Nature commentary that fructose-containing sweeteners added to processed foods deserve special scrutiny and even regulation.

Last month, as the WSJ reported, a study suggested that the mix of carbs, protein and fat doesn’t influence body fat gain — it’s the calories that matter.

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Another Cancer Surgery For Chavez: Venezuelan President Hugo Chavez will have a lesion surgically removed from his pelvis within the next few days, the WSJ reports. Chavez, who has already undergone two other surgeries for cancer, claimed the disease hadn’t spread and there was no reason for alarm, but doctors not involved with his case speculated his situation is more serious than he acknowledges. The type of cancer that Chavez has isn’t publicly known.

Heart Attack Differences: A study of about 1.1 million patients published in the Journal of the American Medical Association finds that younger women are less likely to report chest pain or discomfort after a heart attack, Reuters reports. A study author says the results are preliminary but raise the question of whether public-health messages about symptoms need to be tailored by age and gender. The study also found younger women without chest pain were more likely to die in the hospital after a heart attack than younger men.

No Day in Court for J&J: The U.S. Supreme Court won’t hear a patent-infringement suit brought by a unit of Johnson & Johnson against Abbott over a rheumatoid-arthritis therapy, the WSJ reports. The court let stand a lower court’s ruling overturning an earlier jury award of $1.67 billion in damages to J&J.

Raw (Milk) Data: A study from the Centers for Disease Control finds that unpasteurized, or raw, milk is far more likely to cause outbreaks of food-borne illness than pasteurized milk, USA Today reports. States where raw milk sales are legal also experience more outbreaks than states where sales are banned, the paper says. Advocates of raw milk consumption say the study didn’t distinguish outbreaks stemming from raw milk from those caused by possibly illegally-made soft cheeses.

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Alex Gorsky in 2010.

Johnson & Johnson named Alex Gorsky as its next CEO, succeeding William Weldon, the WSJ reports.

Both Gorsky and Sherilyn McCoy were in late 2010 appointed to an expanded “office of the chairman” and given new duties as part of an apparent succession race to lead the pharma company.

At that time, Gorsky added oversight of the global supply chain, government affairs and policy and J&J’s venture-capital arm to his existing duties heading up the company’s medical devices and diagnostics unit.

As the WSJ reported then, Gorsky and McCoy each took on a portion of the responsibility for dealing with the quality-control problems that led to a spate of recalls.

This is Gorsky’s second stint at J&J. He began his career at the company in 1988 as a sales rep with Janssen Pharmaceutica, according to his company bio, and eventually became company group chairman of J&J’s pharma business in Europe, the Middle East and Africa.

In 2004 he joined the Swiss pharma giant Novartis as head of the company’s North American pharma business.

And in 2008, Gorsky returned to J&J to become company group chairman of Ethicon, a medical device unit that makes surgical equipment and sutures. In 2009 he became worldwide chairman of medical devices and diagnostics.

Gorsky will take over from Weldon at J&J’s annual meeting on April 26.  Dow Jones Newswires reporter Peter Loftus points out to us, citing an SEC filing, that Gorsky will get a raise along with his promotion, to a base salary of $1.2 million.

The WSJ reports, citing a person familiar with the matter, that the company wants to retain McCoy.

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New supplies of two currently hard-to-find cancer drugs are on the way, according to the FDA.

As Dow Jones Newswires reports, the FDA said it would allow the temporary importation of Lipodox, made by Sun Pharma Global FZE and distributed by Caraco Pharmaceutical Laboratories, as a substitute for Johnson & Johnson’s Doxil. The drugs have the same active ingredient.

Doxil has been in short supply since about mid-2011. New supplies of Lipodox are “expected to end the shortage and fully meet patient needs in the coming weeks,” the FDA says.

The FDA also said it had approved a new manufacturer — APP Pharmaceuticals — of preservative-free methotrexate, a drug that is used to treat a type of children’s leukemia and has also been in short supply. The drug should be available in March, the agency says.

Hospira has also “expedited release of additional supplies” of preservative-free methotrexate — 31,000 vials worth, enough to cover a month’s worth of demand, the FDA says. The agency “is actively working with other manufacturers … including Mylan and Sandoz Pharmaceuticals” to meet patient needs, it says.

DJN notes that both shortages can be traced back to the closing of a Ben Venue Laboratories plant in Ohio. Ben Venue, a unit of Boehringer Ingelheim, shut down the plant to deal with manufacturing issues.

Bonus: GAO Report Blames Drug Shortages on Manufacturing Problems

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