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Sort of like the results of a fad diet

Stock value of Orexigen rises and falls based on news of weight-loss drug

Stock of San Diego biotech Orexigen Therapeutics, which produces a weight-loss product, Contrave, has had a full ride in a short time. The Food and Drug Administration (FDA) is irate over the company's release of information from a testing procedure for possible cardiac side effects of Contrave.

A Food and Drug Administration official has told Forbes magazine that the information released by Orexigen was probably "unreliable," "misleading," and "likely false." The company could face fines, civil penalties, and even the withdrawal of Contrave from the market.

On Monday, March 2, Orexigen stock closed at $5.79. On Tuesday, the company, in patent and Securities and Exchange Commission filings, stated that Contrave actually reduced the risk of heart attacks and cardiovascular problems. The stock zoomed, and by Wednesday, March 4, was up to $8.49. After the tongue-lashing by the FDA official, the stock dropped 5.65 percent today, and then another 17.48 percent in after-hours trading, down to $6.61. Now, investors are nervous over Orexigen's breaking of protocol requiring that interim analysis data must remain confidential, even within a company.

The case may be reminiscent of a 2009 misadventure by another local biotech, Sequenom. The company hyped its prenatal test for Down syndrome. But investigations revealed the company's testing procedures were flawed. The chief executive was fired, as was Elizabeth Dragon, senior vice president of research and development, and several other top executives. Dragon was charged by the Securities and Exchange Commission with lying to the public about the Down syndrome tests's accuracy. She died in 2011. The company settled a $14 million shareholder suit.

Note: In mid-February, Don Bauder entered the intensive-care ward of a hospital with a severe case of flu and pneumonia. After four days there, he spent five days in other hospital rooms. He wishes to thank all those who sent him messages. He may be convalescing for another month. He will resume submitting items regularly when he has fully recovered.

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Stock of San Diego biotech Orexigen Therapeutics, which produces a weight-loss product, Contrave, has had a full ride in a short time. The Food and Drug Administration (FDA) is irate over the company's release of information from a testing procedure for possible cardiac side effects of Contrave.

A Food and Drug Administration official has told Forbes magazine that the information released by Orexigen was probably "unreliable," "misleading," and "likely false." The company could face fines, civil penalties, and even the withdrawal of Contrave from the market.

On Monday, March 2, Orexigen stock closed at $5.79. On Tuesday, the company, in patent and Securities and Exchange Commission filings, stated that Contrave actually reduced the risk of heart attacks and cardiovascular problems. The stock zoomed, and by Wednesday, March 4, was up to $8.49. After the tongue-lashing by the FDA official, the stock dropped 5.65 percent today, and then another 17.48 percent in after-hours trading, down to $6.61. Now, investors are nervous over Orexigen's breaking of protocol requiring that interim analysis data must remain confidential, even within a company.

The case may be reminiscent of a 2009 misadventure by another local biotech, Sequenom. The company hyped its prenatal test for Down syndrome. But investigations revealed the company's testing procedures were flawed. The chief executive was fired, as was Elizabeth Dragon, senior vice president of research and development, and several other top executives. Dragon was charged by the Securities and Exchange Commission with lying to the public about the Down syndrome tests's accuracy. She died in 2011. The company settled a $14 million shareholder suit.

Note: In mid-February, Don Bauder entered the intensive-care ward of a hospital with a severe case of flu and pneumonia. After four days there, he spent five days in other hospital rooms. He wishes to thank all those who sent him messages. He may be convalescing for another month. He will resume submitting items regularly when he has fully recovered.

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Comments
17

Good to see a column! Good to know Don Bauder's out of the hospital -- a place to leave asap, no matter the comely and solicitous nurses -- and recuperating. It's springtime, nearly, and that should help your full recovery. Thanks for letting readers know what you've been up to: we have missed you and many were worried by your absence from these pages. No need to reply, please, and no relapses!

March 5, 2015

I've been following biotech developments and the FDA for a few decades now. My advice is to believe nobody. Biotech firms want to make money- be cautious about their claims. The FDA exists to protect the very large companies that they 'supervise'- don't believe anything they say regarding them. Try to find independent studies of whatever interests you that aren't paid for by someone with a financial interest in that area. (It's not easy)

Best wishes, Don.

March 6, 2015

The only weight loss program that works in DIET and EXCERCIZE. While a few people have medical conditions which affect weight most fat people eat the wrong things, and eat too much and do not exercise enough or at all. The best low impact exercise is swimming and the next best is walking. Portion control is the most important aspect of eating. Learn to read labels and understand which ingredients are good and which are bad. Also understand that restaurants cook for taste not for health. Learn to cook and learn what to eat when you go out. All the stupid pills and other crap will not get the fat off only diet and exercise.

March 6, 2015

My theory (admittedly unscientific and based purely on my own gut feel) is this:

Losing weight is SIMPLE but HARD. Eat less food. Eat healthier food. Excercise more. Simple. But hard to do. Requires hard work and big changes in eating habits.

But many Diet / weight loss plans promote the opposite: making it sound like losing weight is COMPLICATED but EASY. The diet plan promoters promote complex relationships between nutrients, fats, carbs, time of day you eat, when you exercise, etc.

I think ultimately it boils down to eat less, eat healthier, excercise more. If a weight loss plan / center helps someone do these things then that's fine. But I think promoting that there is some magic pill or magic plan that works without any effort is highly misleading.

March 6, 2015

One slight disagreement. Not necessarily how much you eat, but what you eat. example, give up that rich sauce on your pasta once in a while and try a little good EVOO instead. Many, many more examples com to mind, but you get the idea.

March 6, 2015

Yes definitely WHAT you eat matters not just how much. I admit I'm oversimplifying things by just saying eat less and eat healthier. I just think a lot of the diet plan people do the opposite and overcomplicate things because complicated solutions sound impressive and seem like they should be expensive - even if they really don't have much value.

March 7, 2015

Let me simplify my comment a bit. If you want to lose weight, eat less calories, make the calories you do eat the right ones by eating the right foods, and get some exercise. Knock off 250 calories, eat right and get 30 minutes of exercise, even if it's just a 30 minute walk at a brisk pace, and you can lose a pound a week.

March 7, 2015

Get well soon Don!

March 6, 2015

Bet they still prescribe uppers for weight loss. That's not good for the heart but has gone on for a long time. Teach Psychology of self control, why people overeat compulsively, junk cravings, winter pound-packing in the DNA... Stop advertising to fat kids. Pisses me off they lie about any side effects, especially vital heart problems. Don - eat your spinach and other nutrient-dense foods. We need your strength.

March 6, 2015

Dr. Oz (show) pointed out research has determined that eating like a caveman "Paleo" is related to higher incidents of cancer. Too much meat/animal.

March 6, 2015

As usual, Dr Oz only relates part of the facts. Those on a "paleo" diet who put a higher emphasis on protein from meat may run a higher risk of cancer in individuals over the age of 50. It has also been found that eating a more balanced form of the diet, less meat heavy with a more even amount of vegetables have been associated with lower colorectal cancer rates. The Paleo diet seems to be healthful if less emphasis is placed on high levels of protein, especially coming from animal products, and more emphasis on non-processed vegetables, fruits, beans, and seeds. This seems be a reasonable conclusion to me since researchers of paleolithic peoples find diets composed of high levels of fresh fruits and vegetables in addition to meat-based protein. Other studies have also shown that a low glycemic index, low-glycemic load diet like the paleo may also decrease the risk of breast cancer:a couple of recent studies have shown that a high glycemic diet may increase the risk for developing breast cancer. The paleo diet is milk and dairy free. Drinking milk can elevate blood estrogen levels and increase the risk for breast and ovarian cancer in women and increase the risk for prostate and testicular cancer in men. I guess it depends on what you want to believe. Personally, I put Dr. Oz in the same boat as Dr Phil.

March 6, 2015

My belief is that eating huge amounts of red meat, as I have witnessed as a bad American habit, will not digest through the gut well. If you compare colonoscopy's you can see the difference between someone who gets enough fiber through vegetables and the rest or not, polyps or not. I relate part of facts but when the main focus of a meal is meat, much else is underutilized. Yes, (red) meats are a source of protein, CoQ10... and should be eaten with greens. Apples for Quercetin. Essential amino acids in meats, seafood, dairy and eggs. Food should be used as medicine and it's hard to do that every day all day if you're eating wrong, like the white stuff. Growing up in a family where everyone was obese but me, I am leaning toward vegan-ish. I mean even fruit juice is too sugary and needs a limit. I don't know if you had to drink a big glass of cow's milk with dinner when you were a kid but we did. Soy is breast-cancer-protective but I know somebody's gonna disagree. I hate to look at a big slab of meat on my plate and I wouldn't eat it either. And yes, cancer grows in a sugary environment.

March 6, 2015

As I said in my comment, a less meat heavy diet with a more vegetables and fruit. I eat meat. And fowl and fish and lots of vegetables, fresh whenever possible, and fruit, and a moderate amount of dairy. As a kid, I had milk with breakfast and also with lunch at school, but rarely drink it now. At 58 years old, my Dr says I am in a good as health as any 40 yr old he sees and better than most. As I said above, I believe it's not as much how much you eat, but what you eat. I suppose it doesn't hurt that I normally run 15-20 miles per week, cycle when the weather is good and hit the gym at least twice a week.

March 6, 2015

My mother always said "everything in moderation"

March 8, 2015

To change the subject slightly, nobody should take flu lightly. After this experience, I"m sure Don will never again do that. It is a very dangerous disease, even although for most of us, most of the time, it is more like an inconvenience. Let's wish Don a speedy recovery so that he can get back in the saddle and write his pieces on the stadium fiasco in the making, and the next sale of the U-T.

March 7, 2015

Then it is about immune system building Food, and lots of it!

March 7, 2015

Check out the many benefits of vitamin D. If you don't get 15 minutes of sun per day you probably need a supplement.

March 7, 2015

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