QNEXA: Money & Politics v.s. Science & Common Sense

In July of 2010, Qnexa, the first new prescription weight-loss pill in more than a decade, failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds.

The FDA vote was 10 : 6 against Qnexa.

The Feds said no to Qnexa because of the following side effects:

  • Depression,
  • Anxiety,
  • Increased heart rate combined with lowered blood pressure,
  • Increased body acids,
  • Impaired attention span,
  • Psychomotor slowing resulting  in difficulty finding the correct words
  • Impaired memory, and
  • BIRTH DEFECTS.

Not too surprisingly, the FDA asked Vivus (the maker of Qnexa) to go back to the lab and come back with a safer product.

Since that time:

  1. The drug has not been modified
  2. The FDA has been under a ton of pressure from politicians & lobby groups to “re-think” their position on Qnexa.

Fortunately for the American public, the FDA is a little gun shy about approving obesity medications known to have heart damaging side effects ever since the whole Fen-Phen death debacle of the 1990s.

Unfortunately for the American public, it looks like the possibility of a new multi-billion dollar fat drug combined with affordable political influence is beating the hell out of common sense and scientific integrity.

On Feb.22 of this year, a new FDA advisory panel voted 20-2 in favor of the approval of Qnexa. The exact same drug that was turned down a year and a half earlier.

How come?

As a condition for approval of Qnexa, the FDA and the drugmaker Vivus proposed:

  • A restrictive program to stop pregnant women from taking the drug,
  • A Qnexa training program for doctors,
  • Limited distribution to certified mail-order pharmacies.

Also, the drug will likely only be recommended for obese patients who have a body mass index over 30, or are overweight but have weight-related health issues.

And if that isn’t enough for those hard-asses at the FDA, Vivus has offered to start a new four-year trial of the affect of Qnexa on cardiac health….sometime after the FDA votes to grant formal approval of Qnexa.

REPEAT: After FDA approval has been given

They’ve offered to test how their drug affects your heart after you’ve already started your prescription.

WTF!!!

And if this wasn’t stupid enough

Because Qnexa is a combination of two already approved drugs (the stimulant phentermine and the epilepsy drug topiramate), it is possible for doctors to sidestep the whole Qnexa/FDA issue by writing scripts for both drugs and marketing themselves as weight loss gurus.

The only thing holding them back would be that pesky Hippocratic oath.

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NOTE – The FDA is supposed to vote on the approval of Qnexa on April 17, 2012….stay tuned

 

Reference

ADIPOTIDE : Snake Oil or Miracle Weight Loss Pill?

The anti-obesity industry is all abuzz about a bright & shiny new weight loss drug called Adipotide.

In a recent study, obese rhesus monkeys….

  • lost 11% of their total body weight, and
  • 27% of their belly fat mass

….in just four weeks of Adipotide treatment.

And while that’s pretty impressive, what really gets me excited about Adipotide  is how it works.

Where other miracle “fat pills” have tried to reduce obesity by:

  1. controlling appetite
  2. increasing metabolism
  3. or preventing absorption of dietary fat

Adipotide works by:

  1. cutting off the blood supply to fat cells by means of a “homing agent that binds to a protein on the surface of fat-supporting blood vessels
  2. and a synthetic peptide that triggers cell death

The result of this is that when the supporting blood vessels have died and withered away, the offending fat cells are starved, reabsorbed and metabolized.

And the fat monkeys become fit monkeys

And it’s not just fat loss.

In this latest study, the obese monkeys saw a drastic improvement in insulin sensitivity and metabolic syndrome symptoms.

What about side effects?

Monkeys in the studies remained bright and alert throughout, interacting with caretakers and demonstrating no signs of nausea or food avoidance. This is potentially an important finding since unpleasant side-effects have limited the use of approved drugs that reduce fat absorption in the intestines.

The principal side effects were noted in the kidneys. “The renal effect was dose-dependent, predictable and reversible,” Barnhart noted.

What about human studies?

It turns out that Adipotide is not the first drug developed using this research.

The researcher’s original work focused on cutting off the blood supply of prostate cancer cells. During this cancer research they found that “blood vessels are more than a uniform and ubiquitous “pipeline” that serves the circulatory system, but differ depending on the organ or tissue that they support” .

This allowed them to design a method of screening peptides – small bits of proteins – and to identify those that bind to specific vascular cells among the many possible “ZIP codes” present in a human vascular map.

For blood vessels that support fat cells, the target protein is prohibitin, which they found in unusual abundance on the blood vessel cell surface.

Based on this discovery, the researchers are preparing for a clinical trial in which obese prostate cancer patients would receive daily injections of Adipotide for 28 consecutive days.

The goal of the study is to see if their prostate cancer becomes better as their body weight and associated health risks are improved.

Future studies focused solely on weight loss are in the planning stage.

So what does this mean to you?

For now…not a whole heck of a lot.

If Adipotide does turn out to be a miracle weight loss pill, it’s going to be a long time before you’ll be able to get a prescription.

But….it is the first sign of ingenuity I have seen coming from weight loss researchers in a long time.

Kinda funny that they’re actually cancer researchers.

Reference

Bye Bye Healthy Lifestyle : Hello Qnexa

Woooo-hoooo!!!!

No more exercise, no more vegetables, no more fish, no more paleo, no more carb/insulin control, no more protein shakes, no more mindfulness, no more healthy anything…

Qnexa is here and as soon as I get my prescription filled, I am gonna lay a beating on the nearest “all you can eat” restaurant I can find.

Because today is the day that the FDA released their review of  Vivus‘ new anti-obesity drug – Qnexa.

And in that 248 page review, the FDA notes that drug trial participants taking Qnexa lost significantly more weight than those taking a placebo, and that those taking the highest doses of Qnexa lost the most weight.

They also noted that there are concerns about Qnexa side effects – which include depression, anxiety, impact upon heart rate, increased body acids, impaired attention span, impaired memory, impaired attention span, language problems and various risks for pregnant women.

But, who cares about a few side effects?

  • I want my cake
  • I want to eat my cake
  • and I want a six pack

Who cares that Qnexa is the offspring of that old-school diet drug “fen-phen“.

Who cares that by replacing the appetite suppressant phentermine with the anti-seizure drug topiramate, Vivus is praying for a weight loss pill with the effectiveness of fen-phen but without all those pesky fen-phen side effects – pulmonary hypertension, heart valve problems and death.

  • Who cares that fen-phen passed all of the same FDA tests and trials that Qnexa is now passing with flying colors.
  • Who cares that analysts estimate that Qnexa could rake in nearly $689 million in sales by 2014.
  • Who cares that Vivus stock has already risen 20% on the news of this FDA report.

.I want my six pack and I want it now.

.Qnexa…here I come.

.Update:

As of Friday, July 16, Qnexa, the first new prescription weight-loss pill in more than a decade, failed to win backing from U.S. health advisers, who said safety concerns about the drug outweighed its ability to help obese patients shed pounds.

The FDA vote was 10 : 6 against Qnexa.

So, what happens now?

Vivus should have the results of a 2 year Qnexa study by the end of this quarter. If those results are positive, Vivus will take another run at the FDA.

However, things get a bit more complicated for Vivus.

To win FDA approval, Vivus will now have to test Qnexa in as many as 10,000 human patients, at a potential cost of $150 million. And to raise that kind of money, Vivus will probably have to partner up with one of the Big Pharma corps..

Obesity Drugs v.s Health Habits

Earlier this morning, Arena Pharmaceuticals announced that the Phase 3 trial results for their new obesity drug Lorcaserin met all efficacy and safety endpoints.

And yet, in just 2 1/2  hours of trading, their share price had dropped by over 32%.

But….they met all their efficacy and safety endpoints.

Why would the market punish a company for meeting all of their efficacy and safety endpoints?

I just don’t get it.

Based on Arena’s data, the average Lorcaserin patient:

  • started out at 219 lbs,
  • lost 12.7 lbs, and
  • ended up at 201.3 lbs.

In contrast, the placebo patient:

  • started out at 213.6 lb,
  • lost 4.7 lbs, and
  • ended up at 208.9 lbs

That means that over the course of 12 months, the Lorcaserin patient lost 8 more pounds than the patient taking the placebo.

8 lbs.

8 lbs over 12 months?

That’s it?

One of my new personal training clients is down 14 pounds in just under 7 weeks.

Another has lost just under 30 pounds since the new year.

Another has lost over 200 pounds over the past few years.

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So, why would anyone want to take Lorcaserin?

For the side effects?

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To be fair, Health Habits isn’t without side effects:

  • Lowered blood pressure
  • Lowered resting heart rate
  • Lowered appetite for sweets
  • Increased strength, endurance, flexibility, confidence, and
  • Inappropriate comments in the workplace

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Herb Crusted Beef Filet

Herb Crusted Beef Filet

In my last post I told you that Pork has some great lean cuts but did you know that Beef also has a lot of lean protein? Now 29 cuts of beef meet government guidelines for being “lean”. So how does it stack up against skinless chicken breast in terms of fat content? When comparing 3-oz cooked servings, all 29 cuts of beef have on average, only 1.2 grams more saturated fat than a skinless chicken breast. Beef is also a great source of vitamin B12, B6,  zinc and iron.

So with that said, here’s a simple and delicious recipe using the lean & mean Filet Mignon.

RECIPE:

5 lb beef filet – trimmed if needed
1 tbsp olive oil
1 tsp salt
1/2 tsp cracked black pepper

CRUST RECIPE:

2 tbsp dijon mustard
2 tbsp fresh thyme – chopped
2 tbsp fresh rosemary – chopped
1/2 tbsp cracked black pepper

DIRECTIONS:

Preheat grill pan (you can use a saute pan as well) on high heat for 2-3 mins. While that’s getting hot, season beef filet with S&P. Drizzle olive oil into your hot pan and sear filet for 2-3 minutes on each side. You’re aiming for a nice golden brown color. Set aside on sheet pan to cool. Next, grab a small mixing bowl and mix together the thyme, rosemary and cracked black pepper and sprinkle onto a cutting board in an even layer. Once beef has cooled smear Dijon mustard on all sides and then roll the beef in the chopped herbs, making sure all sides are coated.
TIP: This can be done up to 12 hours ahead. Just cover and refrigerate until needed.
Herb Crusted Beef Filet

Pre-heat oven to 400F.
When ready to serve pop beef in the oven for 25 mins approx or until internal temp. 120 C. This will be medium rare. Let beef rest for additional 10 minutes which will ensure all the juices are re-distributed within the meat. As you can see in my photo at the top I roasted the filet on top of some baby carrots and shallots. I also made some pureed turnip. I grew up eating turnip in Ireland but people are not into it too much over here. I figured I’d introduce it to some of you.
I used a yellow turnip, also known as a Rutabaga, which is what I’m used to. However, over here the main turnip du jour is white. Both types can be cooked the same way and both types are excellent sources of vitamin C.

TURNIP RECIPE:

1 1/2 lb. turnip (yellow or white) – peeled & rough chopped
1/4 cup broth (chicken / veg)
1 tbsp. olive oil
S&P to taste

DIRECTIONS:
Place prepped turnip in pot of salted water and bring to a boil on high heat, covered. Once boiling reduce heat to medium and continue cooking for 20 mins. approx or until turnip is fork tender and mashable (a word, not sure but you catch my drift). When ready drain in a colander in the sink and return to same pot. Add broth, olive oil and season with S&P to taste. As simple as that. Turnip for me has a very rustic earthy flavor which I love and I think it goes great with steak.
Do yourself a favor this weekend and try this for some friends. I guarantee you’ll come up trumps.

Herb Crusted Beef Filet-Finished

To see more of my recipes and learn about me and my healthy food philosophies head over to www.thehealthyirishman.com.

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Diet Pills Suck

diet-pill-horizontal

Fenfluramine, the appetite suppressant drug banned in the US in 1997 due to fears over its links to heart conditions, has been shown to have serious long-term effects.

In a report published today in the journal BMC Medicine, researchers have shown that people who stopped using fenfluramine eleven years ago had damaged heart valves up to seven years later.

In this study, Charles Dahl from the Central Utah Clinic led a team of researchers who studied the heart condition of 5743 former fenfluramine users. He said, “Valve problems were common in individuals exposed to fenfluramines, more frequent in females and associated with duration of drug use in all valves assessed”.

Heart valves, such as the aortic, mitral and tricuspid valves, ensure that your blood flows in the correct direction around the heart.

When they fail, blood back-flows (termed regurgitation).

If the regurgitation is severe enough, congestive heart failure and/or the need for heart valve surgery may occur.

Dahl said, “We found clear evidence for a strong, graded association between duration of exposure to fenfluramines and prevalence of aortic regurgitation and for mild or greater mitral and tricuspid regurgitation”.

Let’s get this straight.

We take a drug that causes this…

Aortic Regurgitation

aortic-regurgitation

So that we can eat like this…

fatkidatmcds

And look like this…

jessica-alba-david-beckham

What???

Sorry to break the news to y’all, but…

bigfatburger

+

poppin-pills

=

homerheartattack

Thus endeth the rant.

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Reference

EurekAlert

Why are Omega 3s Better than Statins?

Picture this:

  • You have just left the hospital.
  • You have just left the hospital where a loved one lies in a hospital bed after suffering his third heart attack. The first two were minor, but this one, this one almost took him away from you.
  • But, you have left the hospital knowing that he is safe for the moment.

The doctors were able to stabilize him, and now they have started him on a drug therapy that they swear is the best treatment for chronic heart failure. Medical science at it’s very best.

You leave the hospital knowing that the statin drugs coursing through his system give him the very best chance of survival. Right?

Not according to these two nested studies, presented at the 2008 European Society of Cardiology Congress and published in the Lancet.

According to these studies, “Omega-3 fatty-acid supplementation improves morbidity and mortality in symptomatic heart-failure patients, while statins failed to have any beneficial effect in the same group of patients.”

  • Statins failed to have any beneficial effect on the heart-failure patients, while…

So What Are Omega-3 Fatty Acids?

Omega-3 Fatty Acids are a group of fats found in cold water oily fish (sardines, salmon, herring), flax seed, krill, some algae and most recently being added in supplement form to numerous consumer products such as eggs, orange juice and bread.

What Can Omega-3s Do For Me?

When we discuss Omega-3s, we are usually discussing two specific Omega-3s:

  • EPA or eicosapentaenoic acid, and
  • DHA or docosahexaenoic acid

On September 8, 2004, the FDA gave “qualified health claim” status to EPA and DHA, stating that “supportive but not conclusive research shows that consumption of EPA and DHA fatty acids may reduce the risk of coronary heart disease“.

So, according to the FDA, Omega-3s may help you avoid a heart attack.

Let’s see what some others have to say about Omega-3s:

Are Omega-3s Better than Statins?

I am not sure that we should be looking at this question as an either / or proposition, but the results of this latest study show that:

  • After 3.9 years of follow-up, treatment with the omega-3 fatty acids reduced the risk of mortality by 9% and mortality and admission to the hospital for cardiovascular causes by 8%
  • After 3.9 years, the patients being treated with statins (rosuvastatin 10 mg) saw no reduction in the risk of morbidity or admission to hospital. On the good side, there was a 27% decrease in LDL cholesterol after 3 years. This decrease, however, didn’t keep people out of the hospital.

At the end of the day, the Omega-3s did a better job than the statins. Period.

So what does medical science have to say about these test results?

The Chair of the study, Dr. Luigi Tavazzi said ‘the advantage of Omega-3s is that they appear to have a beneficial effect on the mechanisms leading to the progression of heart failure.

Translation: They keep you from suffering heart failure.

Although the exact reasons are unknown, omega-3 fatty acids could possibly exert favorable effects on inflammatory processes, such as reductions in endothelial activation and cytokine production, as well as influence platelet aggregation, blood pressure, heart rate, ventricular function, and autonomic tone.

Translation: They are anti-inflammatory.

Another researcher, Dr. Gregg Fonarow said that while “questions remain about the mechanism of action, optimum dosing, and formulation, supplementation with Omega-3 fatty acids should join the short list of evidence-based life-prolonging therapies for heart failure.

In regards to the performance of the statin drug rosuvastatin, researcher Dr. Poole-Wilson said that “this study is likely to generate disappointment among clinicians, as the results of the study, in light of observational and meta-analyses data, were expected to be positive.

When the trial was designed, some even expressed concern that it was unethical to randomize heart-failure patients to placebo because they were so confident of the benefit of statin therapy in this patient population.

The results, he said, ultimately should humble researchers, especially as they serve as reminder that medical decisions should be guided “science, and not strongly held opinion.”

In terms of why the study failed to show a beneficial effect on clinical outcomes, the researchers note that treatment with rosuvastatin reduced LDL cholesterol as well as high-sensitivity C-reactive protein (CRP) levels.

“These effects might no longer affect the progression of coronary artery disease in patients with ischemic heart failure, perhaps because their effect is attenuated by a biological milieu not favoring the progression of coronary artery disease”.

Translating this into something resembling English, Dr. Fonarow said “that once heart failure is established, statins may not allow patients to escape the underlying heart-disease process”.

Conclusion

According to this pair of studies, Omega-3 Fatty Acids are better than Statins at keeping your heart beating.

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A New and Improved Diet Pill?

The geeks in the lab coats think that they have discovered the Holy Grail of pharmaceuticals:

A Diet Pill that actually works.

Well, sort of.

In a new study, published in the August 31 online edition of Nature Medicine, scientists from the Salk Institute of Biological Studies claim to have identified a genetic master switch for obesity.

This switch, known as TORC1, is designed to turn on a variety of genes in the body.

One of those genes (CARTCocaine and Amphetamine Regulated Transcript) is designed to shut down our appetite for food.

The researchers believe that subtle mutations in TORC1 may result in an inherited risk factor for obesity.

They also believe that “tweaking mutated and inefficient TORC genes may be possible through drug therapy”. “TORC1 is regulated by phosphate handling enzymes called kinases, and kinases often make for very good drug targets”.

So What Does This Mean?

  • A defective TORC1 gene seems to have a role in determining human obesity.
  • Researchers have no idea how prevalent defective TORC1 genes are in the human population.
  • A lot of research needs to be done to determine the prevalence of TORC1 mutation in the human population.
  • If it is determined that TORC1 plays a significant role in human obesity, research into a cure will begin.
  • Initial research will be performed on mice.
  • IF, IF, IF…

In the Meantime…

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References

Salk Institute. “New Master Switch Found In Brain Regulates Appetite And Reproduction.” ScienceDaily 2 September 2008. 2 September 2008 <http://www.sciencedaily.com­ /releases/2008/08/080831151343.htm>.

Health and Fitness in a Bottle: Big Pharma Discovers their Holy Grail

I'm strong to the finish, cuz I eats me spinach....
I'm strong to the finish, cuz I eats me spinach....

Scientists from the Salk Institute’s Gene Expression Laboratory may have discovered Big Pharma‘s Holy Grail of Pharmaceuticals.

A pill that would allow you to reap all of the benefits of vigorous exercise while sitting on the couch watching re-runs of Seinfeld.

How about that!

Scientists from the Salk Institute’s Gene Expression Laboratory have reported (in the July 31 advance edition of the journal Cell) that they have discovered two drugs (GW1516 and AICAR) that were able to transform regular ole’ lab mice into freaky running machines.

AICAR increased the mice’s endurance on a treadmill by 44 percent after just four weeks of treatment.

GW1516 produced a 77%  increase in endurance, but sadly, had to be combined with exercise to have any effect.

The Study

Lead researcher, Ronald M. Evans, Ph.D, had previously discovered that by permanently activating a genetic switch known as PPAR delta, he could turn lab mice into miniature Olympic marathon champs.

In addition to their improvements in aerobic endurance, these super mice didn’t gain weight while being fed a diet high in pizza and beer. In addition to their ripped physiques, they experienced improved insulin sensitivity and lowered levels of blood sugar.

This led Dr. Evans to hypothesize whether a drug specific for PPAR delta would have the same beneficial effects.

So, they doped the mice with GW1516.
After four weeks, the researchers were in for a bit of a disappointment.
I've got the Eye of the Tiger...
I've got the Eye of the Tiger...

The mice were leaner, had an improved fatty acid profile, improved insulin sensitivity and lowered levels of blood sugar, but there was no effect on their exercise performance.

So, like a personal trainer, they upped the mice’s cardio and had them run up to 50 minutes on a treadmill.

And after a few more weeks, the GW1516 mice were lapping the non-doped mice.

In fact, the GW1516 mice improved their exercise endurance 77% higher than the control mice. They also saw a 38% increase in slow twitch muscle fibers.

But wait, the researchers weren’t finished yet. GW1516 looks pretty great, but they were looking for a drug that would provide the benefits of exercise without actually having to do the exercise.

Enter AICAR.

The researchers fed untrained mice AICAR, (a synthetic AMP analog that directly activates AMPK).

After four weeks, the AICAR mice were pushed onto the treadmill and boy did they perform. On average, they ran 44% longer than the control mice. According to the researchers, “That’s as much improvement as we get with regular exercise.”

So there we go, exercise in a pill.

So, How Does it Work?

Well, according to Dr. Evans,  “GW1516 activates the PPAR-delta protein, but the mice must also exercise to show increased endurance. It seems that PPAR-delta switches on one set of genes, and exercise another, and both are needed for endurance”.

AICAR however, “activates the PPAR-delta protein and mimics the effects of exercise, thus switching on both sets of genes needed for the endurance signal”. It “signals the cell that it has burned off energy and needs to generate more. It is pretty much pharmacological exercise”.

Conclusion

Theirs: “This is not just a free lunch,” Dr. Evans said. “It’s pushing your genome toward a more enhanced genetic tone that impacts metabolism and muscle function. So instead of inheriting a great set-point you are using a drug to move your own genetics to a more activated metabolic state.”

“The drugs’ effect on muscle opens a window to a world of medical problems,” he said. “This paper will alert the medical community that muscle can be a therapeutic target.”

Mine: I wonder if we are not straying a leeetle bit too far down the Eugenics path with this research.

Forgetting the potential moral argument of switching our genes on and off, my concern is purely medical. While it will take years and years of animal and human testing before a commercially viable GW1516 or AICAR is available on the market, I still think that I would prefer to improve my body the old fashioned way.

Thanks to EurekAlert! for the original source material.

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