Posts Tagged ‘big pharma’

Obesity Drugs v.s Health Habits

March 30th, 2009

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.

.

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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Diet Pills Suck

November 6th, 2008

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

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Why are Omega 3s Better than Statins?

September 11th, 2008

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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Analysis of the Obesity Drug Markets in the US and EU: Obesity Research Update #5

July 28th, 2008

Q:

  • Which business sector saw it’s sales triple in 2007, and
  • Expects sales to increase at an even greater rate, and
  • Has a target market that is literally getting bigger day by day, and
  • Whose customers keeps buying their product even when they have be proven ineffective???

A:

  • The Obesity Drug Business

According to this research paper:

- An estimated 17% (85m people) of the EU population are obese and a further 32% (160 million people) are overweight. The average rate of obesity in the US is forecast to reach 40% by 2010.

- US sales of obesity drugs more than tripled in 2007 to reach $421m following the introduction of Alli, which accounted for 71% of total revenue. Strong support from GlaxoSmithKline will stimulate further expansion for Alli in both the US and EU.

- The majority of weight loss products currently marketed have proven to be ineffective, with only a small proportion of consumers having been able to achieve and maintain weight loss.

- The US and European obesity drug markets will expand at a combined CAGR of 23.3% between 2008-2012. This growth will be driven by the launch of several products currently in late stage development, and increase revenues to an estimated $3.1b by 2012.

- A large number of novel obesity medications are currently under development, many of which represent novel approaches to the treatment of obesity and new drug classes such as CB1 antagonists and serotonin receptor agonists.

Non-prescription drug availability has reinvigorated the US market for obesity treatments. (see Allis switch from Rx to OTC usage in 2007) GlaxoSmithKline is currently pursuing a similar switch in Europe with approval expected during 2009 at the latest.

But even in this golden age of obesity, not everything is turning up roses for Big Pharma.

Heightened regulatory scrutiny, particularly at the FDA, is causing approval delays and denials for all drug candidates. Sanofi-Aventiss new obesity drug, Acomplia, is widely available outside the US but was rejected by the FDA on safety concerns.

Damn those watchdogs.

So what if a few people grew a third arm out of the side of their necks.

We’ve got fat people to skinnify!

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