Posts Tagged ‘drugs’

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.

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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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Booming Global Obesity Drug Market

March 7th, 2009

obesity-market-sales

Booming Global Obesity Drug Market is the title of the new market research report published by RNCOS, a market research consulting services company specializing in BioPharma, IT, Telecom, Retail and Service industries.

According to the fine folks at RNCOS:

  • The prevalence of obesity is increasing globally at alarming rates
  • The Obesity drug market has shown a radical growth in recent times, but in contrast,
  • The market for Weight Loss drugs has failed to match this growth

Note: I am not sure what the difference between the Obesity Drug Market and the Weight Loss Drug Market is, but according to RNCOS, the Weight Loss drug manufacturers had better step up their game.

By 2012, it’s expected that more than two billion people will be overweight and 600 million will be obese, representing immense opportunities for both markets.

Unfortunately, the market for weight loss drugs is characterized by numerous failures.

A number of drugs have failed to get approval, some have been recalled, and those that have entered the market either suffer from serious side effects or have just failed to give the desired results consumers expected from them.

Maybe that’s why the weight loss drug manufacturers aren’t doing so well – Unapproved drugs, recalled drugs, drugs that don’t work and drugs with serious side effects.

Refusal of healthcare authorities to grant reimbursement to these drugs has also impeded the growth.

Why would governments or insurance companies reimburse drug companies for costs incurred developing weight loss drugs that don’t work or have serious side effects?

One of the most recent examples can be taken from Sanofi’s Acomplia; the drug was hailed as a multimillion blockbuster before it was launched. But Acomplia, like most of its predecessors, failed to have a sufficient benefit to risk ratio and was taken off the market just two and a half years after its launch.

The future of the obesity drugs market, however, may not be so gloomy.

This is because the market has high unmet demand and any drug that manages to provide a high benefit to risk ratio can easily achieve blockbuster status.

Note: What the hell is a high benefit to risk ratio???

Moreover, despite some of its recent failures, the obesity drug pipeline is rich and a large number of drugs are in phase 3 and late phase 2 trials. If some of these drugs manage to reach the market and possess a strong efficacy and safety profile, they can quickly become billion dollar blockbusters.

fat-uncle-samCountry-wise, the U.S. is presently the biggest market for weight loss drugs with around 68% of its population either overweight or obese.

The U.S. is followed by the U.K. and other European countries. In the future, emerging economies such as china, Russia, India and Brazil are also expected to become huge markets for weight loss products.

obesity-chinaWith China’s obesity and overweight levels touch 665-670 million in 2015, the country will emerge as the most potential weight loss market

Way to go China!!!

And, just in case you are one of the lucky few who still have some extra money laying around that you would like to invest:

The RNCOS report gives an extensive and objective analysis on the global market for obesity drugs. It…blah, blah, blah…can give valuable information to investors planning to foray (I don’t think I have ever forayed before) into the obesity drug market…blah, blah, blah…

Interesting isn’t it?

If I was a cynical type of person, I just might think that:

  • Obesity is seen by drug manufacturers as a growth industry, and
  • The fatter we get, the more money they make, and
  • Their need for profit might motivate them to lobby for gov’t policies that result in higher numbers of obesity, and
  • Since a lot of money can be made with drugs that “possess a strong efficacy and safety profile”,
  • They have no motivation to find a cure, because
  • Chronic diseases keep people popping pills for the rest of their lives

Damn, maybe I am cynical…gotta work on that.

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The Cure for Cancer: Prevention?

February 26th, 2009

walk-couple

Earlier today, researchers from the American Institute for Cancer Research and the U.K.-based World Cancer Research Fund released their report:

Policy and Action for Cancer Prevention

Food, Nutrition, and Physical Activity:
A Global Perspective

A few days ago, I talked about the strong link between obesity and cancer that the AICR/WCRF has identified.

With this new report, the AICR/WCRF builds upon that research and makes a strong argument for diet and exercise as the key to fighting cancer.

It calls research and spending on the treatment of cancer “necessary but not sufficient,” and contends that a far better strategy for reducing the world’s annual tally of 11 million cancer cases would be to develop a public-health policy aimed at preventing people from getting the disease in the first place.

Their findings are based on an a review of the nearly 7,000 scientific studies into whether cancer rates are influenced by diet, obesity and exercise.

In their report, they conclude that cancer “is mostly preventable.”

They estimate that about one-third of all cases in advanced countries like the U.S., Canada, Australia and Europe could be eliminated by diets that aren’t loaded with fatty, sugary foods, by people exercising regularly and, if they are obese, by slimming down to an appropriate weight.

And considering that another 1/3 of all cancer cases are due to smoking, the folks over at the AICR/WCRF believe that 2/3 of all cancers are preventable.

But What about Genetics?

For years and years, scientists have looked towards the genome for answers to the mystery of cancer. And since we began mapping out the human genome, that research has intensified.

This report attempts to throw cold water on the genetic hypothesis for cancer.

One of the study’s lead researchers,Dr. Kumanyika said studies tracking immigrants and their children who move from areas of low cancer incidence, such as Asia, to countries with high rates, such as the United States, suggest the genetic factor may be overrated.

Over time, cancer rates among migrants and their children rise toward the levels prevalent in their adopted countries, suggesting that something common to everyone in the new environment is the cause.

So, what do we do now?

According to AICR/WCRF, the short answer to that question is cooperation.

They envision an approach which combines the efforts of 9 separate “actors”. Their hope/belief is that the combined and coordinated efforts of those 9 actors will create a synergistic weapon in the fight against preventable cancers.

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And what are role are we, the people, expected to play in this noble fight against cancer?

aicr-wcrf-people

So, what do you think?

Still not convinced?

Maybe Dr. Marmot can convince you.

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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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A New and Improved Diet Pill?

September 2nd, 2008

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>.

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

August 1st, 2008
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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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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Canada's War on Drugs…and Vitamins

May 14th, 2008

On April 8, 2008, Canada’s federal government tabled bill Bill C-51.

Health Minister, Tony Clement says that Bill C-51 is designed to “modernize the Food and Drugs Act”.

Furthermore, the Bill “proposes to maintain a rigorous assessment of health products prior to making them available. In addition, we’re proposing to gain the ability to continuously monitor the safety of products even after they are approved”.

Sounds good.

Don’t want any tainted vitamins, herbs, etc, getting into the marketplace. And if they do, the government has taken the power and responsibility of recall from the manufacturers and given it to themselves.

So, essentially what the government is doing is asking the natural health product industry to prove that their products will do no harm. Once proven, manufacturers will be able to make claims of efficacy like the pharmaceutical industry.

This may even improve the business model for nutritional supplements in Canada. Vetted health claims might increase the legitimacy of the industry in the public’s eye. And yet, something doesn’t seem right with this piece of legislation.

Here is my problem with Bill C-51.

  • What are they protecting us from?
  • In 2006, the U.S. reported one death associated with the ingestion of vitamins. An unknown vitamin & it was reported that while the vitamin played a part, it was unlikely that it was the cause of death. How they would know that if the vitamin was unknown, I will never know.
  • Compare that to the 2006 data for Pharmaceutical deaths. The full report is here.
  • Pharmaceutical Categories associated with largest number of fatalities (Top 25)
  • Deaths – Substance
    382- Sedative/hypnotics/antipsychotics
    307 – Opioids
    252 – Cardiovascular drugs
    214 – Acetaminophen in combination
    210 – Antidepressants
    203 – Stimulants and street drugs
    139 – Alcohols
    138 – Acetaminophen only
    98 – Muscle relaxants
    93 – Anticonvulsants
    75 – Cyclic antidepressants
    69 – Fumes/gases/vapors
    66 – Antihistamines
    61 – Aspirin alone
    55 – Other nonsteroidal anti-inflammatory drugs
    49 – Unknown drug
    38 – Chemicals
    35 – Oral hypoglycemics
    27 – Miscellaneous drugs
    25 – Diuretics
    25 – Automotive/aircraft/boat products
    22 – Antihistamine/decongestant, without phenylpropanolamine
    20 – Hormones and hormone antagonists
    18- Anticoagulants

Vitamins – 1 death

Aspirin & Acetaminophen – 199 deaths

As far as I am concerned, that should be the end of the story. The government has no business creating a problem where none exists.

Fin

For those of you who want more, here are some interesting links.

video of an anti Bill C-51 rally

Health Minister, Tony Clement’s press conference to discuss Bill C-51

article in the Globe and Mail

article in the Vancouver Sun

The (CHFA) Canadian Health Food Association’s submission to the House of Commons.

article by Andre Picard, Globe and Mail

CHFA response to Picard article

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