ImaginativePRO Blog

ABBVIE INC UNDER ATTACK AS THE FDA APPROVES NEW 'BOTOX' RIVAL DAAXIFY FROM REVANCE THERAPEUTICS

The U.S. Food and Drug Administration approved a new antiwrinkle treatment that could be the most formidable challenger to date to market leader Botox.

Analysts say the drug, from Revance Therapeutics, poses a threat to the market-dominating anti-wrinkle treatment because it promises to last longer.   Revance plans to market Daxxify as a luxury item and emphasize its longer duration than Botox and other toxins.

For about two decades, Botox, now sold by AbbVie Inc., has dominated the aesthetic-drug market it helped pioneer, racking up tens of billions of dollars in sales and successfully fending off challengers.

The FDA’s approval of Revance Therapeutics Inc.’s Daxxify introduces a new rival that doctors and analysts said could succeed carving out a big slice of a lucrative and fast-growing market by promising to last two months longer than Botox’s four months.

The FDA approved Daxxify, also known as daxibotulinumtoxinA, for the temporary improvement of frown lines in adults, Revance said Thursday.

The decision, analysts and doctors said, should touch off a fierce battle between upstart Revance and industry giant AbbVie, which acquired Botox as the centerpiece of a $63 billion deal for its manufacturer in 2020.

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“This marks what we think is the first real competitive threat to Botox,” said Cowen Inc. analyst Ken Cacciatore, who expect011s Daxxify to generate $1 billion in sales as early as 2030.

Botox, derived from the poisonous Botulinum toxin bacteria, blocks signals between nerves mand muscles, causing the muscles to relax. A doctor originally developed the drug to treat an eye disorder, before patients noticed it smoothed their wrink,m1 les.

The discovery prompted a company called Alle rgan to pursue Botox’s cosmetic use, which the FDA granted in 2002, launching a new market for p5mkroducts and procedures that enlarge lips, fill in cheeks and sculpt other body parts.

That aesthetics market was worth $14.6 billion worldwide last year, according to the Aesthetic Society, a professional society of plastic surgeons. Physicians in the U.S. performed about 4.4 million procedures involving Botox and two of its rivals in 2020, the American Society of Plastic Surgeons said.

The aesthetics market has been growing 10% annually, but could increase more rapidly over the next few years, according to McKinsey & Co., driven in part by a proliferation of med spas and social-media-inspired awareness among young people.

The Botox brand name has become a fixture in America’s cultural lexicon, like Band-Aid and Kleenex.

Despite facing a raft of competitors, Botox holds about 70% market share. The drug’s profitability attracted AbbVie, which sought the product as it girded for lower-priced competition for its top-selling drug Humira.

Botox sales totaled more than $4.6 billion last year, up more than $1 billion from the year prior as people working from home because of the pandemic sought to look good in video calls and returned to seeing their aesthetic doctors in person.

Botox is also approved for therapeutic uses. It lasts up to four months, according to the product’s website.

The Revance drug threatens to eat into Botox sales, which last year made up roughly 8% of AbbVie’s $56 billion revenues, behind only Humira’s roughly $20 billion in sales and the $5.4 billion from blood-cancer treatment Imbruvica.

To counter the threat, AbbVie has said it is investing more in its aesthetics business, spending more on R&D, consumer advertising and expanding its sales force in the U.S. as well as China, which the company said is a growing market.

AbbVie has said it is developing a toxin whose wrinkle-reducing duration could last longer than the approved version of Botox and a fast-acting one that has shorter duration.

AbbVie declined to comment.

Revance is taking a different tack than older Botox rivals like Dysport, made by France’s Ipsen Biopharmaceuticals; Xeomin, made by Germany’s Merz Group, and Evolus Inc.’s Jeuveau. The rivals primarily tried to compete on price, according to doctors and analysts.

Rather than discounting its drug to reach a mass market, Revance plans to market Daxxify as a luxury item to high-volume injectors in the U.S. and emphasize its longer duration than Botox and other toxins, Chief Executive Mark Foley said.

The company hasn’t disclosed pricing but has said it expects physicians to pay more than they do for existing toxins. As with other antiwrinkle toxins, doctors would purchase Daxxify directly from Revance and then bill patients, rather than insurers.

“We’re going to be introducing a product that we’re not trying to say is everything to everybody. Now, you can choose,” Mr. Foley said.

Daxxify will face big obstacles, doctors and analysts said, such as overcoming the loyalty of doctors and patients who are longtime Botox customers.

AbbVie can also sell Botox with its other aesthetic products like fat-removing CoolSculpting and dermal filler Juvéderm in exchange for discounts. And physicians will need to be trained to use Revance’s drug because it is prepared and administered differently than Botox.

In a survey of 25 physicians last year by Truist Securities Inc., nearly two-thirds said the new Revance drug would account for none to a small amount of their toxin usage, while most of the remaining physicians surveyed said it would account for a moderate amount of usage.

The FDA was slated to decide on Daxxify in 2020, but pandemic-related travel restrictions delayed the agency’s inspection of Revance’s manufacturing facility in Newark, Calif., according to the company. Several months after completing the inspection last summer, the FDA declined to approve the drug, which Revance said was due to manufacturing concerns.

After resolving those FDA concerns, Revance requested approval again and has since addressed all the agency’s subsequent issues, Mr. Foley said.

In a pair of late-stage trials studying about 600 total subjects, about a third of patients who received the product maintained either no or only mild wrinkles after about six months, according to Revance.

Similar results were reported by researchers in a subsequent open-label trial of about 2,700 subjects. No safety concerns were observed in the studies, according to the company.

COMMENTARY:   The idea that you can market Daaxify as a "luxury" prescription facial injectable wrinkle remover makes me want to laugh.  Differentiator strategy?  The only point of differentiation that Daaxify can really claim is that it lasts two months longer than Botox.  AbbVie has an answer for that:  AbbVie already developed a longer-lasting version of Botox, so Daaxify's advantage will not last very long when they go head-to-head.  Don't know the difference in price between Daaxify and Botox in order to say Daaxify can compete on price.  New entrant into the market?  I have never considered being new into a market a competitive advantage.  Nobody really knows you.  If the Revance Therapeutics, maker of Daaxify were part of Pfizer, I might worry.  

 

Botox dominates the market for wrinkle remover facial injectables with a 70% share of the global market.  It is well entrenched and Botox is the go-to wrinkle remover facial injectable drug by doctors.  Marketing Daaxify as a "luxury" just does not compute with me.  I wasn't aware that there was a "luxury" market segment for wrinkle remover facial injectables.  Will dermatologists ask their patients, "Do you prefer the newer Daaxify or the more popular regular Botox or the newer advanced version of Botox that also lasts eight months?"  

 

AppVie's Botox has huge advantages over new market entrants:  well branded, loyal customers, better or superior product, distribution channels (doctors) all locked-up, huge product development team, and deep pockets to protect its market position.  It's a Lovemark brand by any definition.  Those are huge castle walls to climb and a huge moat to cross.   

 

Sorry, Daaxify.

 

How Big is the wrinkle remover facial injectables market?   Here are a few facts:

 

Factors driving the growth and use of facial injectable products to remove wrinkles are as follows: 

• Demand For Anti-Aging Aesthetics - A growing focus on physical appearance among consumers, especially among women, has led to an increased demand for facial injectables in recent years.
• Increased Demand For Minimally Invasive Procedures - Consumer awareness regarding minimally invasive procedures due to various beauty campaigns being organized by key players in the market is also a driving factor for market growth.
• COVID-19 Pandemic - The ongoing COVID-19 pandemic has increased the time spent on video calls. Known as the ‘Zoom Boom’, several adults are becoming more aware of their appearance. This has increased demand for cosmetic surgeries, with Botox being one of the most popular products preferred.

According to market research by Grand View Research, the global facial injectable market size was valued at USD $16.1 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 9.1% from 2022 to 2030.  

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Vantage Market Research states that the global facial injectable market is driven primarily by new product launches and the market is estimated to reach USD $7.5 billion by the year 2028.  

 

The Global Anti Aging Market is valued at USD 59.1 Billion in the year 2021 and is projected to reach a value of USD 88.1 Billion by the year 2028. The Global Market is anticipated to grow exhibiting a Compound Annual Growth Rate (CAGR) of 6.9% over the forecast period.  The Global Facial Injectables Market revenue stood at USD $4.4 billion in the year 2021 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 9.4% during the forecast period. 

 

On the basis of product, the Anti-Aging Market is segmented into four segments:

• Anti-Wrinkle.
• Hair Color.
• Ultraviolet (UV) Absorption.
• Anti-Stretch Mark.

The Anti Aging sector is currently dominated by anti-wrinkle products, which account for the majority of sales.  Anti-wrinkle products had the largest market share in 2021, and significant growth is expected by 2028.  Because of the harmful effects of cosmetics and chemical-based products, natural products are predicted to expand at the fastest rate.

 

According to market research by Grand View Research, the U.S. facial injectable market size was valued at USD $5.6 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 9.1% from 2022 to 2030.

 

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The anti-aging market is segmented demographically into four segments: 

• Generation X.
• Generation Y.
• Generation Z.
• Baby Boomers.

Generation X has dominated the Anti Aging industry in terms of revenue. Increased disposable income and a greater focus on physical appearance would both help the market flourish. Over the forecasted period, the demographic group Generation Y is likely to grow at a high rate. The target demographic is millennials who are familiar with high-end premium brands like Estée Lauder and Elizabeth Arden. Premium skincare brands are becoming increasingly popular among millennials.

 

Courtesy of an article dated February 8, 2022 appearing in The Wall Street Journal, an article dated June 2022 appearing in Vantage Market Research, an article dated February 2021 appearing in Grand View Research,

HOW PILLPACK REINVENTED THE PILLBOX WITH AN IDIOT-PROOF WAY FOR USERS TO REMEMBER WHEN TO TAKE YOUR MEDS

A startup originally accelerated within Ideo, PillPack is an end-to-end pharmacy and delivery service for pharmaceuticals that is using design to vastly simplify the process of swallowing pills each day. (Click Image To Enlarge)

Take all of the pills in your medicine cabinet that you have to track--the prescription drugs you need to remember to take two or three times a day, the multivitamins and fish liver pills you're not sure make a difference--and imagine that instead of all coming in separate bottles, they came packaged together in a pre-assorted, chronological ticker tape of medicine. Instead of keeping track of which medicines you need to take at which time, you just tear off a square packet from the roll and swallow all the pills inside.

You don't have to worry about pillboxes, reminders, or refills; PillPack takes care of all that for you. (Click Images To Enlarge)

This is the idea behind PillPack, a new service out of Somerville, Massachusetts, that aims to be the Amazon Prime of prescription medication.   PillPack is using design to vastly simplify the process of swallowing pills each day.  You don't have to worry about pillboxes, reminders, or refills; PillPack takes care of all that for you.  All you need to do is tear off the latest M&M Fun Size packet and swallow what's inside when it tells you to.

 

The system PillPack uses isn't new. Long-term care facilities have been getting medicine for their patients in easy-to-distribute, presorted rolls for years to make life easier for nurses who have to juggle the confusing motley of medications taken by dozens of patients multiple times per day.

All you need to do is tear off the latest M&M Fun Size packet and swallow what's inside when it tells you to.  (Click Image To Enlarge)

A long-term care pharmacy in Concord, New Hampshire--got swarmed with requests by friends and neighbors, who caught wind of the rolls of medication he was making for local medical facilities and started clamoring for him to put together pill packs for them, too.

Once you've signed up, PillPack will assemble your medication, presorting the medicines into individually sealed packets lined up chronologically; any interim medication you need while your first PillPack is being assembled is mailed overnight. You get new PillPacks every two weeks. (Click Image To Enlarge)

What makes the PillPack system so well designed is how idiot-proof it is. Getting started on PillPack is as easy as transferring your existing subscriptions from your local pharmacy: according to PillPack, the process takes less than five minutes. Once you've signed up, PillPack will assemble your medication, presorting the medicines into individually sealed packets lined up chronologically; any interim medication you need while your first PillPack is being assembled is mailed overnight. You get new PillPacks every two weeks. When you get your first shipment, all you do is tear off the first packet and swallow the pills inside at the date and time printed on the front. New PillPacks are automatically sent to you when you need them; four weeks before your last scheduled refill of a prescription, PillPack's pharmacists will follow up with your doctor for a renewal.

When you get your first shipment, all you do is tear off the first packet and swallow the pills inside at the date and time printed on the front. New PillPacks are automatically sent to you when you need them; four weeks before your last scheduled refill of a prescription, PillPack's pharmacists will follow up with your doctor for a renewal.  (Click Image To Enlarge)

Patienta should not have to worry about taking their meds as the date and time are printed on each packet.  Each packet is clearly printed with the medications inside. A label on the dispenser has images of the pill, with the name and instructions, so it's easy to know exactly what you're taking.

For now, PillPack is focusing on getting medicine to as many people's doors as possible--they still need pharmacy licensing in 19 states--but there's a lot of possibility for leveraging the data they have on patients to improve the PillPack experience. A dedicated app, says Parker, is the obvious next step, but there's also lot of excitement at PillPack about how they could integrate their service with future wearables such as the iWatch or Google Glass, such as by alerting customers when they haven't taken their pills.

PillPack works with most major insurance plans, and costs $20 per month on top of existing co-pays. At that price, says Parker, the service makes most sense for patients who take more than five pills a month, but even if you just need help remembering the aspirin a day, PillPack can help you keep the doctor away.

COMMENTARY:   I can definitely see how PillPack could become very popular among seniors.  It is very difficult for them to track their medications, and often miss their medications because they have to take so many of them, and often several times a day.  The ability to pack all medications into one pack and tell the patient the day and time to take those medications eliminates a lot of the worry.  PillPack also takes care of refills, scheduling them 8 weeks ahead of time, so that they are authorized by the doctor and can be filled promptly so that the patient never runs out.  PillPack claims that they work with all the major healthcare insurance companies and drugs covered by Medicate Plan D.  It costs the patient a flat $20.00 per month plus the co-pay from their insurance company.  This is a much better way to manage refills, and I can definitely see the day when PillPack becomes the Netflix of prescription drugs.  A one-stop place to refill all prescriptions, and know with absolute confidence that you will not miss your medications when you need to take them.  It's all good, and I see big things for this company. 

Courtesy of an article dated February 6, 2014 appearing in Fast Company Design

HOW TIKUN OLAM, AN ISRALI COMPANY, GROWS MEDICAL MARIJUANA WHICH DOESN'T GET YOU HIGH, BUT RETAINS ALL THE MEDICAL BENEFITS

MOTTO:  "This is the GOD'S doing ; it's marvelous in our eyes​​"

Situated in an undisclosed location near Tzfat, northern Israel, is a government-approved medical marijuana plantation which was founded in 2004 by a retired biology teacher. Named Tikun Olam, the plantation has created a new cannabis strain which contains very low traces of tetrahydrocannabinol (THC), the main constituent in cannabis responsible for making people feel "stoned". By virtually eliminating THC in the new strain, Tikun Olam can now offer the drug's medicinal benefits to those patients who wish to keep a clear head.

Tikun Olam began operations in 2004 on a small scale by a retired biology teacher (Click Image To Enlarge)

Tikun Olam is situated in a secret location somewhere near Tzfat in northern Israel (Click Image To Enlarge)

The Tikun Olam facility includes a 11,000 sq meter growing field, several greenhouses, a cloning facility and a harvesting facility (Click Image To Enlarge)

Marijuana contains over 60 constituents named cannabinoids and though THC is the most famous due to its psychoactive effects, another important constituent is cannabidiol (CBD).

 

CBD is believed by some researchers to offer anti-inflammatory benefits, thus offering the potential to relieve pain without making patients intoxicated, if the THC-to-CBD concentrations can be correctly balanced.

The new cannabis strain offers the drug's medicinal benefits to patients who do not wish to feel intoxicated (Click Image To Enlarge)

Some researchers believe CBD may produce anti-inflammatory effects in patients, resulting in the potential to relieve pain without making patients intoxicated (Click Image To Enlarge)

Some daily users of medical marijuana find it a hindrance to performing every day activities (Click Image To Enlarge)

The new strain of marijuana created at Tikun Olam does just that. Dubbed Avidekel, it contains less than one percent THC, compared to the company's most popular strain Erez, which contains 23 percent THC. Avidekel couples this with an increased concentration of CBD, said to be almost 16 percent. How real-world use of Avidekel compares to existing medical marijuana products designed to limit intoxication, such as the under the tongue spray Sativex, is still unclear.

Although many patients feel the intoxicating effects of THC to be a beneficial element of medical marijuana use, others find it a hindrance to performing every day activities and so welcome the opportunity to take the marijuana while maintaining sobriety.

One of the ten patients to make use of the Avidekel strain in the last six months, while speaking to Reuters said.

"It's a huge advantage.  I can smoke during the day, function with a lot less pain and still be focused, work and drive. It is a great gift."

Recreational use of cannabis is prohibited under Israeli law, however the drug is currently used medically to treat roughly 9,000 people suffering from illnesses such as cancer, Parkinson’s disease, multiple sclerosis and Crohn’s disease.

The promotional video below sheds more light on the Tikun Olam plantation.

 

COMMENTARY:  

About Tikun Olam

Tikun Olam is the first and foremost supplier of medical Cannabis in Israel and the flag bearer for the medical use of Cannabis in Israel.

Since the day of its founding the company has stood for dedicated quality care for its patients while developing professional standards for growing medical grade Cannabis.

In the field of production – emphasis is put on special methods which focus on increasing production of the active ingredient (mainly THC and CBD) so that medical grade plants may be grown.

The medical Cannabis is produced in a careful and sterile way, beginning with the stages of planting, harvesting, processing and until it reaches the patient.

In the field of treatment – the company has developed a unique treatment method (on a global scale) which views treatment with medical Cannabis as a central part of a caring, compassionate and humane treatment for its patients who are coping with a terrible disease, whether chronic or terminal.

Ti​kun Olam has vast accumulated experience (perhaps the most extensive in the world) in personal instruction of patients in safe and effective use of medical Cannabis.

Over the years Tikkun Olam has initiated and maintained cooperation and working relations with doctors, scientists, department heads, nursing facilities and other medical institutes in Israel and abroad.

The company continuously strives to increase awareness among the patients, doctors and the general public.

The company’s facilities (growing and processing) are located in the northern part of the country and are secured according to the highest standards.

In 2007 the Ministry of Health gave license to the Cohen family to grow approximately 50 plants for patients who were given permits for the use of medical Cannabis, all on a voluntary basis.

Half of their home in [unclear] became a greenhouse for the growing and processing the medication and simultaneously the system for treatment and dispensing began to form.

The treatment with Cannabis gained momentum, both because of the high quality of the treatment and immediate feedback from patients and because of the media campaign which the Foundation and the patients embarked on.

During this time (in September 2009) Channel 2 aired the documentary film “Grass by doctor’s orders” directed by Tzach Klein and hosted by television presenter and journalist Avri Gilad.

In 2010, by decision of the Ministry of Health and after five deliberations at the Knesset’s Labor Welfare and Heath Committee, a monthly cost of 360 NIS per patient was set. (Today the price is 370 NIS).

In light of this decision Tikkun Olam Ltd. has opened the first store in Israel for the sale and distribution of medical Cannabis and its products to those possessing legal permits.

The store was opened at 138 Ibn Gabirol St. in Tel Aviv, and to this day it is the only store of its kind in Israel.

In 2012 the company was granted a standards association mark, the first of its kind, ISO 9001 in the field of growing, production, sale and distribution of medical Cannabis and instructing patients.

Tikun Olam's moto is:  "This is the GOD'S doing ; it's marvelous in our eyes​​"

What is Medical Marijuana

Cannabis is a plant with unique medical properties, and refers to the parts of the plant which are used in medicine.

The medical grade is determined by several factors: 

• Manner of organic growing. 
• Maintaining a high concentration of active ingredients. 
• Hybridizing while performing continuous laboratory examinations. 
• Matching and designating various strains to various diseases together with the patient.

Until the 1930’s medications which contained extracts of the plant were part of the world’s pharmacopeia, only in 1937 was medical use of Cannabis in the United States halted.

In Europe, medical use of Cannabis products continued until the early 1970’s.

The plant contains more than 462 substances, from which more than 100 cannabinoids, flavonoids and terpenoids have been identified.

Most famous among the cannabinoids is the THC, which was first identified and isolated in 1964 at the Weisman Institute by Professors Yehiel Gaoni and Rephael Mechoulam, who received the Israel Prize for his research of Cannabis.

Different strains of Cannabis contain different concentrations and ratios of the active ingredients.

 

How Marijuana Affects The Brain

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Diseases and Medical Conditions Benefiting From Cannibus

• Cancer
• Diabetes
• ALS
• Anxiety
• Appetite
• Fibromyalgia
• Nausea
• Multiple Sclerosis
• Arthritis
• Pain
• Sleep
• Crohn's Disease
• Tremor
• HIV
• Alzheimer Disease
• Tourette
• Parkinson

Cannibus Strains

Tikun Olam is focused on the unique methods to increase production of the active ingredients, and especially THC - CBD in order to grow standard medicinal plants.

Medicinal cannabis is produced in a very careful and sterile, from the stage of planting, harvesting and processing until it reaches the patient.

The company's researchers have created the following medicinal cannibus strains:

• Indica Strains - This cannibus class consists of four different strains.
  • EREZ - ​This Strain is composed of 70% Indica 30% Sativa, responds to a wide range of symptoms and illnesses.  This species was developed by Tikun Olam, in its early years, and is named after the first patient.
  • ERAN ALMOG - This Strainis composed of 80% Indica 20% Sativa.
    
  • DORIT - This Strainis is composed of 70% Indica 30% Sativa.  This Strainis was named in the name of Dorit Cohen, the mother of "Tikun Olam".
  • GOG y MAGOG - This Strain is is composed of 70% Indica 30% Sativa.
    
  • LITTLE DEVIL - This Strain is is composed of 70% Indica 30% Sativa.
    
  • JASMIN - This Strain is is composed of 70% Indica 30% Sativa.
    
  • OR - This Strainis is composed of 70% Indica 30% Sativa.
    
• Sativa Strains - This cannibus class consists of three different strains.
  • ALASKA - This Strainis is composed of 70% sativa 30% Indica.
  • MINDATE - This Strainis contains 12% of CBD and 12% THC​, and is composed primarily of Sativa.
  • AL-NA - This Strain is is composed of 70% sativa 30% Indica.
• CBD Strains - This cannibus class consists of two different strains.
  • AVIDEKEL - This Sativa Strain contains 16% CBD without any THC.
  • RAFAEL - This Sativa Strain contains 18% CBD and 1% THC.

Products ​

Tikun Olam is focused on the unique methods to increase production of the active ingredients, and especially THC - CBD in order to grow standard medicinal plants.

An array of Tikun Olam products (Click Image To Enlarge)

Medicinal cannabis is produced in a very careful and sterile, from the stage of planting, harvesting and processing until it reaches the patient.

• Smoking Substitutes - Consumption of medical cannabis in the gut (or through the mucous membranes of the mouth) is much slower and changing from one person that change also depends on the "state" of the stomach during use (full / empty, etc..), Therefore, it is more difficult to control the dosage and without the need many careful attempts to obtain effective, and thus consumption, is recommended for patients not want to smoke or can not physically do it (mental difficulties, if any, to be overcome in training).
  • Cannabis Oil Drops - Medical cannabis extract based on olive oil.
  • Cannabis Powder - Medical cannabis flowers ground and filtered.
  • Capsules - Capsules filled with medical cannabis flowers ground and filtered.
  • Powder oil - Medical cannabis oil available in 1/2/3 grams which contains about 30% THC.
• Delicacies - Cannabis Consumption hrough the gut (or through the mucous membranes of the mouth) is much slower and varies from one person to another, also depends on the "state" of the stomach during use (full / empty, etc..).
  • Chocolate Praline - Fine dairy chocolate made with medical cannabis butter and containing about 40 mg/g THC.
    
  • Pastries - Based on medical cannabis butter and available in several sizes and dosages.
    
  • Tahini Cookies - Organic tahini based on medical cannabis butter and containing 13.5 mg / g THC. 
• Special Products - Cannabis Consumption hrough the gut (or through the mucous membranes of the mouth) is much slower and varies from one person to another, also depends on the "state" of the stomach during use (full / empty, etc..)).
  • Toffee - Toffee sweets based on medical cannabis extract and containing 2mg/g THC.
    
  • Gum - Sweet and sour gum filled with medical cannabis extract and containing 2 mg/g THC. 
    
  • Honey​ - Fine honey based on medical cannabispowder and containing 10.3 mg/g THC.
    
  • Sugar - Brown and white sugar based on medical cannabis powder and containing 7.1 mg/g THC.
    
  • Ointment - Based on herbal ointment medical cannabis for external use and containing about 0.4% THC.
    

Courtesy of an article dated July 6, 2012 appearing in GizMag

THE OVER-MEDICATION OF AMERICA, WE POP TOO MANY PILLS, AND THE PILLS BIG PHARMA PRODUCES DON'T EVEN WORK

AS A COUNTRY, WE'RE TOO HAPPY TO BELIEVE THAT PRESCRIPTION DRUGS WILL ALWAYS CURE US. AND DRUG COMPANIES, DOCTORS, AND INSURANCE COMPANIES ALL PLAY A ROLE IN KEEPING THAT MYTH GOING.

There are few things as private as the medicines we take. You can imagine asking a decent acquaintance who they voted for in 2008, who they’ve dated in the past year, and which family member they hate the most. But I’ll bet it makes you feel queasy to imagine asking them, "Hey! That little blue pill I saw in your bag. What’s that for, anyway?"

It’s no wonder then that America’s problem with overmedication hides in plain sight. While we’re all dimly aware that we take a lot of pills, we have no intuition of how big the problem is. And when you lay out the stats, the figures are nothing short of terrifying, as this infographic shows. While it suffers from rhetorical bombast, the tensions suggested by the chart are stark: Even though we take tons of pills, they seldom actually work. So while 1/2 of all Americans take a prescription drug and 1/4 of women take an anti-depressant, prescription drugs only seem to work 30% of the time. Meanwhile, 85% of new drugs have been found to have little or no benefit. And those miracle anti-depressants? They don’t even outperform placebos:

Click Image To Enlarge

As you might have guessed, the authors of this infographic lay the blame squarely on the shoulders of the drug companies, which spend far more money pushing their drugs with doctors than they do on research, and the FDA, which allows them to market the drugs they sell despite their limited effectiveness.

Click Image To Enlarge

Doctors, in the meantime, straight up get paid to prescribe new drugs. If you’ve ever wondered why so many young, energetic women are making $250,000 a year to be pharmaceutical representatives, there’s your answer.

Click Image To Enlarge

No doubt, doctors and pharmaceutical companies make for troubling dance partners. Without their cozy ties, perhaps the problem of overprescription wouldn’t be so bad.

But the infographic also misses the most important part of the story. While drug companies indeed have a vested interest in marketing their drugs to whomever will buy them, even if they don’t work, they’re abetted by our profoundly screwed up insurance system. In short, it creates some of the worst, most irrational incentives imaginable.

Think about the process behind a drug prescription from the viewpoint of each person involved. For many doctors, the cost of a drug is totally invisible: They don’t prescribe them with any concern for cost-effectiveness or even clinical efficacy--indeed, when I’ve asked a doctor how much something costs, I’ve often gotten a snippy reply, as if asking about money were some kind of moral insult. Instead, there’s merely the doctor’s own vague sense of what usually works. If they’re told about something that’s new and supposedly better, why wouldn’t they prescribe it? If it costs 10x more than a previous generation of drug, who cares? Likewise, patients with insurance don’t pay the costs of medications, so they’re only too happy to take one more drug, under the assumption that it can’t hurt.

The insurance companies, meanwhile, are in a tricky, low-margin business. Try as they might to wring bargains from pharmaceutical companies, they can also earn more profits simply by increasing their reimbursements--which they in turn pass along to consumers as premium increases. The point being, no single actor in this farce is trying to do bad. But none of them has any real incentive to say, "Hey, does the patient really need this? And is it worth the money?"

But there is also a deeper problem within ourselves that drives all of this behavior: Magical thinking. We’re only too happy to believe that we can go to the doctor and simply get a pill that’ll fix us up. Indeed, I imagine that if you went to the doctor about some ailment and were told to eat more vegetables, get more sleep and exercise, and take a few Tylenol, you’d think that doc was a fool. You’d never go back.

Doctors know that. They know what’s expected of them. They know that telling someone, "Hey, your problem will probably go away on its own in three weeks," is a good recipe for going out of business. The question is, will our belief in a little magic pill ever go away, even when the pills lose their magic?

COMMENTARY:   The pharmaceutical industry is one of my favorite industries to hate because of the outrageous prices that they charge for drugs, and the tricks they use to sway consumers to use their prescription drugs, when a less popular brand or generic would do just as well.  The fact of the matter is, the doctors and the pharmaceuticals are in bed with each other, and its been this way for years.  

Pharmaceutical salespeople are among the highest commissioned paid salespeople of any industry other than perhaps what some stock brokerage firms pay their brokers.  The system is rigged top to bottom, and this ads layers of costs to the prices we pay at the drug counter.  

Who's kidding who here, the cost to make a pill isn't that much.  The chemical compounds that go into the pills generally don't cost hat much per pill, and they are made by machines, bottled and labeled all at the same time, but when you ad marketing and sales costs, amortization of new drug development costs, patents, attorneys and FDA approvals, the costs can balloon, but there is a lot of controversy whether the average cost for a new drug, about $250 million, is really accurate or just a scheme by the drug companies to skim us.

If you want to learn more about the pharmaceutical industry, check out my other posts dated December 8, 2009, February 3, 2011, February 10, 2011, April 10, 2011, June 12, 2011, and November 5, 2011.

Courtesy of an article dated February 8, 2012 appearing in Fast Company Design

 

 

DUTCH RESEARCHER CREATES A SUPER-DEADLY INFLUENZA VIRUS WITH THE POTENTIAL TO KILL HALF OF EARTH'S POPULATION

A Dutch researcher has created a virus with the potential to kill half of the planet’s population. Now, researchers and experts in bioterrorism debate whether it is a good idea to publish the virus creation ”recipe”. However, several voices argue that such research should have not happened in the first place.

The virus is a strain of avian influenza H5N1 genetically modified to be extremely contagious. It was created by researcher Ron Fouchier of the Erasmus Medical Center Rotterdam, Netherlands. The work was first presented at a conference dedicated to influenza, that took place in September in Malta.

Avian influenza emerged in Asia about 10 years ago. Since then there were fewer than 600 infection cases reported in humans. On the other hand, Fouchier’s genetically modified strain is extremely contagious and dangerous, killing about 50% of infected patients. The former strain did not represent a global threat, as transmission from human to human is rare. Or, at least, it was before Fouchier genetically modified it.

Fouchier and his team used a pair of ferrets for testing because they react in similar ways as humans, when exposed to the flu virus. Researchers transmitted the deadly virus from one ferret to another, in order to make the virus more adaptable to a new host. After 10 generations, the virus has mutated allowing it to spread through air. The result was that ferrets could get sick just being near another infected animal.

A genetic study showed that new virus strain presented five mutations, and all could be also observed in nature - but only separately, not all five combined. Fouchier’s strain is as contagious as seasonal human influenza, which kills tens of thousands of people, just that, much more lethal.

 

Paul Keim, a specialist in microbial genetics who worked for many years with the anthrax bacillus commented.

“I can not think of a pathogenic organism to be more dangerous than this one.  I think the anthrax is not at all scary, when compared with this virus.”

Keim is the coordinator of the U.S. National Committee dedicated to biosecurity issues and now he has to make a decision. If Fouchier wants to publish his study detailing how the virus was created, Keim’s and his committee must approve.

Many scientists are concerned about possible negative consequences that could precede the publication of this research. There are many fears regarding bioterrorists that might find useful tips or a whole ’recipe’ to plan biological attacks. Demands are beeing made for the establishment of an international institution to oversee such dangerous research projects.

Dr. Thomas Inglesby, a bioterrorism expert says. 

“It’s just a bad idea for scientists to turn a lethal virus into a lethal and highly contagious virus. And it’s a second bad idea for them to publish how they did it so others can copy it.”

On the other hand, if the study becomes available for the scientific community, it could allow researchers to ”be prepared” for a potential H5N1 pandemic. Since Fouchier’s study suggests that the risk for this to occur is greater than previously thought. Some researchers believe that banning the paper will leave mankind helpless if the virus naturally mutates and becomes contagious.

COMMENTARY:    When news of the new super-deadly influenza virus was delivered in July 2011, it was chilling.  It meant that Dr. Fouchier’s research group had taken one of the most dangerous flu viruses ever known and made it even more dangerous — by tweaking it genetically to make it more contagious.

What shocked the researchers was how easy it had been, Dr. Fouchier said. Just a few mutations was all it took to make the virus go airborne.

 

The discovery has led advisers to the United States government, which paid for the research, to urge that the details be kept secret and not published in scientific journals to prevent the work from being replicated by terrorists, hostile governments or rogue scientists.

The experiment in Rotterdam transformed the virus into the supergerm of virologists’ nightmares, enabling it to spread from one animal to another through the air. The work was done in ferrets, which catch flu the same way people do and are considered the best model for studying it.

Richard H. Ebright, a chemistry professor and bioweapons expert at Rutgers University who has long opposed such research said.

“This research should not have been done.” 

He warned that germs that could be used as bioweapons had already been unintentionally released hundreds of times from labs in the United States and predicted that the same thing would happen with the new virus.

He said. 

“It will inevitably escape, and within a decade.”

Though he added that security measures like restricting possession of the virus to fewer scientists and fewer laboratories would lower the chances of that happening so soon.

This reminds me too much of the Hollywood film "Contagion."

This mutated H5N1 avian influenza virus needs to be contained and controlled by as few medical research facilities and laboratories as possible.  If this strain of h5n1 avain influenza virus gets loos in the wild, we will have a catastrophy of incredible dimensions.  God help us if a terrorist organization should get their hands on this virus.  The fact that it is airborne means that it can be transmitted through all living things and we will never be able to get it under control. This truly scary.

Courtesy of an article dated November 28, 2011 appearing in Doctor Tipster

HOW PROTEUS BIOMEDICALS' FULLY-INGESTIBLE EMBEDDED "CHIP-ON-A-PILL" DRUGS WILL REVOLUTIONIZE MEDICINES

Proteus Biomedical, a biomedical technology company out of Redwood City, California, was selected as one of the World Technology Forum's Technology Pioneers for 2009 in the field of intelligent medicine.  

The company develops MEMS (microfabricated, multicomponent electronic components) devices for medical applications, small enough to be attached to pills to be used as "ingestible event markers", as well as potential permanently embedded blood glucose monitoring chips.

A statement by the company:

"Proteus has developed a unique approach to personalizing therapy," said Andrew Thompson, Proteus CEO and co-founder. "We embed micro-sensors into existing drugs and devices, which transmit information, securely, to a person's cell phone via the Internet. A person can understand how their body is responding to their therapy, and, if they choose, share this information with a family member, physician or friend to help them stay healthy. We are delighted that the World Economic Forum has recognized the immense potential of this approach and look forward to actively participating in their programs."

Check out this video interview with Andrew Thompson:

And, Proteus Biomedical's promotional video:

Proteus Biomedical from Proteus Biomedical on Vimeo.

 

COMMENTARY:   That's very cool technology that can give doctors immediate feedback about how a specific drug is performing and how the patient is reacting to that drug.  

In the above video, Andrew Thompson makes one of the best "pitches" that I have heard in a long time.  That's what I call a knockout pitch.

Essentially Proteus Biomedical makes "intelligent medicine" that consist of therapeutic drugs and tiny biosensors on a microchip that are implanted on a pharmaceutical drug pill that communicate with a cell phone via Bluetooth.  

Proteus Biomedical's  intelligent medicine integrates electronics, sensors, and wireless communications into pharmaceuticals like pills.   It offers a monitoring system called Raisin Personal Monitor, a wireless health monitor for remote recording and analysis of heart rate, physical activity, body position, and patient-logged events.

The company which was founded in 2001 and is based in Redwood City, California, develops these biosensors to allow cardiac resynchronization therapy to be tailored and adjusted based on a patient’s cardiovascular physiology.

The biosensors focuses on sensing, communicating, and optimizing cardiovascular performance for chronic heart failure management. It is also an intelligent pharmaceutical systems that communicates patient-specific medication-taking behavior and physiologic response.

Its products address various therapeutic applications, including cardiovascular and respiratory diseases, metabolic and central nervous system disorders, and oncology.

When ingested, any discrete event (such as the ingestion of a specific pharmaceutical) can be recorded. However, it also records any physiologic information such as heart rate, activity, body angle and patient-logged information. The unique ingestion event and all logged information are then communicated via Bluetooth to any computerized device, such as mobile phone applications.  The system is being developed as part of an integrated intelligent medicine system to track response and outcomes-based of treatments. Proteus partners are currently developing these products to treat diabetes, cardiovascular disease, psychiatric disorders, organ transplantation and infectious disease.

Proteus is a privately-held company with financial investors including Adams Street Partners, Asset Management, The Carlyle Group, Essex Woodlands, Fletcher Spaght Ventures, L.P. (FSV), Kaiser Permanente Ventures, and Spring Ridge Ventures.  That's an impressive list of investors.

Courtesy of an article dated December 5, 2008 appearing in MedGadget and an article dated January 30, 2011 appearing in Techmento

By TwitterButtons.com  

INFOGRAPHIC: THE INSANE CHOICES YOU FACE AT THE DRUGSTORE

Your local drugstore offers a cautionary tale about what happens when innovation runs amok.

Just 10 years ago, getting something for a headache or a cold at the drugstore was a simple enough affair: Ibuprofen or Acetaminophen? No longer: Drugstore aisles are now an eye-melting maze of choices, with products advertising everything from time-release to gel-caps to flavors to different dosages. I half-expect to find tooth-whitening Tylenol, one day soon.

But despite all the decision fatigue this induces, I'll bet this infographic will come as a shock. Created by the OTC drug startup Help Remedies, it lays out all the options for headache pills that you typically find at the pharmacy:

Click Image To Enlarge

At first sight, you might assume that this is merely an illustrative chart--that all the branches are simply hypothetical choices that one might face. But the chart, in fact, has real data in it--it just happens to be done so tiny that you can't easily read the actual drugs on offer:

Click Images To Enlarge

This, of course, is by design: The infographic is, after all, an advertisement for Help Remedies, a company which offers single-use packets at drugstores labeled simply with your symptoms. (I.E.: "I have a headache" or "I have allergies" or "I have a blister") Still, the chart does tell an interesting story about what innovation can do to a market at large.

Each of the myriad offerings laid out, whether its gel-caps or something else, was intended to produce a slight edge on a tightly packed, insanely competitive store shelf where virtually identical products can be found just an inch away. As drug makers compete for more and more differentiation, what you get is simply overwhelming. An innovation process that started with the original intention of offering better products leads to an overall product experience that's horrible.

You can spy that trend in all manner of industries: Just think about what buying a computer was like 10 years ago. Or what buying a smartphone is like today. Even if you choose what brand you're interested in, you're faced with myriad choices about options and add-ons. It's exhausting. Apple, of course, was probably one of the first companies to realize that endless options didn't actually make consumers happier: They're product line offers very few options, especially compared to someone like Dell, for example. Help Remedies works on the same idea. You've got to wonder: What other industries could benefit from a radical simplification?

COMMENTARY:   Just guess how many different types of Tylenol there are.  If you ever have to go to a drug store to find headache medication, you will be confronted with so many different choices of headache medication from tablets-to-gel caps-to-capsules, and there are even aspirin powders.  I usually go for the generic brands myself. It's all the same stuff.

Courtesy of an article dated November 3, 2011 appearing in Fast Company Design  

 

 

DIRECT MARKETER STEVE WARSHAK, THE 'KING OF MALE SEXUAL ENHANCEMENT', GETS PRISON TERM REDUCED FROM 25 TO 10 YEARS

CINCINNATI — The founder of an Ohio company that sold male sexual enhancement tablets and other herbal supplements had the prison sentence for his conviction on fraud and other charges reduced to 10 years on Tuesday by a federal judge.

Steve Warshak was convicted in 2008 of conspiracy, fraud and money laundering and sentenced to 25 years in prison. Warshak's company, Berkeley Premium Nutraceuticals, made products including Enzyte, which claimed to enhance male sexual performance and was promoted by a character known as "Smilin' Bob."

 

Warshak and other company officials were accused of bilking thousands of customers who bought Berkeley's herbal supplements via mail order. The fraud included false advertising, lying to banks and making unauthorized charges on thousands of customer credit cards, prosecutors said.

Click Above Image To Run Video

A federal appeals court last year ordered a new sentencing hearing, saying the trial court wasn't clear enough about its basis for arriving at the sentence.

Before reducing Warshak's sentence, U.S. District Judge S. Arthur Spiegel noted that "the court views Steven Warshak as a very clever and confident con man."

The judge said that he was mostly unimpressed with Warshak's claim that he had turned his life around and by the letters written by friends on his behalf, but decided that several factors warranted a shorter sentence, The Cincinnati Enquirer http://bit.ly/qv4fes) reported.

The most important factor was one cited by the federal appeals court — that the money lost by Warshak's customers may have been less than the $400 million estimated at his first sentencing, the newspaper reported. Spiegel defended his original estimate of $400 million, but agreed to reduce it to $100 million.

The judge said another factor was the disparity between Warshak's sentence and those of his 10 co-defendants, who all were sentenced to two years or less.

Warshak thanked the judge for his reduced sentence, adding that

"I know it comes with your high expectations, and I won't let you down."

Federal prosecutors objected to the reduction, saying nothing about the case has changed since Warshak's original sentencing. They also questioned the sincerity of Warshak's remorse, the newspaper reported.

Anne Porter, an assistant U.S. Attorney said. 

"Today is the first time Mr. Warshak has said he is sorry and admitted responsibility.  It's too late."

But Warshak told the judge that he has learned a "life-changing lesson" and wants to teach business ethics after his release from prison.

COMMENTARY:  In a blog article dated October 20, 2009, I covered the arrest and conviction of Steve Warshak, the founder of Berkeley Premium Nutraceuticals, the manufacturer of Enzyte male enhancement pills.   Enzyte natural male enhancement pills, or penis enlargement pills as they are commonly referred to, never worked, and the false and misleading guarantees that Mr. Warshak's company made got him, his mother Harriet Warshak and ten other co-defendants prison time.

In today's advertising market, advertisers use images to attract consumers. One common method used to coerce people into thinking that they need a product is to prey on their insecurities. These modern tools advertisers hide within their advertisements are considered to be modern myths. One of the most widely used myths is that: ". . . Your body isn't good enough ".  This practice is more easily recognized in advertisements geared toward women which tend to prey on female's insecurities about the size and shape of their bodies; however men are also falling victim to advertisements which tell them that their body is not good enough. Advertisers prey on men who buy into the idea that their body needs to be different in order to have a better life. Crafty entrepreneurs are getting rich quick by selling herbal supplements that promise male enhancement to gullible male consumers. The manufacturer of Enzyte used " Smiling Bob " to make millions of dollars to capitalize on men's insecurities, to convince consumers that there is a solution to their feelings of inadequacy, and to mask their false claims about the potential results of using their herbal supplement.

Enyte is one of the latest in a long line of potions and devices that capitalized on men's insecurities about the size and function of their genitalia. Although many men do suffer from erectile dysfunction which may require prescription medication, there are many herbal supplements available that claim to improve sexual stamina and increase penis size.". . . Ever since Viagra exploded on the market eight years ago, it has been almost impossible to watch television without seeing ads for drugs designed to enhance a man's sexual experience (ABC News) . Obviously, there are a lot of men purchasing these herbal supplements, so the market has become flooded with Ads. Even though the ingredients in most of these supplements are similar to those found in most energy drinks, and there is no clinical evidence to prove that they work , advertisers sell these products to consumers whom are willing to try anything once they have been convinced that their body isn't good enough. Enyte's " Smiling Bob " has a convincing smile which has fooled many gullible consumers into believing that they need to use an herbal supplement to have a good sex life.

In the "Smiling Bob " ads, Enzyte wants the viewer to believe that he is inadequate and that by taking an herbal supplement, he will overcome this inadequacy. The idea that one's sexual performance will be enhanced carries the myth that one's body isn't good enough into the subconscious mind of the viewer. The Christmas edition " Santa Bob " advertisement has Bob dressed as Santa Claus with a line of women waiting to sit on his lap, and claims that after taking Enzyte " . . . there's no way of mistaking this Santa for an elf anymore " ( You Tube ). There are even late-night infomercials, paid for by the manufacturers of Enyte, that interview women who say that size does matter. These women talk about how much better sex is with a man who has been taking a male enhancement pill. Many men succumb to the temptation and try a male enhancement pill as a result of these kinds of advertising practices. In order to seduce the prospective buyer even further, Enzyte offers a free trial with a money back guarantee; however, after they have billed a credit card, the first time, the Enzyte pills continue to be shipped to the consumer's address, and the fine print says that Enzyte can continue to charge their credit card.

The Enzyte ads are designed to convince men that not only will they experience a fuller, firmer erection, but that they will actually gain length and girth by taking a once a day male enhancement tablet. There are no clinical trials or studies that support the claims that Enzyte, and other similar companies, make about these sexual enhancement supplements. Even though there is information all over the Internet stating that these herbal supplements do not increase size or enhance performance, advertisements from Enzyte, and other similar male enhancement supplements, are prevalent advertisements on the Internet today.  

A former Vice President of the company testified that Warshak required customers to provide ". . . a notarized statement from a doctor. . ." proving that they had small genitalia in order to get the money back guarantee mentioned in the Enyte Ads! U.S. District Judge S. Arthur Spiegel also ordered Warshak and Berkeley Premium Nutraceuticals, along with other defendants, to forfeit more than $500 million dollars. ". . .   Judge Spiegel said.

"This is a case about greed. Steven Warshak preyed on perceived sexual inadequacies of customers ". 

While reviewing the case.  

As odd as it may seem, there are repeat customers who even today continue to purchase male enhancement supplements similar to Enzyte.   Despite the fact that there is no clinical evidence to support any real results, some men probably get results because of the placebo effect. Either the results are psychosomatic and they choose to continue taking the supplement, or the fact that they couldn't prevent Berkeley Premium Nutraceuticals from continuing to send them refills without providing notarized documentation from a doctor stating that they had small genitalia kept most of its customers quiet.  As for the “ satisfied customers, " they are more than likely plagued, like many men, with anxiety about sexual performance, and would probably achieve the same results with a sugar pill that is labeled the same as the Enzyte that they have been taking. The Enzyte advertisements are a powerful example of the effects that images have on consumers in today's culture. There is no way for consumers to avoid the images all around them, but awareness of the types of myths that are used in conjunction with these images can be the first step toward having a choice about how to feel about one's body.

Let's look at a few of the infamous Enzyte TV commercials with the character Smiling Bob:

 

 

 

 

I hope you've enjoyed this blog post as much as I have.

Courtesy of an article dated September 20, 2011 appearing in The Republic

 

NEW STATISTICAL METHOD USED IN WALL STREET BY STOCK ANALYSTS COULD BE USEFUL IN THE BATTLE AGAINST AIDS

 

Scientists using a powerful mathematical tool previously applied to the stock market have identified an Achilles heel in HIV that could be a prime target for AIDS vaccines or drugs.

The research adds weight to a provocative hypothesis—that an HIV vaccine should avoid a broadside attack and instead home in on a few targets. Indeed, there is a rare group of patients who naturally control HIV without medication, and these "elite controllers" most often assail the virus at precisely this vulnerable area.

  

Scientists have identified an Achilles' heel in HIV, the virus that causes AIDS, with a powerful mathematical method previously applied to the stock market, and think the spot could be a prime target for vaccines or drugs. Mark Schoofs explains.

Nobel laureate David Baltimore. Bette Korber, an expert on HIV mutation at the Los Alamos National Laboratory said, 

"This is a wonderful piece of science, and it helps us understand why the elite controllers keep HIV under control."  

And the study added "an elegant analytical strategy" to HIV vaccine research.

Mark Yeager, chair of the physiology department at the University of Virginia School of Medicine said, 

"What would be very cool is if they could apply it to hepatitis C or other viruses that are huge pathogens—Ebola virus, Marburg virus. The hope would be there would be predictive power in this approach."

Drs. Baltimore, Korber and Yeager weren't involved in the new research.

One of the most vexing problems in HIV research is the virus's extreme mutability. But the researchers found that there are some HIV sectors, or groups of amino acids, that rarely make multiple mutations. Scientists generally believe that the virus needs to keep such regions intact. Targeting such sectors could trap HIV: If it mutated, it would disrupt its own internal machinery and sputter out. If it didn't mutate, it would lie defenseless against a drug or vaccine attack.

The study was conducted at the Ragon Institute, a joint enterprise of Massachusetts General Hospital, the Massachusetts Institute of Technology and Harvard University. The institute was founded in 2009 to convene diverse groups of scientists to work on HIV/AIDS and other diseases.

Two of the study's lead authors aren't biologists. Arup Chakraborty is a professor of chemistry and chemical engineering at MIT, though he has worked on immunology, and Vincent Dahirel is an assistant professor of chemistry at the Université Pierre et Marie Curie in Paris. They collaborated with Bruce Walker, a longtime HIV researcher who directs the Ragon Institute. Their work was published Monday in the Proceedings of the National Academy of Sciences.

To find the vulnerable sectors in HIV, Drs. Chakraborty and Dahirel reached back to a statistical method called random matrix theory, which has also been used to analyze the behavior of stocks. While stock market sectors are already well defined, the Ragon researchers didn't necessarily know what viral sectors they were looking for. Moreover, they wanted to take a fresh look at the virus.

[Click Above Image To View Interactive Slideshow]

So they defined the sectors purely mathematically, using random matrix theory to sift through most of HIV's genetic code for correlated mutations, without reference to previously known functions or structures of HIV. The segment that could tolerate the fewest multiple mutations was dubbed sector 3 on an HIV protein known as Gag.

 

In an interview with WSJ's Mark Schoofs, NIAID director Dr. Anthony Fauci reflects on his thirty years spent fighting AIDS, and how he believes science is at a turning point where it has the potential to dramatically shrink the size of the AIDS epidemic across the globe.

Previous research by Dr. Yeager and others had shown that the capsid, or internal shell, of the virus has a honeycomb structure. Part of sector 3, it turns out, helps form the edges of the honeycomb. If the honeycomb suffered too many mutations, it wouldn't interlock, and the capsid would collapse.

For years, Dr. Walker had studied rare patients, about one in 300, who control HIV without taking drugs. He went back to see what part of the virus these "elite controllers" were attacking with their main immune-system assault. The most common target was sector 3.

Dr. Walker's team found that even immune systems that fail to control HIV often attack sector 3, but they tend to devote only a fraction of their resources against it, while wasting their main assault on parts of the virus that easily mutate to evade the attack. That suggested what the study's authors consider the paper's most important hypothesis: A vaccine shouldn't elicit a scattershot attack, but surgical strikes against sector 3 and similarly low-mutating regions of HIV.

"The hypothesis remains to be tested," said Dan Barouch, a Harvard professor of medicine and a colleague at the Ragon institute. He is planning to do just that, with monkeys. Others, such as Oxford professor Sir Andrew McMichael, are also testing it.

The Ragon team's research focused on one arm of the immune system—the so-called killer T-cells that attack other cells HIV has already infected. Many scientists believe a successful HIV vaccine will also require antibodies that attack a free-floating virus. Dr. Chakraborty is teaming up with Dennis Burton, an HIV antibody expert at the Scripps Research Institute in La Jolla, Calif., to apply random matrix theory to central problems in antibody-based vaccines.

COMMENTARY:    The HIV virus is one of the most sophisticated viruses known to man.  The way it attacks and infects the host cells that makeup the human immune system is just incredible. It binds to and then penetrates the membrane of the host cells and the HIV DNA then in an assembly-like fashion combines with the host cell DNA to form a new DNA.  No wonder the damn thing can't be killed.  If you kill the "new" HIV DNA strands, you kill the host cells too and kill the patient. This process of binding, penetration and combination is too damn complicated to try to explain, so the following YouTube video animation might help explain this better than I could.

 

AIDS can kill you in so many different ways, it was no wonder that medical health experts were baffled with the disease before they were finally able to identify the HIV/AIDS virus and how it enters, infects, combines and replicates inside the human body.  Here are some of the many symptoms of AIDS.

Here's a time lapse video of an African female named Salinah infected with AIDS who agreed to be filmed over a period of 90 days.  WARNING:  This video is a bit gruesome and may make some of you sick, but this is what AIDS does to you.

 

The HIV virus was first discovered in 1959, seeming to indicate that the virus did not exist beforehand. It was initially found in the blood of a man from Congo, but spread to the rest of the world over the next decade. Although AIDS was previously a very rare disorder, it became a common problem after the introduction of the HIV virus. AIDS was initially depicted as a virus spread by homosexual sex, but it became clear that the disease could be transmitted by any sexual contact, not just anal sex. A 1999 study reported that the HIV virus appeared to have first infected a subspecies of chimpanzee, then was somehow transmitted to African hunters via exposed blood. In spite of this, some conspiracy theorists claim that the virus was engineered to wipe out the homosexual population.

The HIV virus is transmitted mainly through bodily fluids, such as blood and sexual secretions. It can also be transmitted through saliva, although instances of transmission via this medium are rare and typically only occur when there is an open wound in the oral cavity. AIDS infections are best prevented by using sexual contraceptives, such as condoms, that prevent mixing of bodily fluids during sexual activity. Since donated blood is tested for AIDS before transfusions, you are pretty safe in the hospital, but you should always wear rubber gloves when dealing with other people's blood. Lastly, pregnant mothers infected with HIV often transmit the virus to their child.

Once the HIV virus enters a person's bloodstream, it begins to reproduce and inhibit the production of T-cell antibodies. Prior to the introduction of anti-retroviral therapies, HIV infections caused AIDS within 10 years in half of the infected people studied. Now, with the presence of anti-retroviral therapies, which slow the reproduction of the virus, AIDs can be delayed much longer. Since the treatment is relatively new, no statistics exist on how much this type of therapy delays AIDs.

There is currently no cure for AIDS, although its symptoms can be treated and you can prevent yourself from getting it by being careful. If you are infected with bacteria, you can still take antibiotics, but they won't help you with a viral infection. Unsurprisingly, most victims of AIDS die after contraction of a viral disease.

Since its discovery in 1981, AIDS has rivaled the worst epidemics in history. An estimated 25 million people have died, and 33 million more are living with H.I.V.

In 1983, Dr. Montagnier and Dr. Barré-Sinoussi, a member of his lab at the Pasteur Institute in Paris, published their report of a newly identified virus. The Karolinska Institute said that discovery led to blood tests to detect the infection and to anti-retroviral drugs that can prolong the lives of patients. The tests are now used to screen blood donations, making the blood supply safer for transfusions and blood products.

The viral discovery has also led to an understanding of the natural history of H.I.V. infection in people, which ultimately leads to AIDS and death unless treated.

In October 2008, the Nobel prize for medicine was awarded to Dr. Harald zur Hausen, 72, of Germany, and French virologists Dr. Françoise Barré-Sinoussi, 61, and Dr. Luc Montagnier, 76 for their research that led to the discovery of the human immunodeficiency virus or HIV virus that causes AIDS.  The three researchers split the $1.4 million Nobel prize.

The Ragon Institute was officially established in February 2009 at Massashusetts General Hospital (MGH), MIT and Harvard with a dual mission:  To contribute to the accelerated discovery of an HIV/AIDS vaccine and subsequently to establish itself as a world leader in the collaborative study of immunology. Founded with a commitment of $100 million from Mr. and Mrs. Ragon, the institute is structured and positioned to significantly contribute to a global effort to successfully develop an HIV/AIDS vaccine by:

• Creating non-traditional partnerships among experts with different but complementary backgrounds (e.g., engineers, basic immunologists, computational biologists, immunogeneticists, clinicians).   
• Providing a means for rapidly funding promising studies (e.g., elite controllers, innovative viral vectors) and emerging concepts in the field (e.g., innate immune system memory).
• Integrating key facets of current vaccine development efforts that have tended to follow separate tracks (e.g., seeking a combined antibody and T-cell solution).   
• Providing a substantial pool of accessible, flexible funding that will help lower the threshold for scientists to pursue risky, unconventional avenues of study that are unlikely to attract funding from traditional sources. Such funding will encourage innovation, compress the time it takes to conduct bench-to-bedside research and attract new minds to the field.The Institute creates a singular opportunity and environment to engage scientists, engineers and clinicians in challenging research for which there may be no greater benefit – saving lives and curing the ill.

The World Health Organization (WHO) prepared a Global Summary of the HIV/AIDS Epidemic for 2009, and I have included below.  The HIV/AIDS statistics are just incredible. 

Hiv aids global report 2010 - world health organization

View more presentations from turk5555.

 

Courtesy of an article dated June 21, 2011 appearing in The Wall Street Journal's Business

THE DIRTY TIES BETWEEN AMERICAN DOCTORS AND PHARMACEUTICAL INDUSTRY, AND WHY DRUGS COST MORE IN THE U.S.

There's a perverse system of incentives behind the spiraling cost of drug prices.

Amid all the debate about our rising health care costs, one thing you almost never hear about is rising drug costs. Think about it: You hear plenty about emergency rooms and chronic care, but nothing about drug prices, which are the main interaction most of us have with the medical industry.

And that's totally ridiculous: No wonder health care costs are rising so fast, when your doctor prescribes you a $100-a-month drug that could be replaced by a generic, but whose cost neither you nor your doctor is aware of, thanks to the mediating presence of an insurance company.

There's something fishy afoot, and all you need to do is follow the money, as this superb, vitally important infographic fromMedicalBillingAndCoding.Com does. Relying on hard-core investigative reporting from the likes of The New York Times and Pro Publica, it lays out the rivers of cash that drug makers use to ingratiate themselves with the medical community.

Obviously, the drug makers have every incentive to sway the decisions of doctors. They're protecting a $300 billion industry; keeping drug prices rising at an astronomical 8% a year is just good business. (If 8% a year doesn't sound like much, consider: If something whose cost is $100 now rose by that rate for 10 years, it would cost $216.)

Via: MedicalBillingandCoding.org 

Doctors, meanwhile, are the decision-makers in this whole process. And to be fair, they often don't realize that to prescribe a brand-name drug often means switching from a generic that costs many times less. Costs are invisible to them. Which perversely means that the money that drug makers pump into the system has that much more power to sway their decisions. If they're constantly being cozied up to by drug makers pushing potentially spurious benefits, why wouldn't they prescribe those brand names?

On the one hand, you have huge informal perks offered to practicing doctors, and on the other, you have a whole class of shady doctors hired to push drugs onto their peers. And these guys are often straight-up criminals.  Here's what the major pharmaceutical companies have paid our doctors since 2009.

• Eli Lilly: $144.1 million
• Glaxo-Smith-Kline: $96.4 million
• AstraZeneca: $22.8 million
• Pfizer: $19.8 million
• Johnson & Johnson: $10.6 million
• Merck & Co: $9.4 million

Isn't all this wrong, you might ask? Doesn't it mean that doctors are swayed to over-prescribe drugs, and that big pharma has every incentive to make that happen? In fact, yes. And many of the major drug makers have paid hundreds of millions -- even billions -- of dollars in fines, related to such charges. But there are resources you can tap, if you want to help address the problem.

Granted, by acting according to those suggestions, you seem to be helping no one except maybe the insurance companies (although rising drug prices also allow them to justify higher premiums). But maybe it's enough comfort to know that you're helping fight the problem, just a little bit.

If you want to learn more about the perverse system of incentives that creates all this misbehavior in the drug industry, we highly recommend this report from NPR's Planet Money podcast.

[Click here to see the infographic larger; Hat tip to WeLoveDataVis]

COMMENTARY:    The pharmaceutical industry is one of the industries that I mistrust and despise the most.  There's  a love-hate relationship.  We can't do without them, and most importantly, the pharmaceutical industry knows that only to well, and they take advantage of us.

America may have the best healthcare system in the world, but if it truly was, shouldn't we have lower healthcare costs, and be paying less for our prescription and over-the-counter medications? Unfortunately, nothing could be further from the truth, and in a blog post dated January 7, 2011 titled, "An Unabashed Look at the U.S. Health Care System, The Greatest Health Care System in the World, Damn Gummit", I explained in great detail why this is the case.  And, this is not liberal propaganda, but the goddamn truth. 

According to The New England Journal of Medicine, the percentage of the personal health care dollar spent on prescription drugs has grown faster than any other segment, including doctor and hospital bills, partly because the prices of prescription drugs have risen an average of 17 percent a year in the last few years. That is over 1,000 percent higher than the 1998 inflation rate of 1.6 percent. 

There are a lot of reasons for this, but the biggest reasons why drugs cost more in the U.S. than ANY country in the world are as follows:  

• Research & Development Costs - The high costs of research and development are often cited by the pharmaceutical industry to justify the steep prices charged for prescription medicines.  However, in a study published in February 2011, two health policy experts argue that drug companies spend around $60 million on average to discover and test a new biologic or small-molecule drug, not the the $1.3 billion estimate that goes back to a 2003 report from a team led by Joe DiMasi, a health economist at Tufts University Center for Drug Development in Boston.  Says study co-author Donald Light, a health policy researcher at the University of Medicine and Dentistry of New Jersey in Stratford, “Economists over the last 35 years have found more and more ways to make the costs as high as possible, and that’s been the chief lobbying tool for the industry.” 
• Price Controls - Prices of brand name drugs in the U.S. are higher than ANY other country in the world.  Brand name drugs in the U.S. are often marked-up 1000%.  As a consequence, other countries have established price controls in order to keep drug prices reasonably affordable for their local residents.  The price differential for brand-name drugs between the U.S. and Canada has led Americans to purchase more than US$1 billion in drugs per year from Canadian pharmacies.
• Pharmaceutical Industry Lobbyists - The pharmaceutical industry has thousands of lobbyists in Washington, D.C., that lobby Congress and protect their interests. The pharmaceutical industry spent $855 million, more than any other industry, on lobbying activities from 1998 to 2006, according to the non-partisan Center for Public Integrity.
• Advertising and Marketing Costs - The pharmaceutical industry has quickly discovered that advertising actually works.  Up to a third of consumer's watching a drug advertisement ask their physician about that drug.  As a consequence, the pharmaceutical industry is one of the largest US advertisers.  It is estimated that the pharmaceutical industry pays $2.5 billion per year for direct-to-consumer advertising, and their some of their ads have made drug companies and their brand products household names. An AARP Bulletin reported that pharmaceutical giant "Merck spent more advertising Vioxx, according to NIHCM, than the $125 million spent promoting Pepsi or the $146 million spent on Budweiser beer ads. It even came close to the $169 million spent promoting GM's Saturn, the nation's most advertised car."  TV commercials, like the ones for male erection dysfunction drug Viagra another example of big spending on advertising for just one drug. In spite of shifting regulatory hurdles and economic malaise, direct-to-consumer (DTC) ad spending on prescription drugs increased in 2009, largely on the strength of blockbuster brand promotion in traditional mass-market media.  
• Legal, Litigation, Fines and Penalties - Pharmaceutical companies incur some of the highests costs for litigation and fines and penalties for drug crimes and civil wrong doings. Allergan, (AGN) paid the government $600 million to settle criminal and civil charges arising from the company selling their Botox product as a remedy for headaches – despite forgetting to get FDA approval to do so. Novartis (NVS) coughed up $422.5 million to get rid of criminal and civil liability problems for illegally marketing some of their products.  AstaZeneca (AZN) kicked in $520 million for marketing an anti-psychotic drug for uses not approved by the FDA and for paying kickbacks to doctors.  Pharmaceutical companies are also being tried in federal courts as an answer to their exploitation of Medicare. AstraZeneca Inc. had to pay $280 million in civil penalties and $63 million in criminal penalties to the federal government after the company "paid kickbacks to health care providers and coached them to cheat Medicare to promote a prostate cancer drug." 

If you found the above article troubling and of concern, you might enjoy reading my other blog posts dated December 6, 2009, February 10, 2011 and April 10, 2011.

Courtesy of an article dated June 9, 2011 appearing in Fast Company Design, an article dated March 7, 2011 appearing in Spoonful of Medicine, and article dated June 2009 appearing in the National Council of State Legislatures