Humair's Blogs

Herbal/Vitamin Supplement Industry – Good or Bad?

Humair — Sat, 29 May 2010 16:20:55 +0000

On some interesting news I read a few months ago, Pfizer’s (a major pharmaceutical company) patent on its impotence drug Viagra has been partially rejected after the U.S. Patent and Trademark Office (USPTO) said it wasn’t different enough from a Chinese herb called yin yang huo (more popularly known as Horny Goat Weed).

Yin Yang Huo (Horny Goat Weed)

It seems an appeals board has upheld a decision that an element, or claim, of the patent for a method of treating male erectile dysfunction didn’t cover a new invention. Interestingly, the patent claim was key to a patent-infringement suit Pfizer had filed in 2002 against another pharma company, Eli Lilly and Co., over its rival Cialis drug. In 2002 Pfizer had filed a lawsuit that accused Eli Lilly of infringing its patent by selling the erectile dysfunction drug Cialis which can give up to 36 hours of duration as compared to only 4 to 6 hours of duration via Viagra. Soon after the suit was filed, Eli Lilly and Bayer (which sells another erectile dysfunction drug named Levitra) requested re-examination of the patent before the USPTO. Of course, this does not mean Viagra is off patent, it just means certain claims were rejected as not patentable.

Well all this erectile dysfunction reading got me thinking about the herbal supplement industry… Clearly there are herbs that have high medicinal

Foxglove (Used to extract Digitalis)

value, not only is there Horny Goat Weed (which as we see is used in some pharmaceutical drugs), but there are herbs and plants that have helped form the foundation of the pharmaceutical industry that exists today. Digitalis (extracted from foxglove) was known to stimulate heart muscle and was therefore used to treat various heart conditions. Two common brand drugs are Crystodigin and Lanoxin. Quinine, which was obtained from the barks/roots of a plant a plant from the Cinchona genus, was used to treat malaria. It was the first effective treatment for malaria caused by the protozoan parasite Plasmodium falciparum and was in therapeutic use during the 17th century. It remained the dominant and preferred antimalarial drug until the 1940s when new drugs replaced it; however, it is still used in some cases today.

For treating dysentery, a drug called Ipecacuanha (obtained from the bark/roots of the plant genus Cephaelis) was used.

Cinchona Tree (Quinine extracted from bark)

Ipecacuanha was used for many years to induce vomiting mostly if someone accidentally swallowed a poisonous or harmful substance. It has since been mostly replaced in the US by other drugs but can still be found in use around the world. There are plenty of other examples; the list of pharmaceutical drugs that contain plant/herb extracts as the main active ingredient is quite exhaustive. Four US patented brand-name heart drugs containing bark-extracted quinine include Cardioquin, Quinaglute Dura-tabs, Quinidex Extentabs, and Quin-Release. It must be mentioned that today most all drugs are manufactured by direct chemical synthesis but this does not take away from the point that there is definitely much medicinal value in herbs/plants.

So in any case, I have quickly shown that it is futile to say the herb industry is total nonsense as some people claim. Pfizer in the case mentioned above argued that there was no credible evidence that yin yang huo treated erectile dysfunction and that there was no basis for concluding that there was an effective amount of the herb in the drug to treat erectile dysfunction.

Viagra

Pfizer then went on to state that the drug included a mixture of yin yang huo and other things. The judges responded that the treatment contained the purported aphrodisiac ingredient icariin (derived from yin yang huo) and that the prior art disclosed oral administration of the herb in an amount effective to treat erectile dysfunction.

The fact that natural herbs and plants can be used to derive new medicines to fight disease should be embraced by all pharma/biotech companies. As I have already shown, the pharma industry owes its very foundation and success to this fact. Now the more pressing concern is the danger of the unregulated vitamin and herb supplement industry. It is important to remember that although the pharma/biotech industry is regulated and watched heavily by the FDA (Food and Drug Administration), there is no such scrutiny and regulation for the multi-billion herb and vitamin supplement industry.

As you can imagine, this has schemers and hustlers salivating over the thought of making a quick profit. The Internet is littered with horror stories of people duped out of hundreds of thousand of dollars or worse yet people who’ve suffered negative health consequences with some cases even causing death. Take the case of Dr. Christine Daniel who promised to her patients the improbable – the chance to cure cancer through a herbal treatment. She apparently raked in $1.1 million over three years. Being a minister as well as a doctor she convinced patients to stop their medically prescribed cancer treatment and buy her “treatment” for upwards of $5,000 with some reports of people losing as much as $13,000. The saddest part is that some patients died from the actions of this scam artist. I am perplexed it took three years to catch this scam. Just do an Internet search and you can find all kinds of supplements with ridiculous claims made through carefully worded legal jargon.

In all, I’m not one to say go with all natural remedies or don’t take chances with any kind of herbal supplements. I think like everything there must be a balance and a lot of research before you decide to put anything into your body. With pharmaceutical drugs, it’s nice to know the FDA is out there doing monitoring, but, at the same time, I don’t want to take a prescription drug for every issue I have. And if I’m ever diagnosed with cancer, I probably won’t take a mixture of herbs and spices mixed with cabbage juice that someone off the Internet states will cure all diseases. It’s all about balance and knowledge – and perhaps circumstances.

Oracle – Running with Java

Humair — Thu, 13 May 2010 09:28:33 +0000

Today at the “Bay Area JUG Roundup 2010″ at Oracle’s office in Redwood City, I got my first glimpse into what the future of Java may be under Oracle. It was a fun event and a good sign that Oracle is heading in the right direction with its approach to Java.

Before even attending the conference, I already felt Sun Microsystems was a good buy for Oracle in 2009. I’m not sure why IBM let the opportunity to snatch Sun slip away, but I’m sure they have regretted it. Oracle scooped up Sun for $7.38 billion or about $9.50 a share. IBM reportedly raised its offer to $9.50 a share before the deal collapsed. From sources I’ve talked to and reports I’ve read, I think IBM just took too long to get there and Oracle came in and offered a deal that was more tempting and seemed less problematic. Now Sun’s arsenal will only power Oracle to compete on a broader level against IBM and other IT giants such as Hewlett-Packard. In actuality, Sun is much more beneficial to Oracle than it would have been to IBM anyway. Sun brings much hardware and software that Oracle can leverage. IBM would most likely have only leveraged the software side of Sun’s business and sold off or stripped away the hardware assets.

In any case, I think Oracle is doing the right thing by putting their support behind events such as the “Bay Area JUG Roundup 2010.” Oracle CEO, Larry Ellison, has described Java as “the single most important software asset we have ever acquired.” And Java has long been decomposing with its mismanagement by Sun. Now with some fresh money and a thriving company behind it, Java may once again have a bright future ahead of it as it once did in the distant past. However, much of this will depend on the developer community behind it, and Oracle seems to have realized this early on. I have noticed an uptake in marketing, newsletters, and “buzz” around Java since Oracle took the reins.

The event tonight was a good way for Oracle to show their passion for keeping things “alive” in the developer community and to communicate their agenda. I can definitely see that the passion and intent is there, but, as far as the agenda and outcome, I guess only time will tell.

One interesting thing that was mentioned today was that the TIOBE Index shows that as of April 2010 “C” has overtaken Java for the #1 programming language spot. The following explanation is stated on the TIOBE site:

After more than 4 years C is back at position number 1 in the TIOBE index. The scores for C have been pretty constant through the years, varying between the 15% and 20% market share for almost 10 years. So the main reason for C’s number 1 position is not C’s uprise, but the decline of its competitor Java. Java has a long-term downward trend. It is losing ground to other languages running on the JVM. An example of such a language is JavaFX script that is now approaching the top 20.

This only provides more reason for Oracle to really get to work in keeping Java ahead of the game. With competitors on their heels and the downward trend of Java, they have their work cut out for them, even though, in my opinion , Java is still a great and highly advantageous technology.

Further, some individuals tonight raised concerns about Java’s future since the father of Java, James Gosling, decided to resign from Oracle last month, only a few months after the acquisition of Sun. On his blog Gosling stated the following:

“As to why I left, it’s difficult to answer: Just about anything I could say that would be accurate and honest would do more harm than good.”

I think the departure of Gosling is, of course, a blow to Oracle but not one they are incapable of handling. Oracle has a lot of work to do, but they they also have a lot of opportunities; they have the hardware, software, great foothold in the enterprise industry, and now a cult Java following. It will be interesting to see how things play out.

Celebration of Darwin’s 201st birthday

Humair — Tue, 30 Mar 2010 08:49:32 +0000

Charles Darwin

Last month I attended the “9th Annual Evolutionpalooza! – Darwin Day in San Francisco.” The event was at the main branch of the San Francisco Public Library. The short presentation by NASA Astrobiologist Dr. Lynn Rothschild on Darwin and some of his achievements as well as her brief intro on Astrobiology was interesting. Most of the information presented was nothing ground-breaking to those who are avid readers or dedicated scientists/researchers; however, I find it always good to hear information from different perspectives for discussion purposes and for refreshing one’s memory. One of the reasons I love the Bay Area so much is that there are many intellects in the area that are willing to organize events like this and participate regularly in regards to intellectual conversation. Also, the location was ideal as many library attendees who otherwise may never take interest in such a subject had an opportunity to attend and engage.

Interestingly, the event was organized by an atheist organization. I am not a religious person and will always follow where the evidence takes me, but this event raised an important question in my mind: can one truly accept the facts of evolutionary theory and still be religious? And if one does tend to accept evolutionary theory and hold religious beliefs at the same time, which will they put first in an academic or research setting: science or faith? I have spoken to individuals in the past who hold faith so staunchly that they will disregard any evidence that conflicts with their religious beliefs no matter how solid or abundant the facts may be.

When Charles Darwin published his famous book “On the Orgin of Species” in 1859 it shook the world and the foundation of all major religions. Many people saw his evolutionary theory as radical and conflicting with the religious teachings of Genesis; of course, it did conflict with the teachings and still does. Darwin and his famous book immediately received a harsh tongue lashing from his own Great Britain, as well as the rest of the European continent, United States, and the Roman Catholic Church. Nearly 150 years later the Church of England gave an official apology to Darwin for rejecting his theory on evolution and Pope John Paul II has decreed that evolution is consistent with the teachings of the Roman Catholic Church.

I will not get into debating about religious views here, but I do believe it is a great danger towards science and innovation if truth is not sought at all costs even if it takes us down a road we may not like. Can you believe even some of the greatest minds of our time such as Albert Einstein and Stephen Hawking, because of their anti-religious statements, have been savagely criticized as being theologically untrained and misunderstanding the nature of God? I am sure these legends or dare I say ‘Gods’ of science have the capacity for critical thinking and understanding!

There are many today who are trying to persuade schools to exclude evolution from the curriculum solely on religious beliefs. Think of the negative impact such a stance could have on innovating new technologies, drugs, and ideas. The study of any scientific field should have one goal at its core and that is to follow the evidence using scientific methods and make appropriate conclusions based on the facts at hand. If this is ever lost, science and innovation will lose ground that may never be able to be recovered.

Collection of Fossil Hominids:

Collection of Fossil Hominids

* (A) Pan troglodytes, chimpanzee, modern
* (B) Australopithecus africanus, STS 5, 2.6 My
* (C) Australopithecus africanus, STS 71, 2.5 My
* (D) Homo habilis, KNM-ER 1813, 1.9 My
* (E) Homo habilis, OH24, 1.8 My
* (F) Homo rudolfensis, KNM-ER 1470, 1.8 My
* (G) Homo erectus, Dmanisi cranium D2700, 1.75 My
* (H) Homo ergaster (early H. erectus), KNM-ER 3733, 1.75 My
* (I) Homo heidelbergensis, “Rhodesia man,” 300,000 – 125,000 y
* (J) Homo sapiens neanderthalensis, La Ferrassie 1, 70,000 y
* (K) Homo sapiens neanderthalensis, La Chappelle-aux-Saints, 60,000 y
* (L) Homo sapiens neanderthalensis, Le Moustier, 45,000 y
* (M) Homo sapiens sapiens, Cro-Magnon I, 30,000 y
* (N) Homo sapiens sapiens, modern

Interesting Facts: Man-made Urea

Humair — Tue, 30 Mar 2010 06:46:24 +0000

Urea - a molecular compound in human urine

Friedrick Wohler

In the past, organic compounds were restricted to those that could be produced only from living entities. These compounds were thought to contain a “vital force” based on their natural origin. This “vital force” concept was disproved in 1828 by a Geman chemist, Friedrick Wohler. Wohler synthesized a molecular compound found in human urine called urea. To accomplish this task he used the molecular compounds ammonia and cyanic acid. Urea became the first organic molecule synthesized by a chemist.

Disease-causing agents – a potential source of medicine?

Humair — Sun, 14 Feb 2010 10:54:47 +0000

We can learn a lot from the world of parasites, which in general also includes bacteria, viruses and fungi. The medical profession has long focused on bacteria and viruses more-so than parasitic protozoa partly due to the fact of how causes of disease have traditionally been identified. A pathogen had to be shown to be associated with a particular disease. In this respect it had to be isolated, grown in a pure culture, and inoculated into a host which would then produce the disease. The organism in the host also had to be shown to be the pathogen that the host was inoculated with. Bacteria and viruses were easily characterized as disease causing agents within these set of rules, but protozoa, despite their ability to cause severe disease, never really fell easily into this category. Protozoa have an extremely complex process not only in terms of the biological sense but also in terms of survival and the means in which they infect their hosts.

Regardless of the historical context and how parasites may be categorized, I want to focus on the the fact of how these disease causing agents are all good at what they do, and some are so good that we don’t even understand their process or how to mimic their process. Think about the possibility of hijacking a particular parasite’s chemistry so we can alter it’s behavior to actually fight disease instead of causing it.

Take hookworm for example, a parasitic nematode worm that lives in the small intestine of its host and believed to infect 600 million people worldwide. Two species of hookworms that commonly infect humans are Ancylostoma duodenale and Necator americanus. When a hookworm starts eating by tearing up a part of the intestine, the blood starts to clot. In the human body, when a blood vessel is torn, it picks up molecules from cells in neighboring tissue. Some of the new molecules then combine with compounds in the blood. After a series of reactions, special cells known as platelets are activated. The platelets surround the wound and stick together while a mesh of fibers is created around them; this forms a hard clot that stops the bleeding.

Hookworm

For a hookworm, this clotting is a bad thing because it means starvation, so the parasite responds with a sophisticated process that biotechnologists have been trying to mimic. It releases molecules that interfere with the clotting mechanism thereby keeping the platelets from clumping together. If the hookworm created an aggressive kind of blood thinner, the host would become a hemophiliac and bleed to death.

A San Diego biotech firm, Corvas International, has tried and failed to develop an anti-clotting medicine derived from the hookworm. Shortly after it also failed in the development of an experimental stroke medication also derived from the hookworm. Corvas International’s failure in no way means the idea is bad, it just means they couldn’t succeed in mimicking the sophistication of the hookworm. Parasites have highly sophisticated processes and one can spend a lifetime just studying one parasite alone.

The example of the hookworm derived medicine gives a brief glimpse of the possibilities of a new class of drugs that are based off the knowledge of the biological processes of sophisticated disease causing agents. As another example, take a look at the research in the field of cancer today. There has been a lot of ongoing research by scientists who are exploring the use of the herpes virus as a possible treatment for cancer. The virus would be engineered to selectively replicate in cancer cells, to trigger an immune response against cancer cells. The herpes virus would replicate and destroy cancer cells and kill the tumor, and patients would not actually contract the herpes virus.

MediGene, a German biotech company, is developing cancer-killing viruses (oncolytic viruses) for the treatment of various types of cancer. The viruses they are focusing on for this endeavor are the herpes simplex viruses, or HSVs, which

HSV 1 Virus

is most commonly known as the cause of cold sores. MediGene modifies these viruses so they can be used as a therapeutic agent in humans. This is achieved by switching off certain viral genes that normally enable the virus to multiply in specific healthy cells, thereby destroying these cells. By genetically modifying the virus, the oHSVs reproduce in tumor cells only, since only these degenerated cells are able to compensate for the loss of the removed viral genes. The result is that MediGene’s herpes simplex viruses are able to replicate specifically in the tumor cells, destroying them (oncolysis) without harming healthy tissue. In January 2009, MediGene presented positive results obtained in a phase I/II trial in the indication advanced colorectal cancer metastatic to liver. Louisiana State University School of Veterinary Medicine have engineered a herpes virus to potentially fight breast cancer, and they believe their virus destroy the cells more efficiently then MediGene’s. Research is on-going.

The possibilities of using a parasitic agent to fight disease can have a huge impact on the treatments of many diseases/health issues across the board. Another example is the drug VT-111 which is being developed by a clinical stage

A rabbit sufferring from a Myxoma virus infection

biopharmaceutical company named Viron Therapeutics Inc. VT-111 is to be used as a therapeutic to prevent damage due to inflammation, in particular cardiovascular inflammation and inflammation caused by solid organ transplantation. VT-111 is a viral anti-inflammatory protein which is being successfully adapted into a therapeutic for the treatment of human disease. Researchers identified the specific gene in the myxoma virus (a virus that attacks rabbits but not humans) responsible for the protein curtailing inflammation. Viron Therapeutics produced a purified form of the protein, and the resulting drug was named VT-111.

Helping the poorest of the poor fight disease

Humair — Sun, 20 Dec 2009 23:17:54 +0000

Sufferers of sleeping sickness

Imagine living day to day in a place plagued by constant poverty and unimaginable disease. AIDS, African trypanosomiasis (sleeping sickness), dracunculiasis (guinea worm disease), malaria, nodding syndrome, and onchocerciasis (river blindness) are some of the most common diseases the people of southern Sudan have to live in constant fear of. Although some of the diseases widespread in southern Sudan such as AIDS and malaria are also found elsewhere, southern Sudan is also plagued by some of the more exotic diseases such as guinea worm disease, nodding syndrome, river blindness, and sleeping sickness that are almost entirely local to Sudan and neighboring African countries. For instance, Sudan is known to have 80 percent of the world’s reported Guinea worm cases; practically all of these cases are in the war-torn region of southern Sudan. Guinea worm disease is a parasitic worm infection that people get when drinking infected water. Inside the human body, the larvae mature, growing as long as 3 feet and eventually escaping their hosts by punching a blister through the leg and crawling out over the course of a few days.

Trypanosoma brucei, the protozoon responsible for sleeping sickness.

Some of these diseases are not just deadly but extremely cruel by their nature of total physical and psychological devastation leading to a slow painful death. Take sleeping sickness for example, a disease caused by a single-celled parasite called trypanosome and contracted through the bite of a tsetse fly. The trypansomes enter the bloodstream and begin to steal oxygen and glucose. The symptoms begin with fever, headaches, and joint pains. The parasites enter through both the blood and lymph systems; this often causes the lymph nodes to swell up to enormous sizes. The parasite evades the immune system and eventually symptoms spread to include anemia, endocrine, cardiac, and kidney diseases and disorders. The trypansomes multiply and the parasites eventually overrun the body causing stiffness, swelling, and eventual immobility. Sleeping sickness gets its name from the way the parasites wreck the biological clock of the victim. When the parasite passes through the blood-brain barrier the second phase or neurological phase starts; the disease starts to cause confusion and reduced coordination. It is in this phase the sleep cycle is disturbed with constant fatigue and manic periods progressing to daytime sleeping and night-time insomnia. Progressive mental and physical deterioration eventually lead to coma and death.

As destructive and devastating as sleeping sickness is, the saddest part of the tragedy is the fact that sleeping sickness is a curable disease. If detected early from serological tests and/or checking for clinical signs, appropriate medication can be given. Currently, Pentamidine (for Trypanosoma brucei gambiense) and Suramin (for Trypanosoma brucei rhodesiense) provide first stage treatment and Melarsoprol and Eflornithine (for Trypanosoma brucei gambiense) for second stage treatment. First stage treatment is highly desirable as second stage treatment significantly increases undesirable and even life threatening side effects. For example, Melarsoprol is made of 20 percent arsenic and can melt ordinary plastic IV tubes. If melarsoprol manages to seep out of the veins it can cause enough severe damage to result in amputation. For second stage treatment, Eflornithine can be used as an alternative to Melarsoprol. Eflornithine is less toxic than Melarsoprol but the regimen is strict and difficult to apply. Unfortunately, Eflornithine is not effective against the Trypanosoma brucei rhodesiense form of sleeping sickness. However, it is effective against the Trypanosoma brucei gambiense form which represents more than 90% of the reported cases of sleeping sickness according to the World Health Organization (WHO).

The question that arises is how can the developed countries and those able to help the people of Sudan and others suffering from rare or geographically-confined diseases. There are many problems these people face, but I see at least three major hurdles:

Constant war has continuously kept help away and forced people to live in extreme poverty and poor sanitation. One result being that health services is practically non-existent and the population depends entirely on outside volunteers and support.
The fact that many of the diseases are not currently a threat to the developed nations where much of the medical research is done does not provide a sense of urgency and incentive for those nations to push the matter. Just think of the news swine flu made after barely becoming a threat to some of the more developed countries.
The high cost of drug development means that the market for a drug has to be large enough to compensate for the risk and costs concerned with producing that drug. A disease that is rare and localized to a poor population does not provide as much incentive for those willing to take the risk and invest the money. And even when a viable drug is available, the costs of production and distribution still exist.

Sudanese boys using pipe filters to prevent Guinea worm disease.

Unfortunately, these are the sad realties of the world we live in today, and I do not have the answers and will not try to tackle here how these issues can be resolved. However, the success of the eradication of guinea worm disease from many undeveloped countries has shown one promising pathway. Although there is no cure for guinea worm disease, tremendous progress has been made in fighting the disease by prevention and health education efforts. According to The Carter Center, by the end of 2008, there were fewer than 5,000 cases in six nations in Africa: Sudan, Ghana, Mali, Ethiopia, Nigeria, and Niger. Prevention and health education with the help of organizations such as The Carter Center and The Bill and Melinda Gates Foundation have no doubt made a significant impact on controlling the spread of diseases such as guinea worm disease and AIDS.

However with diseases spread by mosquitoes/flies such as malaria, river blindness, and sleeping sickness, the key will be improved methods for mosquito control and access to new drugs and vaccines. Funding is obviously the major issue. Many afflicted people today depend on the good will of charitable foundations and donations of vaccines and drugs from drug companies and other organizations. Further, outbreaks of dangerous pathogenic agents such as Ebola and new mysterious diseases such as nodding syndrome further complicate matters and brings more misery and fear for the already impoverished people of so many poor nations.

To help the people of Sudan and other impoverished countries, it will take a global effort on the part of volunteers, organizations, drug companies, and local governments. There is much work to be done to eradicate diseases and setup a sanitary environment to prevent future outbreaks.

Additionally, more research into parasites such as trypansomes may lead to advanced break-throughs in other areas of medical research. Trypansomes are easily able to evade the immune responses by periodically switching their major variant surface glycoprotein (VSG), a phenomenon called antigenic variation. As trypanosomes multiply in the bloodstream, the host eventually mounts an antibody response against trypanosomes expressing a given VSG. Interestingly, as trypanosomes can switch to new VSG coat variants not recognized by host antibodies, these can evade antibody mediated lysis and form the next round of infection.

Ascaris lumbricoides roundworm

Think of it as your immune system identifying an intruder and just as the intruder is identified, it switches coats and the immune system knows no better and the cycle continues repetitively. This is likely only one of many mechanisms enabling this parasite to easily deceive the immune defenses.

Realize this – most people carry parasites. Over 1.4 billion people (or about a quarter of the world population) are infected with with the snakelike roundworm Ascaris lumbricoides that lives in the intestines, 1.3 billion carry blood-sucking hookworms, and about 1 billion have whipworm. Sure these specific parasites are all treatable, but think of the millions of parasites that exist, many of which are still undiscovered and may be the root causes of diseases such as Alzheimer’s or Parkinson’s.

Pharmacogenetics – The future of “Personalized Medicine”

Humair — Sun, 01 Nov 2009 12:48:19 +0000

European Americans are ten to forty times more likely than African Americans to get a very aggressive type of skin cancer called Melanoma. People of Asian descent are more likely to have the inability to process alcohol efficiently – exposing them to more toxicity. People of Northern European descent have a predisposition for Type 1 diabetes. High blood pressure is twice as common in African Americans than in the rest of the American population. Native Americans have higher rates of tuberculosis, pneumonia, and influenza. I’ll stop there; the list is rather large.

I mention the above statistics to bring the point home for the need for more targeted or “personalized” drugs within the Pharma industry. A “one size fit all” approach for every disease/disorder simply does not aim for maximum effectiveness. Clearly the above example and more importantly common sense points to the fact that every human being is not like every other human being when it comes to appropriate medical treatment and disease prevention. Individuals have different germlines based on many factors within the evolutionary track of a specific population.

To some this may mean the end to “Blockbuster” drugs that could be prescribed to anyone who falls under a certain ailment. At the same time it may also mean capturing a higher percentage of a subgroup such as Asians or African Americans with diabetes; this would also be side-by-side with a higher success rate. But a change in drug development philosophy will come with a change in processes ranging from compound identification to clinical trials. Depending on the overall impact of these changes, they may or may not be welcomed. Whether Pharma companies will welcome the strategy of developing drugs toward specific groups or try to hold on to the past “one size fits all” model has yet to be seen.

The heart failure drug BiDil was approved by the FDA in 2005 and was the first medication marketed for a specific racial group; in this case African Americans. Although it must be mentioned, BiDil was never meant to be a drug targeted for a particular racial group; it just ended up that way after trials of the drug on the general population of severe heart failure patients showed a benefit only in African Americans. Since its approval, it has disappointed on the market with only $12.1 million in sales for 2006. A drug is considered a “Blockbuster” usually when the $1 billion barrier is broken. Further, BiDil has reached only about 1% of the 750,000 African Americans in the US with congestive heart failure. In January of 2008, NitroMed, the drug’s manufacturer, announced plans to end all promotional activities of the drug.

Unfortunately, some may see BiDil as a case of failure for “personalized medicine.” The fact is there were many factors that could have contributed to the outcome such as marketing, coverage restrictions under the Medicare drug benefit, and the availability of a generic alternative to name a few. Also, if all is judged off the expectations set by the multi-billion dollar sales of past “Blockbuster” drugs then, sure, it may not be a success under that definition. Of course, the monetary concerns of Pharma companies are not something to be brushed aside because there is a high cost to innovation and drug development.

My take on this is that science and the facts show that “personalized medicine” is needed. This may not be true for every disease or disorder, but it certainly is the case for quite a handful. Pharmacogenetics, or the study of how genetic variation can affect pharmaceutical treatment, will aid in developing a new more effective class of drugs. Personalized drugs, cost reduction, lean clinical trials, and a higher success rate is the way to a successful future.

UC Berkeley Java Certification

Humair — Thu, 24 Sep 2009 04:09:11 +0000

I just finished up my last class to get the UC Berkeley Java Certificate. The program is offered by UC Berkeley Extension, an arm of UC Berkeley. The program consists of taking and passing three Java programming courses spanning 90 hours of instruction by seasoned professionals. It’s a great way to keep your skills up-to-date, expand your skills, and network with others. However, it is a bit expensive at around $700 – $800 a class + books.

In addition to the certification program, I took another class regarding J2EE taught by a senior developer at Oracle (Oracle recently bought Sun Microsystems and now is the owner of Java); this instructor was phenomenal. I’ve also taken some other math/business courses. It seems like all the instructors are well qualified, although some are clearly better at teaching than others. UC Berkeley Extension offers many courses and certificates in different fields. I know times are tough right now with the slumping economy, but I highly recommend UC Berkeley Extension for those who want to continue learning and sharpening their skills. It can even make you more marketable for that desired job.

Pharma Mega-Mergers: When you can’t innovate, merge

Humair — Mon, 22 Jun 2009 14:24:35 +0000

In April of 2009, Pfizer agreed to buyout Wyeth for $68 billion; Pfizer’s market cap at that time was just around $100 billion. The following month Merck trumped the Pfizer deal with a $41 billion merger with Schering-Plough. What was Merck’s market cap at the time? – Roughly around $50 billion. Not to be outdone, Roche rounded-up the mega-mergers of 2009 (so far) with a $46.8 billion deal to acquire Genentech. However, it must be mentioned that Roche already had a majority stake in Genentech (55.8%), so we’re really talking about $46.8 billion for the remaining 44.2 % of Genentech it did not already own.

So why are these behemoth size deals taking place – especially in the face of the greatest recession in the United States since the Great Depression? Could this be another round of rash and risk-bloated decisions by big business as that seen by the banking and mortgage industries? It is my opinion that these mergers may reflect failure on part of the respective companies to innovate new ideas and drugs. Pfizer, even with it’s army of researchers and billion dollar buyouts, only has one drug in the top ten by sales in 2008 – Lipitor. Lipitor was the number one selling drug in the world in 2008 and brought in $13.5 billion (25% of revenue) for the company. With the patent for Lipitor ready to expire in 2010 and fourteen other patents expiring through 2014, it’s no wonder Pfizer is flexing its muscle while it still has muscle to flex. Pfizer has to be careful that it is not just making this bubble of a mess larger such that when it finally does burst, it won’t be bad but rather catastrophic. That’s usually how big business goes out – with a violent bang like Arthur Anderson, Enron, Bear Stearns, Morgan Stanley, AIG, and Lehman Brothers. It seems like Pfizer was bent hell on the deal paying a 29 percent premium over the share price and borrowing $22 billion to do so. The acquisition was financed by four banks that received U.S. government bailout money: Goldman Sachs, JPMorgan Chase, Citigroup and Bank of America. Now, this deal may help Pfizer to buy some time and explore some opportunities. Unfortunately, initially at least, instead of focusing on the pipeline, Pfizer will have to diligently work on merging together two giant Fortune 500 companies. If you’ve ever worked at a Fortune 500 company, you should get shudders just thinking about all the combining and streamlining of processes, systems, jobs, etc.

On to Merck and Schering-Plough – what do I really have to say here? The numbers speak for themselves: a company swallowing another company that’s about the same size. Merck, the worlds seventh largest pharmaceutical, does not even have a drug on the top ten sales chart for 2008. It’s pipeline, although not as bad as Pfizer’s, is nothing short of dismal. Merck’s hypertension drug, Cozaar, is set to expire in 2010 and its asthma drug, Singulair, expires in 2012. This merger makes Merck the second largest pharmaceutical company in the world and doubles the number of drugs that Merck has in late-stage development to 18. Basically, this seems like another failure to innovate story and “buy ourselves into short-term profits” strategy. Eventually it could catch-up with Merck, because if the core strategy, policies, and procedures failed you once, they will fail you again unless you can transform in time – and the larger you get, the harder it is to transform.

Roche already owned 55.8% of Genentech, so in my mind, a 16% premium over the stock price was considerable. Fortunately, Genentech is a highly innovative company and a great acquisition, but I think to buy up the rest of the company at such a cost is not necessary unless you need to please Wall Street and have little else in the pipeline of your own. Partially owning other great companies is a great strategy that balances profits and risk. Still, even at the price Roche paid, I feel they got the best deal of the three.

It will be interesting to watch the future of these companies unroll. Pfizer and Merck more-so; they have a lot of work to do. Roche will probably ride it out and benefit both short-term and long-term from the Genentech buyout.

I’m not trying to blast these companies as I feel all three can succeed and do fairly well; it all depends on the decisions and moves they make from here on forward. Pharmaceutical companies are some of the most innovative and risk-taking companies around, but one must always be ready to praise and constructively criticize when necessary.

Google App Engine goes Java

Humair — Thu, 09 Apr 2009 21:33:28 +0000

At a Google Technology User Group meet-up last night, I listened to a presentation by a Google App Engine Engineer, Jeff Scudder. This past Sunday night Google announced the support for Java on there App Engine service. Previously, the only language that was supported was Python. Also, there is now integration with Google Web Toolkit, and a Google Plugin for Eclipse.

I saw several presentations from those who have successfully used App Engine to launch their product/services. One application in particular I was really impressed with was by Dave Westwood, Founder & App Engine Developer at Buddypoke. With just two co-founders forming the team, within a few months, they have managed to capture a user base of several million. Think of BuddyPoke as something similar to a SuperPoke on FaceBook or a Smiley icon on AIM – only now add a lot more animation, artwork, and creativity and you got Buddypoke.

Google is changing the landscape of traditional web development. Google App Engine enables developers to build web applications on the same scalable systems that power Google applications. This service/product is exciting for any developer, but especially for start-ups or lone developers. If you are a lone developer or start-up with a small team and tight budget, it is very difficult to have all the expertise required for traditional web development (database management, system administration, servers, networking, scalability, etc…). The App Engine gives developers a kick-start and allows developers to concentrate on what they do best – develop. With App Engine, there are no servers to maintain: The developer can simply upload his/her application and it is ready to serve customers.

The App Engine makes it easy to develop applications that are easy to build, easy to maintain, and easy to scale as traffic and data storage needs grow. As an added perk – there is a free quota of 500 MB of storage and around 5M pageviews per month. After that you will have to pay for the resources required. The prices do seem fairly reasonable and can be seen here. Hopefully, if you’re getting that much traffic, you should be making enough money to support the required resources. What I like the most about the price model is that you can set a max limit on how much you are willing to pay if your site exceeds the resource limit for what you have bought – you set the limit for how much bandwidth you use tailored to your need and cost. For example, unlike some other web hosting companies, where the developer has to depend on himself for developing a solution to not exceed the bandwidth, Google takes care of this for you – you don’t ever have to worry about receiving a bill for $30,000.