Vladislav Gurin :: BioTech & Pharma consulting

Bioterrorism is the term used to describe the offensive employment of biological substances or toxins with the objective of causing harm to an individual or a group of individuals. These activities, in general, cause damage, intimidation, or coercion, and are usually associated with threats causing public panic. The most common biological agents used as weapons are microorganisms and their associated toxins, which can be used to promote disease or death in people, animals, and even plants. The agents of contamination can be dispersed in the air, water, food, and elsewhere.

Bioterrorism has been a problem throughout human history. One of the first reports of bioterrorism dates back to the 6th century B.C., when the Assyrians poisoned the wells of their enemies with ergot, a toxin-producing fungus often found in rye. A more recent report suggests that in the 1500s, Pizarro, in the conquest of South America, gave clothes contaminated with smallpox to native Indians. Another similar report alleges that Britain might have used pathogens to weaken their opponents during the colonization of North America. The country might have deliberately distributed blankets contaminated with smallpox to Native Americans. Terrorism using chemical or biological weapons often spreads quietly, but it can have devastating impacts.

The first convention banning biological weapons was signed in Geneva in 1925. In 1972, under United Nations leadership, 103 countries signed the Convention on Biological Weapons, which prohibits the development, production, stockpiling, and use of biological weapons. The objective of this convention was to completely eliminate the use of biological agents and toxins as weapons of mass destruction.

During a conference on bioterrorism held in San Diego, California in early 2000, experts concluded that the US was not prepared for a biological attack with pathogens such as smallpox, anthrax, Ebola, botulism, and others. At the second National Symposium on Bioterrorism in Washington, DC in 2000, one of the conclusions was that the American public health system was not prepared to respond to an attack with biological weapons. Additionally, in March 2001, researchers at the Center for the Study of Bioterrorism and Emerging Infections at the St. Louis University School of Public Health revealed that 75 percent of health agents feared that some city in the United States would suffer an attack with biological weapons within the next 5 years. The forecasts by the experts were correct: In October 2001, just four months after the meeting, the United States had its anthrax attack.

Anthrax and especially smallpox are considered the most serious threats of biological bioterrorism, due to the high fatality rate among infected individuals, the possibility of transmission in an aerosol form, and the relative ease of large-scale production. Various government-sponsored biological warfare programs have researched many other pathogens as well.

The list of pathogens with potential terrorist applications ranges from salmonella to super virulent (highly infective) strains of the bacteria that causes bubonic plague (Yersinia pestis) genetically modified by recombinant DNA technology. There are also toxins such as ricin, the organic phosphorous sarin gas, or the Ebola virus. Recently, the North Atlantic Treaty Organization (NATO) listed 39 biological agents that could be used as weapons by terrorists.

A wake-up call for the risk of bioterrorism occurred when sarin, a gas affecting the nervous system, was used in an attack carried out by the religious cult Aum Shinrikyo in a Tokyo subway in 1995. Interestingly, according to the Monterey Institute of International Studies (http://www.miis.edu), of more than 100 other terrorism acts recorded since 1960, the great majority has failed. However, interest in bioterrorism has increased significantly after the anthrax cases that occurred in late 2001. The U.S. Department of Health spent, as of the last decade, about $160 million annually on bioterrorism prevention. After the September 11 terrorist attack and the anthrax cases that followed, it is believed that investments in this area will rise substantially with an increase in the reality of terrorist threats.

As discussed, biotechnology can be used in the development of pathogens with higher virulence and increased antibiotic resistance, when in the wrong hands, but the science can also be used in the development of biodefenses as well. Early warning indicators, more precise diagnostic procedures, therapy, vaccines, pathogen identification, and new pharmaceuticals are only some of the areas in which biotechnology can be of help in the area of bioterrorism.

The main objectives in preventive bioterrorism are the production and stockpiling of vaccines and the development of early warning systems in the event of an attack. Genome sequencing also promises to facilitate the development of biodefenses and decontamination. An ongoing project at the University of Michigan is developing a mechanism to kill anthrax, using a solution of droplets of soybean oil in aqueous suspension. The droplets of this emulsion fuse with the bacterial membrane by means of a chemical reaction, thereby generating sufficient energy to destroy bacterial spores. Another interesting area of research is the production of synthetic antibodies to improve the treatment of infection.

Experts know that most of the progress in biotechnology is not only useful to combat biological agents spread intentionally, but also for naturally occurring disease epidemics. Considering that the real threat of bioterrorism is present worldwide, preventative measures are catching the attention of governments and of the public.

The use of bioweapons requires the cultivation, purification, stabilization, and large-scale production of the pathogen, as well as the development of an efficient means for dispersal. For instance, the dispersion of bacterial spores with a size ideal for uptake into the bronchioles of the lung can be an additional challenge for terrorists without scientific knowledge. Experts believe, however, that it is not difficult to find leads to bioterrorism programs in the international market. It is widely believed that thousands of trained scientists with expertise in biological warfare lost their jobs after the collapse of the former Soviet Union in December 1991.

In virtually every industry, there is a considerable lag between the discovery or invention of a new technology and a practical, marketable product based on the technology. This incubation time represents a delay in acceptance by the market, which is traditionally modeled as a sigmoidal adoption curve of early, middle, and late adopters. Slow acceptance of a new technology can be caused by issues of price, immature technology, or simply the human tendency to resist change.
For example, in the case of the Western pharmaceutical market, economic events linked to war served as a catalyst to significantly shorten adoption time.
In the United States, the Civil War (1861–1865) catapulted E.R. Squibb’s nascent laboratory virtually overnight to the status of the US Army’s primary supplier of painkillers and other pharmaceuticals used on wounded soldiers. Spurred on in part by Squibb’s success, the next several decades were marked by a flurry of activity in the US pharmaceutical industry, including the founding of Parke, Davis & Company (1867), Eli Lilly Company (1876), Abbott Alkaloidal Company (1888), and Merck and Company (1891).
Much of the economic success in the pharmaceutical market in the United States and Europe in the mid-to-late 19th century is attributed to the development of pills as alternatives to the elixirs, powders, and loose herbs used until that time. With the introduction of drugs compressed in pill form, the mass production methodologies developed during the industrial revolution could be applied to the production, packaging, and distribution of medicine. Furthermore, pills were readily accepted by the medical community because they delivered standardized, reproducible dosages of drugs. Pills were considered safer and more effective than alternative forms of drug delivery, because the quantity of active ingredients in tea made from loose herbs varied as a function of the freshness of the herb as well as the time the patient spent steeping the tea, for example.
Although the technologies of pill production were developed in Europe, they were initially exploited by firms in the United States. For example, in the first half of the 19th century, the French developed mass production of sugarcoated pills, and the English developed the first tablet compression machine. In addition, a tablet compression machine was developed in the US during the Civil War. However, the pill wasn’t fully utilized until the spurt of market activity in the US following the Civil War. William Warner began producing pills in 1866, and Parke, Davis & Company commercialized the gelatin capsule in 1875.
Paradoxically, Silas Burroughs and Henry Wellcome, who trained in the United States, brought mass-produced pills to Britain in 1880, where they patented their pill production process. Although not as popular as pills for adult patients, salves, ointments, creams, syrups, and injectables also benefited from the mass production and quality control techniques developed during the industrial revolution.
Leading up to World War I, the chemical revolution was in full swing in Germany, where organic chemists used by-products of coal tar to synthesize dyes, such as indigo, that were costly to extract from natural sources. Germany enjoyed a virtual monopoly on the synthetic dye market.
By chance, many of these dyes and their derivatives, proved to be therapeutically useful. As a result, several pharmaceutical companies were started, often as offshoots of large chemical production facilities. Because of Germany’s expertise in the chemical industry, and its close ties with university laboratories, it became the center of pharmaceutical development. However, to attribute the modern pharmaceutical industry to German entrepreneurship would be to ignore the numerous contributions of scientists and entrepreneurs in other countries.
Consider the path of aspirin to the consumer market. Folk medicine had long identified the medicinal qualities of willow bark. However, it took two Italian scientists to identify the active ingredient in the bark in 1826, and a French chemist to purify it in 1829. A Swiss pharmacist extracted the same substance from a plant, which a German chemist identified. The molecular structure of this compound was identified by a French chemistry professor. Another German modified the compound to its present form so that it wouldn’t cause as much stomach upset. By 1899, the synthetic compound became known as aspirin, and in 1900, the German drug company, Bayer, secured patents on the compound.
Bayer’s success was short-lived, however, even though aspirin eventually became the most popular drug of all time. With the start of World War I in 1914, the patents and trademarks of German factories in countries at war with Germany were sequestered. Forced to stop trade with Germany, many of the countries at war with Germany began manufacturing dyes on their own. What’s more, the 1919 Treaty of Versailles forced Germany to provide its former enemies with large quantities of drugs and dyes as part of war reparations. The United States government confiscated and auctioned off all of Bayer’s American assets, including the names “Bayer” and “aspirin” and associated trademarks—which remained outside the German company’s control until it bought them back from SmithKline Beecham in 1994.
Despite major setbacks from the pre-war pharmaceutical boom, by the 1930s, the German pharmaceutical industry was in modest recovery, producing insulin under license from Canadian researchers, and synthesizing sulfa antibiotics from dyes. In addition, German companies such as Hoechst manufactured penicillin on a large scale through the early 1940s and into World War II. The demand for antibiotics increased dramatically during World War II, sparing the lives of many soldiers with wounds that would have been considered lethal in World War I.
The aftermath of World War II also accelerated the development and production of antibiotics for civilian use, and several new pharmaceutical companies sprang up worldwide to fill the growing demand for antibiotics.
Growth was fueled by the brisk demand for second-generation antibiotics, such as streptomycin and neomycin, because of the bacterial resistance that developed in response to the liberal use of penicillin. The biotech startup phenomena of the 1970s, which was centered in the US, sparked further development in the pharmaceutical industry. These biotech companies were technology driven and primarily run by those with little real experience in the pharmaceutical industry, and with little knowledge of the lengthy drug development process and its associated regulatory hurdles. As a result, most of these firms failed. The ones that survived did so through mergers with other startups and by being acquired by established pharmaceutical companies.

Several days ago one friend of mine came to me and asked several questions about the Viagra’s description. It was not spontaneous because all of us know there are many suppliers of such pharmaceuticals as Viagra, Cialis, Tramadol, Edex, Levitra. Unfortunately, many of them don’t have valid licenses or even speculate with counterfeits.
First of all, dear readers, make your purchases only from recognised and officially-approved firms that are selling you such drugs everyday.
Secondly, I’ve already collected the description information on all drugs that are very popular and spreading quickly online, like epidemia.

• DESCRIPTIONS

LEVITRA® (Schering)
(vardenafil HCl)
Tablets

LEVITRA® is an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f ][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, mono-hydrochloride.
Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5″, “5″, “10″, and “20″ on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.

VIAGRA® (Pfizer)
(sildenafil citrate)
Tablets

VIAGRA®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H -pyrazolo[4,3- d ]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate.
Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VIAGRA (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD & C Blue #2 aluminum lake.

CIALIS® (Eli Lilly ICOS)
(tadalafil)
Tablets

CIALIS® (tadalafil), an oral treatment for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41.
The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.
CIALIS is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

EDEX® (Schwarz)
(alprostadil for injection)
For Intracavernous Use Only
Sterile Powder and Diluent
(sterile 0.9% sodium chloride) in Cartridges
Rx Only

Edex® (alprostadil for injection) is a sterile, pyrogen-free powder containing alprostadil in an alfadex ((alpha)-cyclodextrin) inclusion complex. Alprostadil is an endogenous substance known as prostaglandin E 1 (PGE 1 ). Edex® is supplied in single-dose, dual-chamber cartridges.

Edex® is lyophilized in single-dose, dual-chamber cartridges intended for use with the reusable edex® injection device. One chamber of the cartridge contains alprostadil, alfadex and lactose as a sterile, pyrogen-free powder. The other chamber contains 1.075 mL of sterile 0.9% sodium chloride. The edex® cartridges are supplied in three strengths: 10 mcg cartridge (10.75 mcg alprostadil, 347.55 mcg (alpha)-cyclodextrin, 51.06 mg lactose); 20 mcg cartridge (21.5 mcg alprostadil, 695.2 mcg (alpha)-cyclodextrin, 51.06 mg lactose); 40 mcg cartridge (43.0 mcg alprostadil, 1,390.3 mcg (alpha)-cyclodextrin, 51.06 mg lactose). The edex® injection device is used to reconstitute the sterile powder in one chamber with the sterile 0.9% sodium chloride in the other chamber. After reconstitution, the edex® injection device is used to administer the intracavernous injection of alprostadil.

The chemical name for alprostadil is (1R,2R,3R)-3-Hydroxy-2-[(E)-(3S)-3-hydroxy-1-octenyl]-5-oxocyclopentane heptanoic acid. The empirical formula is C 20 H 34 O 5 and the molecular weight is 354.49.
The (alpha)-cyclodextrin inclusion complex improves the water solubility of alprostadil. The empirical formula of (alpha)-cyclodextrin is C 36 H 60 O 30 and the molecular weight is 972.85.

Alprostadil alfadex is a white, odorless, hygroscopic powder. It is freely soluble in water and practically insoluble in ethanol, ethyl acetate and ether. After reconstitution, the active ingredient, alprostadil, immediately dissociates from the (alpha)-cyclodextrin inclusion complex. The reconstituted solution is clear and colorless and has a pH between 4.0 and 8.0. When the single-dose, dual-chamber cartridge containing either 10.75, 21.5 or 43.0 mcg of alprostadil is placed into the edex® injection device and reconstituted, the deliverable amount of alprostadil in each milliliter is 10, 20 or 40 micrograms, respectively.

It’s not a secret anymore…

The top killers of Americans, according to the Centers for Disease Control and Prevention, are:
1. Heart Disease
2. Cancer
3. Stroke
4. Chronic lower respiratory diseases
5. Accidents
6. Diabetes
7. Pneumonia/flu
8. Alzheimer’s disease
9. Kidney disease
10. Suicide

Pharmacists today have unparalleled opportunities in management as well as in patient care. But along with the diverse array of opportunities come responsibilities and accountabilities more complex and greater than any time in the past. On a broad palette, people with pharmacy degrees are being sought after by a host of industries — from insurance to computers; from automation industries to government — that had not previously considered them. An increasing number of other channels for job recruitment are being directed at pharmacists as well. The result is a multitude of pharmacists who have elected to become specialists or who have moved up to the managerial level of pharmacy. Those individuals who choose to be specialists and managers generally need advanced postgraduate education in formal degree programs, and are actively seeking these degrees.
As in every field, pharmacy managers have to deal with and keep abreast of ever-changing issues, practice policies and new technologies (for instance, Biotechnology). In pharmacy, these include the understanding of every new drug (like Viagra, Cialis, Tramadol, Levitra, Edex and many other) that comes to market.
The number of these available new drugs has expanded exponentially, and the outcomes attendant on their use are unparalleled. People who might have died from an ailment in the past survive today because of these new therapeutic options. Another factor to be incorporated in the managing pharmacist’s purview is an increasingly aged population in this country, which has dramatically driven up the demand for more and better healthcare services. An increase in the number of patients needing medical services leads to a need for more people to serve them. On still another level, the expectations for positive therapeutic outcomes and financial consequences are on a higher plane now, so managers must be increasingly attentive to areas such as purchasing, distribution and assessment of outcomes.
Managers in insurance, for example, will be chiefly concerned with policy issues, which are concentrated on getting the greatest benefit for the lowest cost. Whereas a single hospital clinic might focus on how to treat the patient best and most cost effectively, managers must concern themselves with the cost of the newest drugs and how best to get them to the patients who need them but who may not be able to afford them.
Today’s managers must rethink the labor issue. There is clearly a scarcity of pharmacists, a lack which makes it critical to keep those pharmacists currently on staff happy and engaged in their work environments. Due to the shortage, there is a growing need everywhere for supervisors to re-engineer their work forces, developing systems that allow and encourage the best qualified people to do the most important work, that provide strong support staff, and have technology-oriented people doing the more routine operations.
Pharmacists cannot and should not work in isolation, and it’s up to the administration to set the path that blends them and the support staff into interdisciplinary-health teams.
Money remains a major concern and brings to the fore the problem of supplying a patient’s need for infinite resources with a company’s finite resources. There is no question that today’s pharmacy managers have to do considerably more with less. Every organization within medicine, it seems, is working with a shortage of both money and staff. This is a situation that usually can be surmounted with some creativity and discipline.

Pfizer’s scientists recently published the information on the researches of Viagra’s interactions with various biologically active ingredients. Here you’ll find the recommendations on its usage.

Physicians should discuss with patients the contraindication of VIAGRA with regular and/or intermittent use of organic nitrates.

Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician.

Physicians should advise patients to stop use of all PDE5 inhibitors, including VIAGRA, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE5 inhibitors.

Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Physicians should advise patients that simultaneous administration of VIAGRA doses above 25 mg and an alpha-blocker may lead to symptomatic hypotension in some patients. Therefore, VIAGRA doses above 25 mg should not be taken within four hours of taking an alpha-blocker.

The use of VIAGRA offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.

One of the driving forces in the biotech economy is patent protection.
Without it, pharmaceutical companies would be averse to spend upwards of $800 million to develop a new drug for the market. Furthermore, universities and research institutes would have less economic incentive to invest years of effort in isolating human genes. Royalties for the patent holder of a successful drug can be significant. For example, when the obesity drug Redux® (dexfenfluramine) was pulled from the market because of the fen-phen debacle, MIT lost an annual royalty stream of over a million dollars.
The purpose of patents is to stimulate innovation by rewarding people for new inventions. The inventor agrees to place the details of the innovation in the public domain, in exchange for having a temporary monopoly on selling the invention. Though the initial monopoly raises consumer costs for the life of the patent, the idea is that the result is ultimately beneficial to society. In the case of pharmaceuticals, it means that low-cost generics will appear on the drug store shelves as soon as a drug goes off patent. However, some groups contend that the current practice of patenting human, animal, and plant genes is an abuse of the patent system because it increases the price of gene tests and allows companies to monopolize genes for yet-to-be-discovered applications.

A major challenge in evaluating the business of biotech is deciding what the space encompasses. At a minimum, biotech is synonymous with the high-stakes pharmaceutical industry. However, even with this narrow perspective, the number and range of stakeholders involved in the biotech value chain is significant. Bringing a drug to market involves equipment manufacturers, highly skilled researchers, research and production facilities, a fulfillment infrastructure, a score of legal personnel to handle patents and liability issues, a marketing and sales force, advertising agencies, journals, and other media outlets. Furthermore, the pharmaceutical industry affects retail drug stores, hospital formularies, third-party payers, physicians, and, ultimately, their patients.
A broad interpretation of biotech incorporates pharmaceuticals as well as dozens of other industries, from dairy, brewing, and computing, to medicine, the chemical industry, academia, materials manufacturing, and the military. For example, the production of yogurt, cheese, and baked bread are as reliant on genetically manipulated microorganisms as is the production insulin produced by bacteria that have been genetically modified through recombinant DNA technology.
For practical purposes, a reasonable compromise in discussing the biotech industry is to focus on the six interdependent categories that will most likely dominate the field over the next decade: pharmaceuticals, medicine, agriculture, biomaterials, computing, and military applications. The common thread that runs through these categories that will continue to fundamentally shape the biotech industry is dependence on the function of genes at the molecular level. Our knowledge of genes and their application in each of these areas didn’t suddenly appear with the preliminary sequencing of the human genome in 2000 or the complete sequencing in April 2003, but has roots that extend back across the millennia. Recent advances made possible by the industrial and chemical revolutions of the eighteenth and nineteenth centuries and the technology revolution of the twentieth century are especially significant. The following sections provide an overview of the progression of technologies and markets in each of the six key categories of the biotech industry.

Biotechnology is a diverse field dealing with the application of biological discoveries to industry, agriculture, and medicine. From an investment perspective, it has fallen victim to the same hype that plagued artificial intelligence (AI), real estate, junk bonds, and, most recently, dotcoms.
Much of this hype can be attributed directly to overzealous promotion of the potential of biotechnology companies to cure diseases, develop new drugs, and feed the world’s hungry through genetically engineered foods.
In addition, the press has naturally gravitated to the more sensational aspects of biotechnology, from the race to sequence the human genome to the wild speculation over the value of newly discovered genes for curing medical maladies from obesity to cancer. In the resulting confusion over what is real and what is fanciful speculation, biotechnology is variably portrayed as either the next dot-com ride for those with excess capital to invest or as simply not worth following as an investment vehicle. The public outcry over cloning, over the use of embryonic stem cells, and over the potential threat to the environment from genetically modified foods has also heightened the uncertainty of the short-term performance of investments in biotechnology.
To ignore the field as an investment vehicle because of less than triple digit returns on investment is myopic at best. In many firms and academic centers, scientists, engineers, and entrepreneurs are diligently engaged in successful research and development of the core technologies that are resulting in practical applications and products. As a result, few dispute the belief that biotechnology is the seed of an inevitable revolution of business— and life on this planet—that will have a much larger social, environmental, religious, ethical, and business impact than the industrial or technology revolutions. The issues revolve around timing, the sequence in which specific sectors of the biotechnology industry will blossom, and the risk associated with some of the more technically challenging or politically charged biotechnologies.
The ongoing biotechnology revolution invites comparison and contrast with the information technology revolution of the previous century.
For example, there are global pockets of technical expertise, capital, and demand for high-technology goods and services, and these areas don’t necessarily overlap geographically. For example, a labor force of predominantly Asian heritage is fueling many advances in the biotechnology field. Several hundred thousand researchers from Asia are studying and working in the biotechnology industry in the United States and Europe. Furthermore, in the increasingly shrinking global economy, many of these researchers rotate between centers of excellence in Asia and the West. Instead of value chains built around RAM, motherboards, and computer subsystems, the commodities of the biotechnology arena are sequencing machines, gene chips, and the myriad data that these and similar devices produce. The data, are massaged, transported, analyzed, and stored on the computers and with the software made readily available by enabling information technologies.
Investment in biotechnology varies considerably from one country to the next by virtue of corporate and government funding, variations in public acceptance of biotechnology products, and the country’s political environment. Since all of these factors are rarely favorable in any one place, a mosaic of interdependencies results that serves to drive international cooperation on a variety of levels. For example, the bright spots of government and corporate funding of biotechnology research and development are in the United States and Europe, but research and development there, in several key areas, is less than optimal. Much of Europe restricts or tightly controls genetically modified agricultural products, and, with the exception of California, the United States is an unfriendly environment for companies doing stem cell research and certain forms of cloning and genetic engineering. In contrast, the sociopolitical environments in Asia, Australia, and New Zealand are not only receptive to biotechnology research in excelling in stem cell research and other U.S.- sensitive areas, but they actively support research activity. Genetically modified foods are consumed by unknowing—or uncaring—consumers in the United States and China, while Mexico and many countries in Africa are beginning to prohibit the importation of genetically modified foods because of health concerns and to protect the local ecology from possible contamination by a genetically modified crop. Japan is a major driver for the pharmaceutical industry because it ranks third worldwide in its consumption of pharmaceuticals.

It’s a well-known fact that modern pharmaceutical market is full of super drugs, but only small groups of professionals know about the possible threats lurking around… That’s why I’ve decided to discuss it and provide you, my dear readers, with such information.

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including VIAGRA, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

VIAGRA has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg). While this normally would be expected to be of little consequence in most patients, prior to prescribing VIAGRA, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

Patients with the following underlying conditions can be particularly sensitive to the actions of vasodilators including VIAGRA - those with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.

There is no controlled clinical data on the safety or efficacy of VIAGRA in the following groups; if prescribed, this should be done with caution.

• Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months;
• Patients with resting hypotension (Blood Pressure <90/50) or hypertension (Blood Pressure >170/110);
• Patients with cardiac failure or coronary artery disease causing unstable angina;
• Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of VIAGRA. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil. If VIAGRA is prescribed to patients taking ritonavir, caution should be used. Data from subjects exposed to high systemic levels of sildenafil are limited. Visual disturbances occurred more commonly at higher levels of sildenafil exposure. Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200-800 mg). To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended.