Hair Loss in Men

Androgenic Alopecia, also known as “male pattern hair loss” is the most common type of hair loss problem in men which eventually leads to baldness. The cause of male hair loss is genetically determined sensitivity to androgens – the male sex hormones, occurring in certain parts of scalp. The condition is passed on from one generation to another in a never-ending process.

The underlying cause of androgenic alopecia is the effects of the hormone dihydrotestosterone or DHT on the genetically vulnerable hair follicles. This sensitivity is most common in the hair follicles residing on the top of the head, particularly the front part. This creates a pattern of hair loss, and therefore, it is also known as male pattern hair loss.

In the recent past, baldness was undesirable. But with the sudden change in fashion and modern style, baldness and a clean shaven head have made a mark. However, that often is not sufficient to satisfy those men who prefer to have hair. Hair regrowth seemed impossible not too long ago. But with the advent of FDA approved Propecia (generic Fanasteride) there are more reasons for men to smile as they can now have their hair back once again.

Causes of Hair Loss in Men

Generally, hair loss in men was considered to have come from their mother’s side. However, the truth is hair loss can be inherited from either parent’s gene pool. Recent research has found that the x-chromosome more heavily influences hair loss, which makes the inheritance from one’s mother’s side slightly stronger than that of the father’s side.

DHT also plays a role in encouraging hair loss in men. It shortens the growth cycle of hair, decreases the size of the hair follicles, produces shorter and finer hair which eventually disappears.

Irrespective of the causes of hair loss, the only FDA approved solution is Propecia or generic Fanasteride.

What is generic Fanasteride?

Generic Fanasteride is an active ingredient present in Propeica. It mainly targets hair loss. Propecia is a widely used medication for hair loss; it is the only FDA approved drug for treatment of male pattern baldness that has helped people since 1992.  As the primary cause of hair loss is DHT, generic Fanasteride helps in stopping or reversing the process thereby bringing back the hair you lost and preventing additional hair loss.

The Working Mechanism

Propecia belongs to the group of “5 alpha reductase inhibitors”. Available in the form of 1 mg tablets, this is one medicine that blocks the enzyme called Type II alpha-reductase, thereby reducing the hormone level in the scalp that shortens the growth cycle of hair and reverts back to its normal cycle of growth. This eventually leads to cessation of hair loss and increased growth of hair in men.

When used for a period of 4 to 6 months, Propecia can help in getting back lost hair without causing any side effects.

Is it for everyone?

Propecia is a prescription drug. It is only recommended for men; it is not for women or children. It is also not for people below 18 years of age. These are just a few restrictions.

Does it Work?

Well, clinical trails have proved that it works dramatically. The results have been impressive, which is why it is the only FDA approved  solution to male pattern hair loss.

Concerns

There isn’t anything to talk about when Propecia is taken according to dosage specified by a doctor. It has minimal side effects. However, in some rare cases temporary reduced libido, decreased volume of ejaculation, erectile dysfunction, rashes and itching have been noticed. These are very unusual symptoms.

In one word, Propecia is safe and effective!

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There are less than 100 cases of Viagra induced permanent blindness. There are less than 7,000 cases of cardiac death connected with Viagra use. Risks are elevated for men with heart disease, high blood pressure, diabetes, high cholesterol and high lipoprotein levels. Viagra’s interaction with statin drugs are a problem, especially for men with heart disease. Post heart attack men are in a dangerously high risk group.  Some scientists recommend post heart attack men not use Viagra.

Pfizer received FDA approval for Viagra in 1989. This product generated a two billion dollar market for treatment of erectile dysfunction (ED). Pfizer claims 30 million users to date.

Vision risks:

The FDA clinical trials identified a temporary vision impairment side effect related to light sensitivity and blue, green color distortion. These warnings are on the package labeling.

The University of Minnesota published evidence linking Viagra to non-arteritic ischemic optic neuropathy (NAION). NAION is described as a “stroke of the eye,” occurring when blood flow to the optic nerve is cut. Of the 42 reports of blindness, 38 of them have been made in regard to Viagra blindness and the other four related to Cialis.

Because of this linkage, the FDA is in discussions to revise package warnings to include the risk of permanent blindness. Pfizer’s position is the incidence of Viagra induced NAION is less than that occurring in the general population and can not be linked directly to Viagra usage.

The onset of permanent blindness occurs within 24 to 36 hours after Viagra usage. There is an anatomical predisposition to permanent vision loss identified by a low cup to disk ratio. This ratio is an expression of the blood flow in the optic nerve to eyeball connection. Patients with a low ratio are higher risk for vision loss when using Viagra.  Elevated blood pressure, cholesterol, blood lipids and diabetes increase the risk of permanent vision loss.

Viagra constricts the vestals in the eye causing an interruption of the normal blood flow to the optic nerve eyeball connection. Some patients experience temporary vision impairment and others permanent vision loss.

Cardiac risks:

As of July 1999, a period of one year after Viagra release, an estimated 16 million men worldwide had taken Viagra. According to data in the Journal of the American Medical Association, 564 deaths were reported by this date.

The number of cardiac deaths related to Viagra, Cilias and Levitra are poorly reported. Extrapolating the above data and considering increased user volume, would indicate that there have been 7,000 to 10,000 Viagra related heart attack deaths to date. The above numbers are related only to Viagra. The total for all three ED products would be much greater.

It is difficult to identify Viagra’s roll in cardiac death. Pfizer, Ely Lily and Glaxo Smith Kline produce Viagra, Cialis and Levitra respectively. These pharma giants are motivated to minimize reporting significance and manipulate data related to their products. Post release reporting is not the same caliber as FDA approval trials. Once the drug is released it is difficult to contradict the FDA trial data with case studies.

Viagra labeling warns against use in conjunction with nitrates which are used by heart patients with advanced heart disease for relief of angina (chest pain). Both nitrates and Viagra are vasodilators which relax blood vestals and allow more blood flow through compromised coronary arteries. In combination this can lead to insufficient blood supply to compromised coronary arteries due to dangerously low blood pressure. You might think of it as an over dose of vasodilator. The lack of adequate blood supply can lead to a myocardial infarction (heart attack), myocardial meaning heart tissue and infarction meaning cessation of blood supply.

There are two additional cardiac risks that are poorly recognized at this point.  The first affects heart patients and the second men with no history of heart disease. Both have caused cardiac deaths.

Men with heart disease:

Cardiac deaths fall into two categories, cardiac arrest which is an interruption of the electrical pacing of the heart and infarction a cessation of blood supply to heart mussel tissue due to coronary artery blockage typically by a blood clot. This risk is related to the electrical pacing of the heart. There is an interaction between Viagra and common cardiac drugs. The danger is related to the interruption of normal electrical impulses that cause the heart to beat which may lead to cardiac arrest.

In the normal heart contraction and rest cycle there is a regeneration of electrical potential during the rest period which prepares the heart for the next contraction. This regeneration of electrical potential is called repolarization. It is most critical in ventricle contraction because these chambers are considered the main pumping component of the heart. The mineral calcium plays the major roll in repolarization.

Common heart drugs that interact with Viagra are statins, such as  Zocore and Lipator, calcium channel blockers such as Norvasc and, Lotrel as well as over the counter antihistamines. Viagra in conjunction with these drugs in men with heart conditions cause an extended QT (repolarization) segment which can lead to cardiac arrest.

This is the conclusion of a scientific study at the University of Montreal, Québec, Canada. The language is a little technical but you can get the idea.

Conclusions
Sildenafil (Viagra) blocks I_Kr and prolongs cardiac repolarization (QT) at concentrations that may be seen after drug overdose (elevated dosages i.e. 100 mg Viagra) or in the presence of impaired drug elimination (poor kidney function). Clinical attention to QT prolongation and triggered ventricular tachyarrhythmias (irregular heart beat) is warranted in patients with hepatic (liver) or renal (kidney) insufficiency or suffering from the long QT syndrome (post heart attack – heart disease) and in patients on multi-drug regimens (meaning the typical heart patient).

Men with no cardiac history:

This risk is related to clotting factors that cause healthy men as well as men with heart disease to experience elevated clotting that has caused myocardial infarction (heart attack) in both groups. It is difficult to sort out the causes of death because the pattern is the same for non Viagra users.

Researchers have identified an unexpected effect from a drug group that was thought to decrease clotting. The research produced an outcome that dramatically surprised researchers. The biochemical cGMP in past investigation was thought to lower clotting factor. However this new research showed that its initial effect was to increase clotting factor then reduce it. Earlier research keyed onto the later effect of reduction. Scientists identified a dramatic increase in initial clotting (platelet aggregation) when Viagra is taken. They characterized the effect this way. “It is similar to an external wound. The platelets initially respond by becoming sticky and aggregate (clot) to stop blood loss. When this phase is over platelets decrease clotting to allow blood flow to heal the wound.”

This elevated clotting factor combined with moderately narrowed (ischemic) arteries can trigger a heart attack. Men perceived to be healthy may actually be at risk for a cardiac event. Studies have shown that men in their twenties have 50% to 70% blockage. This coupled with Viagra’s elevated clotting effect is like Russian roulette. You don’t know if your make up will trigger a fatal event.

Hearing loss:

On October 18, 2007 the FDA announced changes to Viagra labeling to include sudden hearing loss. Two thirds of hearing loss cases resulted in permanent hearing loss. There has been minimal scientific investigation on the cause of hearing loss experienced by Viagra users. Other diseases assign hearing loss to reduced blood supply. Given the vascular constriction documented in NAION blindness above it seems apparent that this effect may be the cause of hearing loss.

 Therapeutic goods in the United States comprise most medications and are regulated by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only. The intent of the FDA is to require a valid prescription for therapeutic goods classified as prescription only. However there is a huge grey area for legitimiztion of online pharmacies because of their FDA manufacturing compliance as well as the excessive cost of therapeutic goods for uninsured, under insured and seniors on low income. Several state have programs legalizing online non prescription pharmacies. Therapeutic goods imported from Canada are allowed if they meet certain FDA conditions. Learn more

 Offshore non prescription pharmacies answer the question: “Is it legal to purchase online with out a prescription”. Their answer:  “Yes, because generic product is shipped from different countries, and depending on the medication, laws in that country do not require that you have a prescription”. This response is a true reflection of FDA policy. The FDA defers to the country of origin regarding dispensing regulations and credentialing of pharmacists or suppliers. In other words the FDA has no interest in prosecuting the overseas supplier or the U.S. consumer. 

 Non-controlled substances (therapeutic goods) comprise most of the medications used to treat common diseases including: ED products, certain weight loss produces, antidepressants and antibiotics. These are considered to have a low potential for abuse or dependency. The FDA regulates and enforces non controlled substances.

 Controlled substances are categorized, evaluated and enforced by the Drug Enforcement Agency (DEA). The uses of these substances have a high potential for abuse and dependency.  Some of these substances are staples in the medical community and some are illegal street drugs. Examples of illegal street drugs are Heron, Ecstasy, and Peyote. Examples of medically recognized products are Vicodin, Codeine and Morphine.

 The 1970 Controlled Substance Act (CSA) was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. This act only addressed controlled substances.

 In April 2009  the Ryan Haight Pharmacy Protection Act an amendment to the CSA which targeted internet sales of controlled substances was enacted into law. While this amendment applies to controlled substances the conceptual implication could be applied to non-controlled substance. However the language again excluded the consumer as a culpable party in any illegal sales from the internet.

Ryan Haight provides additional clarification of  the the term “valid prescription”. This is important for internet sales of controlled substances however therapeutic goods fall outside this legislation. The lawyers see this as a huge vote in favor of online and overseas pharmacies. Their interpretation leaves the door open to legal wrangling. But the larger implication is this was deliberate to allow non-prescription offshore therapeutic goods a clear path to the U.S. consumer.

Indian suppliers are the generic sourcing choice for Canadian and online pharmacies because globalization is driving them toward U.S. FDA compliance in the move to more collaborative relationships with the US, EU and Japan. Learn more.

Be sure that your online vendor uses FDA compliant suppliers. This page represents proper disclosure that would be reassuring for a consumer.

Evolution of the Indian pharmaceutical industry:

In the 50’s and 60’s India had minimal domestic pharmaceutical production.  They were dependent on western sources for medicines which they could ill afford. The Indian government instituted tariffs and liberalized patent laws to nurture a domestic pharmaceutical industry. The patent laws allowed Indian companies to copy expensive original preparations by foreign firms and produced these by means of alternative production procedures. This had the effect of allowing Indian manufactures to duplicate western formulations before the expiration of the patent in the country of origin, typically the US. This environment caused western pharmaceutical companies to withdraw from India.

From the 70’s to 2005 the Indian pharmaceutical industry experienced double digit growth. They became expert at producing western preparations using a slightly modified process to stay within Indian patent law. They became known as the “Pharmacy of the poor”. Low wages and high educational standards lent it self well to super charging the growth of the pharmaceutical industry. Focusing on generic production eliminated developmental risk as well as prohibitively expensive research dollars.  India holds 20% of the world generic market but 2% of the pharmaceutical world market. 22% of total generic production is exported and of that 80% goes to US and the EU.

After the 2005 patent law reform, which resulted in the adoption of the Agreement on Trade-Related Aspects of Intellectual Property Rights, the industry entered a more collaborative environment with western pharmaceutical industry than during the earlier developmental period. This reorientation of the industry resulted in these important changes.

1. A segment still focuses on generic as its prime business. In this segment 80% of generic production is targeted for US, EU and Japan.

2. A major segment is focusing on development of new medicines. This has spawned new research relationships between Indian firms and western giants like Ely Lily.

3. Contract manufacturing for western giants is the last segment of the reorientation.

The most significant change resulting from patent reform is movement of the entire Indian pharmaceutical industry toward US FDA compliance due to the new western focus on so many touch points. The US, EU and Japan are the most lucrative world markets. Since the US FDA governs the major segment of export target market the move to FDA standards serves the reorientation of the Indian pharmaceutical industry.

Here are some relevant excerpts and website links.

The Indian pharmaceutical industry is also getting increasingly U.S. FDA compliant to harness the growth opportunities in areas of contract manufacturing and research. Indian companies such as Ranbaxy, Sun Pharma, and Dr. Reddy’s are increasingly focusing on tapping the U.S. generic market. Recently, Ranbaxy Laboratories Ltd has received a tentative approval from the US Food and Drug Administration to manufacture and market Lamivudine tablets (150 mg), a medicine used in treating HIV infection. This tentative approval has been granted under the US President’s Emergency Plan for AIDS Relief Initiative (PEPFAR).

Wage costs in the Indian drugs industry come to only about 30% of the European level or 20% of the US level. Overall drugs manufacturing in India is up to 50% cheaper than in western industrial countries.

Here is an overview of the Indian pharmaceutical regulatory structure. Click on full screen and use finger to advance through slides.

These circumstances generated the investigation which produced this information.

The event:

In November of 2006 I had a second heart attack. This event was in addition to the first heart attack and stent in 2002 and a 2005 a bad stress test report led to two more stents. This second heart attack was the first event which resulted in heart tissue loss. This loss was due to blockage from clotting in the LAD diagonal artery.

In August 2006 we moved from NJ to GA. I had no contact with a Cardiologist at this point.  The November 2006 heart attack left me at the mercy of the ER to produce a qualified Intervention Cardiologist. The surgery was to no avail. The artery was too firmly blocked to get a stent implanted. The LAD diagonal was lost. I was put on a Coreg a beta blocker designed for post heart attack patients.  Here is the difference between domestic brand and Canadian generic sourced from India.

Validate per pill pricing  Carvedilol  (Generic Coreg)

The story:

My plan was to get the med from Canadian online to save money. At this point I was three years short of being eligible for Medicare. I had no insurance. Investigation into private coverage produced the same answer from several insurers. I was uninsurable because of my cardio history. They said they could do something with corporate coverage but not private. Ultimately the whole 2006 event cost me around $10,000 cash. The hospital gave a 40% discount and the doctor around 30% for a lump sum cash payment. The alternative to cash would have been a pay schedule with interest.

In the follow up visit I asked the doc for a one month brand prescription which was called into a local pharmacy as well as a hand written script to fax to Canada. The reason for the one month local prescription was to accommodate the two to three week delivery time for Canadian generic product that would come from an Indian supplier. I found that local pharmacies will only give you a thirty day supply but Canadian or online pharmacies will fill a ninety or one hundred eighty day order.

When I went to pick up the prescription the local pharmacist frightened me. He was very adamant that the non-domestic suppliers universally produced unsafe, impure and ineffective products. After this unsettling experience I was determined to get to the bottom of this quality issue. So took the one month order of the brand from him and went home to investigate. Obviously I was very interested in getting proper effectiveness from this med.

I went on the computer and searched the word Coreg. This produced some Canadian pharmacies which had a generic. I looked up the generic name a Cardivas. This was very comforting. The word Cardivas let me to Intas Pharmaceutical a manufacturer in India. The above link shows that Intas is FDA approved and inspected.

These images show the 2005 and 2006 stent procedure. I had bypass surgery in 2008. I asked the 2006 surgeon “you think I would be better served with a bypass?” He said “no”. The bypass was done at the Atlanta VA by Dr. David Vega and the Emory University heart transplant team which does heart procedures at the VA twice per week. I felt very blessed to have that world class team do the procedure.

Heart images 2005-2006

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There are currently over 40 million people who are uninsured or under insured and cannot afford prescription medications. Most of us have felt the pinch of health care expenses. It seems that we contribute more to our premiums and co-pays than ever before.

There are a half a million American’s falling out of the job market every month. Paying extend medical benefits is in many cases prohibitivly expensive if you loose your income. There is a large segment of the population that needs relief from the high cost of pharmaceuticals. I am offering a solution to the high cost of meds which will provide relief for this growing segment of the population.

I was introduced to online pharmacy savings by my father-in-law who used this avenue to manage his AARP-United Healthcare drug plan allowance. Learn more.

There are considerations related to safety, purity and effectiveness that are insured by our FDA (Food and Drug Administration). Learn more.

We all want safe and reliable pharmaceuticals. There are offshore supplier issues that concern each of us. We want to know that the source of our pharmaceuticals are regulated and inspected by proper authority.  This fits together in a complex relationship of vendor, supplier and regulator. Learn more.

The upcoming health care reform legislation highlights the urgency of resolving some of the prohibitively high cost of services. The new legislation targets the insurance industry that controls healthcare delivery.  This implies the high cost of drugs will not be resolved by the new legislation. I believe there will continue to be price benefits to be gained by using online pharmacies. The cost of drugs will continue to be prohibitively expensive for millions of Americans.

I would like to close this article with a positive personal experience. These offshore suppliers are able to pass on mind boggling savings. They can produce FDA quality product for about five cents on the dollar. I will give two examples. First example: I ordered some generic product that was to be in tablet form and it came as a capsule.  My interest was being able to cut the tablet and get a more economical per pill cost.  I called and told the vendor’s representative, I was expecting a tab and got a cap. The representative said no problem we will send a replacement tab order. I enquired about returning the cap order. The representative said they were not expecting to have the incorrect cap order returned. Whew – I was impressed. I got to keep a double quantity for the price of one order. But I thought how can they do that?  The implication is that production costs must cover this eventuality. I don’t know the precise details but the message was clear. They can deliver meds at a dramatically reduced cost.  Second example: Some vendors offer a 20% coupon for initial order and a reorder price reduction of 10% or 20% more product.  So there is a pretty big margin some where. All this on top of a 90% lower price point than paid in the first world markets.  Think about that. – Wow!