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Scientists in Germany have discovered a gene that links the gum disease periodontitis and increased risk of coronorary heart disease (CHD) and although they don’t yet fully understand the underlying mechanism of the link, they urged dentists to make sure they diagnose and treat cases of periodontitis as early as possible to mimimize the risk of heart disease.

The discovery, was the work of Dr Arne Schaefer, of the Institute for Clinical Molecular Biology at the University of Kiel, and colleagues. Schaefer presented their findings to the annual conference of the European Society of Human Genetics in Vienna on Monday 25 May.

CHD is the leading cause of human deaths worldwide, and periodontitis, a type of gum disease that results in loss of connective tissue and the bone that supports the teeth, is the major cause of tooth loss in adults over 40 years old.

Periodontitis is very common and affects over 90 per cent of people over 60 years old.

Scientists already knew that periodontitis and CHD were linked somehow and that it was most likely genetic, but until this discovery they weren’t certain.

Schaefer and colleagues found a gene on chromosome 9 whose variant is shared between gum and heart disease.

A genetic locus on chromosome 9p21.3 was already known to be associated with myocardial infarction (heart attack), so they decided to study it in two groups of patients: 151 patients with aggressive early stage periodontitis, and 1,097 patients with CHD who had already had a heart attack.

“The genetic variation associated with the clinical pictures of both diseases was identical,” said Schaefer.

The researchers confirmed the link by studying two other groups: one of 1,100 CHD patients and another of 180 periodontitis patients.

“We found that the genetic risk variant is located in a genetic region that codes for an antisense DNA called ANRIL”, said Schaefer, explaining that it was also “identical for both diseases.”

When genes make proteins they first unravel their two strands of DNA double helix. On strand makes messenger RNA (mRNA), which goes on to make the protein and the other reverse strand, called “antisense” DNA, often carries antisense RNA that complements the mRNA and can bind to it and inhibit its ability to express protein.

Schaefer said they now want to find out more about how this RNA works and the pathway it uses in healthy and diseased gums.

“In the meantime, because of its association with CHD, we think that periodontitis should be taken very seriously by dentists and diagnosed and treated as early as possible”, he cautioned.

Men and more likely to suffer from CHD and periodontitis and the two diseases share similar risk factors such as smoking, diabetes and obesity.

An imbalanced immune reaction and chronic inflammation are also features of both diseases, and scientists have also discovered for example that the presence of specific bacteria in periodontal pockets might explain the relationship between periodontal disease and acute coronary syndrome.

This study confirms the genetic link hinted at by these factors, said Shaefer, who urged:

“Patients with periodontitis should try to reduce their risk factors and take preventive measures at an early stage.”

“We hope that our findings will make it easier to diagnose the disease at an early stage, and that in future a greater insight into the specific pathophsyiology might open the way to effective treatment before the disease can take hold,” he added.

In January 2007, US scientists also reported a link between pancreatic cancer and gum disease, and last month scientists in Japan suggested that periodontal disease could act as a risk factor for reactivating latent HIV-1 in affected individuals.

We have picked up reports that say that the big three impotence drug manufacturers namely Pfizer, Bayer and Lilly Icos are being investigated following allegations that they could be fixing the prices of their erectile dysfunction medicines Viagra, Levitra and Cialis. The competition authority in Switzerland namely WEKO has noted that the prices of all three impotence medicines are nearly identical and that they were also concerned about the similarities in prices of a host of other drugs sold at pharmacies.

Viagra the original erectile dysfunction drug entered the market in 1998 and took the world by storm and still leads the competition as the best selling impotence drug all over the world however its rivals Cialis and Levitra have taken a considerable section of Viagra’s market share.

Cialis is made by Lilly Icos and recently announced that it intends to manufacture a Once A Day version of Cialis so that impotent men may be always in a position to respond to sexual stimulation without having to resort to pill popping when an opportunity for sex occurs. The normal version of Cialis is at present the longest lasting erectile dysfunction medication in that it can last for 36 hours with one pill compared to 4 hours for Viagra and Levitra. In France Cialis sells better than Viagra and is known as the Weekend Pill for its ability to give men erectile function all weekend.

Levitra made by Bayer is famous for having got Jerry Hall the former wife of rock star Mick Jagger to front its promotion campaigns. Levitra is a PDE5 inhibitor like Viagra and Cialis and has taken market share from them both.

At this point the three manufacturers of the erectile dysfunction medicines have declined to comment on the allegations but we will be following the story carefully and hopes that the prices of the impotence drugs will be lowered if they are found to have been fixed.

We are aware of the concerns of the medical establishment as to fact that not everyone who uses the trio of erectile dysfunction drugs (Viagra,Cialis,Levitra)actually is suffering from a serious erection problem but they may just be requiring a boost in the bedroom department. The problem is not helped by the fact that Viagra is a household name now and that men no longer have a reason for not being able to perform all the time and the pressure on men to perform is greater than it ever was. The sexual liberation of many women has meant that they demand much more from their men these days.

The advertising of the erectile dysfunction drugs has meant that men are increasingly looking to the drugs to boost their performance in bed and it is the women who get the most benefits from the drugs as their men are able to last longer and have harder erections. The makers of Viagra, Cialis and Levitra all say that they aim their advertising and promotion at men with real erection problems but the definition of an erection problem is difficult to define and difficult to prove to a doctor who examines you.

If you go to a docor and say you have an erection problem and you tell him you are healthy and well and have no blood pressure problems it is almost impossible for him to refuse you treatment with either Viagra, Levitra or Cialis. However this doesn’t mean that the drug is always abused as it has been known to save many a flagging marriage and give new impetus and intimacy to a relationship that is dying. Ukmedix takes great pride in the fact that it has helped thousands of couples who have sexual problems and who have a difficulty facing a doctor face to face with the problem, something that can be very humiliating and distressing for both parties in a sexual relationship.

The similarities of Viagra, Levitra and Cialis are numerous. They all function as phosphodiesterase-5 (or PDE-5 for short) inhibitors and the medical names of these drugs are sildenafil for Viagra, vardenafil for Levitra and tadalafil for Cialis. In fact all three drugs work in the same way namely by preventing the breakdown of the all important nitric oxide in the blood vessels. Nitric oxide is a compound that allows the blood vessels to relax and open in the penis so that blood can flow and an erection can be created. If the nitric oxide is plentiful enough the blood vessels stay open and the erection will be sustained for a long time.

A common myth is that is you take these drugs (PDE-5 inhibitors) you will automatically get an erection. This is not the case as unless sexual stimuli are present the mechanism of blood flowing to the penis can start. The erectile dysfunction drugs just enable the whole process to work better and faster and the great thing about them is that they boost erections irrespective of the reason for the impotence in the first place. Viagra, Levitra and Cialis in clinical tests have been shown to produce a bigger amount of erections and sexual experiences for a longer period in all men with erectile dysfunction from many different causes such as diabetes, spinal cord damage, depression and even those having prostate cancer.

While the drugs are basically the same their manufacturers are keen to differentiate them and argue for the efficacy of their own drugs. Some people prefer Viagra for example for being the original product and others might prefer Cialis for the length of time of works for. The manufacturers in fact deliberately have added different chemical compounds to the active agents so that they react differently and over a different length of time. However so far no serious study has been conducted to actually compare the efficacy of the three PDE-5 inhibitors directly.

Cialis is fast becoming referred to as The Weekend Pill as it can last for 36 hours and is also the only erectile dysfunction drug that can be taken with food. Viagra is often preferred as it the most researched and best selling impotence drug in the world and Bayer, the manufacturers of Levitra say that it is lighter on the stomach than other the other erectile dysfunction drugs.

The generic drug approval process has evolved over the past 30 years. In 1970 FDA established the Abbreviated New Drug Application (ANDA) as a mechanism for the review and approval of generic versions of drug products that had been approved between 1938 and 1962. For drugs approved after 1962, manufacturers of generic products were required to submit complete safety and efficacy data. Until 1978 manufacturers conducted clinical efficacy and safety trials. After 1978, however, manufacturers were required to cite published reports of such trials documenting safety and efficacy. Neither of these approaches was considered satisfactory, as the former was quite expensive and the latter required evidence that was usually unavailable, i.e., data that had not been published. In 1984 the Drug Price Competition and Patent Term Restoration Act focused on modifying and accelerating the ANDA procedure and gave FDA statutory authority to approve generic versions of innovator products approved after 1962 as safe and effective.

Unlike the New Drug Application (NDA) process, by which new chemical entities are approved for marketing, the ANDA process as revised in 1984 does not require manufacturers to include preclinical or clinical data establishing the active ingredient’s safety and efficacy[8] because these data were previously documented during the approval process for the innovator product. Because the generic product must be pharmaceutically equivalent and bioequivalent to the innovator product, it is expected that the two products will also be therapeutically equivalent. In other words, the assumption is that if the active ingredient has been shown to be safe and effective after it is absorbed into the bloodstream, any product that gives rise to the same concentrations of active ingredient in the body to the same rate and extent will produce the same effect; therefore, preclinical and clinical studies of the generic product are usually deemed unnecessary. FDA classifies products as therapeutically equivalent if they:

• Have been shown to be safe and effective.
• Are bioequivalent in that there is no known or potential bioequivalence problem and the products meet acceptable in vitro standards or, if the products do present a potential or demonstrated bioequivalence problem, they meet appropriate bioequivalence requirements.
• Have similar potential for safety and efficacy.
• Are appropriately labeled.
• Are manufactured in compliance with Current Good Manufacturing Practice guidelines.

An Abbreviated New Drug Application (ANDA) is an application for a US generic drug approval for an existing licensed medication or approved drug.

The ANDA contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.

Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA’s approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.

Drug stores are aware of the concerns of the medical establishment as to fact that not everyone who uses the trio of erectile dysfunction drugs (Viagra,Cialis,Levitra)actually is suffering from a serious erection problem but they may just be requiring a boost in the bedroom department. The problem is not helped by the fact that Viagra is a household name now and that men no longer have a reason for not being able to perform all the time and the pressure on men to perform is greater than it ever was. The sexual liberation of many women has meant that they demand much more from their men these days.

The advertising of the erectile dysfunction drugs has meant that men are increasingly looking to the drugs to boost their performance in bed and it is the women who get the most benefits from the drugs as their men are able to last longer and have harder erections. The makers of Viagra, Cialis and Levitra all say that they aim their advertising and promotion at men with real erection problems but the definition of an erection problem is difficult to define and difficult to prove to a doctor who examines you.

If you go to a docor and say you have an erection problem and you tell him you are healthy and well and have no blood pressure problems it is almost impossible for him to refuse you treatment with either Viagra, Levitra or Cialis. However this doesn’t mean that the drug is always abused as it has been known to save many a flagging marriage and give new impetus and intimacy to a relationship that is dying. Ukmedix takes great pride in the fact that it has helped thousands of couples who have sexual problems and who have a difficulty facing a doctor face to face with the problem, something that can be very humiliating and distressing for both parties in a sexual relationship.

Generic competition is associated with lower drug prices, with the entry of the second generic competitor being associated with the largest price reduction. We base this conclusion on an analysis of IMS retail sales data for single-ingredient brand name and generic drug products sold in the U.S. from 1999 through 2004.
We define a product as having the same compound (active ingredient) and dosage form, ignoring differences in strength and package sizes. For every branded product in the database, we computed the price per dose (extended unit) each month. For the generics, we computed, for all manufacturers of a product, the average price per dose each month and the number of manufacturers. We then combined these two datasets, by product and month, and computed the ratios of the average generic price to the corresponding branded product’s price. We ignored any products for which we did not have both branded and generic sales of at least 1000 doses in a given month. Finally we grouped the ratios according to the number of generic manufacturers and computed the average of the individual price ratios.

On average, the first generic competitor prices its product only slightly lower than the brand-name manufacturer. However, the appearance of a second generic manufacturer reduces the average generic price to nearly half the brand name price. As additional generic manufacturers market the product, the prices continue to fall, but more slowly. For products that attract a large number of generic manufacturers, the average generic price falls to 20% of the branded price and lower.

Makers of generic drugs are not required to repeat the extensive clinical trials that have already been used in the development of the original drug, says Buehler. “But they must scientifically demonstrate that their product is bioequivalent. This means that it performs in the same way as the brand-name drug.”

In the United States, trademark laws do not allow generic drugs to look exactly like the brand-name drug. Thus, colors, flavors, and certain other characteristics may be different. “But these differences don’t affect the way the drugs work or the way they are evaluated by FDA,” says Buehler. “The generic drug must have the same active ingredients.”

Consumers and their health care providers should decide whether it is best to use the brand-name or generic version of a medicine. In addition, consumers should always ask whether they are being prescribed a generic or brand-name drug, and why that particular drug was prescribed.