Issues & Discourse | Clinuvel Pharmaceuticals news and discussion blog

Sun protection: Appearance is a greater incentive than health for young people

Monday, November 21st, 2011

According to the U.S. Preventative Services Task Force (USPSTF), the best way to deter teens and young adults from overexposure to the sun is to demonstrate the effects ultraviolet (UV) radiation can have on their appearance.

The USPSTF, an independent panel of experts assigned to provide recommendations on an array of health prevention issues, looked at evidence indicating behavioural counselling could help to prevent skin cancer. The newly released recommendations, an update of the 2003 statement, suggest that teens’ behaviour can indeed be changed through counselling; particularly that which highlights the physical changes UV radiation causes to skin, such as premature aging and wrinkling. (more…)

EPP results and clinical relevance

Friday, November 4th, 2011

A protoporphyrin IX molecule

Over recent months I have written several times of the need for Clinuvel to prove clinical relevance in our trials with the use of SCENESSE® (afamelanotide) in erythropoietic protoporphyria (EPP). In orphan populations the need to demonstrate how a novel drug assists in their daily activities and improve their lives is at the forefront of the regulators’ minds. And so it should be, after all the objective of the pharmaceutical industry is to develop drugs which address either disease or symptoms adequately and safely. The results the company released yesterday from our Phase II US study of the drug in EPP (CUV030) have given us important data towards demonstrating clinically relevant improvement of patients’ lives. (more…)

Ultraviolet A more cancer-causing than once thought

Tuesday, October 18th, 2011

While the evidence linking sunbeds to the development of skin cancer continues to mount, recent research provides new insight into the underlying mechanisms.

Radiation from both the sun and tanning beds is made up of various wavelengths, including visible light and several types of ultraviolet (UV) radiation. Ultraviolet B (UVB) rays, those which cause sunburn, have long been heralded the culprit which initiates skin cancer. It does this by damaging the genetic information (DNA) within skin cells, forming lesions known as cyclobutane pyrimidine dimers (CPDs) and pyrimidine (6-4) pyrimidone photoproducts (6-4PPs). These lesions create mutations in the DNA which can lead to the development of skin cancer (you can read about this process here). (more…)

Susceptibility genes for nonsegmental vitiligo

Thursday, October 13th, 2011

Nonsegmental vitiligo is a common pigmentary disorder where the skin gradually loses its colour (melanin) in patches. It is unknown precisely what causes the condition, though it is generally thought to be a result of autoimmune damage to the pigment-producing cells, called melanocytes. Vitiligo is a complex, multifactorial disease, meaning that it occurs as a result of interactions between ones genes and their environment. The fact that vitiligo often presents in close relatives (10-30% of vitiligo patients report a family history of the disorder) indicates that, to some extent, it is a heritable condition. In other words, in some cases a person’s genetic make-up can predispose them to vitiligo. (more…)

Who wins from pharma cost-cutting?

Friday, September 23rd, 2011

Earlier this month Sanofi, the world’s fourth largest pharmaceutical company by revenues, announced that it would go on a cost-cutting spree, trimming its expenditure by $US2.9billion annually and cutting many thousands of jobs in the process. Amidst the upheaval, Sanofi stated its key goal for 2012 onwards was ‘generating sustainable growth’ for shareholders (the complete presentation can be viewed here). One of the key targets for its cuts was R&D costs, both in terms of overall spend and employee headcount. (more…)

‘Off-Label’ Drugs: Regulations and Policies

Tuesday, September 20th, 2011

As we recently discussed, a number pharmaceutical companies have been fined for promoting off-label uses of their drugs. These practices are difficult to control and the monetary penalties seem to have had little effect on manufacturers, as the number of off-label breaches being reported continues to grow.

In the world of contemporary medicine, off-label prescribing plays a fundamental role in providing the best available standard of care for several health problems. In some areas of practice, including oncology, pediatrics and obstetrics, off-label prescribing provides some of the best known interventions for patients. Yet, off-label prescriptions can also threaten the safety of the patients if they are not supported by legitimate scientific evidence. Hence, promoting such uses of drugs is not encouraged by the regulatory authorities with a view to safeguard the health of patients (a key regulatory role). (more…)

British Skin Foundation scratches the surface

Friday, September 16th, 2011

In a striking new campaign, the British Skin Foundation have teamed up with photographer Rankin to try and visualise the physical and emotional impact that skin diseases can have on individuals.

Launched earlier this week at London’s National Portrait Gallery, the works posted online feature models crawling with bugs, with cracked and dried skin and covered in barbed wire. For many living with skin disorders such sensations can feel all too familiar, although the symptoms aren’t always visible. (more…)

The mystery of melanin

Tuesday, August 30th, 2011

The brown-coloured pigment melanin is present in many different species – from humans, to birds, to microbes. It is well known that melanin affords these organisms some protection from the damaging effects of UV radiation, however the latest research indicates that melanin may also be providing a defense against ionising radiation (such as x-rays and gamma rays). (more…)

Study: pharma ads failing FDA guidelines

Thursday, August 25th, 2011

The marketing model for US prescription pharmaceuticals is often debated for its direct-to-consumer (DTC) advertising as the United States is one of the few jurisdictions globally which allows this type of marketing. Yet equally debated is promotion directly to physicians, key decision makers in the prescription process. Physician promotion comes in many forms, ranging from one on one visits with sales representatives to educational sponsorship to the ubiquitous branded pen. (more…)

Can Vitamin D Prevent Diabetes?

Friday, August 5th, 2011

Recently, Vitamin D has gained a lot of interest for its potential to prevent chronic diseases. The latest article released this year by Mitri et al., linking the risk of diabetes to low levels of vitamin D in the body, has created media speculation about the potential of vitamin D to help prevent diabetes.

(more…)