Inequality in global healthcare
Over 230 science journals from 37 countries simultaneously published articles last week (October 22, 2007) which focused on global poverty and development. This was possible through the initiative of the Council of Science Editors which organized the “global theme issue on Poverty and Human Development” to promote awareness of this topic, especially in developed countries [1].
Over 750 articles were published globally, including many scientific and medical research conducted in developing countries.
One of participating journals, the British Medical Journal (BMJ), particularly focused on reports on healthcare issues in different countries and the apparent disparity in health services between developed and developing countries [2].
Other topics touched upon are: “childbirth safety, HIV/AIDS, malaria treatment, food insufficiency and sexual behavior, environmental and nutritional interventions to improve child survival, physician brain drain from the developing world, and altered immunity and influenza’s impact on poor children.” [1].
Photo description: Cover of BMJ issue
Personalized Genetic Information: Making Money with Our Genome
When the human genome project was finally completed at the beginning of the millennium, there was a lot of speculation about the business prospects that all these DNA information can have. However, nobody came up with anything concrete at that time. Six years later, a couple of biotech companies in the US seem to finally have found a way of making money with what we know about the human genome [1].
The nobel prize laureat James Watson made headlines earlier this year when he became the first human being to have his genome sequenced. However, sequencing a whole genome is a tedious and expensive endeavor that is unlikely to go mainstream.
The key is to focus on variations in short DNA sequences (both nuclear and mitochondrial) called single nucleotide polymorphisms or SNPs which can give a lot of information ranging from an individual’s predisposition to certain diseases to inherited traits and ancestry.
Business will probably proceed in two directions: medicine and genealogy.
The use of personalized SNPs to assess the risk factors for certain diseases will definitely be a good selling point. Additional services on genetic counseling will also bring in big bucks. This is the direction that the company Navigenics seems to be following.
On the other hand, the curiosity of knowing one’s ancestry cannot be underestimated. Another start-up 23andMe, offers “to connect you to the 23 paired volumes of your own genetic blueprint” thus gaining insight into your “ancestry, genealogy, and inherited traits.” [2]
It is expected that more and more entrepreneurs will follow these companies’ examples and come up with new ways to make money out of DNA information. However, it is not clear what regulations would apply to these types of genomic products.
Photo credit: US National Library of Medicine
Stem Cells for Safer Medicines
The closing date for expressions of interest to join Stem Cells for Safer Medicines (SC4SM) is fast approaching - on 24 October 2007 [1].
SC4SM is an independent nonprofit organization formed through a consortium of public agencies and private companies which include three international drug companies GlaxoSmithKline, AstraZeneca and Roche and the government agencies Department of Health, the Department for Innovation, Universities and Skills (DIUS), the Scottish Government, the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC).
The main objective of SC4SM is “to enable the creation a bank of stem cells, open protocols and standardized systems in stem cell technology that will enable consistent differentiation of stem cells into stable homogenous populations of particular cell types, with physiologically relevant phenotypes suitable for toxicology testing in high throughput platforms.”
This is the first open involvement of pharmaceutical companies in human embryonic stem cell research and certainly the first consortium of its kind. [2]
Viracept back in the European market
The protease inhibitor Viracept (nelfinavir) is available again in Europe. On 19 Oct 2007, European regulatory authorities reinstated this anti-HIV drug’s market authorisation in the EU [1].
Nelfinavir was first introduced in 1999 and Roche is responsible for supplying the drug in Europe. Last summer, several batches of Viracept were found to have higher-than-normal ethyl mesylate sulphonate (EMS) content. EMS is a known mutagen and teratogen.
There was a wide-spread recall of the product and it was taken off the European market upon the recommendation of European Medicines Agency (EMEA) [2].
Roche immediately took the appropriate steps to correct the manufacturing problems which apparently satisfied the European regulatory authorities, leading to its reinstatement.
ENDEAVOR DES System Gets Thumbs Up from FDA
The FDA Advisory Committe recommends approval of a new type of stent system – the Medtronic ENDEAVOR zotarolimus-eluting coronary stent system [1].
Data from the latest clinical trials which included over 4100 patients affirm the efficacy and safety of ENDEAVOR.
ENDEAVOR Efficacy in terms of target vessel failure (TVF) and target lesion vascularization (TLV) is shown to be comparable to that of TAXUS. ENDEAVOR safety profile is shown to be better than that of TAXUS and CYPHER [2].
After the recent safety concerns about DES, ENDEAVOR might just save the day.
Diagnosing and managing lower back pain: New Guidelines from ACP/ACS
Earlier this month, a series of articles in the Annals of Internal Medicine covered the pharmacologic and nonpharmacologic management of lower back.
Systematic reviews [1,2] of English-language studies included in MEDLINE and the Cochrane Database of Systematic Reviews were conducted to assess the most common pharmacologic [2] and nonpharmacologic [1]interventions indicated for acute or chronic back pain. Based on these reviews, the American College of Physicians (ACP) and the American Pain Society (ACS) recommended a Joint Clinical Practice Guideline [3]. Some of the main points of the guideline are as follows:
Clinicians should conduct a thorough physical exam and medial history review to categorize patients into 1 of 3 broad categories, namely:
· “nonspecific low back pain
· back pain potentially associated with radiculopathy or spinal stenosis,
· back pain potentially associated with another specific spinal cause.”
In patients with nonspecific low back pain, imaging tecnhiques and other diagnostic tests shouldn’t be routinely used. These techniques should only be performed “when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination.” MRI seems to be the preferred method to check for radiculopathy or spinal stenosis while CT-scan is only recommended for patients who are “potential candidates for surgery or epidural steroid injection.”
Recommended first-line medications are paracetamol and NSAIDS.
Clinicians should also advise patients on effective self-care options as well as nonpharmacologic adjunct therapies like exercise, acupuncture, massage, spinal manipulation, yoga, or progressive relaxation.
Bad News and Good New for Novartis
Within a period of 2 days, Novartis has suffered a loss in the US and scored a victory in Europe.
On 27 Sept 2007, the USFDA disapproved the COX-2 inhibitor Prexige (lumiracoxib). The drug is indicated for the treatment of osteoarthritis. Although marketed in many countries, the FDA is not fully convinced of the drug’s benefit-risk balance even after submission of additional safety data [1].
On the positive side, Galvus (vildagliptin) was granted marketing approval in the EU on 28 Sept 2007. Glavus is an oral DPP-4 inhibitor indicated for Type 2 diabetes. The centralised procedure marketing license is valid in 27 EU countries and the two EFTA countries Norway and Iceland.
It is not smooth sailing for Galvus in the US, either. Its approval in the US is delayed this year due to safety issues concerning patients with renal impairment. New clinical trials are ongoing to resolve these issues.[2].
[1] Novartis Media Release, 27 Sept 07. Prexige® receives ‘’not approvable'’ letter in the US despite being one of the most studied COX-2 inhibitors.
[2] Novartis Media Release, 28 Sept 07. Galvus® receives European approval as new treatment for type 2 diabetes with broad range of indications.