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GLG News by this Author

Can we trust Sinovac swine flu results?

September 9, 2009

Analysis of:Sinovac gets Chinese government's order to supply H1N1 vaccine | www.pharmabiz.com

The quoted dates for Sinovac's vaccine development sound too god to be true The clinical trial was commenced just 5 weeks after vaccine production started - how was quality control fitted into this The Chinese govt who desperately need >1 billion doses of swine flu vaccine to prevent a national disaster are encouraging Sinovac to export most of its initial production which seems very odd Was there really sufficient time for proper regulatory approval of this new vaccine?

How much store to put on Sinovac press release?

August 4, 2009

Analysis of:Sinovac Provides Update On Clinical Trial For H1N1 Vaccine Trials | www.medicalnewstoday.com

In their press release Sinovac don't make any mention of their swine flu vaccine trial design or how the vaccine is madeAccording to their dates, they started their clinical trial on exactly the same day as CSL in Australia, which would if correct place them equal second in the race to the clinic with Australian company Vaxine Pty Ltd, with which I am associated, coming a clear first by 2 days using recombinant protein technology developed by US company Protein Sciences Corporation!

First swine flu vaccine in the world goes into human trials

July 21, 2009

Analysis of:Swine flu vaccine trials start | www.news.com.au

The first major challenge has started between old and new influenza manufacturing technologies What cannot be contested is that the new technology got to the clinic faster than the old technology  Now what needs to be seen is which technology can provide the best protection

Old-fashioned influenza vaccine manufacturing just doesnt cut it in pandemic

July 19, 2009

Analysis of:Swine-Flu Vaccine Production Hits a Snag | online.wsj.com

The current swine flu pandemic has shown that traditional egg-based influenza vaccine manufacturing is too slow and cumbersome to deal with a real pandemic.The problem with this style of manufacturing is that the viral strain needs to be optimised for egg growth and this takes too long in a pandemic context.With a nonoptimised virus yields are often extremely low, hindering vaccine roll outOnly recombinant protein vaccine strategies bypass these problems being not reliant on virus culture

Random finding does justify change in Byetta prescribing

August 11, 2008

Analysis of:Lilly Diabetes Drug Shows a Life-Extending Promise | www.nytimes.com

Posthoc analyses are notorious for turning up observations that cannot be confirmed when formally tested Clinicians should base their treatment choices on facts not supposition In the unlikely case that Byetta does turn out to confer a survival advantage it is likely that oral DP4 inhibitors like Januvia will have the same benefits Hence this doesnt take away the problem that Byetta is injectable whereas Januvia is oral Dont expect sales of Byetta to take off any time soon

Focus on hypertension and cholesterol to reduce heart disease in type 2 diabetes

June 9, 2008

Analysis of:Tight Rein on Blood Sugar Has No Heart Benefit | www.nytimes.com

These are not the only glucose lowering studies to show no cardiovascular disease benefit in type 2 diabetes - after all the UKPDS study which went for 15 years failed to show any benefit

Don't expect vested interests in intensive glucose lowering in type 2 diabetes to give up that easily

June 9, 2008

Analysis of:Tight Rein on Blood Sugar Has No Heart Benefit | www.nytimes.com

The whole idea that intensive blood glucose control in type 2 diabetes might reduce heart disease was due to a major misunderstanding of disease pathogenesis and confusion with type 1 diabetes None of the many previous studies of intensive control in type 2 diabetes supported a significant impact on heart disease so the current findings should come as no surprise Heart disease in type 2 diabetes is multifactorial and more dependent on elevated blood pressure, hyperlipidaemia and inflammation than to elevated blood glucose. Vested interests in intensive glucose lowering in the for-profit and not-for-profit domains are unlikely to accept this latest data which threatens their business model but will find some excuse to continue to promote unrealistic blood glucose targets in type 2 diabetes

Novartis Needs To Be Nimbler Than Larger Rivals

June 6, 2008

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

Novartis Vaccines being smaller than its rivals has the opportunity to steal a base by being more adventurous and striking out into new areas Whilst meningococcal vaccines will be profitable, Novartis needs to build its early vaccine pipeline further with novel projects

Is Novartis finally conceding that MF59 is a bad flu adjuvant?

March 17, 2008

Analysis of:Intercell completes Phase I clinical trial for improved seasonal Flu vaccine formulated with IC31(R) | www.pipelinereview.com

Why is Novartis  licensing Intercell's IC51 adjuvant for development of adjuvanted flu vaccines when they already have an MF59-adjuvanted flu vaccine on the market? Published data on efficacy of MF59 in flu is not very convincing with independent negative studies not supporting Novartis's internal claims MF59 also has major safety and tolerability issues with high frequency of significant injection site pain Likely conclusion is that Novartis is preparing to jettison MF59 completely with hope of replacing it with Intercell's IC51 IC51 has long way to go before it is proven in humans and in a position to be approved by FDA

Obsession with glucose in type 2 diabetes overlooks importance of real CVD risk factors

February 18, 2008

Analysis of:Diabetes Study Partially Halted After Deaths | www.nytimes.com

No surprises here, truth is that a causal link between reduction of hyperglycaemia and reduction in cardiovascular disease has never been proven and in truth probably doesn't exist

Dont be surprised that ENHANCE STUDY did nothing of the sort!

February 18, 2008

Analysis of:Schering releases ENHANCE data today | www.tradingmarkets.com

This is yet another trial proving that clinicians should not be fooled by surrogate endpoints - only the real thing counts, namely hard end-point studies. Just like the negative FIELD study before it this just shows that over-confidence in surrogates like plasma cholesterol, HDL or triglycerides is not substitute for the real thing, namely demonstrated CVD events.

Begining of the end for Western vaccine manufacture

December 3, 2007

Analysis of:BHARAT BIOTECH LAUNCHES TWO NEW VACCINES IN INDIA (Bio-Hib and Comvac4-HB vaccines) | www.therapeuticsdaily.com

India and China are set to become major players in the vaccine market Already India vaccine manufacturers have moved from simple single component vaccines to more complex conjugates and combinations.   In the next 10 years India and China will become global vaccine suppliers.

Do Dynavax's vaccine adjuvants cause Lupus!

December 3, 2007

Analysis of:Dynavax Reports Progress in Lupus Program With Inhibitor of TLR7 and TLR9 | www.pipelinereview.com

Dynavax promotes its TLR9 activating compounds as vaccine adjuvants Now they announce that doing the opposite, namely blocking TLR9 inhibits Lupus This logically suggests its TLR9 vaccine adjuvants will increase risk of Lupus in susceptible individuals If so are they set to abandon their adjuvant programs

HPV vaccines have a long way to go

May 24, 2007

Analysis of:Cervarix® Data Show That Higher Levels Of Antibodies In The Bloodstream Correlate To Higher Levels In Cervico-vaginal Secretions | www.medicalnewstoday.com

What is currently on the market is only the first generation of HPV vaccines, Merck, GSK and no doubt others are already developing improved versions T cell immunity is no doubt critical to HPV vaccine effectiveness but this parameter is not currently being measured in HPV vaccine studies As well as number of included serotypes, a major point of distiction between the Merck and GSK vaccines is the adjuvant used, Merck have opted to go with aluminium hydroxide salt whereas the GSK vaccine uses their newer and potentially more effective ASO4 adjuvant Neither of these first generation vaccines is likely to be around in 10 years time, and hence in terms of lonterm effectivess we will have to wait to see what new vaccines eventuate to replace the current versions

Rosiglitazone meta-analysis without merit

May 24, 2007

Analysis of:Meta-Analysis Links Rosiglitazone (Avandia) to Risk of Myocardial Infarction | www.medpagetoday.com

Meta-analyses are hypothesis generating tools and in themselves have no statistical validity -  more often than not when properly tested the conclusion is found to be false. Despite including numerous dissimilar studies, the number of key AMI events separating the rosiglitazone from the placebo groups is miniscule and could easily be attributable to chance or pooling of unmatched data No consistent trend of increased AMI risk was seen in largest rosiglitazone studies where such effects should have been most noticeable.  

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