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GSK Leads Way On Ethics
Interesting article ranking pharma in terms of their ethical reputations and it's good news for GSK as they come out on top. Covalence's quarterly ranking for Q1 2007 is based on 45 criteria such as labour standards, waste management, product social utility or human rights policy.
Infact GSK was the 9th ranked multinational across all industry sectors, which is a great achievement for them and a boost for the reputation of the pharma industry as a whole.
Ethics have never been so high on the political agenda. On a slight tangent I remember an article a short while ago arguing against multi-centre clinical trials on the grounds that they had a big carbon footprint....
Chinese Drug Safety Chief Sentenced
Avandia
There has been something of a furore in recent days over suggestions that GSK's Avandia (rosiglitazone) has caused an increased incidence of heart attack. A meta-analysis of 42 reported clinical trials of the drug by Steve Nissen (of Vioxx fame) led to the conclusion that rosiglitazone is associated with a statistically significant risk of cardiac events. An immediate consequence of this has been that the 4500 patient RECORD trial - which was due to run til 2008 - may have to be stopped after an undisclosed number of patients dropped out.
GSK stock dropped 8% on the news, but we should remember there are some differences between Avandia and Vioxx. The latter's withdrawal was based on analysis of Merck's own data, the Avandia outcome is the result of pooled data from a number of trials - none of which were looking specifically at cardiac risks or events, and as the number crunchers did not have access to original source data the outcomes were based on publicly disclosed summaries of events.
It will be interesting to see how this one plays out in the days and weeks to come. A withdrawal seems unlikely at this time (and would deny many patients a product that seems to be working well for them), whilst after the Seroxat / Paxil clinical trial controversy the last thing GSK want is allegations of another cover up.
Clinical trials in India
Nan Singh said:
My company is based in India. We are looking for US companies to be working with us in clinical trials. We can provide patients and data collection.We can also supply products from EU companies Nan
IMP licences
John Bradley as asked:
'My company repacks pharmacuetical products, we are looking at clinical trials packaging but we are told we need a IMP licence. Can any one tell me how and what we have to do to get this'. John
Lung Cancer Breakthroughs
Front line non small cell cancer treatments such as Roche’s Tarceva are hugely effective, but only in around a fifth of patients. Researchers in
A separate set of researchers have designed a new method of evaluating treatment effectiveness in non small cell lung cancers. Dubbed disease control rate (complete response rate plus the partial response rate plus the rate of patients whose disease stabilized) it is said to offer a better prediction of how drug intervention will affect survival, and so, say researchers, enable them to design better trials.
And finally, in perhaps the least surprising clinical trial result yet, researchers at the prestifgous Duke University Medical Centre in the
DTC Advertising Debate
During its annual meeting in
The legislation is of course under fire from advertisers and media companies, to whom the DTC market is worth $4 billion per year. They argue that advertising has increased consumer awareness and encouraged visits to doctors and want a voluntary code of practice.
More and more this is starting to look like the litigation trap that the EU was hoping to avoid when it placed severe restrictions on DTC advertising.
Marketing Illness
More and more we are hearing accusations in the media about pharma ‘inventing’ conditions at the same time as releasing expensive treatments for them. Depending on your point of view this is might gross exploitation and profiteering, fantastic marketing or entirely unfounded rumour mongering.
Probably the most commonly cited example is Restless Leg Syndrome, a condition whereby sufferers have an irresistible urge to move, disrupting sleep and everyday life to a sometime debilitating degree. No one is denying the existence of RLS – it was identified in the 1940s – but the big question is whether normal, minor, everyday maladies are being diagnosed and treated with powerful drugs.
With patient knowledge apparently at an all time high this once again opens up the debate about direct to consumer advertising, which is prevalent in the US but banned by law on this side of the Pond. Research has shown that it can be surprisingly easy to convince doctors of the existence of a condition, particularly a less well known one. One thing that can’t be disputed is that sales of GSK’s Requip, the first FDA approved treatment, have jumped from $97million to $146million since its approval and marketing campaign.
Parexel Cleared... Then Slammed
CRO Parexel has been cleared by the MHRA of contributing to the recent events at
As the majority will only be aware of the time top line of the report in the headlines tonight it appears that this report will do little to enhance public support for the clinical trials process – about which only bad things seem to be have been reported in the media since the celebratory and hysterical headlines that Crestor could turn back the clock on so called ‘bad’ cholesterol.
Roche's Trial Register
Recently published data shows that Roche’s new clinical trials database has received over 100,000 hits since being launched and has published in excess of 300 protocols and result summaries. Roche’s lead is admirable as having this type of information to hand is useful not only for patients but also doctors and people working within the clinical trials industry.
The secrecy inherent within the industry typically leads to a lost of time spent trying to locate data that currently is only released on a voluntary basis. Add to this the heavy
Currently, there are several registers of clinical trials around the world but there is little coordination between them, which makes them practically useless from a research point of view, so any movement towards a standard system will certainly be welcomed by us.
Phase 2 and 3 Trials
Bob said:
Hi I am student working in the clinical trails sector. Can anyone help me I want to know if I can find out what companies have trials in phase 2/3. Do you now any site that I could use. Regards Bob
Bob you can start by looking at some of the sites listed in our links section but I'm sure other readers have other suggestions?
GSK Wins Court Injunction
Pharma is in the public eye once again this week on the back of GSK applying for and receiving an extraordinary injunction barring persons unknown from intimidating a number of its small investors who have been targeted by animal rights extremists the Animal Liberation Front. The injunction will make it illegal for the activists to publish the personal details of investors in GSK on the web with any person found in breach facing prosecution and possible imprisonment for contempt of court.
The spat, which like a number of others in this country has it’s roots in the use of the Huntington Life Sciences testing company resulting in a Newsnight interview with an animal rights activist who appeared neither to know GlaxoSmithKline’s name nor be able to control his mouth being cut off in typical Jeremy Paxman style.
It is encouraging to see GSK taking this issue so seriously, especially when we consider that the ALF has in the past resorted to placing explosives under its ‘targets’ cars. Although somewhat of a hackneyed argument it would be interesting to see how one of these ‘campaigners’ would react when faced with a choice between death or an animal tested treatment. I don’t think anyone is arguing for the use of animal testing when there are alternatives, but for the time being at last that isn’t always the case.
Volume Of Phase IV Trials To Increase In US
The volume of phase IV clinical trials in the
Crucially for those of us in the industry it would appear that pharma are generally keen to conduct the trials, and following a 12 month consultation period the way should hopefully be lit for these studies to take place, potentially generating a vast amount of business for CROs and other outsourcing providers.
Path Cleared For Generics In Developing Countries
Moving forward as sedately as ever news from Brussels that a World Trade Organisation agreement originally agreed in December 2005 is a step closer to becoming law in Europe, hopefully as soon as 2007.
The process to ensure that developing countries are given access to expensive patented medicines began way back in 2001 with the so called Doha Declaration. Waiving the usual intellectual property licencing rules in a move Trade Commisioner Peter Mandelson said “shows that the EU is committed to the WTO process, and to ensuring that the WTO system can respond to the public health concerns of poor countries in need of affordable medicines” by allowing generic manufactuers to produce licenced pharmaceuticals for export to poor countries without the permission of the patent holder.
Companies in the EU will now be able to apply for a licence to manufacture products for export to countries in need of medicines and facing public health problems. Whilst there are no specific restrictions it will be interesting to see how pharma responds to the caveat “that they are required to address public health problems.” In theory, provided countries in need notify to the WTO the medicines they need, it would be up to generic companies to decide to apply for licences to manufacture them, with regulation prohibiting re-importation into the EU.
To me this is welcome news, and should hopefully go some way towards easing the ridiculous obstacles in getting healthcare products to people in need to less developed countries. From personal experience the current regulatory climate can mean that charities are unwilling to accept pharmaceuticals gifted to them by companies in light of the costs assocaited with clearing them. This ruling seems like a step in the right direction, assuming companies can be persuaded to seek the licences and that big pharma don’t put too many obstacles in their way.
European Pharma To Post Results
After last week’s flurry of reporting over in the States this week sees the turn of the big players in the European market. Pharma in the
Whilst cost cutting is as part a part of European strategey as American, overall analysts report that as “Europeans have better fundamentals and topline growth" 1Q earnings are expected to be more solidly based on sales growth than their
Swiss based Novartis which totaled $32 billion in 2005 sales and reports today. Based on top seller Diovan ($3.7 billion), chronic myeloid leukemia treatment Gleevec ($2.2 billion) and bone cancer treatment Zometa ($1.2 billion) some analysts are claiming “they are probably about the best positioned as any pharma company on the globe” based on on pipeline strength and limited patent expirations.
Sanofi-Aventis, with $33.6 billion sales in 2005 reports on May 5th driven by stong sales of anti platlet drug Plavix ($5.8 billion) whilst GSK reports earning on April 27th and is also expected to do well.
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Big Pharma To Announce Results
It’s once again results time in big pharma land with analysts are sitting on the fence and predicting outcomes to be ‘mixed’ on the back of increased generic competition and the slow introduction of new products. Amgen and
Merck reports on April 20th and the results should interesting. On the one hand it is believed to be facing in excess of 10,000 lawsuits relating to Vioxx, but on the other sales of Zocor have smashed forecasts. Again though, patent expiry is looming, with the company hitting back with combination drug developed alongside Schering-Plough. Schering of course is at the centre of a takeover war, with fellow Germans Bayer now believed to have closed a deal worth $20 billion which will create the merged Bayer-Schering with the loss of 6,000 jobs – 10% of the combined workforce.
The Wall Street week will close with Lilly and Wyeth and both are expected to report single figure revenue rises.
Pfizer To Offload Consumer Products
Big pharma is once again abuzz with potential acquisition activity, with Forbes leading on the story that both GSK and Colgate-Palmolive are both considering submitting bids for Pfizer’s billion dollar consumer products division. Pfizer announced plans last February to sell the division which includes brands such as Listerine and Benadryl. Johnson & Johnson and Procter & Gamble are also being banded as potential buyers.
Also on Forbes analyst Mark Schoenebaum said
Animal Testing
Always an emotive issue, especially in the recent climate of new laboratories being built and the recent disastrous Parexel trial the issue of animal testing is once again in the news. There has been talk for a while now about ‘microtesting’ first in human trials, whereby a tiny amount of the active substance is introduced to a controlled blister on the patient in order to establish the products interactions with human tissue, and now the European Centre for the Validation of Alternative Methods (ECVAM) has approved six new testing methods. These tests use cell cultures rather than animals to establish toxicity responses, and are said to perform better than animal tests. Essentially scientists see the current law – which requires non animal tests where possible – being extended to make unnecessary animal testing illegal.
Researching Development
Following Gordon Brown’s recent Budget announcements promising increased
With the cost of clinical trials and clinical R & D “spiraling out of control” according to many analysts, we are now arguably in a situation where despite technological breakthroughs R&D productivity in the last decade is at a historical low and even that these innovations are taking away from the essential elements of research that have produced the blockbuster drugs of old. Of course the death or otherwise of the blockbuster is a separate topic in itself, but what seems clear is that the enormous amounts of data modern research techniques generate are taking so long to sift through that actual productivity is being slowed and budgets stretched to breaking point and beyond.
The tendency of big pharma towards mergers is another often cited factor, with diluted decision making, bureaucracy, short sightedness and the rigidity of big corporations’ structures all coming under scrutiny.
Hopefully the establishment of a new European Research Council will go some way to redressing the balance and allow R & D workers to concentrate their energies where they will have the most beneficial effect for industry.
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Clinical Trials (12)
May 2007
GSK Leads Way On Ethics
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