Evidence-based decisions in challenging times

Rebecca Aris provides an overview of the topics and themes discussed at the recent ‘Evidence-based decisions in challenging times’ event held by Cegedim Strategic Data.

With over 290 billion dollars of sales at risk from patent expiration from 2012–2018, it is no doubt that these are scary times in the pharmaceutical world. Some key facts that opened the ‘Evidence-based decisions in challenging times‘ event held by Cegedim Strategic Data, demonstrating the challenges we are currently presented with, include:-

• $33 bn loss to generics in 2012 alone

• Tightened patenting requirements to deny IP protection in incremental innovations

• 100 leading oncologists have risen against drug prices, accusing the industry of having lost its moral compass

• Loss of major patent dispute in India

Are we living in a crisis or is this the new normal, questioned Adam Harris, Commercial Director at Cegedim Strategic Data in his opening presentation?

Is it time to refresh our image, he suggested? With an increasing loss of trust in the industry, evidence would suggest so.

Adam highlighted the five strategies offered to accelerate the transformation of the pharmaceutical industry by 2020, according to KPMG:-

• Reassess product strategy

• Invest in the marketing and sale infrastructure of 2015 and beyond

• Acquire more talent and experience from other industries

• Prioritise and rationalise the R&D portfolio

• Review and revise governance standards

Importance of full evidence-based decisions in medical practice

Ben Goldacre, author of Bad Science and Bad Pharma, was clear on what he thought could improve the industry and the image of it.

 

“…100 leading oncologists have risen against drug prices, accusing the industry of having lost its moral compass…”

 

He opened his presentation by stating that he thought there were many good people working within pharma but that his issue with the industry was a wider system failure that he thought needed addressing.

In his opinion, the most important problem in the industry is that of withheld clinical trial results, and he spoke of several examples to support this case, some of which are listed below.

Lorcainide hydrochloride

In the case of Lorcanaide negative trial results have gone missing that suggested the drug’s association with arrhythmias. By not publishing phase I trial results that suggested an increased risk of dying, unnecessary deaths (an estimated 100,000 according to Ben) were caused.1

Reboxetine

When Ben prescribed Reboxetine, an antidepressant, to a patient who wasn’t responding to other treatments he first read the available trial data, which showed positive results. However, negative trial results for this treatment had gone unpublished. The treatment was actually no better than placebo. This drug was effectively, explained Ben, worse than doing nothing as you were exposing the patient to unnecessary side effects by prescribing this drug.

It has since been found that ‘Reboxetine is, overall, an ineffective and potentially harmful antidepressant. Published evidence is affected by publication bias, underlining the urgent need for mandatory publication of trial data. 2

With this case, explained Ben, patients were harmed as a result of clinical trial results being withheld.

Erick Turner, a medical doctor at the FDA has since looked at all FDA trials for 12 antidepressants to find 38 positive results and 36 negative results, however the published literature represented 48 positive results and 3 negative results.3

In addition, evidence has shown that positive results are twice as likely to be published than negative results.

 

“We will look back on this problem in the future, Ben concluded, like we now look back on medieval doctors letting blood.”

 

The answer to solving this publication bias, Ben says, is for all clinical trial results to be published. The AllTrials campaign is petitioning exactly for this. Interestingly, no one in the room had heard of this AllTrials campaign, let alone signed up to it.

Ben closed his presentation by sharing the arguments against transparency and his counter arguments:-

Arguments against transparency

-Too expensive to fix (LEO AZ two weeks ago)

-the EU Ombudsman says admin burden sharing CSRs is not significant

-This is confidential information

-the EU Ombudsman says this isn’t true

-This will harm EU research

-nobody is asking for only EU results

-This is confidential patient info

What was interesting was the number of people within the room who hadn’t heard Ben speak before, who hadn’t read his latest book Bad Pharma and who hadn’t heard of the ALLtrials campaign. To date, GSK is the only drug company to sign it. With everyone from bus drivers to teachers reading the book, there are more external people who know more about the industry than people within it, Ben suggested.

Those working in industry are important people in this picture he said, they can help by blogging and talking about it.

We will look back on this problem in the future, Ben concluded, like we now look back on medieval doctors letting blood.

Conclusion

Evidence-based decisions are clearly important in a world where pharma’s reputation is not at its best.

And with the European Parliament’s Committee on Environment and Public Health (ENVI) recently backing a series of amendments to the Clinical Trial Directive to ensure greater transparency through a series of measures, it seems the fight for trial transparency cannot be ignored.

Advances in this area, accompanied by the strategies outlined by KPMG will hopefully help to transform the pharmaceutical industry and restoring trust in the industry.

References:

1. http://www.ncbi.nlm.nih.gov/pubmed/8349379

2. http://www.bmj.com/content/341/bmj.c4737

3. Erick Turner et al, NEJM, no 3, 2008 252-260.

About the author:

Rebecca Aris is Managing Editor of pharmaphorum, the primary facilitator of thought leadership and innovation for the pharmaceutical industry featuring news, articles, events / company listings and online discussion.

Rebecca was the first full time employee to join pharmaphorum, starting in her current role in mid-2010, and is responsible for coordinating all editorial content on the site. Prior to working at pharmaphorum she was a medical writer at a healthcare PR agency. In addition, she spent three years working as a commissioning editor on three journal titles at a biomedical publishing company. Rebecca holds a BSc (Hons) in pharmaceutical science.

For queries she can be reached through the site contact form or via Twitter @Rebecca_Aris.

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