Drug companies conducting their own clinical trials leads to Conflict of Interest a Debate

Ben Goldacre @bengoldacre argues that the financial interests of drug companies lead to distorted evidence, but Vincent Lawton believes that adequate safeguards exist to keep bias in check. Full text of the article is published on BMJ

Dr Goldacre and Prof Lawton faced each other on the same issue recently as opposing speakers at PharmaTimes’s Great Oxford Debate in September, when Dr Goldacre told drugmakers that, by withholding or distorting data, “you shoot yourself in the foot, you undermine your own credibility and mine as a doctor.”

The Pharmatimes review is available at their website http://www.pharmatimes.com/clinicalnews/article.aspx?id=16978&src=EWorldNews

This is interesting , I had written about an actual initiative taken by The Massachusetts Institute of Technology  and 12 Major drug makers to share clinical trial data called NEW Drug Development ParadIGmS or NEWD. details on my earliar post – collaborative clinical trials

World Ecconomic Forum India Economic Summit | Collaborative strategy for drug discovery

The Coverage of the World Ecconomic Forum India Economic Summit is available at  http://blog.livemint.com/wefindia/

I was more interested in the Collaborative Strategy for Drug Development read the interview with Suven Lifesciences a prefered partner to Eli Lilly and Co in Drug Discoverya dn Development in India. http://www.livemint.com/2009/11/10204140/India-Economic-Summit–Collab.html

 

National Library of Medicine wants health care organizations to test drive Medical mapping tool

The National Library of Medicine wants health care organizations and vendors to test drive its new mapping tool that covers 5,000 standardized clinical terms , to create a standard medical vocabulary to support applications for electronic health records

The Obama administration is distributing more than $19 billion in payments to doctors and hospitals that buy and use digital record systems for patients.

The library released a draft mapping tool that links terms from the Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT) to the International Classification of Diseases, Ninth Revision (ICD-9). The SNOMED-CT is the terminology used for clinical purposes, while the ICD-9 has terms used for billing and administrative support.

The map was designed with help from SNOMED-CT terms most often used by Kaiser Permanente and the University of Nebraska, to support semi-automated administrative reporting and reimbursement for health care services.

The library wants users to “test drive”’ the map from Dec. 1 through Feb. 1, 2010, and to provide feedback to guide developing related maps. The related maps include mapping of SNOMED-CT to the ICD-Tenth revision, Clinical Modification and Procedure Coding System.

Linkedin and Social Media is ruining my people- feeble attempts to fight of Social Media and the Compliance nightmare

There has been a flurry of discussion around social media and its implication in the last few  months , So I thought it would be good to have some of these arguments laid out in one single post. Social Media has entered every business and industry even, inside the US Intelligence Community, who sorted out their knowledge-sharing problem and a problem with locating expertise—throughout the  bureaucracy of 16 federal agencies—using  simple tools like an intelligence community–wide Wiki and blogging environments among other things

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Social Media and Sales

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: that usual rhetoric many sales managers would say now a days.   Does Social Networking help sales people sell I liked that statement especially since it came from Microsoft executive.  As I have also faced the ire of top management for using social media in my career, . So this report is an eye opener for opponents of social media for sales. Read the Full Article.

LinkedIn insiders know that you can use the site’s information for more than job, sales, and partnering leads – you can find out what others are up to as well. There are downside to using Linkedin last fall an Apple employee revealed that he was managing a team developing a new chip for the iPhone while the information was still secret. . So be careful LinkedIn or any other social tools can bite you back if not used properly.

I would partly agree to the argument that social media and internet created a lot of distractions, but I dont think this is something new, we had distractions in our daily life and in office environments even before theadvent of internet. the only difference now it is easier not to do your job and indulge in something else while you are supposed to be at work when in office.

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Social Media and Influence on Decision Making

Second on my reading list was the study conducted by Don Bulmer (Vice President Global Communications- SAP ) with Society for New Communications Research. Take a look at this in his blogpost  at Social Media’s Impact on Business and Decision Making Everyday Influence blog .  Result of the study concludes that Top execs  are influenced by social networks . The copy of the report is on SNRC website

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Social Media Investments

Third on the reading list was a New Study from Deloitte, Beeline Labs and the Society for New Communications Research Indicates Despite the Recession, 94 Percent of Enterprises Continue to Invest in Online Communities & Social Media  Full Article

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Then there was  presentation by Steven Tylock, on Social networking meets sales , the presentation is on  Microsoft website

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Compliance and Social Media

The Society of Corporate Compliance and Ethics and the Health Care Compliance Association conducted a survey among compliance and ethics professionals in late August 2009 to see what employers are doing about the use of these sites by their employees.

They got back almost 800 responses from their members using an online survey tool.

  • 50% of respondents reported that their company does not have a policy for employee online activity outside of the workplace
  • Of those companies that do have a policy, 34% include it in a general policy on online usage
  • Of those companies that do have a policy, just 10% specifically address the use of social network sites

It would be interesting to see How companies are going to include a clause on their information protection and compliance rules to define what information an employee can add to his linkedin profile during or after his tenure with the organization, especially information related to projects.

For example When an IA rep uses Twitter to send a link to an article from an online magazine, newspaper, or other site to clients and prospects “following” him, that communication is subject to SEC advertising rules. However, Bernstein says that merely sending a link is not advertising—as long as you don’t give your opinion.

A “recommendation” on your Linkedin profile by a client does indeed constitute a testimonial and, thus, violates SEC rules prohibiting RIAs from using client testimonials in advertising.

The SEC will be busy in coming months addressing the many issues posed by advisor use of social media. FDA has already release its framework on use of social media in Drug Marketing.

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Drugs, Heallthcare, FDA and Social Media

The FDA is currently considering how to handle social media, such as SideWiki, Facebook, etc. Companies such as Google, Sermo, and Twitter are playing an increasing role in marketing products to consumers and healthcare professionals, whether our customers like it or not. Technology and Life Sciences companies are pushing the FDA to come up with standards and templates. The following article has some great links to presentations from PhRMA, Google, and even from Pfizer’s Chief Medical Officer.  

Read about Googles pitch to FDA for online Drug Advertisements from the wall street journal

An archived webcast and other details of the FDA  Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools is available at the FDA website

Here what emerged from this hearing

FDA explained in the Federal Register notice that “entities should review any Internet sites sponsored by them for Drug Adverse Event Information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an Adverse Drug Event on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.”

Numerous speakers stated that drug manufacturers are hesitant to fully engage in online social media specifically because they want to avoid learning about potential AEs and the resulting reporting obligations, particularly because the guidance in this area is unclear

Pending further guidance, companies should prepare for further FDA scrutiny of this area by developing compliance
policies to address the challenges of involvement in Internet and social media tools, including but not limited to:

„„policies relating to employee involvement in social media, and in particular statements regarding company products;

„„company involvement in physician and patient-focused social media, including both company-sponsored sites and third-party sites run by third-party organizations (and particularly those receiving manufacturer support through grants or other funding);

„„addressing the challenge of Sidewiki and similar functions that make third-party generated information directly available in conjunction with company websites;

„„updating promotional review policies to ensure consistency with developing FDA approaches to risk communication on the Internet, including sponsored links;

„„policies regarding statements that company-affiliated parties (e.g., investigators, patients) may make on the Internet, which may constitute endorsements or testimonials requiring both review and specific disclosures; and

„„ensuring a consistent and compliant approach to pharmacovigilance with respect to Internet-reported adverse events of Drugs.

 

I know one company that provides  Content Monitoring, Control & Recording across Web 2.0; User Behavior Reporting over Multiple Modalities, Regulatory Compliance for management and security of Web 2.0 applications such as social networking, blogs, wikis, webmail and social networking sites such as Twitter, Facebook and YouTube instant messaging, and Unified Communications. But at a cost of $9,200, it would be out of reach for individual and SMEs.  Still have a look at the recent press release by factime on its FaceTime’s Unified Security Gateway

Myth=My sales people are wasting valuable time on Linkedin when they should be selling, Reality= Social Networking helps in Sales -Top execs say they are influenced by social networks

My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: Now thats what most sales managers would say. I know thats true , I have irritated fare share of my managers by using social media to create and close sales and in lead generation. And I continue to do it today, thanks to my current orgnaizations forward looking ways , this time around I have the support of my management to these activities.

Society for New Communications Research (SNCR) has oublished a research that shows that company executives are influenced by their online networks.

Here are some key findings from this survey 365 business professionals:

– Professional decision-making is becoming more social – enter the era of Social Media Peer Groups (SMPG)

  • Traditional influence cycles are being disrupted by Social Media as decision makers utilize social networks to inform and validate decisions
  • Professionals want to be collaborative in the decision-cycle but not be marketed or sold to online; however online marketing is a preferred activity by companies.

– Professional networks are emerging as decision-support tools

  • Decision-makers are broadening reach to gather information especially among active users

– Professionals trust online information almost as much as information gotten from in-person

  • Information obtained from offline networks still have highest levels of trust with slight advantage over online (offline: 92% – combined strongly/somewhat trust; online: 83% combined strongly/somewhat trust)

– Reliance on web-based professional networks and online communities has increased significantly over the past 3 years

  • Three quarters of respondents rely on professional networks to support business decisions
  • Reliance has increased for essentially all respondents over the past three years

– Social Media use patterns are not pre-determined by age or organizational affiliation

  • Younger (20-35) and older professionals (55+) are more active users of social tools than middle aged professionals.
  • There are more people collaborating outside their company wall than within their organizational intranet

I have also found a similarlt interesting  blog . Hosted at Sales20Book.com

“My sales people are wasting valuable time on Facebook and Linkedin when they should be selling”: Now thats what most sales managers would say. But does Social Networking help sales people sell Full Article . I liked that statement especially since it came from Microsoft executive. . As I have also faced the ire of top management for using social media in my career, some time even in Oracle. So this report is an eye opener for opponents of social media for sales.

The complete presentation and arguments are available on http://www.sales20book.com/wp/2009/05/social-networking-in-sales-show-me-the-money/

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The plan calls for hundreds of new hires and new research facilities in Changshu.

Novartis is  waging a high-stakes court fight over patent protection for the cancer blockbuster Gleevec, No wonder the Novartis CEO Daniel Vasella had enough and announced that the subcontinent’s reputation as a low-cost R&D center is losing its luster.

In 2006, Novartis made a commitment to build a $125 million R&D facility in Hyderabad. The next year, after the company lost a patent battle over its blockbuster cancer drug, Gleevec (
I thought China also didnt had a great IP law to speak of. How many times we saw news stories about fake chinesse counterbrands.
But here is the upside , the chineese dont challenge the patents in Courts. China is behind India in pharmaceutical chemistry, so they are not so keen in spending time to another way to manfacture the drug. But China is way ahead of India in Medicinal Chemistry,  pre-clinical and toxicological study infrstructre. SFDA the Chineese equivalent of FDA, is taking a lot bold steps and investment to ensure fast trial registration, proper Pharmacovigilance reporting etc. net net it is faster to run R&D in China
India is yet to have solid infrastructre or plans for clinical trial monitoring or pharmacovigialance . The WHO fund for a national pharmacovigilance monitoring policy and infrastructre has already elasped in 2008. And we are yet to see any increase in number of adverse events reported in India .
India will make similar progress, he opined, when Indian pharmaceutical companies have more IP they want to protect. Then, the companies will force the government to act and increase IP protection.
Pfizer announced it would close six out of its 20 R&D facilities around the globe as part of its post-Wyeth-acquisition consolidation but the company’s Shanghai R&D operation is not affected – an implicit endorsement of China’s R&D.
Ok we Indians will wait till then , and just pray that the Red Dragon is not going to burn the Indian the pharma industry till that time

Shorter Path to drug Discovery share research on failed compounds between companies the new MIT lead approach-

The moment I learned about this new project started by MIT, I could think of only one thing, I want to be part of it.  The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program  to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

  • Aetna
  • Bayer Healthcare
  • Brookings Institution
  • Centers for Disease Control and Prevention (CDC)
  • Eli Lilly and Company
  • U.S. Food and Drug Administration (FDA)
  • Johnson & Johnson
  • Medco Health Solutions Inc.
  • Pfizer Inc.
  • Quintiles Transnational Corp.
  • Vertex Pharmaceuticals Inc.
  • WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1.  share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother  waste many millions going down experimental paths that their competitors have already tried and failed.

A visual Path of the changes suggested in the Enterprise Transformation is shows here , the document can be downloaded from the MIT website

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