AVANDIA for Diabetes - Safe After All?

June 18, 2013 06:38 AM

What a SHOCKER that hit the pharma newswires this past week - AVANDIA - the poster-child for a "bad drug" all these years, the drug that supposedly causes heart attacks - may actually be safe after all!!

Here's a brief history

•  Avandia was launched in major markets around the world in 1999
•  it quickly became a top-selling diabetes drug ($3 Billion in annual sales at its peak)
•  in 2007, a meta-analysis of  studies led by Dr. Nissen, a leading cardiologist from the Cleveland Clinic, concluded that Avandia gave patients a 43% higher risk of MI (heart attack) than other diabetes drugs
•  MDs defected in droves - turning to rival drug Actos in many cases
•  Avandia's sales plummeted from $3 Billion to just $10 Million - patients on the drug fell from 250,000 to just 2,400 -
•  Europe banned the drug altogether - in the US and Canada it became much more difficult to prescribe and was considered a drug of last resort

Now, it seems that GlaxoSmithKline (GSK), (its maker) has been vindicated in a NEW ANALYSIS of all data on Avandia that is reportedly more sophisticated than original assessments.
The implications of this case are huge, including:

•  the obvious significant loss of revenue for GSK since 2007
•  the credibility gap that GSK suffered was enormous - imagine yourself desperately trying to show your innocence if you were wrongly convicted in a murder trial - and that's what you have here - all the circumstantial evidence seemed to point to convicting GSK - and it was convicted via Avandia getting severe restrictions - but GSK appears to have been innocent all along!
•  because of Avandia, all diabetes drugs need to demonstrate that they are "heart-safe" - this has led to the delays of virtually all other diabetes drugs since Avandia, that could have likely been available sooner to patients
•  Actos, the chief beneficiary of the Avandia debocle, has itself been linked to bladder cancer - imagine if you were an Avandia patient, switched to Actos, and you now have bladder cancer - what an unkind twist of fate for you!

The moral of the story here may be very simple … here's my editorial
… perhaps a little less government (FDA or TPD) authority (or its equivalent around the world) - a little more freedom for the docs to prescribe what they feel is best for the patient
… and maybe this case would never have happened!

Thanks for reading - and thanks for keeping Vanguard on the move!!

—Kevin

Kevin's Blog is an occasional correspondence to employees and other associates of Vanguard Pharma Inc., and Vanguard Pharma, LLC.  The blog strictly is provided for non-business and entertainment purposes only. The views and commentary in Kevin's Blog are solely those of the author and do not necessarily reflect those of Vanguard Pharma Inc., and/or Vanguard Pharma, LLC.  Other views are welcome.

ObamaCare & the Medical Device Industry - a Taxing Situation!

February 6, 2013 01:04 AM

Did you know as of January 1, 2013, a new tax went into effect to help pay for ObamaCare that is of very serious concern to our colleagues in the US medical device industry.

Despite the fact that there's been a lot of TALK of about the US federal govt reducing the corporate tax rate to be more competitive in the business world, ….you wouldn't know it by this new tax - which seems to me like a total cash grab by Uncle Sam.

Here's a little background:

•  the tax is 2.3% which may not sound like much, but this is 2.3% on SALES, (not profits) so companies who are not yet making money will still owe the tax
•  if we assume the device company is making money, the 2.3% tax on sales translates into about a 15% incremental absolute tax on profits - which would typically raise the tax rate for the company from 35% to 50%!!
•  money zapped away for this tax will lessen the investment funds available for hiring workers, investments in buildings etc …, and of course, R & D investments to discover new and better medical devices!
•  80% of companies in this industry have fewer than 50 employees - small businesses will be hurt by the tax
•  in another industry, you could simply pass along the tax to customers - but in the device business, purchases are made by contracts in a long buying cycle - it will be very difficult for businesses to collect the tax from customers

Why did the President want to do this?
Well, the theory behind the tax is that ObamaCare will provide a windfall of new patients to treat for the medical device companies, and with all the extra business they could then afford the tax.
The only problem is that there is no evidence for this (even if you consider Massachusetts as the test state for this theory - same conclusion - no windfall from universal coverage! ...probably because many of the patients who get medical devices are elderly and already quality for coverages in many cases).

Unfortunately, the layoffs have already begun, with Boston Scientific and Stryker being 2 big industry names with mega-layoffs announced this year, part of the estimated 46,000 jobs that will be lost this year due to the tax.
Many device companies are moving operations out of the country to avoid the tax - who can blame them?
This is an example of a bad tax - and the unintended consequence is that it will do serious harm to a very productive industry

Thanks for reading - and thanks for keeping Vanguard on the move!