Posts Tagged ‘FDA’

If you’re a diabetic, your doctor would have told you this  - “With Diabetes your chances for heart diseases are now higher”!

So what happens if your medication prescribed for diabetes also comes with an added risk for cardiovascular disease? Scary? Yes it is! And this is what’s happening with GlaxoSmithKline’s Avandia or  rosiglitazone.

A Senate Finance Committee report had some hard-hitting words for GSK and this was what was said:

GlaxoSmithKline, knew the type 2 diabetes drug had possible harmful cardiac effects several years before a 2007 New England Journal of Medicine study initially raised concerns about Avandia.

It all began three years ago when Dr. Steven E Nissin conducted a study and found that Avandia raised the risk of heart disease and this snowballed into a Congressional inquiry and report resulting in a drop in stock value for GSK. NYT reported the following:

A Congressional investigation released Saturday concluded that GlaxoSmithKline had threatened scientists who tried to point out Avandia’s risks, and internal memorandums from the Food and Drug Administration show that some government health officials want Avandia withdrawn. The drug is still being taken by hundreds of thousands of patients, and sales last year were $1.19 billion.

GlaxoSmithKline has today fired a rebuttal and has in its 30-page “white paper” response made it very clear that:

It has been “proactive in investigating the safety data” of rosiglitazone and has kept all regulatory agencies, including the FDA, aware of its investigations.

They have even gone on to say that they rumours of them trying to silence people were simply efforts made to ensure the right information goes out about their product.

Avandia is a very popular drug for Diabetes and for the hundreds of thousands using it everywhere nothing couldn’t be scarier than this. The best advice we can give is to contact your doctor and not decide things yourselves.

As for GSK, trying to arm-wrestle out of this with a 30-page rebuttal may not be enough. Coming clean on research results funded by them and allowing this to be evaluated or going back to the lab to improve the medicine maybe the way to go.

Finally the word from FDA : The FDA warns that patients who are taking Avandia should be monitored for signs and symptoms of heart failure, including excessive and rapid weight gain, difficulty breathing and/or swelling. “This work is ongoing and no new conclusions or recommendations about the use of rosiglitazone in the treatment of type 2 diabetes have been made at this time,” the agency announced.

While GSK handles this reputation management problem, what transpires next should be interesting indeed! Watch this space for updates!

Johnson & Johnson is doing what a company should be doing during a crisis. The top brass have decided to voluntarily recall the Tylenol Arthritis Pain Caplets due to complaints of mouldy smell that can cause nausea and sickness.

The Food and Drug Administration is a strict watchdog when it comes to complaints. The website has “Report a problem” tabs where anyone can make a complaint. If anyone’s on the watch it’s the FDA and so a company like J&J wouldn’t want these complaints to snowball into a reputation management nightmare.

The prudent thing to be done is to make a recall of the suspected lots, claim that “these are minor problems”, assure people “there is no cause for worry” and finally fix the problem. J&J has done just that.

We recommend this follow-up action: Keep up the positive content on the brand and ensure company reputation does not take a beating. Put out news everywhere that recalls are being made and that the problem is being fixed. Even follow up with news of freshly tested new batches of meds in the days to follow.

This is damage limitation at its best and crisis management that actually works!

Nestle – as if the controversy was not enough for their Honey Shreddies, here comes another blow from FDA over their Juicy Juice drink BOOST.  The company claims it is a complete Nutritional Drink.  FDA says – ‘Nestle is promoting the drink as a medical food and that it treats “failure to thrive” and helps children in chronic illness.

Well about Nestle “Their actions are so loud, one cannot hear what they say“. Nestle seems to oversee the fact that consumers aren’t fools, this age when the world is just a click away it will not take much time for your reputation to go for a ride in matter of minutes. In the recent case we have seen how Twitter and Facebook were flooded with articles and calls to boycott them.

While we know that Nestle is always in controversy, what surprises me is they have no action in place to counter it and are always wondering what hit them.

Strangely they say one thing and go on doing something else. Nestle responses are always generic – send them an e-mail only to get a reply ‘the mail is forwarded to the Switzerland, Headquarters. Their handling of a situation is poorly managed – they bask on PR, which is just an aspect of the approach and not a substitute of Reputation management.

Buying time will only make matter worse; the consumer has the power of Internet. Nestle should let it be known that they are transparent. You cannot hide things from consumer; the skeletons will be out and the rest internet will ensure that you don’t stay in single piece.

Better late than never Nestles should do some brainstorming. Internet and plenty of social media out there it’s a classic example of “word to mouth” for your reputation.