I've always been astounded at medicine regulators from around the world. The FDA and its inability to act upon reports of bad medicine...not to mention the revolving door that exists between ex pharmaceutical employees and FDA officials. The MHRA fair no better, a backward system of reporting adverse drug reactions, a Chairman, who is an ex-employee of GSK, who thinks the whole Seroxat scandal is "nonsense" and a Head of Licensing being former World Safety Officer at GlaxoSmithKline. GlaxoSmithKline's lawyers even called upon the services of ex-MHRA employee, Rashmi Shah, to be their star witness in the UK Seroxat litigation.
Health Canada, the Canadian drug regulator, lay low whilst the MHRA and FDA come under attack from writer's such as myself, Evelyn Pringle, Ed Silverman and countless patient advocates.
One would think that Health Canada would like it to remain that way. Surprising then that a recent document that landed in my inbox shows quite a controversial step, one that, to my knowledge, has not been covered by any of the mainstream media.
In a public communication published on the Health Canada website yesterday, they announced "Endorsed Information on Important New Restrictions on the use of rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL)"
Avandia has been the subject of much controversy over the years and it's licence was recently suspended in the UK following a recommendation by the European Medicines Agency (EMA).
The EMA decided that the benefits of Avandia no longer outweighed its risks, risks that included increased risk of heart problems, including heart attacks and heart failure.
The FDA have not suspended the licence for Glaxo's diabetes drug, opting instead to "restrict its use."
Meantime, Health Canada have been in consultation with GlaxoSmithKline and their announcement yesterday appears odd, to say the least, the most striking of which is this:
Before starting or renewing a prescription for AVANDIA/AVANDAMET/AVANDARYL, doctors will complete the PATIENT INFORMED CONSENT PROCESS.
o Discuss other diabetes treatment options and the benefits and risks of AVANDIA®/AVANDAMET®/AVANDARYL® therapy with patients
o Ask patients to read the Consumer Information for AVANDIA®, AVANDAMET® or AVANDARYL®
o Ask patients to read and sign a form (see Informed Consent Form at the end of this Public Communication) indicating that the patient understands the heart-related risks of the medication and has discussed other options to treat their diabetes with their doctor.
There is the usual 'Talk to your doctor' utterances to make the patient feel like they are talking with God.
Now, the informed consent form appears to waiver patient rights to sue GlaxoSmithKline should Avandia cause any of the problems mentioned above.
The consent form reads:
Patient Informed Consent
My doctor has recommended one of the following medicines to treat my diabetes (please check one of the boxes below, as appropriate):
□ AVANDIA □ AVANDAMET □ AVANDARYL
Please read this Patient Informed Consent (“Consent”) and the individual Consumer Information for AVANDIA/AVANDAMET/AVANDARYL and discuss any questions or concerns with your doctor before you sign this Consent.
Do not sign this Consent and do not take AVANDIA/AVANDAMET/AVANDARYL if there is anything you do not understand about the information you have received.
I am aware that:
AVANDIA/AVANDAMET/AVANDARYL are medicines used in addition to diet and exercise to lower blood sugar in people with type 2 diabetes when all other diabetes medicines taken orally (by mouth), either alone or in combinations, have not lowered blood sugar enough or are not appropriate.
Rosiglitazone, the active ingredient in AVANDIA and one of the active ingredients in AVANDAMET and AVANDARYL, may increase the risk of serious heart problems, including:
• heart failure
• angina (chest pain)
• heart attack (myocardial infarction)
• fluid retention (with or without weight gain)
AVANDIA/AVANDAMET/AVANDARYL should not be used if I have or have had heart problems.
There are other options to treat my diabetes, as explained by my doctor.
There are other risks associated with AVANDIA/AVANDAMET/AVANDARYL that are outlined in the individual Consumer Information for AVANDIA/AVANDAMET/AVANDARYL and I have been given the opportunity to ask and discuss any questions or concerns about those risks with my doctor.
I understand that in order to be prescribed AVANDIA/AVANDAMET/AVANDARYL, I am required to sign this Consent.
My doctor has explained the above to me, I have been given time to read this Consent and the individual Consumer Information for AVANDIA/AVANDAMET/AVANDARYL carefully, and to discuss it with my doctor. I now authorize my doctor to continue/begin my treatment with AVANDIA/AVANDAMET/AVANDARYL
Patient or Legally Appointed Guardian signature lines are below. AVANDIA/AVANDAMET/AVANDARYL are not recommended for use in people under the age of 18.
Patient (and Legally Appointed Guardian if applicable) Name(s)
Patient / Legally Appointed Guardian Signature:
Quite a U-turn from GlaxoSmithKline who have, for years, denied there was any problem with Avandia.
The public communication from Health Canada can be downloaded HERE.
GSK has sent a letter to Canadian healthcare professionals informing them of this new safety information.
For Health Professionals
For the Public
DON'T SIGN YOUR LIFE OR RIGHTS AWAY FOLKS!
ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING