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Eu commission

Nice, France; September 28, 2009

The European Commission
D.G. Enterprises and Industries
Health and Consumer Protection
B/1049 Brussels, Belgium

Gentlemen,

The Friends of Guenady is an animal defense association, based in Nice,
France, with, for one of its stated objectives, the intention to contribute to
improving understanding between consumers of veterinary medicine and
veterinarians.
Making reference to the EU general safety requirement, we write to inform the
Commission that our association, over the eight years of its existence, has
received various reports concerning adverse drug events (ADEs) relating to
veterinarian-prescribed medicines. In addition to the ADEs themselves, the
reports point to a general, but not systematic, lack of appropriate information
regarding medicines prescribed, whether in the availability (or lack) of Client
Information Sheets (« Notices ») accompanying the medicines, or in the
advice and information provided (most often only orally) by the veterinarian
at the moment the prescription is written.
We bring this information to the attention of the European Union (Health and
Consumer Protection) because the victims of these ADEs report a consistent
refusal by veterinary pharmacovigilance authorities in France to take ADE
reports seriously. Clearly, the probability of 'under-reporting' of ADEs is
heightened by either the refusal to consider reports of ADEs or the summary
dismissal of such reports, to the entire dissatisfaction of the consumer who
has been subjected, through a beloved animal, to the pain and suffering of an
adverse drug event, sometimes resulting in injury or death.
Why does it seem that a discrepancy exists between the stated aims of
pharmacovigilance and the practical functioning of the Pharmacovigilance
Agency in France? Certainly, one can imagine that the pharmaceutical
establishment is allowed too much influence and control in the treatment of
ADE reports.
We applaud the EU's intention to release pharmaceutical products
information to the general public. (See http: // www. emea. europa. eu, then
vet docs.) At the same time, we observe that certain pharmaceutical
products sold in France seem to be slipping under the wire of the EU's critical
observation, and thus contributing to ADEs which are, too often, under-
reported or dismissed (as already observed). And yet, in order to protect
consumer health and safety, Community law stipulates that producers may
place only safe products on the market.
In passing, we mention that we also deplore the exclusivity which

veterinarians enjoy in France in regard to domestic animal therapies and
treatments which, outside accepted pharmaceutical treatments, stiffle and
suppress alternative therapies of all sorts, globally referred to as 'holistic
veterinary medicine', a fast-growing sector of veterinary practice in, for
example, the USA. Democratic institutions, as well as the principle of
freedom of information and choice in medical matters, ethically require the
pharmaceutical industry and veterinarians who rely on it, to tolerate other
approaches to animal health and well-being, with consumers being the
ultimate decision-makers for treatments used to restore and maintain pet
health.
With all these points in mind, we write to the Health and Consumer Protection
Division of the European Commission to ask that it undertake a comparison
of 'notices' (i.e., Client Information Sheets - CISs, or Package Inserts, PIs)
which accompany, or fail to accompany, veterinary medicines sold in France,
and this with the correct, known properties of each pharmaceutical
substance, particularly in regard to Counter-Indications and Undesirable Side
Effects, in order to ensure a consistently accurate and reliable correlation
between the two, as well as to take every precaution to avoid ADEs.
The provision of such information is the prerequisite for an informed choice
on the part of consumers, and indeed the provision of such information is a
principle enshrined in French public opinion and law. Unfortunately, due to
the withdrawal of the « Code Déontologique des Vétérinaires » from public
access (at least, we are no longer able to find public access to this
document), we are no longer able to affirm the practicing veterinrian's
obligation to inform and advise clients regarding pharmaceutical products
prescribed. Nevertheless, the logic of this obligation is so strong that we
take it for granted that the European Medicines Agency also recognizes this
obligation, and shares our concerns about the provision of accurate
information, to allow an informed choice regarding treatments on the part of
the consumer.
In order to reinforce our request for such a systematic comparison, we point
to two notable examples of discrepancies between known pharmaceutical
substance information and the 'Notice' (CIS or PI) for two pharmaceutical
medicines marketed for dogs in France, Carprofen and Ketoconazole.
I. CARPROFEN
Carprofen, a non-steroidal anti-inflamatory drug, was originally develped and
sold in the US for human use against arthritis pain. Early on, carprofen was
withdrawn from the market, according to the manufacturer, for commercial
reasons. Quite possibly, there may have been too many ADEs that captured
too much public attention. Whatever, Carprofen was then repackaged and
sold for use against arthritis pain in dogs.
Dr Carolyn Dean wrote, in 2005, about the history of carprofen for dogs,
marketed under the brand name, Rimadyl.

« As for putting animals at risk to the dangers of modern
medicine, I even wrote about an example of a crossover drug [N.B.
a drug that is developed for humans, then repackaged and sold as
veterinary medicine] that Pfizer, one of the members of the
“strategic partnership” [N.B. National Commission on Veterinary
Economic Issues (NCVEI)] was so anxious to sell. It was its animal
arthritis pain killer drug, Rimadyl, which was promoted through a
Christmas card $10 discount coupon campaign.

.Rimadyl, a Vioxx-type drug, had big problems from the get go.
According to a report put together by The Senior Dog Project, The
FDA’s Center for Veterinary Medicine reported that by May 1,
2003, 2,133 dogs had died as a result of using Rimadyl since its
introduction in 1997.
An even more alarming article published in USA Today reported
that through November of 2004, the FDA received almost 13,000
adverse-event reports about Rimadyl, which was much higher than
any other dog pain reliever. USA Today also reported that another
dog drug in the same Vioxx-type class as Rimadyl, is Dermamaxx,
developed by another of the American Veterinary Medical
Association’s “strategic partners”, Novartis. Since its launch in
2002, the FDA has had 2,813 adverse event reports including 630
deaths.
The market for dog arthritis pain meds tops $130 million a year
and, according to USA Today, it is growing about 13% a year.
However according to the FDA, 3,200 dogs have died and records
show there have been almost 19,000 adverse reaction to them. »

Dr. Carolyn Dean, MD, ND and Elissa Meininger
October 13, 2005
« BIG PHARMA JUST BOUGHT YOUR DOG AND MIGHT PUT YOU
IN JAIL? » See : NewsWithViews.com

The class of drugs that Dr Dean refers to here is known as NSAIDs
(AINS in French), Non-Steroidal Anti-Inflammatory Drugs. As there is
no reason to believe that dogs in France are biologically different from
dogs elsewhere, it does seem that information is lacking on the
« notice » (see copy attached to the present) of possible deadly side
effects, and probably ADEs in France are significantly under -reported :

Translated from French : (see attachment)
« Counter-indications

.Do not use in case of :
- severe hepatic or renal ailments
- gastro-intestinal ulceration or bleeding
- any hemorrhagic syndrome
- hyper-sensitivity to NSAIDs
.
« Undesirable side effects
In rare cases, cutaneous eruptions, vomiting, loose stools or
tearing have been observed.
Ulcerations of the gastro-intestinal tract linked to the
administration of carprofen in dogs are rare at theapeutic doses.
Hepatic or renal effects of the idiosyncrasic type have been
observed during administration of this specialty to dogs. In the
event of such trouble, treatment should be stopped. »

Clients of veterinarians have contacted us to protest that carprofen has
been given to them by veterinarians in blister (or bubble) packets with
no « notice » or CIS or PI, and no verbal information or warning, either,
and for problems as slight as pain associated with tooth extraction!
Certain dogs have died from NSAID treatments, sometimes after as little
as one dose! In that case, the consumer hasn't got time to see the
adverse event, and react. Contacted about this frightening lapse in the
duty to provide information about the treatment proposed,
veterinarians invariably reply that they have been using the drug for
years and have never had an adverse reaction. Informed of this, their
clients tell us that veterinarians will immediately claim, in the event of
an ADE, « The animal was already borderline something-or-other
(reference to a malady); it's just a coincidence that this previously
undetected illness has manifested during this drug treatment. »
Of course, these observations remain anecdotal given the pressure
exerted on consumers by veterinarians, laboratories doing blood and
specimen analyses, and the pharmacovigilance authorities to dismiss
reports of ADEs.
Let us for a moment briefly consider another of the same class of
veterinary drugs, NSAIDs. Metacam (meloxicam) is marketed in France
with a (reasonably) informative « notice »:

[Translated from French]
« What are the undesirable side effects of Metacam?
« In dogs and cats, the undesirable effects produced by Metacam
are those observed with NSAIDS, in particular loss of appetite,
vomiting, diarrhea, blood in stools and apathy (absence of vitality).
In dogs, these side effects occur generally during the first week of
treatment and are most of the time transitory (temporary). They
disappear after the end of treatment, but can be serious or deadly
in certain very rare cases.

.
« Other information relative to Metacam :
« The European Commission delivered a marketing authorization
valid in all the European Union for Metacam from Boehringer
Ingelheim Vetmedica – Germany, on January 7, 1998. Information
relating to the prescription of this product figures on the
packaging label. »

See « Rapport Européen Public d'Evaluation - Metacam » at
« www. emea. europa. eu »

In conclusion, in regard to carprofen (Rimadyl), we ask that the EU
Commission intervene to ensure that not only is this product, marketed
in France accompanied by a 'notice' which properly corresponds to the
dangers associated with this drug (including mention of the 'wash-out'
period, which should intervene between administration of one NSAID
and any other, as well as with certain drugs of other classes). We ask as
well that veterinarians be formally informed of these dangers so that
they can alert their patients each and every time they prescribe this
drug, informing the client of the symptoms to watch for which indicate
'hypersenstitivity to NSAIDs'.
N.B. It should always be remembered that, when informing consumers
of the dangers associated with pharmaceutical drugs, the veterinarian's
duty to inform is primordial, as most consumers trust their vet and do
not even read the 'notice'-- until after something has gone wrong.
II. KETOCONAZOLE
Info from Janssen Pharmaceutica, USA (see attachment) :

« NIZORAL (KETOCONAZOLE) TABLETS
NIZORAL TABLETS ARE NOT APPROVED FOR VETERINARY
USE, CONSEQUENTLY WE CAN NOT RECOMMEND THE USE
OF OUR PRODUCT IN THE MANAGEMENT OF DISEASES IN
THE ANIMAL POPULATION; »


We compare this statement with this text, taken from the KETOFUNGOL
Oral-Antimycosic-for-Dogs Client Info supplied by Janssen-Cilag in
France :

(Translated from French) (see 'notice' attached) :
KETOFUNGOL200 mg is an oral antimycosic of systemic activity with for
active substance ketoconazole, a synthetic derivative of imidazole-
dioxolanne which after oral administration, exercises wide activity on
dermatophytes.

Dosage : 200mg per 20 kilos of body weight (=10mg/kg) daily for 3 to 4
consecutive weeks.
Secondary effects : KETOFUNGOL 200mg is very well tolerated. In rare
cases,vomiting may occur immediately after administration.
Precautions for user : Keep out of the reach of children.]


Returning to info supplied by Janssen USA (see attached), we read :

WARNING / WHEN USED ORALLY, KETOCONAZOLE HAS BEEN
ASSOCIATED WITH HEPATIC TOXICITY, INCLUDING SOME
FATALITIES. PATIENTS RECEIVING THIS DRUG SHOULD BE
INFORMED BY THE PHYSICIAN OF THE RISK AND SHOULD BE
CLOSELY MONITORED.
Hepatotoxicity, primarily of the hepatocellular type, has been
associated with the use of Nizoral (ketoconazole) tablets, including
rare fatalities. The reported incidence of hepatotoxicity has been
about 1:10,000 exposed patients, but this probably represents some
degree of under-reporting, as is the case of most reported adverse
reactions to drugs. The median duration of NIZORAL Tablet therapy
in patients who developed symptomatic hepatotoxicity was about 28
days, although the range extended to as low as 3 days. The hepatic
injury has usually, but not always, been reversible upon
discontinuation of NIZORAL tablet treatment. Several cases of
hepatitis have been reported in children.
Information for Patients :
Patients should be instructed to report any signs and symptoms
which may suggest liver dysfunction so that appropriate biochemical
testing can be done. Such signs and symptoms may include unusual
fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine or
pale stools.

In two cases brought to our attention, dogs died as a result of ketoconazole
treatment, according to the conviction of their owners. Neither could get
pharmacovigilence authorities to take their ADE reports seriously. Both felt
that they had been fobbed off (one recounts how he was told by a veterinarian
at his « Laboratoire Vétérinaire Departemental », 'If we took every case like
yours seriously, why we wouldn't be able to treat at all anymore!'). The other
dog owner recounted how he had been obliged to insist on a necropsy for his
dog, in the face of the resistence of the Departmental Laboratory habilitated
to perform necropsies. 'There's a dog shelter just down the road', he was told.
'Why don't you go get yourself another dog, and let us get on with our work!'
We also ask the Commission to note the following :

LIVER TOXICITY AND THE USE OF ORAL KETOCONAZOLE (NIZORAL)
FOR FUNGAL INFECTIONS
March 3, 2008 - The March issue of Drug Safety Update published by
the British counterpart of the Saudi Food and Drug Authority (SFDA),

the Medicines and Healthcare products Regulatory Agency (MHRA),
reported that because of the risk of liver toxicity the approved uses of
oral ketoconazole (Nizoral) have been restricted in Great Britain. The
British authorities have received reports of serious liver toxicity
associated with the use of the drug, including cases resulting in death or
that required liver transplantation.
http: // www. sfda. gov. Sa / En / Drug / News / 270-en-10-3.htm

In light of these two recent rulings, we ask the European Commission to not
only consider requiring KETOFUNGOL (ketoconazole) veterinary medicine to
include the proper warnings on the information supplied to consumers who
buy this drug but, even more, to consider suspending the right to prescribe
this drug, which is (it seems) not approved for veterinary use in any other
country of the European Union, just as it is not approved for veterinary use in
the USA.
Ketoconazole, packaged and sold for human consumption, can still be
prescribed off-label in Europe (unless the Commission decides otherwise) in
which case the Nizoral CIS or PI or 'notice' delivers proper information to the
consumer (see copy enclosed) regarding symptoms of possible adverse
reaction and the injunction to stop treatment in the event of one or more
symptoms and immediately consult one's doctor.


The present total absence of appropriate consumer information and warnings
on the KETOFUNGOL veterinary medicine CIS and PI, or 'notice' is, in our
opinion, a grave breach of public trust and a state of affairs which we hope the
Commission will quickly and wisely bring to an end.
Before concluding this correspondence, we wish to make reference to other
types of veterinary medicines which escape the vigilance of consumers : those
which are administered directly by veterinarians, often without explaining
what they are administering or why they have chosen to administer it (after
all, informed consent is a sacred principle to the enlightened consumer, and
ought to be respected as well when the veterinary medicine is administered by
the veterinarian).
III. Zoletil
One consumer contacted us concerning the death of his female labrador
following administration by a veterinarian of zoletil, a tranquilizer, before
taking x-rays of one of the dog's hind legs.
The veterinarian's treatment report, written in a state of stress just after the
dog's death is auto-incriminating. He indicates that he injected, at 3:00 pm a
proper dose of the product, that the x-raying went smoothly, and that the
labrador awoke (translated from French, see attachment) 'without problem

because at 4:30 pm the dog was sitting up in her cage barking loudly.
The only reaction this barking elicited from the veterinarian, he admits was
annoyance. He writes that he and his staff considered calling the owner to
come get the dog earlier than arranged. The loud barking continued up to
about 5:40 pm when ' . one of my nurses, going to get another animal in the
cage room, noticed that the labrador was convulsing and alerted me right
away.'
The veterinarian reports that he immediately carried out an
eletrocardiogram, to discover that the dog was in cardiac arrest with
ventricular fibrillation.
According to the MERCK online Manual on ventricular fibrillation: '.if the
disorder is not rapidly treated, death follows. Cardiopulmonary
resuscitation (CPR) must be started within a few minutes, and it must be
followed by defibrillation (an electrical shock delivered to the chest) to
restore normal heart rhythm. It [ventricular fibrillation] is fatal unless
treated immediately. The most common cause of ventricular fibrillation is
inadequate blood flow to the heart muscle due to coronary artery disease, as
occurs during a heart attack. Other causes include the following : Shock (very
low blood pressure.). Electrical shock. Drowning. Very low levels of
potassium in the blood (hypokalemia). Drugs that affect electrical currents
in the heart.'

The veterinarian continues, 'One injection of adrenalin by IV and intra cardial
with a series of cardiac massages did not revive the dog after 20 minutes. I
myself proposed to the owner of the dog to carry out an autopsy by an expert
colleague, or at the veterinary school at ===, before incinerating the animal,
when I saw lack of belief in my statement on the part of the owner's sons, as I
concluded in the existence of underlying heart disease, undetected and
undetectable, to provoke lethal cardiac trouble with 1 cc of zoletil 100 given
intravenously 2 ½ hours after its injection!! » (emphasis his)


Having spent precious minutes on the electrocardiogram, the veterinarian
finally began heart massage, which he says he kept up for twenty minutes, but
which failed. We can hazard a guess as to the amount of time wasted at the
critical moments when every second counted.
Should the veterinarian have started CPR ( resuscitation) immediately, given
the condition of the animal, without needing an ECG to confirm what seems to
have been clearly apparent? Still more pertinant, should the veterinarian
have reacted earlier, hearing the loud and insistant barking (which is one of
the recognized signs of overdose with zoletil – see product info attached), and
should he have at least gone to check on the animal in the cage room? The
answers to these questions do not figure in the veterinarian's written report.
Instead, he gives a full paragraph to HIS surprise and anger that the son of
Talia's owner, witness to the scene, expressed disbelief in the veterinarian's
immediate explanation for Talia's death, that is, 'an undetected and
undetectable(!)' heart disease which was responsible for the reaction to the
drug. And yet, laymen that we are, when we consult the Client Information

Sheet, we read (see attached, translated from French, emphasis ours) :
Zolétil - In strong doses -Excessive salivation (reduced by atropine) --
muscular spasms –vomiting –nervousness, BARKING –short periods of
apnea --high blood pressure –tachycardia. A RESPIRATORY DEPRESSION
MAY BE INDUCED AFTER ADMINISTRATION OF HIGH DOSES. IF THIS
DEPRESSION BECOMES TOO GREAT, THE ANIMAL CAN BECOME
CYANOTIC [NB : discolored due to lack of oxygen in the blood].
REANIMATION MEASURES MUST THEN BE IMMEDIATELY TAKEN, SUCH
AS ARTIFICIAL RESPIRATION OR THE USE OF OXYGEN.'
In the veterinarian's report, he expresses righteous indignation that the son
of Talia's owner, witness to the failed attempt at cardiac massage, did not
believe his conclusion that the dog had a previous undetected, and
UNDETECTABLE, heart disease. The veterinarian counseled the family, he
writes, to have an autopsy done BY A FRIEND OF HIS or at a veterinary
school, FOLLOWED BY INCINERATION. We change nothing in the advice
given by this veterinarian : an autopsy carried out by someone he
recommended, followed by incineration. Why the recommendation of
someone he knew to carry out the autopsy? Why the inclusion of the advice to
incinerate immediately after the autopsy? Why would it come to this
veterinarian's mind at such a moment to advise the rapid destruction of the
corpse?
Faced with the son's frank refusal to believe the veterinarian's explanation for
Talia's death, the family nevertheless followed this advice, and the autopsy
was carried out by the pathologist recommended. The conclusion? The family
was right, Talia did not die of a previously undetected and UNDETECTABLE,
heart disease. She died of a previously undetected brain condition. Also
undetectable? We can ask ourselves many questions. But there will never be
formal answers, for Talia was incinerated, according to the veterinarian's
advice.
Conclusion


Clearly, many veterinarians and many manufacturers of veterinary medicines
do not respect the principle of informed consent, whether by design or by
incompetence hardly matters. What matters is to change 'the way things are
done', instituting checks and balances into the treatment process, so as to be
sure to respect the duty to inform, as well as to respect the duty of the
veterinarian to BE informed about the pharmaceutical products s/he
prescribes.
In the last cited case, certainly we can and do deplore the apparent ignorance
of this veterinarian when it came to the signs of adverse reactions to the drug
zoletil. What can the consumer do to protect himself, or rather his animal,
from negligent veterinary practice? We feel that this question can only find
an answer within the veterinary associations, and we hope that raising this
concern at the level of the Commission will result in a more serious attitude
on the part of the profession to inform itself about new drugs and new drug
therapies, while checking to be sure not to sluff off information about other

therapies regularly used.
If the health and the lives of our animal companions are worth the high cost
we pay for veterinary care, then the veterinarian owes not only to consumers,
but to himself and his profession as well, to be up-to-date in his knowledge of
the pharmaceutical products he employs or prescribes, or else s/he should
refrain from prescribing and using them.
In the meantime, we request that veterinary products administered directly
by veterinarians be included in the procedures about which the consumer
should be informed and subsequently to which s/he should give consent.
We hope that the European Commission will give serious consideration to our
request for a study/comparison between information contained in the CISs,
PIs and 'notices' with the known product information about each individual
veterinary medicine, so as to ensure that the information is accurate and up-
to-date.
We thank the Commission for its time and serious consideration of our
request. We also remain at the disposal of the Commission for any further
information we might be able to provide.

The Friends of Guenady Association
Janne Sieben
Marie Isaia
Hannah Straite
7 rue Lamartine
06000 Nice, France
33 4 93 85 59 50

Source: http://rivierazur.free.fr/EU_Commission_eng.pdf

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