Pharmaceutical industry's lobbying wonder

Veterinary medicine as bn Euro business!

Levetiracetam (Keppra)
Just like Felbamate, Levetiracetam requires a dosage schedule of approximately three doses per day. It can also be slightly expensive, sometimes costing pet owners from $200-$300 per month (depending on the size of the dog being treated). The dosage is different for each dog, so it may require an "experimental dosage" procedure to find the proper beneficial treatment level of this medication.

The pharmaceutical industry lobby is spending more than 40 million euro annually to influence decision making in the European Union - nearly half is spent by drug manufacturers on in-house lobbyists!

FDA Issued Keppra Warning

The study by Brandt et al. does not provide a definitive answer
as to whether levetiracetam has an antiepileptogenic effect.
The issues of appropriate dose, timing of dose, and outcome
measures are sufficiently complex that it would take years to
work out the answer with any true certainty. This initial study
(as substantive as the efforts by Brandt and colleagues were) suggests,
within its important limitations, that it does not have an
antiepileptogenic effect.

FDA - Suicidality and Antiepileptic Drugs

Outtakes from lectures about epilepsy

"Hard to calculate drug interactions are a substantial complication in the treatment of elderly people with epilepsy! It´s no use, the doctor treating an elderly epilepsy patient has to know the relevant interactions, at least make an educated guess, which combination poses a potential threat!"
"A sudden stop of the drug medication will result in massive withdrawal symptoms, probably causing a series of seizures! We estimate the change of medication will take a year, and slowly reduce the dosis by one quarter of a tablet."

Belgian Prime Pill Pusher

..with subsidiary Schwartz-Pharma lobbyists througout Germany!
The belgian pharma group UCB accelarates it´s growth course. After the takeover of the british bio tech company Celltech for 1,53 billion pounds in January of 2005 UCB has now completed the takeover of Schwarz Pharma for 4,4 billion Euro.
UCB turned 42% of it´s annual revenue with medication for the central nervous system, 36% with allergy medication. The most prolific product with a turnover of 365 million Euro was the epilepsy medication Keppra!
UCB annual report
Due to these facts Keppra will be the first anticonvulsive drug that can be administered intraveniously during acute treatments! With this we will reach a wider range of "non controlled patients".
Market analysts
Stocks analyst Catherin Isted from Morgan Stanley Dean Witter rates the stocks of the pharma group UCB with the predicate "outperform".
A further money gatherer being Keppra, an anti epilepsy compound. Managing director Georg Jacobs sees more than a one billion turnover.
Pressures on the turnover due to monetary effects, generic competition and gouvernmental intervention in pricing were evaded by UCB thanks to the growth of income due to the epilepsy compound Keppra. Cleared the turnover for Keppra in the first 6 months grew by 44% to 498 million Euro!

From the authorisation for human use

5.1 Pharmacodynamic properties Pharmacotherapeutic group: antiepileptics, ATC code: N03AX14. The active substance, levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances.Mechanism of action. The mechanism of action of levetiracetam still remains to be fully elucidated but appears to be different from the mechanisms of current antiepileptic medicinal products. In vitro and in vivo experiments suggest that levetiracetam does not alter basic cell characteristics and normal neurotransmission.

Like all medicines, Keppra can cause side effects, although not everybody gets them.Tell your doctor if you have any of the following and they worry you.
Very common side effects (>10%) reported with Keppra are:

• somnolence (sleepiness);

• asthenia/fatigue (tiredness).

Common side effects (> 1% - 10%) reported with Keppra are:

• nervous system disorders: dizziness (sensation of unsteadiness), convulsion, headache,

hyperkinesia (hyperactivity), ataxia (impaired coordinated movements), tremor (involuntary

trembling), amnesia (loss of memory), balance disorder (equilibrium disorder), disturbance in

attention (loss of concentration), memory impairment (forgetfulness);

• psychiatric disorders: agitation, depression, emotional instability/mood swings, hostility or

aggression, insomnia, nervousness or irritability, personality disorders (behavioral problems),

thinking abnormal (slow thinking, unable to concentrate);

• digestive disorders: abdominal pain, nausea, dyspepsia (indigestion), diarrhoea, vomiting;

• nutrition disorders: anorexia (loss of appetite), weight increase

• ear and labyrinth disorders: vertigo (sensation of rotation);

• eye disorders: diplopia (double vision), vision blurred;

• musculoskeletal and connective tissue disorders:myalgia (muscle pain);

• injury: accidental injury;

• infections: infection, nasopharyngitis;

• respiratory disorders: cough (increase of pre-existing cough);

• skin disorders: rash, eczema, pruritus;

• blood disorders: decreased number of blood platelets.

Other side effects reported with Keppra are:

• nervous system disorders: paraesthesia (tingling);

• psychiatric disorders: abnormal behaviour, anger, anxiety, confusion, hallucination, mental

disorder, suicide, suicide attempt and suicidal ideation;

• digestive disorders: pancreatitis, hepatic failure, hepatitis, liver function test abnormal;

• nutrition disorders: weight loss;

• skin disorders: hair loss;

• blood disorders: decreased number of red blood cells, and/or white blood cells.
Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dosage increase. These effects should however decrease over time.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

EMEA

Not exactly tolerable odds for the safety of patients, but enough for the EMEA (an Agency whose mandate is the authorisation and supervision of medicines for the benefit of public health). As it seems these guys tolerate any drug that does´nt cause instant fatality! Maybe the future drug testing should be done on these lobby workers or the elite of the UCB Pharma Corporation! Swallowing their own medicine could prevent harm to hapless patients!

The bottom Line

The picture shown by the UCB and their wonder pills Keppra proves that the case of Mrs. K. is not an individual case. Instead we see systematic marketing of dangerous drugs in conjunction with a careless and dangerous attitude of doctors toward the patients, the costs for consumers and the health system.
Anticonvulsive drugs are by no means harmless, they are certainly no sweets that one aquires just for the taste! The risks of medication changes demand a year for correct results without bodily harm to the patients! The big question remains unanswered, how can a product that is not allowed to advertise in public, that has been released for monotherapy just one year ago, become "top performer" on the "market"? The "market" being patients with an illness that, unprofessionally treated, will result in serious consequences for themselves and their familys! The changing of medication in the span of one week without consulting the patient can be defined as assault and battery! The fact that the performing neurologists of the Asklepios Clinic advise a continuation of medication even though seizures where recorded needs to be looked into by the german authoritys.
What is Keppra? The medication has been in use for years, on dogs! Well, if they have side effects you can shoot them, right. Since dogs usually don´t have a medical plan the UCB Lobbyists used their influence to pass some tests and get an authorisation for human use. As we´ve found out the hard way, our family will not eat dog food nor let any of UCBs animal drugs near our house again!
The newest blunders from officials seem to be on the side of the Landeskriminalamt, after having knowledge of the criminal intent they actually ask us if we want to uphold the claim of continued intentional assault and battery, although German law explicitly says that if there is knowledge of a crime, it must be prosecuted! Well, dear law enforcement officers, we certainly intend to uphold our accusation!

Hochbahnvictims Keppra Warning

++++++++During Hospital visits be sure that you or your relatives do not get changes of anticonvulsive drugs without proper education as to what time frame or dosis is necessary. If seizures occur without any other indication than a change to Keppra inform the authorities and the carriers. Due to serious side effects many patients are not able to communicate their problems. Especially nurses or people caring for older patients should be very alert to this problem, since the doctors and pharma corporations see these as an easy target group.++++++++++++