Tags: health | Industry | Pharmaceutical

A brief look at Thalidomide, its roots in the Third Reich, its connection  to the Bush family, and its modern day incarnation.

Thalidomide, Third Reich production?

The Thalidomide trust team claims that the drug responsible for the birth of limbless babies was developed by a Third Reich scientist.

Prescribed for expectant mothers between 1957 and 1961 to treat morning sickness, thalidomide was previously believed to be the invention of the German firm Chemie Grunenthal in the early 1950s.

The director of the Thalidomide trust team, Martin Johnson, however, claims that thalidomide was developed by Third Reich scientist Otto Ambros as an antidote to nerve toxins in case of a chemical war."

http://www.presstv.ir/detail.aspx?id=85586

Naturally, I was intrigued, so I did a quick Google search on Herr Ambros, and came across this little gem of an article from Toxipedia:

"Otto Ambros was a chemist at the German company [IG Farben] and was a leading figure in developing Germany's Chemical Weapons arsenal. He was questioned in the Spring of 1945 after the German surrender and claimed to be a "plain chemist" during his interview though he was integral in development of all German nerve agent advances."

http://toxipedia.org/wiki/display/toxipedia/Otto+Ambros

What's that? I G Farben you say?

"How Bush's grandfather helped Hitler's rise to power

Rumours of a link between the US first family and the Nazi war machine have circulated for decades. Now the Guardian can reveal how repercussions of events that culminated in action under the Trading with the Enemy Act are still being felt by today's president

George Bush's grandfather, the late US senator Prescott Bush, was a director and shareholder of companies that profited from their involvement with the financial backers of Nazi Germany.
The Guardian has obtained confirmation from newly discovered files in the US National Archives that a firm of which Prescott Bush was a director was involved with the financial architects of Nazism.

His business dealings, which continued until his company's assets were seized in 1942 under the Trading with the Enemy Act, has led more than 60 years later to a civil action for damages being brought in Germany against the Bush family by two former slave labourers at Auschwitz and to a hum of pre-election controversy."

http://www.guardian.co.uk/world/2004/sep/25/usa.secondworldwar

Yet another case of Nazi horrors surviving the war to be unleashed upon the citizens of the world by the Elites. Yet another dark chapter from the dark history of one of the world's most sinister families. And lest we forget, I G Farben are the people that gave us Zyklon B.

"The drug has been approved in the US to treat a rare type of leprosy, and is used in Africa also to treat AIDS. And with its use, come more tragedies.

This little boy, Freddie, was born in Kenya. His parents tried to get him a visa to the UK for treatment, and after a media campaign they eventually succeeded. He died of a fungus infection a few days ago."

(2006)

http://www.voxpublica.org/archives/002021.html

So it's back, apparently, and its a US firm pushing it. Meet Thalomid, by Celgene.

First, the good news:

"THALOMID® (thalidomide) in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma.

The effectiveness of THALOMID® is based on response rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as an improvement in survival.

THALOMID® (thalidomide) is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).

THALOMID® (thalidomide) is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

THALOMID® (thalidomide) is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence."

Now the bad:

"WARNINGS:

1. SEVERE, LIFE-THREATENING HUMAN BIRTH DEFECTS
IF THALIDOMIDE IS TAKEN DURING PREGNANCY, IT CAN CAUSE SEVERE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILE TAKING THE DRUG. EVEN A SINGLE DOSE [1 CAPSULE (REGARDLESS OF STRENGTH)] TAKEN BY A PREGNANT WOMAN DURING HER PREGNANCY CAN CAUSE SEVERE BIRTH DEFECTS.

BECAUSE OF THIS TOXICITY AND IN AN EFFORT TO MAKE THE CHANCE OF FETAL EXPOSURE TO THALOMID® (thalidomide) AS NEGLIGIBLE AS POSSIBLE, THALOMID® (thalidomide) IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION PROGRAM APPROVED BY THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED THE “SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY (S.T.E.P.S.®).” UNDER THIS RESTRICTED DISTRIBUTION PROGRAM, ONLY PRESCRIBERS AND PHARMACISTS REGISTERED WITH THE PROGRAM ARE ALLOWED TO PRESCRIBE AND DISPENSE THE PRODUCT. IN ADDITION, PATIENTS MUST BE ADVISED OF, AGREE TO, AND COMPLY WITH THE REQUIREMENTS OF THE S.T.E.P.S.® PROGRAM IN ORDER TO RECEIVE PRODUCT.

2. VENOUS THROMBOEMBOLIC EVENTS
THE USE OF THALOMID® (thalidomide) IN MULTIPLE MYELOMA RESULTS IN AN INCREASED RISK OF VENOUS THROMBOEMBOLIC EVENTS, SUCH AS DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLUS. THIS RISK INCREASES SIGNIFICANTLY WHEN THALIDOMIDE IS USED IN COMBINATION WITH STANDARD CHEMOTHERAPEUTIC AGENTS INCLUDING DEXAMETHASONE. IN ONE CONTROLLED TRIAL, THE RATE OF VENOUS THROMBOEMBOLIC EVENTS WAS 22.5% IN PATIENTS RECEIVING THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE COMPARED TO 4.9% IN PATIENTS RECEIVING DEXAMETHASONE ALONE (P = 0.002). PATIENTS AND PHYSICIANS ARE ADVISED TO BE OBSERVANT FOR THE SIGNS AND SYMPTOMS OF THROMBOEMBOLISM. PATIENTS SHOULD BE INSTRUCTED TO SEEK MEDICAL CARE IF THEY DEVELOP SYMPTOMS SUCH AS SHORTNESS OF BREATH, CHEST PAIN, OR ARM OR LEG SWELLING. PRELIMINARY DATA SUGGEST THAT PATIENTS WHO ARE APPROPRIATE CANDIDATES MAY BENEFIT FROM CONCURRENT PROPHYLACTIC ANTICOAGULATION OR ASPIRIN TREATMENT.

ADDITIONAL WARNINGS:

Birth Defects: THALOMID® (thalidomide) can cause severe birth defects in humans. Because thalidomide is present in the semen of patients receiving the drug, males receiving thalidomide must always use a latex condom during sexual contact with women of childbearing potential, even if he has had a successful vasectomy. The risk to the fetus from semen of male patients taking thalidomide is unknown. Patients taking THALOMID® (thalidomide) should not share their drug with others or donate blood. Male patients taking THALOMID® (thalidomide) should not donate sperm.

Drowsiness and Somnolence: THALOMID® (thalidomide) frequently causes drowsiness and somnolence. Patients should be instructed to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness without adequate medical advice.

Peripheral Neuropathy: THALOMID® (thalidomide) is known to cause nerve damage that may be permanent. Peripheral neuropathy is a common, potentially severe, side effect of treatment with thalidomide that may be irreversible.

Dizziness and Orthostatic Hypotension: Patients should also be advised that THALOMID® (thalidomide) may cause dizziness and orthostatic hypotension and that, therefore, they should sit upright for a few minutes prior to standing up from a recumbent position.

Neutropenia: Decreased white blood cell counts, including neutropenia, have been reported in association with clinical use of THALOMID® (thalidomide). Treatment should not be initiated with an absolute neutrophil count (ANC) of <750/mm3.

PRECAUTIONS:

Hypersensitivity: THALOMID® (thalidomide) is contraindicated in any patients who have demonstrated hypersensitivity to the drug or its components.

Bradycardia: Bradycardia in association with THALOMID® (thalidomide) use has been reported.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Serious dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, which may be fatal, have been reported.

Seizures: Although not reported from pre-marketing clinical trials, seizures, including grand mal convulsions, have been reported during post-approval use of THALOMID® (thalidomide) in clinical practice. Patients with a history of seizures or risk factors for the development of seizures should be monitored closely.

Nursing Mothers: It is not known whether THALOMID® (thalidomide) is excreted in human milk. Because of the potential for adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

ADVERSE REACTIONS:

Multiple Myeloma

The most frequently reported serious adverse events in multiple myeloma patients (occurring in ?20% of patients treated with THALOMID® (thalidomide)/dexamethasone compared with dexamethasone alone) were: fatigue (79% vs 71%), hemoglobin (decreased) (78% vs 86%), hyperglycemia (73% vs 79%), hypocalcemia (72% vs 59%), constipation (55% vs 28%), sensory neuropathy (54% vs 28%), hyponatremia (43% vs 48%), muscle weakness (40% vs 37%), creatinine (35% vs 42%), leukocytes (decreased) (35% vs 29%), bone pain (30% vs 36%), neutrophils (decreased) (31% vs 24%), confusion (28% vs 12%), edema (57% vs 46%), dyspnea (42% vs 31%), thrombosis/embolism (23% vs 5%), anxiety/agitation (26% vs 14%), tremor (26% vs 6%), alkaline phosphatase (increased) (27% vs 28%), and rash/desquamation (30% vs 18%).

Other serious reported adverse events in multiple myeloma controlled clinical trials (THALOMID® (thalidomide)/dexamethasone vs. dexamethasone alone) were: hypokalemia (23% vs 23%), insomnia (23% vs 47%), depression (22% vs 24%), neuropathy-motor (22% vs 16%), fever (24% vs 20%), weight loss (23% vs 21%), weight gain (22% vs 13%), platelets (decreased) (24% vs 33%), anorexia (28% vs 25%), nausea (28% vs 23%), pain-other (25% vs 26%), headache (20% vs 23%), dry skin (21% vs 11%), and SGOT (increased) (25% vs 24%).

Erythema Nodosum Leprosum

Common adverse events reported in THALOMID® (thalidomide) treated patients in controlled clinical trials in ENL: somnolence (38%), rash (21%), headache (13%), asthenia (8%), malaise (8%), pain (8%), vertigo (8%), pruritus (8%), and impotence (8%)."

http://www.thalomid.com/thalomid_history.aspx

Wow. That's an amazingly dangerous chemical...

So I wanted to know naturally who Celgene are, considering the history and all. Going onto their site, I found the link below, the Board of Directors:

http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-govBoard

My there are some interesting names popping up in those histories. Glaxo Holdings, Johnson & Johnson, E Merck AG, J.P. Morgan, the Rockefeller University, General Electric Company, one is a former Commisioner for the US Food and Drug Administration...

I'll let you draw your own conclusions from that little list of highlights.

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