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Genetech's Herceptin Increases Risk of Heart Defects

by Shows Animal Testing is Unreliable Wednesday, Jan. 25, 2012 at 1:18 PM

The breast cancer drug called Herceptin manufactured by Genentech has shown to increase the risks of heart defects and cardiotoxicity in older patients. This supports evidence provided by the ALF that states animal tests are not only cruel, though are also ineffective at determining the risk to humans.

Past CV disease, diabetes up trastuzumab cardiotoxicity risk in elderly with breast cancer

August 11, 2011 Nick Mulcahy

Barcelona, Spain - The risk of cardiotoxicity from trastuzumab (Herceptin, Genentech), already an issue for women receiving the drug for breast cancer, is even higher in elderly women who have a history of heart disease or diabetes, according to a small single-center study [1].

It's the first ever to carefully examine trastuzumab-related cardiotoxicity in elderly breast-cancer patients, in this case 70 years of age and older, according to the authors, led by Dr César Serrano (Vall d'Hebron University Hospital, Barcelona, Spain). The pivotal clinical trials of trastuzumab were conducted in younger women, 65 years and younger, who had "optimal performance status," they write. Their study was published online August 9, 2011 in the Annals of Oncology.

In a chart review of 45 patients aged 70 years and older who had been treated with trastuzumab for early or advanced breast cancer at one center since 2005, the investigators found that 12 (26.7%) of the women developed heart problems, usually heart failure or asymptomatic systolic LV dysfunction. This rate of cardiotoxicity is slightly higher than what was seen in the pivotal clinical trials, note Serrano and colleagues.

Asymptomatic cardiotoxicity (about 18% of cases) was defined as an absolute drop of 10% or more in LVEF with a final LVEF below 50% or an absolute drop above 20%. The median duration of trastuzumab-based treatment was 49 weeks.

Most of the cases of cardiotoxicity (92%) resolved in a median of five weeks. "One of the main characteristics of trastuzumab cardiotoxicity is its reversibility. It is a well-known phenomenon that differs from other chemotherapeutic agents such as anthracyclines. Reversibility normally happens with treatment discontinuation but also can also occur spontaneously," explained Serrano, who is now at Brigham and Women's Hospital (Boston, MA), in a press statement [2]. "The decision to reintroduce trastuzumab or to continue with it must be taken case by case together with a cardiologist."

The investigators saw that 33% of women with a history of heart disease developed asymptomatic or symptomatic cardiotoxic effects as a result of receiving trastuzumab, compared with only 9.1% of women without such a history (p=0.01); 33.3% of women with diabetes developed such problems, compared with only 6.1% without diabetes (p=0.017).

In univariate analysis, development of trastuzumab-related cardiotoxicity was significantly associated with obesity (p=0.045), history of heart disease events—including heart failure, arrhythmias, myocardial ischemia, or valvular heart disease (p=0.047)—and diabetes (p=0.017). Not significantly related to cardiotoxicity were prior or current anthracycline exposure, prior treatment for hypertension, baseline LVEF, and smoking history.

But only a history of heart-disease events and diabetes were significant on multivariate analysis.

Despite its limitations, the new paper is a valuable addition to the literature about trastuzumab, according to an expert not involved in the study. "This paper starts to define what puts older women at increased risk for cardiotoxicity on this drug," Dr Ilene Browner (Johns Hopkins University, Baltimore, MD) said in an interview.

It also suggests that there is an "apparent similar tolerance" to trastuzumab in this older population when compared with the younger patients in the drug's pivotal trials, she said. "Most clinicians assume that older patients can't tolerate chemotherapeutic agents used in the treatment of cancer as well as younger patients do."

Patients with or without cardiovascular risk factors require "aggressive monitoring," according to Browner, who said that the standard of care is "frequent monitoring with echocardiograms," as indicated by the drug's package insert.

But, she said, "If a woman has cardiotoxicity risk factors, be even more vigilant." Clinicians may need to weigh the risks and benefits of trastuzumab for some of these patients, she advised.

The authors acknowledge the limited number of patients in their series and say that their findings need to be interpreted cautiously. But, they note, "The fact that the mortality rate at five years after diagnosis of congestive heart failure is about 50% in patients [older than] 65 years warrants close surveillance of early symptoms and cardiac function in the elderly breast-cancer population to be treated with trastuzumab."

From the ALF resource "Making A Killing";

Why Animal Tests Don’t

Protect People

The number of drugs that pass as safe in animal

experiments and then either fail in human clinical

trials or go on to cause death and disability is

testament to the failure of animal tests in protecting

people. Animal tests cannot reliably predict how a

drug will affect people for several crucial reasons:

1) Species differences in anatomy, organ

structure and function, metabolism,

chemical absorption, genetics, mechanism

of DNA repair, behaviour, lifespan and the

inherent sensitivity of cell populations to

toxicants. For example:

– Small animals have proportionately larger

organs, a shorter blood circulation time and their

metabolism is generally faster than that of

larger animals.38

– Different species have different metabolising

enzymes, which breakdown chemicals. The

breakdown products generated (metabolites)

can be highly toxic. A drug may therefore

appear safe in tests on animals but be toxicto humans because of a metabolite, which is only produced when broken down by humanspecific


– The anatomy of the intestine, as well as the

variety and abundance of bacteria it harbours,

varies between species and affects the absorption

of drugs from the gastrointestinal tract.40

– The cells or organs targeted by a drug may

simply be more vulnerable to toxins in some

species than in others.41, 42 For example,

human liver damage is the most frequent

reason cited for withdrawal of a drug, with more

than half of acute liver failures being caused by

drugs. Yet liver toxicity in animal tests and

human clinical trials correlate only 50 per cent

of the time.43

– The placenta is more permeable in some

species, such as rats and rabbits, than in

humans, so teratogenicity (birth defect) tests in

animals may give misleading results.44 Even

tests using non-human primates correlate with

human teratogens only 50 per cent of the time.45

2) A homogenous group of animals living in

well-controlled experimental settings cannot

predict the response of varied human

patients living in natural conditions.46

For example:

– Test animals are usually all the same age,

strain and sex (it is still common practice to use

exclusively male rats47) and are not exposed to

the variety of pathogens and chemicals, which

free-living humans encounter on a daily basis.

– Unlike many human patients, animal models

rarely suffer from multiple illnesses

simultaneously and are not exposed to multiple

drugs or treatments at the same time.48

3) Artificially created diseases in animals in

laboratories do not reflect naturally occurring

human illness. Therefore, responses to drug

treatment cannot be extrapolated from one

to the other. For example:

– For decades, pharmaceutical companies

tested candidate anti-cancer drugs in animals

carrying transplanted human tumours but very

few drugs that appeared effective in the

animal models worked in humans. More

importantly, according to the US National

Cancer Institute, the animal models missed

effective human drugs.49

– More than 4,000 studies have been reported

demonstrating the efficacy of more than 700

drugs in animal models of stroke.50 About

150 of these drugs have been tested in human

clinical trials and all failed to show benefit.51

4) The stress caused to animals by routine

laboratory practices such as handling, blood

collection, physical restraint, injections and

gavage, results in altered physiological

states, which compromise test results.

For example:

– A review of 80 published animal studies found

that routine laboratory procedures caused

significant physiological changes associated

with stress such as raised cortisol, prolactin and

growth hormone levels; increased heart rate

and blood pressure; and abnormal behaviours

such as excessive grooming. The changes

were pronounced and lasted for 30 minutes

or longer.52

– Researchers at York’s Central Science

Laboratory found that having different

experimenters perform the same test using

the same equipment and rats from the same

breeding colony within the same room of the

same laboratory produced significantly different

results depending on whether the handler

was familiar to the rats or not.53

5) Many negative side effects of drugs are

not outwardly visible or measurable and

therefore cannot be detected in animal

tests.54 For example:

– Headache, nausea, dizziness, fatigue,

depression, confusion and double vision are

some of the most common, and often most

debilitating, side effects of drugs yet there is

no way to detect them in animals.

On a personal note my mom is one of the people who is suffering with a heart defect after being put on Herceptin. Did the doctor not know of the risk? Is it good medical practice to treat breast cancer at the expense of a once healthy heart? Does the CEO of Genetech feel that this can be balanced out by using statistics to make it acceptable, as in how many women are cured of breat cancer in the spotlight while those who suffer with heart defects as a result are ignored and downplayed by their public relations wizards?

Here is the latest unfortunate individual to make the top of my personal "black list";

Genentech CEO Arthur Levinson - CEO pay report

April 25, 2008 — 1:44pm ET | By Maureen Martino

Arthur Levinson - Genentech

Total Compensation: .8 million

Details: Levinson declined a pay raise, keeping his base salary at 5K. He received .73 million in incentives and .77 million in stock option grants, bringing his total direct compensation to .9 million in 2007. His direct pay was .6 million lower than in 2006 due to the company's lower stock value in 2007

photo of Mr. Levinson here;

Read more: Genentech CEO Arthur Levinson - CEO pay report - FierceBiotech


Anyone out there who could help me getting the message to Mr. Levinson safely would be my hero. Otherwise i will be forced to take matters in my own hands, and as an independent "lone wolf" type let's just say that i don't follow the ALF creed of "harm none". For me this CEO Arthur Levinson would make a great dinner. Not kidding about my desires to emulate Dr. Lecter's hunger with this one.

If ALF activists can do it themselves without harming anyone, that would allow me to remain free instead of being committed to a state forensic hospital or prison for taking matters into my own hands. Though i love my freedom i feel that i need to seek justice for what was done to my mother.

Thanks again to the ALF for putting out the facts and risking their own freedom to educate people about the fallacies of animal testing.
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