Tamoxifen for prevention in high-risk breast cancer

The global study was led by University of Melbourne and the Peter MacCallum Cancer Centre and published in the Journal of Clinical Oncology.

The study involved about 2,500 women from Europe, North America and Australia who have inherited mutations in BRCA1 or BRCA2, the breast cancer susceptibility genes, and who had been diagnosed with breast cancer. About one-third of these women were placed on tamoxifen.

Tamoxifen has been used for decades to treat breast cancer and has recently been shown to prevent breast cancers in many women.

Until now, there has been limited information about whether it reduces breast cancer risk for women who are at the very highest level of risk with BRCA1 or BRCA2.

Lead author, Professor Kelly-Anne Phillips says this study, the largest to date, suggests that it could work for these high-risk women by halving their breast cancer risk.

"In the past, the only way of reducing breast cancer risk for these high-risk women was to do invasive surgery to remove their breasts and/or ovaries. For women who choose not to undergo such surgery, or who would prefer to delay surgery until they are older, tamoxifen could now be a viable alternative."

Such was the case for US actress Angelina Jolie who was found to carry a mutation in one of these genes.

Previous research led by Professor Phillips revealed that only 1 in 5 Australian women with a mutation in BRCA1 or BRCA2 choose to undergo bilateral mastectomy to prevent cancer.

Professor John Hopper, co-author from the School of Population and Global Health at the University of Melbourne, says "In light of our findings, it is clear that women who have a mutation in BRCA1 or BRCA2 should review their management plan with their specialist and re-discuss the options available to them to lower that risk."

This important finding has come from more than 20 years of research involving breast cancer families recruited from cancer registries and clinics across the country.

"Without the generous contributions of those families we would not be able to make such discoveries which help future generations fight breast cancer," he says.

However, we should be aware of how the study was carried out. According to William Hait, director of the Cancer Institute of New Jersey, who pointed out that Tamoxifen is effective in ER(+) cancers about 50% of the time. Around 70% of breast cancer is ER(+), and that means that if you treat all patients with breast cancer with Tamoxifen, you will see responses only 35% of the time, whereas if you treat only ER(+) cancers you will see responses 50% of the time. Therefore, more details must be needed.  

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Pfizer Inc

Pfizer is a research-based global pharmaceutical company. The company discovers, develops, manufactures and markets medicines for humans and animals, as well as consumer products.

Pfizer is the largest and richest pharmaceutical enterprise in the world. Fortune® named Pfizer as the fifth-best ‘wealth-creator’ in America. The company is a global leader in human pharmaceuticals, and also has a large array of consumer health care, confectionery, and animal health care products. In 2000, its revenues equalled $29,6 billion (£20,14bn), eight of Pfizer’s pharmaceutical products attained sales of at least $1 billion (£680,4 million) each. Pfizer’s main competitors are Merck, Glaxo SmithKline, Novartis, Brystol Myers Squibb and AstraZeneca.

In 2001, Pfizer has budgeted approximately $5 billion (£3,402 bn) for research and development -more than any other drug company in the world. However, the company is likely to spend even more money on marketing. Extensive marketing practices (e.g. huge TV advertising campaigns) have turned some drugs, like Claritin and Viagra, into household names. According to the Financial Times (26 April 2001), ‘Pfizer has powered its way up the global ranking list to its unassailable position thanks mainly to its marketing prowess.’

History:

The company was incorporated as Charles Pfizer & Co in the US in 1942 but the original business dates back to a partnership founded in 1849. Until the turn of the century this partnership produced only citric acid but then began to expand into other chemicals and pharmaceutical products. A phase of rapid growth began with the production of penicillin in World War II (it was Pfizer penicillin that arrived with the Allied forces on the beaches of Normandy in 1944) and the development of the company’s most famous product, the antibiotic Terramycin in 1949. Based on this strength, Pfizer grew in the 40s and 50s through horizontal integration in the US as well as through internal development.

Under the methodical directive of John Powers, head of international operations and future president and chief executive officer, Pfizer’s foreign market expanded into 100 countries and accounted for $175 million (£199 million) in sales by 1965. It would be years before any competitor came close to commanding a similar share of the foreign market. Pfizer’s 1965 worldwide sales figures of $220 million (£149,7 million) indicated that the company might possibly be the largest pharmaceutical manufacturer in the US. By 1980 Pfizer was one of the two US companies among the top ten pharmaceutical companies in Europe, and the largest foreign health care and agricultural product manufacturer in Asia. Powers guided the company in a new direction with an emphasis on research and development.

By 1989, Pfizer operated in more than 140 countries. Pfizer entered the 90s facing controversy about heart valves produced by Shiley, a Pfizer subsidiary. In 1990, 38 fractures of implanted valves were reported (see also crime section). Pfizer became a household name in the late 90s with its development of the break-through male impotence drug Viagra, which became the world’s fastest-selling pharmaceutical product (until overtaken by another Pfizer brand).

It appears Viagra also had an effect on the company’s senior executives; in 1999 they began forcing their intentions on rival Warner-Lambert, finally harassing the smaller company into a shotgun marriage in the first ever-hostile take-over in the pharma sector. This take-over turned Pfizer into the largest and richest pharmaceutical enterprise in the world.

Pfizer has worked its way up the global ranking list by way of internal growth and development, acquisitions, the licensing of products from competitors (Pfizer generously borrowed research from its competitors and released variants of these drugs. While all companies participated in this process of ‘molecular manipulation’, whereby a slight variance is produced in a given molecule to develop greater potency and decreased side effects in a drug, Pfizer was particularly adept at developing these drugs and aggressively seizing a share of the market), research & development, and by way of comprehensive marketing efforts.

Pfizer’s successful marketing efforts impinged on other companies in the pharma sector. (Pfizer’s modern market campaigns broke tradition in the pharma industry. Pfizer’s Terramycin campaign turned the company –a relative newcomer to the industry—into the largest advertiser in the American Medical Association’s journal. Some companies did not appreciate Pfizer’s ‘hard sell’ tactics and attacked Pfizer. However, after Pfizer’s campaign proved to be highly effective, other companies took a similar lead) It is manifested in the "arms race" of escalating numbers of sales representatives, particularly in the US; the huge pre-launch marketing budgets when companies try to make as big a splash as possible; and aggressive TV advertising campaigns in which drugs are seemingly being treated and presented to the consumer audience as any other consumer product.

Pfizer recently announced a new mission: to become the world’s ‘most valued’ company. Pfizer CEO McKinnell declared that the new mission came about because the old mission set in the 1990s (to lead the pharmaceutical industry) had been achieved. He explains: ‘Becoming most values simply means that we emerge as the company recognised as the best by patients, customers, business partners, and the communities where we live and work. It’s a long term mission focused on making Pfizer’s success a winning proposition for everyone.’

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Januvia User Says Side Effects Worse Than High Blood Sugar

Against his doctor’s advice, Don, age 47, stopped taking Januvia, saying he would rather deal with high blood sugar than kidney stones, blood in his urine and severe abdominal pains.

“As soon as I started taking Januvia, my stomach started burning, and about a year ago, I started to urinate blood clots,” says Don, who was on Januvia for about two years. “Then my urine turned a brownish color and I passed some kidney stones - the pain was so bad I wound up in hospital. They x-rayed my abdomen and found a sharp kidney stone that I hadn’t passed. By January, I could barely urinate at all and my toes went numb - not pleasant.”

Don adds that, after researching the side effects, he is worried about Januvia pancreatitis and Januvia cancer. His doctor advised him to stay on the diabetes drug to keep his blood sugar levels in check, but Don decided to stop taking it anyway. “I didn’t have any of these problems before I took Januvia,” he says, “and nobody could tell me why I was getting these symptoms. I wasn’t on any other meds so it was too much of a coincidence. But I did take antibiotics for a urinary tract infection because the kidney stone I passed was sharp as a razor blade.

“Before I took Januvia, my blood sugar was about 400, and after I took the pill, it ran up to 490 for an hour or two, then went back down to 400. ‘You aren’t worried that you could destroy your kidneys and your heart could shut down?’ my doctor asked me. I would rather live with high blood sugar and take my chances than possibly develop Januvia side effects. Now I’m afraid to take any drug now. Instead I just watch my diet and exercise, and I’m feeling a lot better since I stopped Januvia - it just made things worse.”

Don adds that his health issues first started when he was prescribed Seroquel: he developed diabetes from the drug, filed a lawsuit against AstraZeneca and settled in federal court.

Don is hopeful that he can join other patients who have filed Januvia lawsuits against Merck, and whose cases have now been consolidated to a special federal multi-district court in California. 

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Diabetes and Crestor, Zocor and Other Cholesterol Reducing Drugs

There has been a lot of publicity surrounding one of the side effects of the cholesterol-reducing drug Lipitor and some of its side effects. It has been shown that the highly prescribed drug increases the risk of diabetes slightly, especially in older women and those already at risk of the Type II form of the illness.

Other cholesterol-reducing drugs, particularly Crestor (rousuvastatin) and Zocor (simvastatin), also have been shown to increase the risk of diabetes. The connection is much less clear with earlier cholesterol reducing drugs, such as Pravachol and Prevocor, probably because they are less powerful.

Patients taking 20 milligrams of Crestor had a one in 167 chance of developing Type II diabetes. The risk increased to one in 125 at higher doses. According to one New York Times article, patients taking the three most popular cholesterol-reducing drugs have a one in 200 chance of developing Type II diabetes, when all doses and drug brands are taken into account.

It turns out that for people who have already had a heart attack or stroke, the benefits of taking Crestor or Zocor outweigh the risks of developing diabetes. However, people who have not had any health incidents before may do better trying non-drug methods of reducing their cholesterol levels. These include diet, exercise, weight loss and stress reduction and other approaches.

Crestor is manufactured by AstraZeneca. The company has issued warnings that there is an increased risk of side effects in Asian populations in general, and that it is more potent among those of Asian ethnicity than Caucasians. Doctors should begin treating Asian patients with Crestor at the lowest dose available, five milligrams.

A 2008 study sponsored by Crestor showed that there was an elevated risk for Type II diabetes, as did later studies of the same drug and other statins. Researchers have hypothesized that the link between such drugs and diabetes is because the medicine increases muscle resistance to insulin. This, however, has not been conclusively demonstrated.

The Food and Drug Administration (FDA) responded to research indicating the increased risk of developing diabetes when taking cholesterol-lowering drugs by issuing a warning label for Crestor, Lipitor and for other cholesterol-lowering statin drugs that include:

Zocor 

Lescol 

 

Pravachol

Mevacor 

 Livalo

The warning says that patients taking these drugs and their generic equivalents face a slightly increased risk of high blood sugar levels and of being diagnosed with diabetes. The warning was added in 2012. However, studies conducted earlier, including those mentioned above, established some degree of risk several years prior to the FDA changing required warnings. 

If you developed diabetes after taking one of these drugs, call the Cleveland attorneys at Elk & Elk. They will know what to do.

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Statines: le Crestor est trop prescrit en France

Le Crestor est dans le viseur de l'Assurance-maladie. Il fait partie de la famille des statines, une classe de médicaments utilisés pour faire baisser le taux de cholestérol dans le sang. Il est très largement prescrit en France, beaucoup trop selon la Sécurité sociale.

La Cnam a mené une étude auprès de 163.801 patients suivis pendant trois ans, pour comparer l'efficacité de deux molécules différentes, l'une disponible sous forme générique, la simvastatine, l'autre non, la rosuvastatine, plus coûteuse.

Or, les résultats ne montrent "pas de différence significative d'efficacité sur la morbimortalité" (mortalité due à la maladie).

La rosuvastatine, seule molécule n'ayant pas d'équivalent générique et vendue sous le nom commercial de Crestor, représente 30% des volumes prescrits en France. Ce qui est bien plus élevé que dans les autres pays européens. Dans sept pays en effet (Allemagne, Royaume-Uni, Pays-Bas, Italie, Finlande, Norvège, Espagne), sa place reste très minoritaire : 7,8% des volumes en moyenne, seulement 3,9% au Royaume-Uni et 0,5% en Allemagne.

Les médicaments anti-cholestérol représentent un "potentiel d'économies majeur" pour le système de soins français car, contrairement à d'autres pays européens, les génériques, moins coûteux et à l'efficacité comparable, ne sont pas assez prescrits, selon l'Assurance-maladie.

Près de 6,4 millions de patients suivent un traitement anti-cholestérol (statines) en France, ce qui a représenté 1,2 milliard de remboursements en 2012.

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