Tamoxifen

Tamoxifen (Nolvadex®) is the oldest of all the SERMs (Selective Estrogen Receptor Modulators). It has been used for more than 20 years to treat patients with advanced breast cancer. It is prescribed for women with hormone-receptor-positive breast cancer before and after menopause.

Below is a question posted in Dr. Andrew Weil's newsletter:

No more Tamoxifen
Q: My mother had breast cancer so I always considered myself at high risk and was planning to take tamoxifen for prevention. I just heard that it won't help. Why not?

A: Tamoxifen is an oral drug that blocks the effects of estrogen, the hormone that promotes the growth of some types of breast cancer. Tamoxifen has been used for many years to prevent recurrences of estrogen-receptor-positive breast tumors – that is, tumors that need estrogen to grow. In 1998, results of a study involving more than 13,000 women showed that tamoxifen can also lower the risk of breast cancer among healthy women, cutting the anticipated number of cases by 49 percent. However, until recently, no study looked at tamoxifen's effects on overall survival.

The latest on tamoxifen comes from an analysis showing that the drug doesn't change the life expectancy of many of the women who take it to prevent breast cancer. This is because of serious side effects:

• increased risks of cataracts,
  
• deep vein thromboses,
  
• endometrial cancer and uterine sarcoma,
  
• and strokes.
  
• In addition, women who do develop breast cancer while taking tamoxifen preventively are more likely to have estrogen-receptor-negative tumors, which are more aggressive and deadly.

Researchers at the University of California, Davis, looked at how all the tamoxifen-associated health risks affect life expectancy. Considering the impact of these health problems, the researchers found no benefit to taking tamoxifen preventively for women at the low end of the risk spectrum. While there was an improvement in life expectancy seen in this study, it was mainly among women who had hysterectomies and therefore were no longer at risk of developing any type of uterine cancer while on tamoxifen. Women who had not had hysterectomies would benefit only if their risk of breast cancer exceeded three percent over five years.

The study also looked at how much it would cost to save a single life at the current U.S. price of tamoxifen: a whopping $1,335,690 per year. In Canada, where drug prices are much lower than they are in the U.S., the cost per year of life saved was a far more modest $123,780. Even at Canadian drug prices, tamoxifen only seemed to improve life expectancy when a women's 5-year risk of developing breast cancer was at least 4 percent.

Bear in mind that tamoxifen isn't the only breast cancer prevention strategy. You may be able to reduce your risks by lowering your estrogen levels through lifestyle changes:

• get more exercise,
  
• reduce or eliminate alcohol consumption,
  
• eat hormone-free beef and dairy products (if you eat those foods),
  
• and have a first baby earlier in life rather than later.
  
• Eat soybeans and whole soy foods frequently, plus plenty of fresh organic fruits and vegetables and cold-water fish or flaxseed for their omega-3 fatty acids.
  
• Don't take birth control pills and,
  
• at menopause, avoid hormone replacement therapy.

Bottom line: unless you're at very high risk of breast cancer, taking tamoxifen preventively is unlikely to affect your lifespan. You can calculate your personal risks by logging on to www.cancer.gov/bcrisktool/ and answering the questions on the risk assessment form.

Andrew Weil, M.D.

Gleevec

Severe congestive heart failure and left ventricular dysfunction have occasionaly been reported in patients taking Gleevec (imatinib mesylate).

Any patient on the drug Gleevec who develops signs or symptoms of cardiac failure should be evaluated and treated. Gleevec has been linked to severe congestive heart failure and left ventricular dysfunction in 10 patients, according to a report published online by Nature Medicine this July.

A letter to health professionals have been isssued on 19 October, 2006. Click link below.
FDA MedWatch
Nature Medicine

Anthracyclines

More info for you
What is anthracyclines?

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The New England Journal of Medicine Resident e-Bulletin
Vol.355 No.15, October 12 2006

Q: What serious side effect can occur with the use of anthracyclines as chemotherapeutic agents?

A: At certain doses, anthracyclines are associated with dilated cardiomyopathy. Among adults who have survived childhood cancer late-onset cardiomyopathy is associated with previous anthracycline exposure and should be monitored and screened for.

Teens Living with Cancer says this: Anthracylines are a group of chemotherapy drugs used to treat a variety of childhood cancers. There is both good and bad news associated with anthracyclines. The good news: significantly increased survival rates. The bad news: possible heart problems that may not show up for 10 -1 5 years.

Anthracyclines include:

• Adriamycin
• Daunomycin
• Idarubicin
• Mitoxantrone

So, what is the big deal with anthracyclines?

We know that these drugs can effect the functioning of the heart's left ventricle. This is a problem when the heart needs to work harder, like during exercise or strenuous activity. The weakened left ventricle - responsible for pumping oxygen-rich blood back into the body - may not be capable of this heavy duty pumping action.

Cancer Answers: Anthracyclines technically are also antibiotics, although their high toxicity precludes their use as such.

Herceptin

More info for you
Cancer Research & Statistics
Herceptin for Breast Cancer
Greater Incidence of Heart Failure with Herceptin
Delayed Disease Progression

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Trastuzumab (Herceptin®)
Source: Cancer Backup
Chemocare.com

Herceptin® is used to treat women with breast cancer. It only works in people who have high levels of the HER2 protein. It appears to have little effect in those who do not. At the moment it seems that only about one in five women with breast cancer have tumours that will be sensitive to Herceptin.

Herceptin is considered as a possible treatment for women with HER2 positive breast cancer following surgery and adjuvant chemotherapy (and radiotherapy if appropriate). It is also used to treat women with advanced breast cancer.

What is Herceptin?

Herceptin is one of a new group of cancer drugs called monoclonal antibodies.

Herceptin is said to be effective when given with certain chemotherapy drugs. If it is given with some chemotherapy drugs, particularly Taxol and Taxotere, it increases the effectiveness of the chemotherapy and may improve survival.

Herceptin on its own causes a shrinkage of the cancer in a few women and stops it growing in others.

Herceptin is given by a drip (infusion) through a fine tube (cannula) inserted into a vein. The drug may be given once a week or once every three weeks.

Possible side effects

Body pain
Weakness
Nausea
Headaches
Diarrhea
Abdominal pain
Back pain
Infection
Flu-like symptoms
Vomiting
Cough
Shortness of breath
Rhinitis or pharyngitis
Insomnia
Rash
Dizziness
Swelling of feet, ankles or hands

Comment from Cancer Answers: The treatment by Herception costs US$40,000. It delays disease progression for a few months. It is not shown to cure breast cancer at all.

Source from this site: http://www.susanlovemd.com/community/questions/q000512.htm
A letter sent by Herceptin's manufacturer, Genentech, to thousands of clinicians who treat cancer patients stated that 62 cases of serious side effects-- including 15 deaths -- had been associated with Herceptin use since the drug was approved two years ago.

Erbitux

Erbitux prolongs life by two months
at a hefty cost of US$ 30,000
Source: Reuters - July 21 2004

Dying colon cancer patients may live an extra two months with help from a new drug called Erbitux but the price tag is a hefty US $30,000 – $2,400 per weekly injection.

According to the report, when given to 218 colon cancer patients for whom the anti-cancer drug irinotecan had stopped working, the typical survival time was 8.6 months. By comparison, 111 volunteers given Erbitux alone after the irinotecan stopped working typically lived 6.9 months.

Dr. Charles Erlichman of the Mayo Clinic in Rochester, Minnesota, USA, said: the benefits of Erbitux were modest in terms of stopping the cancer, patients’ response to the drug, and survival.

Dr. Deborah Schrag of the Memorial Sloan-Kettering Cancer Center in New York said: the high cost of colon cancer treatments highlights the need to restructure the way drugs are developed and priced.

... Although the survival rate for colon cancer has nearly doubled over the past decade, it has been accompanied by a 340-fold jump in the cost of drugs used to treat the disease.

To read more on ERBITUX MARKET, click link below:
Erbitux = Big Money
Cetuximab

Avastin

More Info For You
Avastin: Questions & Answers
Side Effects of Avastin
Problems with Avastin
Avastin Warning

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The New York Times, 15 February 2006
Source: International Herald Tribune

What price for health and drugs? by Alex Berenson

Avastin, a widely used drug for colon cancer is said to cost about US $50,000 a year. The same drug is used at twice the dose for lung and breast cancer, hence costing US$ 100,000 per year.

Avastin can prolong the lives of breast and lung cancer patients for several months when combined with other cancer treatments. While used to treat colon cancer, it generally is prescribed only to patients with late-stage disease and, when taken for 11 months, extends survival for an average of five months when compared to other treatments.

The press duped it as a billion-dollar drug. There is a huge potential patient pool for this drug. Sale pf this drug can grow up to $7 billion by 2009, compared with $1.1 billion last year.

Drug makers have typically defended high prices by:

• The high costs of developing new medicines.
• But the owners of Avastin are now using a different argument. They cited the inherent value of life-sustaining therapies. Avastin's price is based on the value of innovation, and the value of new therapies. If society wants the benefits, it must be ready to spend more for treatments like Avastin.

After all another cancer drug like Herceptin (for breast cancer), sells for $40,000 a year.

Avastin’s owner said: As we look at Avastin and Herceptin pricing, right now the health economics hold up, and therefore I don't see any reason to be touching them. The pressure on society to use strong and good products is there.

Iressa

More info for you
Trials and Tribulations
Fatal Side Effects

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Lung Cancer Drug Iressa Should Be Removed From Market
For Immediate Release: March 4, 2005
Source: Monheit Law - A Professional Corporation

Drug Approved Through Fast Track, But Failed to Reduce Death Rate

WASHINGTON, D.C. - Iressa, a drug approved to treat non-small cell lung cancer, should be pulled from the market because it does not improve survival rates and has been linked to deaths in Japan and the United States, Public Citizen told the U.S. Food and Drug Administration (FDA) today.

Iressa was approved in May 2003 under an accelerated approval program. Because it had been demonstrated only to reduce tumor size, its approval was conditioned on the manufacturer, AstraZeneca, studying the drug further to determine whether it prolonged survival. That study has been done; patients taking Iressa didn't live any longer than patients taking a placebo.

Iressa has been linked to deaths. In January, Japanese scientists linked Iressa to a total of 1,473 adverse events and 588 deaths in that country.

The continued use of Iressa "puts all patients at risk for a serious and potentially fatal lung disease that is occuring with a relatively high incidence," said Dr. Peter Lurie, deputy director of Public Health Research Group. "Leaving Iressa on the market increases the likelihood that patients will be diverted from an effective therapy to an ineffective therapy, endangering their lives. Keeping a drug on the market while effectively telling people to avoid taking it is not an adequate public health response."

The petition is available at http://www.citizen.org/publications/release.cfm?ID=7369.

Public Citizen is a national, nonprofit consumer advocacy organization based in Washington, D.C.
Web site http://www.citizen.org/

Vectibix

A Drug that Does Not Cure, but only Delay Disease Progression or Death by 36 days at the cost of US$24,000 plus per month?

FDA Approves New Drug for Colorectal Cancer

Sep. 27, 2006: The FDA has granted accelerated approval to Vectibix (panitumumab) for the treatment of metastatic colorectal cancer in patients who have progressed on standard chemotherapy.

The approval was fast-tracked based on results of a randomized, controlled trial of some 450 patients with metastatic colorectal cancer after undergoing chemotherapy.

• Overall survival was similar in the Vectibix and control groups.
• However, the mean time to disease progression of death was 96 days for patients receiving Vectibix compared with 60 days for those receiving standard care. This means a prolongation of life or disease progression by 36 days.
• In a large, randomized clinical trial, Vectibix has been shown to delay progression of disease compared to best supportive care.

In addition, 8% of patients receiving study drug experienced tumor shrinkage.

Vectibix's manufacturer, Amgen, says will cost about 20% less than the colorectal cancer drug Erbitux (cetuximab). Erbitux costs about $4000 every 2 weeks.

Important safety information:

• Dermatologic toxicities: dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures.

• Dermatologic toxicities were reported in 89 percent of patients treated with Vectibix and were severe in 12 percent of patients.

• Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage.

• Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients.

• Severe infusion reactions were identified as anaphylactic reactions, bronchospasm, fever, chills, and hypotension.
  

• Other adverse reactions: paronychia, fatigue, abdominal pain, nausea and diarrhea.

• Hypomagnesemia occurred 6 weeks or longer after the initiation of Vectibix. In some patients, hypomagnesemia was associated with hypocalcemia.

Seriousness of Colon Cancer

Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 146,940 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006.

Colorectal cancer is the second leading cause of cancer death among men and women in the United States and Canada (after lung cancer). It has been estimated that 56,370 people will die from colorectal cancer in 2006. That means that one person in the United States dies of colorectal cancer every 9.3 minutes.

One out of 18 people in this country will develop colorectal cancer in their lifetime and 20 percent of colorectal cancers are found after the disease has spread to distant organs." said Amy Kelly, director and co-founder of the Colon Cancer Alliance. "That means that a person in the U.S. is diagnosed with colorectal cancer every four minutes.”

Costs of Cancer Drugs

More Info For You
Ebitux = Big Money
Roche Not Embarassed
Cancer Drug Top US$100,000 a year
Unsustainable Cost of Cancer Drugs
Costly Drugs Force Life, Death Decision
Cost of Survival
Attack on Cancer Drug Cost
Cancer Drugs for Fortunate Few
Selling Hope or Selling Drugs That Don't Cure
Not Cure, But at a High Expense
Expert Question High Cost of Drugs
Subsidising High-cost Drugs
High Cost of Cancer
US$800 Million Dollar Pill
Cancer Drugs: Rising Cost a Concern

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This question and answer was downloaded from a newsletter from Dr. Andrew Weil. Prices quoted are in US dollars.

Cancer Drug Cost
As a newly diagnosed cancer patient, I'm appalled by the cost of some of the drugs. I'm not directly affected (yet), but how do people of limited means manage? This seems unconsionable.

--- Dan K. ---

Answer (Published 08/25/2006)

The reported costs of some of the newer cancer drugs is shocking. One, Avastin, used for colon cancer treatment, costs about $50,000 per year. The manufacturer, Genentech Inc., has indicated that it will ask the FDA to approve Avastin for the treatment of breast and lung cancer, at an estimated cost of $100,000 per year! In early July, 2006, Genentech Inc. reported that its second quarter net income rose 79 percent, in large part from the sale of Avastin.

Another of the same company's drugs, Herceptin, used to treat the more aggressively invasive her2-positive breast cancer, reportedly costs $40,000 a year. And the reported cost of Erbitux, a colon cancer drug distributed and marketed by Bristol Myers Squibb, is in excess of $17,000 a month!

Do they save lives? Not really, but they may extend survival. Studies have shown that Avastin can prolong the lives of breast and lung cancer patients for several months when combined with other cancer treatments. While used to treat colon cancer, it generally is prescribed only to patients with late-stage disease and, when taken for 11 months, extends survival for an average of five months when compared to other treatments.

Andrew Weil, M.D.