Taxol
(Paclitaxel) & Docetaxel (Taxotere)
quotes
[back] Taxol & Taxotere
In a major setback for the advocates of adjuvant chemotherapy, research published in the New England Journal of Medicine has shown that the widely used drug Taxol (paclitaxel) does not benefit women with the most common form of breast cancer. It is estimated that more than 20,000 US women per year are given Taxol after surgery, in an attempt to prevent a recurrence. This represents about half of all the women who get chemotherapy for breast cancer. [2007] TAXOL DOES NOT HELP PREVENT RECURRENCE OF MOST COMMON BREAST CANCERS by Ralph Moss
Docetaxel (Taxotere) AD FOR LUNG CANCER. Taxotere is a semi-synthetic derivative of the Pacific Yew tree, similar to
Taxol. In non-randomized clinical trials in breast cancer, there was indeed a
very high rate of responses. While only 2 out of 37 patients had
complete
responses, another 18 (49 percent) had partial responses. The median time to
progression was 26 weeks, while with the older drug Adriamycin it was 21 weeks.
Thus, at best, there was a gain of five weeks. The median survival time
(which, as I have said, is the key indicator of benefit) was 15 months with
Taxotere compared to 14 months with Adriamycin, a gain of one month. But
87 percent of patients had fluid retention or other serious side effects with
Taxotere {J Clin Oncol 1999;17:2341-54}. One must question what the quality of
life is during that extra month.
Taxotere has also been approved for the treatment of non-small cell lung
cancer. According to advertisements, Taxotere is "the first single agent to show
a significant one-year survival benefit with a predictable and manageable safety
profile." However, when scientists at M.D. Anderson Cancer Center compared both
a high-dose and a low-dose regimen to placebo, they conceded that "overall
survival was not significantly different between the three groups" {J Clin Oncol
2000;18:2354-62}. I find this study unusual in that it actually included a
placebo group-something that has been eliminated from most studies performed in
support of FDA approval. The failure of taxotere to impact positively on
survival is omitted from the company's four-and-a-half page advertisements
appearing in medical journals. There was also lung toxicity in 40 percent of
those who took Taxotere as well as many other side effects. [2000] The Grand Illusion
of Chemotherapy by Ralph W. Moss, Ph.D.
The National Cancer Institute spent $32 million of taxpayer's money researching its 'cure du jour,' taxol, a toxic drug made from the bark of Pacific yew trees. It then gave exclusive rights to harvest the yew, as well as "monopoly control over the data from federally funded research," to Bristol-Myers Squibb, the world¹s largest producer of chemotherapy. In this sweet deal, BMS pays no royalties on taxol sales and only a pittance for the rights to the yew tree bark. Yet it charges hapless consumers $1,000 per treatment, or eight times what it cost the NCI to synthesize. These are some of the insights in "Unhealthy Alliances" by Linda Marsa (Omni, 2/94). [1994] NCI & BRISTOL-MYERS MAKE A DEAL (TAXOL) by Ralph W. Moss, Ph.D.
The book is about how Bristol-Myers Squibb ripped off U.S. taxpayers and U.S. cancer patients and their insurers. ....The deal the NCI struck with Bristol-Myers raises two questions: Why Bristol-Myers? Why did the NCI fail to extract from Bristol-Myers a promise to return some of the profit from the sale of Taxol to the taxpayers who had financed three decades of research on Taxol? Goodman and Walsh make a reasonable effort to answer the first question; they make no effort to answer the second. They discuss the possibility that Robert Wittes, an NCI employee from 1983 to 1988, was the link between the NCI and Bristol-Myers who cemented the NCI agreement with Bristol-Myers. Wittes became a vice president at Bristol-Myers in November 1988 just as the discussions about finding a partner for NCI were beginning. He became an NCI employee again in August 1990. But, NCI denied any wrongdoing by Wittes. The authors conclude, “[T]he reasons why Bristol-Myers Squibb emerged as the successful contender remains hidden from public view.” [Review by Kip Sullivan] The Story of Taxol . Nature and Politics in the Pursuit of an Anti-Cancer Drug By Jordan Goodman & Vivien Walsh
The Bristol-Myers/NCI CRADA gave the firm exclusive rights to NCI's government-funded research, including the records of research completed before Bristol-Myers entered the Taxol picture, as well as all "new studies and raw data" from future NCI-funded Taxol research, which NCI agreed to make "available exclusively to Bristol-Myers," so long as the company is "engaged in the commercial development and marketing of Taxol." The company also received the exclusive rights to harvest the Pacific Yew trees found on federal lands. In return, the government receives no money or royalties, but only Bristol-Myers Squibb's "best efforts" to commercialize Taxol, including a commitment to supply Taxol for government-run clinical trials, which were needed to obtain FDA marketing approval for the drug, and to an ambiguous "fair pricing" clause for Taxol [2002] The Other Drug War by James Love
The adverse reactions to Taxol are well known. These are tabulated in the
drug's prescribing information and can be readily found at the FDA Web site,
www.fda.gov. Here are a few statistics, derived from a study of the single-use
of Taxol in 812 breast cancer patients.
Neutropenia - 52 to 90 percent of patients, depending on the dose.
Leukopenia - 17 to 90 percent
Anemia - 16 to 78 percent
Infections - 30 percent
Hypersensitivity reactions - 41 percent
Hypotension - 12 percent
Abnormal ECGs - 23 percent
Peripheral neuropathy, any symptoms - 60 percent
Myalgia/arthralgia - 60 percent
Nausea and vomiting - 52 percent
Alopecia (hair loss) - 87 percent
Injection site reactions - 13 percent
Some of these problems, such as numbness and tingling in the hands and feet,
persist for months and years following Taxol treatment.
[2007] TAXOL DOES NOT
HELP PREVENT RECURRENCE OF MOST COMMON BREAST CANCERS by
Ralph Moss
A Tale of Taxol By Frank Stephenson Since 1993, Bristol-Myers Squibb has introduced only one cancer drug to the pharmaceutical market—Taxol. As of August 2002, Taxol is still the only taxane product in its line of oncology drugs. When the company's exclusive, five-year right to market Taxol under the CRADA expired in 1997, technically opening the door to generic brands of the drug, the company successfully fought off the introduction of generics until December 2001, a move that added more than $4 billion to lifetime Taxol sales that by last August approached $11 billion.