Preemptive Drugs, Part 1
On Monday the FDA approved AstraZeneca’s Crestor for men over 50 and women over 60 who have “high-sensitivity C-reactive protein (hsCRP) ≥ 2 mg/L, and the presence of at least one additional [cardiovascular disease] risk factor, such as hypertension, low HDL-[Cholesterol], smoking, or a family history of premature coronary heart disease.”
According to the Wall Street Journal, “FDA's approval broadens the indication for Crestor as a preventative treatment for cardiovascular disease … The approval was based on a AstraZeneca-sponsored study of almost 18,000 patients known as ‘Jupiter,’ which looked at patients whose cholesterol levels were normal or slightly elevated but who had an elevated C-reactive protein (CRP) level.”
“CRP is a non-specific measure of inflammation,” says ACSH’s Jeff Stier, who wrote for HealthFactsandFears about the possibility of using statins like Crestor to prevent heart disease in patients with elevated CRP. “We didn’t realize how important CRP was until the JUPITER study. We applaud the FDA for broadening the indication for using Crestor. The notion that we can now medicate people who are not yet sick is strange to a lot of people, but it has potential to save a lot of healthcare dollars as well as lives, given that cardiovascular disease is the leading killer of Americans.”
Preemptive Drugs, Part 2
Another example of the life-saving potential of preemptive pharmaceutical use is that of tamoxifen, which works by blocking estrogen activity in breast tissue to lower the risk of breast cancer. Still, a study published in the journal Cancer Epidemiology, Biomarkers & Prevention by researchers at the National Cancer Institute shows that very few U.S. women at high risk of breast cancer have chosen to use tamoxifen.
“These statistics are scary,” says ACSH’s Dr. Gilbert Ross. “51,500 higher-risk women were taking tamoxifen in 2005 out of approximately 2.4 million women for whom the potential benefit of the drug outweighs the risk. This and similar drugs such as raloxifene (Lilly’s Evista) do have risks, as do all drugs. Tamoxifen, for example, is known to increase risk of uterine cancer since it promotes the growth of endometrial cells. Still, the threat of breast cancer is much greater, and preventive drugs should be considered.”
“Given that breast cancer is such a feared disease among American women, it is really puzzling to me that women at high risk of breast cancer would not avail themselves of a medicine to reduce their risk,” says ACSH’s Dr. Elizabeth Whelan. “From a rational point of view, it does not make sense.”
“There are many breast cancer advocacy groups out there, and if they were truly interested in reducing women’s risk of breast cancer, they would encourage women to speak to their doctors about the use of drugs like tamoxifen and raloxifene for women at high risk,” says Stier. “Not only are some of them chasing the wrong causes – like BPA in bottles – but here we have an example of something they could do to really make a difference, and they’re not doing it. That’s something we should consider before we donate money to them or go to the park to run in their 5K.”
For more information, see ACSH’s publication about reducing breast cancer risk with drugs.
Now That The Whole Wakefield Debacle is Behind Us …
A study in the February issue of the journal Autism Research which analyzed more than 5 million births found that a woman's chances of having a child with autism increase as she ages, but the risk may be less for older dads than previously suggested.
“It’s such an obvious hypothesis that we should have been looking at it from the beginning,” says Dr. Whelan. “This goes back to previous discussions over the years that there is strong evidence that autism is genetically based, so it might well be related to the mother’s genetic changes as she ages.”
Larger Doses, Fewer Commutes, Same Outcomes
A lower overall radiotherapy dose given in fewer, larger doses may result in better quality of life for patients with breast cancer, according to a study published in The Lancet Oncology.
“Standard protocol for radiation therapy to treat breast cancer is to get the radiation five days per week for six weeks,” says Dr. Whelan. “This discovery could be very important for a number of reasons, not just because of the medical advantage. For example if you live in New York City you don’t think about this, but if you live in rural Montana and the medical center is 3 hours away, this would make these treatments more available and more practical for you.”
“The results of this study are based on self-perceived symptoms among the patients,” says Dr. Ross. “Still, the outcomes for this modified schedule were as good or better in terms of recurrence and especially quality of life.”
Curtis Porter is a research intern at the American Council on Science and Health (ACSH.org).