FDA Response to Budget Cuts for Office of Women’s Health

February 28th, 2007

I received the following response from an FDA representative regarding questions about possible budget freezes within the FDA's Office of Women's Health (message from FDA spokeswoman Julie Zawisza, published with permission):

Rachel,

Thanks for your message. I think there may have been some misunderstanding of how FDA proceeds during the 2OO7 Continuing Resolution process by which FDA develops a spending plan that is approved by Congress. We do not have final budget numbers yet for any of our operating components so it is premature to discuss what the final budget may look like.

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HPV Vaccine Discussion on the NewsHour

February 28th, 2007

The NewsHour on PBS aired a segment tonight, "New Study Stirs Debate over Mandatory Cervical Cancer Vaccination." The NewsHour health correspondent, Susan Dentzer addresses a new study of HPV infection rates, the HPV vaccine, and debate over making the vaccine mandatory. A transcript is available, as are audio versions via RealAudio and mp3 download.

The study mentioned above, released today in the Journal of the American Medical Association, reports that 1/3 of American women are infected with HPV by the age of 24, according to this article in the Washington Post. JAMA is providing the full-text of the article, "Prevalence of HPV Infection Among Females in the United States," for free on its website. According to the report, prevalence of HPV infection among women ages 14-19 was 24.5%. Interestingly, the two most frequently detected types of HPV were not those the Gardasil vaccine protects against, but were considered low-risk forms of the virus. There were no statistically significant differences in rates of each type of HPV found except for the greater frequency of those two low-risk forms. According to the study, "Overall, HPV types 6, 11, 16, or 18 were detected in 3.4% of the study participants, corresponding with 3.1 million females with prevalent infection with HPV types included in the quadrivalent HPV vaccine. Few participants (0.10%) had both HPV types 16 and 18 and none had all 4 HPV vaccine types. At least 1 of these 4 HPV types was detected in 6.2% (95% CI, 3.8%-10.3%) of females aged 14 to 19 years."

Original source here ...

WHO Warns Europe About H5N1

February 27th, 2007

FT.com reports that the WHO is once again warning Europe about the possibility of the deadly H5N1 bird flu strain spreading.

The deadly H5N1 strain of avian influenza is making a seasonal resurgence in Asia and could easily spread to Europe again this year, the World Health Organisation warned on Sunday.

The alarm follows four human deaths in Indonesia in the last five days, the first human case in China for six months (though the infected man has since recovered) and new poultry outbreaks in Vietnam - despite a huge campaign against it - and northern Nigeria.

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Long-Term Study of Cancer and Cell Phones Ordered

February 27th, 2007

The Times Online reports that a mass study of 200,000 cell phones users will look at the possibility of a long-term cancer risk from cell phone use.

More than 200,000 volunteers, including long-term users, are to be monitored for at least five years to plot mobile phone use against any serious diseases they develop, including cancer and Parkinson's and Alzheimer's diseases.

Professor Lawrie Challis, who is in the final stages of negotiation with the Department of Health and the mobile phone industry for the &3 million that he needs to fund the study, told The Times that research has shown that mobiles are very safe in the short term but that there is a "hint of something" for people using them longer.

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WHO Says End to Bird Flu Threat Still Years Away

February 27th, 2007

Reuters reports that WHO Director-General Margaret Chan warned that the threat of a H5N1 pandemic has not diminished and will not go away anytime soon.

The world is years away from stamping out bird flu in poultry, and the threat of a human pandemic will remain until it does, the head of the World Health Organization (WHO) said on Monday.

Addressing the U.N. agency's 34-state executive board, WHO Director-General Margaret Chan said that in the past three years the H5N1 bird flu virus had proven virulent.

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FDA Considering Drug Report Cards

February 27th, 2007

The FDA is considering issuing drug report cards that inform the public about problems with drugs and drug side effects. This would be for drugs that the FDA has already approved. MSNBC.com reports the FDA is looking for new ideas following the "public outcry over the withdrawal of the painkiller Vioxx."

As part of a pilot program, the Food and Drug Administration will issue drug "report cards" that would detail unexpected side effects that emerge only after a drug has been approved. The reports also would include follow-up studies and details about how the drugs are being used.

The proposal is one of roughly a dozen initiatives, new and ongoing, that the FDA unveiled Tuesday in response to a recent report by a committee of experts at the Institute of Medicine that criticized the agency's handling of drug safety in the wake of the Vioxx case.

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CDC Categorizes Flu Epidemics Like Hurricanes

February 27th, 2007

The CDC is now categorizing flu epidemics as Category 1 through 5 just like hurricanes are categorized. A Cat 5 flu would be far more devastating than a Cat 5hurricane. It would leave 1.8 million dead and it would shut down major cities for months. The new categories are part of a Pandemic Severity Index released as part of a new comprehensive strategy to deal with a severe influenza outbreak. You can see the Pandemic Severity Index graph on the right.

You can see the new Community Strategy for Pandemic Influenza Mitigation from the government here on the PandemicFlu.gov website. The plan was developed by the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services in collaboration with other Federal agencies and partners in the public health, education, business, healthcare, and private sectors.

The New York Times has a report on the new guidelines. The Times says it was partly based on the response to the 1918 epidemic. Read the rest of this entry »


Ghost-Filming? - Biotech Commissions a “Documentary”

February 26th, 2007

A while back, we posted about how a pharmaceutical industry group sponsored the writing of a novel that would support the group's negative point of view about reimportation of drugs from other countries. This seemed at the time to be an audacious example of stealth marketing in health care.

Now, one biotechnology company has sponsored the making of a "documentary" movie, just released in theaters, that just happens to underline the suffering that having particular diseases entails, diseases that are now remarkably treatable by drugs that include the company's product. Per the Philadelphia Inquirer,

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Blowing Our Own Horns: Health Care Renewal Bloggers at SGIM Annual Meeting

February 26th, 2007

Health Care Renewal bloggers Wally Smith and Roy Poses will be giving a "pre-course" at the annual Society for General Internal Medicine (SGIM) meeting in Toronto, Ontario, Canada. Our session is on Wednesday, April 25, 2007, from 1:30 -5:30 PM, entitled "Changing Physician Behavior - When to Do It? How to Do It? and How Not to Do It?" The latter topic may be of special interest to Health Care Renewal readers. The complete course description is here under PR07. Please note that the course description in the official printed program (available here) was both truncated and garbled.

In addition, bloggers Russ Maulitz, Smith, and Poses (and also not a blogger Robert Crausman MD) will be presenting an oral abstract during the first abstract session (session A), in the Health Policy section, entitled, "Selling Them the Rope: Prevalence of For-Profit Health Care Corporate Directors Among Academic Medical Leaders." This should be of special interest to Health Care Renewal readers.

Finally, I will be chairing a meeting of the Professionalism Sub-Committee of the SGIM Clinical Policy Committee during the annual meeting (time not yet known). This sub-committee's mission, to uphold physicians' professionalism, especially against external threats, including those due to concentration and abuse of power in health care, should be of particular interest to Health Care Renewal readers. If any SGIM members who are not members of the sub-committee are interested in joining, and/or want to attend this meeting, please contact me, Roy Poses, directly. (roy underscore poses at brown dot edu or rposes at firmfound dot org). Read the rest of this entry »


More Emergency Contraception Research

February 26th, 2007

The current issue of the journal Contraception has two articles on emergency contraception availability and awareness, and the journal Women's Health Issues has an article on California women's knowledge of emergency contraception.

For this study, the researchers recruited adult (18-45) English-speaking women from two urgent care clinics in San Francisco from Mar-Jul 2005. They excluded women who were currently pregnant, had had a hysterectomy or tubal ligation, had an IUD in place or a partner who had had a vasectomy, were over 45, or who planned to relocate or did not have a telephone. Women completed a computerized survey while they waited for their appointments. The 10-question survey asked about their knowledge of emergency contraception (EC), which was made available without a prescription in California in 2002. 446 women completed surveys that were analyzed. Younger women (<30) and women who had had a prior abortion were more likely to know that EC is currently available in California. Overall, women scored poorly, averaging only 4 correct answers out of 10.

  • Only 39% knew that emergency contraception is effective in the 3-5 days after intercourse.
  • Only 27% knew that EC is very or extremely safe, and only 39% knew it is very or extremely effective at preventing pregnancy.
  • 50% knew that EC poses no risk to future fertility, but only 19% knew it does not cause birth defects or miscarriage.
  • 84% knew that EC offers no protection from sexually transmitted infections.
  • Only 19% reported a personal or religious objection ot abortion, and only 7% reported a personal or religious objection to EC.
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