fpa Reacts To MHRA Approval Of Over-The-Counter Chlamydia Treatment, UK

The Medicines and Healthcare products Regulatory Agency has given approval for a medicine to be made available from a pharmacist without a doctor’s prescription to treat chlamydia. Reacting to this decision Natika H Halil, Director of Information, fpa said:

“For people who are already testing themselves at home it is a really positive step forward that the treatment can now also be bought from pharmacies. This will ensure fast and effective access to treatment. This service has the potential to play an important part in reducing rates of chlamydia, which is the most common sexually transmitted infection. Pharmacists are well placed to provide this service to those who wish to access treatment in this way, but there is still free testing, treatment and advice available from the NHS for all sexually transmitted infections.”

fpa (Family Planning Association) is the only registered charity working to improve the sexual health and reproductive rights of all people throughout the UK.

http://www.fpa.org.uk Continue reading

USAID Issues $15M Grant To Ugandan Religious Coalition

USAID on Thursday through the President’s Emergency Plan for AIDS Relief issued a $15 million three-year grant to the Inter-Religious Council of Uganda — a coalition of five religious groups that promote faith-based strategies to fight the HIV/AIDS epidemic, AFP/Today Online reports. The grant will enable IRCU to widen HIV/AIDS services to local communities through faith-based health units, nongovernmental organizations, churches and mosques, according to the U.S. embassy in Kampala, Uganda. According to Alyson Grunder, an embassy spokesperson, the health units associated with IRCU provide 40% of health care services in the country and will provide the program’s clinical components. IRCU also will mobilize and train volunteers to provide care, support, antiretroviral therapy and referrals for specialized care for HIV-positive people. According to the IRCU grant proposal, the coalition also plans to use the money for “promoting delayed initiation of sex among adolescent youth (and) increasing mutual fidelity among couples.” IRCU, which was created five years ago, includes the Anglican Church of Uganda, the Catholic Church in Uganda, the Uganda Muslim Supreme Council, the Uganda Orthodox Church and the Seventh Day Adventist Church (AFP/Today Online, 9/14).

Antiretroviral Drugs Expire in Uganda
Antiretroviral drugs in Uganda worth up to $500,000 recently have expired in government medical shops, Plus News reports. According to David Bogonza, general manager of Uganda National Medical Stores, by the time the antiretrovirals — which have a shelf life of 18 to 24 months — were stocked, some that were meant to be available for two months had expired. Bogonza added that the problem was exacerbated by an “unprecedented” increase in treatment sites, as Uganda expanded its antiretroviral treatment program from 26 sites in 2004 to 210 sites currently. “For drugs to expire in stores when we have only 80,000 HIV-positive Ugandans enrolled on [antiretrovirals] is inexcusable. It shows that the health ministry is incompetent to manage HIV,” Beatrice Were of ActionAid International said, adding, “Once treatment is interrupted, we will have problems like resistance, for example, to tuberculosis treatment, and this can be grave for people living with HIV/AIDS.” New stocks of antiretrovirals are available at accredited centers, and officials have said the shortage has been rectified, Plus News reports. Sam Zaramba, director-general of health services, said the situation was under investigation and that “[a]ppropriate action” would be taken against people who did not follow the correct drug distribution protocol (Plus News, 9/14).

“Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Diabetes Type 1 Vaccine – Diamyd(R) Phase III Study Approved By Six European Countries

Today Diamyd Medical (Pink Sheets:DMYDY)(STO:DIAMB) reported that six European countries have approved the initiation of a Phase III study with the Diamyd® diabetes vaccine for type 1 diabetes.

The application processes to the national regulatory agencies and ethics committees have proceeded according to plan, and the company has now received agency approvals for a European Phase III study of children and adolescents with type 1 diabetes in the Netherlands, United Kingdom, Finland, Slovenia, Spain and Sweden.

“We are delighted to report this good news to the market today,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “The fact that Diamyd successfully pursues a project as large as its Phase III program on its own with limited resources demonstrates that we have an extremely competent and committed organization. The different cultures, languages, regulations and regulatory procedures for different countries demand a lot from the applying company. We have met all of this year’s intermediate goals on time, and we are continuing our strategy of building a market-oriented pharmaceutical company in the area of diabetes.” Diamyd Medical is conducting two clinical Phase III studies with the Diamyd® diabetes vaccine for type 1 diabetes, one in Europe and the other in the US. The studies apply to people recently diagnosed with type 1 diabetes, i.e. within the last three months.

Diamyd Medical is a Swedish biopharmaceutical company focusing on development of pharmaceuticals for treatment of autoimmune diabetes and its complications. The company’s most advanced project is the GAD-based drug Diamyd® for type 1 diabetes and for which Phase III trials are ongoing in both the US and Europe. Furthermore, the company has initiated clinical studies within chronic pain, using its Nerve Targeting Drug Delivery System (NTDDS). The company has also out-licensed the use of GAD for the treatment of Parkinson’s disease.

Diamyd Medical has offices in Sweden and in the US. The share is quoted on the OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further information is available on the company’s web site: http://www.diamyd.com

This information is disclosed in accordance with the Securities Markets Act, the Financial Instruments Trading Act or demands made in the exchange rules.

Diamyd Medical Continue reading

Boston Scientific Announces FDA Approval Of TAXUS(R) Express2(TM) Atom(TM) Stent System, First Drug-Eluting Stent For Small Vessels

Boston Scientific
Corporation (NYSE: BSX) announced that it has received approval from
the U.S. Food and Drug Administration (FDA) to market its TAXUS(R)
Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System. The TAXUS
Express Atom Stent is a highly deliverable drug-eluting stent (DES)
specifically designed for treating small coronary vessels. It is the only
DES approved by the FDA for use in vessels as small as 2.25 mm in diameter.
No other DES for sale in the U.S. market is approved for use in vessels
smaller than 2.50 mm in diameter. The Company plans to launch the product

The Company also announced FDA approval of its TAXUS(R)
Express2(TM) Paclitaxel-Eluting Coronary Stent System for the treatment of
in-stent restenosis in bare-metal stents. This is the first such approval
granted by the FDA, making the TAXUS Express2 Stent System the only
drug-eluting stent approved in the United States for the treatment of
in-stent restenosis in bare-metal stents.

“The TAXUS Express Atom Stent will provide better options for U.S.
patients with coronary artery disease in small vessels,” said Gregg Stone,
M.D., Chairman of the Cardiovascular Research Foundation and Professor of
Medicine at Columbia University Medical Center, and Principal Investigator
of the TAXUS IV and V clinical trials. “This is a welcome addition to the
range of available drug-eluting stents, since patients with small vessels
who are currently treated with bare-metal stents experience high rates of
restenosis. In the TAXUS V clinical trial, the TAXUS Express Atom Stent
significantly reduced the chance of restenosis and the need for repeat
procedures compared to bare-metal stents, in patients with small vessel

“Our TAXUS Express Atom Stent addresses an unmet need and will help
interventional cardiologists better treat small vessel disease,” said Jim
Tobin, President and Chief Executive Officer of Boston Scientific. “With
the recent FDA approval of our PROMUS(TM) Stent and now the TAXUS Express
Atom Stent for small vessels, Boston Scientific offers the most
comprehensive DES portfolio in the industry, offering physicians and their
patients the broadest size matrix and the industry’s only two-drug

“In addition to being a welcome product approval, we believe this is
also an important indication we have made significant progress toward
resolving the issues related to the Corporate Warning Letter,” added Tobin.

TAXUS stents have been evaluated by the industry’s most extensive
randomized, controlled clinical trial program, with follow-up to five years
in some cases. These trial results have been supplemented by data on more
than 35,000 patients enrolled in post-approval registries. To date,
approximately 4.6 million TAXUS stents have been implanted globally, making
them the world’s most frequently used drug-eluting stents.

Boston Scientific is a worldwide developer, manufacturer and marketer
of medical devices whose products are used in a broad range of
interventional medical specialties. For more information, please visit:

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements may be identified by words like “anticipate,”
“expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar
words. These forward-looking statements are based on our beliefs,
assumptions and estimates using information available to us at the time and
are not intended to be guarantees of future events or performance. These
forward-looking statements include, among other things, statements
regarding clinical trials, product performance, competitive offerings,
procedural volume, overall market size and our market position. If our
underlying assumptions turn out to be incorrect, or if certain risks or
uncertainties materialize, actual results could vary materially from the
expectations and projections expressed or implied by our forward-looking
statements. These factors, in some cases, have affected and in the future
(together with other factors) could affect our ability to implement our
business strategy and may cause actual results to differ materially from
those contemplated by the statements expressed in this press release. As a
result, readers are cautioned not to place undue reliance on any of our
forward-looking statements.

Factors that may cause such differences include, among other things:
future economic, competitive, reimbursement and regulatory conditions; new
product introductions; demographic trends; intellectual property;
litigation; financial market conditions; and, future business decisions
made by us and our competitors. All of these factors are difficult or
impossible to predict accurately and many of them are beyond our control.
For a further list and description of these and other important risks and
uncertainties that may affect our future operations, see Part I, Item 1A –
Risk Factors in our most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission, which we may update in Part II, Item 1A
- Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file
thereafter. We disclaim any intention or obligation to publicly update or
revise any forward-looking statements to reflect any change in our
expectations or in events, conditions, or circumstances on which those
expectations may be based, or that may affect the likelihood that actual
results will differ from those contained in the forward-looking statements.
This cautionary statement is applicable to all forward-looking statements
contained in this document.

Boston Scientific Corporation
http://www.bostonscientific.com Continue reading

Sen. Brown Requests Information On FDA Fast-Track Designation

Sen. Sherrod Brown (D-Ohio) last week filed a request with the Congressional Research Service for more information on the fast-track designation that FDA awards to reduce review times for new medications for serious diseases, the Cleveland Plain Dealer reports. Last month, the Plain Dealer published a series of articles based on a seven-month investigation on the fast-track designation and “concluded the designation … provides little actual benefit to consumers” and “has amounted to a government blessing … for drug companies and a boon for investors looking to make quick money on the stock market.”

Brown requested the information in preparation for meetings with Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions Committee, to decide whether lawmakers should revise or eliminate the fast-track designation, which Congress established in 1997.

Brown said, “We’ll have a better understanding then, when I go to Kennedy and his people to talk about this,” adding, “They can see what they want to do then.” Kennedy in a statement said, “Fast-track designation is meant to speed the review of urgently needed medicines, and it should not be abused to artificially inflate a company’s profits,” adding, “Congress should see that the fast-track process is not abused and retains its intended purpose of seeing that important new medicines reach the patients who need them without undue delay” (Rutchick/Zeltner, Cleveland Plain Dealer, 1/10).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading

Opinion Pieces Examine Obama’s Commitment To Reduce The Need For Abortion

The Atlanta Journal-Constitution on Wednesday published two opinion pieces debating whether President-elect Barack Obama will fulfill his pledge to reduce the need for abortions. Summaries appear below.

~ Alexia Kelley, Atlanta Journal-Constitution: “The time is ripe to break the abortion stalemate,” Kelley, executive director and co-founder of Catholics in Alliance for the Common Good, writes in an opinion piece. Although Obama “supports a woman’s right to choose an abortion, his commitment to poverty reduction, affordable health care and addressing the root causes of abortion is encouraging,” Kelley writes. She continues that the Democratic Party’s platform “[f]or the first time” includes references to the “essential role social and economic supports play in reducing abortion.” This approach, as well as Obama’s outreach to religious Americans, “bodes well for continued dialogue and the potential for new coalitions and fresh solutions,” Kelley writes. She continues that officials should address economic and social issues through a “comprehensive abortion prevention strategy” to “make real progress reducing the number of abortions” in the U.S. According to Kelley, “Reducing the abortion rate by 95% in 10 years is an essential and achievable goal.” However, she writes, “[p]eople of faith have a particular responsibility to both collaborate with and challenge the new administration” (Kelley, Atlanta Journal-Constitution, 1/14).

~ Jonathan Merritt, Atlanta Journal-Constitution: “In years past, abortion has been a black and white issue,” Merritt, national spokesperson for the Southern Baptist Environment and Climate Initiative writes, adding that abortion-rights advocates “have been villainized as murderers” while abortion-rights opponents “have been called religious fanatics.” Merritt writes that the abortion debate recently “has evolved with the inclusion of one simple word: reduction,” adding that reduction has “struck a chord with Americans on both sides of the issue.” Merritt asks whether Obama will “make good on his promises” to reduce the number of abortions, whether abortion reduction will be a “priority” for the Obama administration and whether Obama has the “resolve to spend the necessary political capital” to reduce abortion. Merritt writes, “Unfortunately, by all indications, the answer to each of these questions is ‘no.’” He continues that “Obama has an abysmal record when it comes to abortion,” citing Obama’s statement in 2007 that he would sign the Freedom of Choice Act. According to Merritt, FOCA “would invalidate almost every restriction” on abortion and would result in “more abortion, not less.” He adds that it would be “unfortunate for America” if Obama does not reduce abortion because “[b]oth pro- and antiabortion rights voters have finally found something on which we can agree.” Merritt concludes, “If Obama wants to add another mark on the checklist under ‘unprecedented and historical,’ he will fulfill his promise to reduce the multitudinous number of abortions currently allowed by the United States” (Merritt, Atlanta Journal-Constitution, 1/14).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2009 The Advisory Board Company. All rights reserved. Continue reading

El Pasoans Driven Across The Borderfor Healthcare Due To Lack Of Insurance, According To Researchers AtUT School Of Public Health

One-third of El Paso’s residents cross the Texas-Mexico border to Ciudad Juarez to purchase medication and health care services, according to a study by researchers at The University of Texas School of Public Health El Paso Regional campus.

Results from this study are published in the February issue of the Journal of the National Medical Association.

“This is the first report on the patterns of cross-border purchase of health care and medications from a random sample of persons living in El Paso and Ciudad Juarez,” said Victor Cardenas, M.D., Ph.D., M.P.H, associate professor of epidemiology at the UT School of Public Health. Other study investigators were Jose Rivera, Pharm.D, director of The University of Texas at Austin Cooperative Pharmacy Program at El Paso; and Melchor Ortiz, Ph.D., professor of biostatistics at the UT School of Public Health.

According to the authors, cross-border medication shopping and medical attention can present health dangers, including medications laced with toxic substances that are banned in the U.S. market; incorrect medications or dosage prescribed by unqualified personnel; and counterfeit medications. The U.S. Food and Drug Administration (FDA) and Texas State Board of Pharmacy do not have any strict regulations against cross-border medication and U.S. Customs typically allows the entry of limited quantities of medications, Cardenas said.

The study found while 33 percent travel from El Paso to Ciudad Juarez, only 5.2 percent travel from Ciudad Juarez to El Paso seeking more affordable and easily accessible medication and health care services.

According to an estimate of the Pan-American Health Organization, 11.5 million people lived in counties along the U.S-Mexico border in 2000. There are an estimated 2.3 million people living in El Paso and Ciudad Juarez, making it the largest bi-national metropolitan area in the U.S., according to the City of El Paso.

“The border region is underinsured and underserved in terms of healthcare provision. It is a major concern that clearly plays a role in the cross-border healthcare phenomenon,” Cardenas said. He believes the lack of health insurance among El Paso residents is directly associated with crossing the border to purchase easily accessible prescription medications and healthcare services at lower costs.

Pharmacies and health care providers openly advertise their bilingual services to visiting U.S. residents. However, Rivera said many people receive their diagnosis and prescription at the pharmacy counter by nonprofessionals.

“This [study] is a mirror of what happens across the entire U.S.-Mexico border. The three main reasons people travel across border lines are affordable medications and services; savings on doctors’ fees by using a pharmacy attendant as a doctor; and the attentiveness of bilingual pharmacy attendants who can answer questions in depth for patients,” Rivera said.

According to Mexico’s National Institute of Statistics, Geography and Informatics, 62.3 percent of Ciudad Juarez residents are enrolled in government insurance plans, which provide them with more overall access to healthcare. Cardenas’ study found that 59.6 percent of El Paso residents and 82.8 percent of Ciudad Juarez residents were insured.

The study also found that Ciudad Juarez residents without insurance were three times more likely to travel to the U.S. to receive medical attention and purchase medications. Cardenas said that Ciudad Juarez residents who crossed the border were more educated, had more purchasing power and were not enrolled in government insurance plans. More men than women traveled to the U.S. to purchase medications with cash.

Cardenas believes increasing the access to affordable health care in the United States would prevent most of the cross-border purchase of medications and use of medical services in Mexico.


The study was supported by funds from the Paso del Norte Health Foundation and received support from the University of Texas Health Science Center at Houston’s School of Public Health.

Source: Jade Waddy

University of Texas Health Science Center at Houston Continue reading

Several States See Action On Women’s Health-Related Legislation, Ballot Proposals

The following summarizes recent action on women’s health-related legislation and ballot initiatives in Colorado, Georgia, Nebraska, Nevada and Kansas.

~ Colorado: On Friday, Colorado’s secretary of state announced that Personhood USA has secured enough valid signatures for a November ballot that would ask voters whether the state constitution should grant human rights to fetuses, the AP/Google News reports. Colorado voters rejected a similar amendment in 2008. Personhood USA submitted 80,000 signatures to the state in February — 4,000 more than the required amount to place a measure on the ballot — but thousands of the signatures were rejected. The group has since collected several thousand more signatures, which were submitted last week. Personhood USA is supporting similar efforts in 40 states (AP/Google News, 3/27).

~ Georgia: The state Senate on Friday voted 33-14 to approve a bill (SB 529) that would make it a crime for anyone to coerce a woman into having an abortion, the Atlanta Journal-Constitution reports. According to the article, bill sponsor and state Sen. Chip Pearson (R) claimed that “doctors, boyfriends, pimps and even parents can face criminal charges” if they encourage a woman to terminate her pregnancy. The bill also would allow criminal charges against health care providers who perform abortions based on the race or gender of the fetus. According to the Journal-Constitution, “a mother telling a child not to come home with a child could be charged with a misdemeanor based on the bill.” Abortion-rights supporters strongly opposed the bill, which now goes to the state House. “This bill was created under the false assumption that abortion doctors solicit women of color, particularly black women,” state Sen. Donzella James (D) said, adding, “This bill calls into question all who make a deeply private and personal medical decision.” State Sen. Curt Thompson (D) questioned how evidence of coercion would be gathered. Pearson replied that evidence would be based on eyewitness testimony. The vote on the measure — which came after more than three hours of debate — was mostly along party lines (Suggs, Atlanta Journal-Constitution, 3/27).

~ Kansas: State House and Senate negotiators are nearing an agreement on a proposal to rewrite a state law on abortion later in pregnancy, the AP/KOAM reports (AP/KOAM, 3/25). The current law permits abortion beyond 22 weeks’ gestation only if the woman otherwise would experience “irreversible impairment of a major bodily function.” Currently, no clinic in Kansas offers abortions after 22 weeks of pregnancy (Women’s Health Policy Report, 3/25). The negotiators are expected to meet to review a final draft of the bill early next week. State Sen. Pat Apple (R) said the bill will include a provision that would allow a woman or her family to sue an abortion provider if they have evidence that the abortion did not fall within the legally allowable circumstances. The legislation also is expected to include provisions that would require physicians to provide the state with more information about late abortions (AP/KOAM, 3/25).

~ Nebraska: State Sen. Jeremy Nordquist said Friday that a tentative plan to restore publicly funded prenatal care to pregnant, low-income women would cost the state between $2.7 million and $3 million annually, the AP/CNBC reports. Nordquist is one of a small group of senators attempting to develop a legislative proposal to restore coverage to some women who lost Medicaid prenatal care benefits after the federal government informed Nebraska that it was violating federal rules by including undocumented immigrants in the program (AP/CNBC, 3/26). Nebraska previously provided prenatal care to low-income women through Medicaid, regardless of immigration status, under the rationale that their children would be natural-born U.S. citizens and therefore eligible for Medicaid. The federal government allows documented immigrants to receive prenatal care through Medicaid, but undocumented immigrants are barred from the program. Earlier efforts to restore the prenatal care benefits were unsuccessful because they would have included coverage for undocumented immigrants, which Gov. John Heineman (R) and some lawmakers oppose (Women’s Health Policy Report, 3/25).

~ Nevada: The American Civil Liberties Union filed a brief Friday asking the Nevada Supreme Court to block a ballot initiative petition that would define “personhood” as beginning at conception, arguing that the language of the proposal is too vague, the AP/Las Vegas Sun reports. The court is scheduled to hear oral arguments for April 6. According to ACLU attorney Lee Rowland, the proposed ballot initiative states that fertilized eggs, embryos and fetuses would be considered persons, which would effectively end legal abortion. “No matter how much proponents try to emotionalize this litigation, if the initiative were to be placed on the ballot, Nevadans would have no idea what they are actually voting on,” Rowland wrote in the brief. ACLU — which also is representing Planned Parenthood — is asking the state Supreme Court to uphold a Jan. 8 ruling by Carson City District Judge James Russell that the initiative could not appear on the ballot because it is overly vague and violates a state requirement that initiatives address a single subject. According to the AP/Sun, the court will try to issue a ruling by May 18, the deadline for placing initiatives on the ballot for November. Personhood Nevada supports the ballot initiative, but four conservative groups — the Nevada Eagle Forum, the Independent American Party, Nevada Families and Nevada Life — oppose the effort because they say the language is too vague and might not pertain to abortion (AP/Las Vegas Sun, 3/27).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women’s Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women’s Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

© 2010 The Advisory Board Company. All rights reserved.

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China Increasingly Using Condoms In Fight Against HIV/AIDS, Wall Street Journal Reports

The Wall Street Journal on Tuesday examined how China is increasingly promoting condoms as a method of HIV prevention. While HIV “has long thrived quietly on the fringes of Chinese society” among injection drug users and tainted blood recipients, there is now a risk of HIV spreading further into the general population. One reason is the “booming ” sex work industry in China which “has helped make sex the most common form of” HIV transmission in the country, according to the Journal. This has given rise to increased promotion of condom use to prevent HIV from spreading. A recent survey by UNAIDS conducted in six major cities in China found that 54% of respondents said they would use a condom when having sex with a new partner

China’s “hopes of stopping the disease from turning into the country’s next health crisis may rest with the efforts of people like Guan Baoying,” who has “defied standard government attitudes about high-risk groups” such as sex workers, the Journal reports. Guan first encountered HIV/AIDS in the mid-1980s when she worked at Beijing’s Center for Disease Control. She then began visiting detention centers in Beijing that held sex workers to educate women about HIV/AIDS prevention. According to the Journal, “[t]ens of thousands of massage parlors and karaoke bars double as brothels, where businessmen and migrant workers can contract the disease and carry it to their hometowns and families.” Sex workers are “disadvantaged people in society,” Guan said, adding, “No one cares about them.”

In 2004, Guan garnered support from 12 government departments for a regulation that aimed to increase condom access in Beijing. In March 2006, a regulation issued by the State Council required government-designated public places, including hotels, to install condom vending machines or provide access to condoms through another method. Beijing in May 2008 began requiring that condoms be placed in all public places, such as restrooms, karaoke bars and large construction sites. “It is by no means easy for Beijing to take this step, and I am very happy to see it happen finally,” Guan said.

Guan in 2007 retired as the head of disease control at the Beijing Municipal Health Bureau and now works for the Beijing office of the HIV/AIDS program of the Global Fund To Fight AIDS, Tuberculosis and Malaria. Although many parts of China have not adopted her approach to HIV/AIDS prevention, the Bill & Melinda Gates Foundation in 2007 adopted Guan’s prevention and outreach model and began replicating it in 12 provinces. “We have done our best to make people aware of the importance of wearing condoms, but it’s hard to judge how many of them will actually do it,” she said (Zamiska/Fowler, Wall Street Journal, 11/18).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

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Editorial, Opinion Piece Address Whether FDA Approval Of Medications Should Exempt Companies From Liability Lawsuits

USA Today on Friday published an editorial and an opinion piece that addressed whether FDA approval of medications should protect pharmaceutical companies from product liability lawsuits filed in state courts. The Supreme Court this year will hear a case that could decide the issue. Summaries of the editorial and opinion piece appear below.
USA Today: “FDA’s endorsement of a medicine or a warning label could be enough to bar” such product liability lawsuits in the event that pharmaceutical companies and the Bush administration “get their way” in the Supreme Court case, and, “in a perfect world, that’s how it should be,” a USA Today editorial states. According to the editorial, FDA “would be able to police the pharmaceutical companies, detect fraud or deceit, and monitor drugs effectively after they’re released to the market.” However, in the “real world,” the “underfunded, understaffed FDA can be overmatched by pharmaceutical companies that withhold or manipulate information when seeking FDA approval, or are slow to report adverse results once drugs are in widespread use,” the editorial states. “That’s where the legal system comes in” because “litigation or fear of litigation plays important roles in backstopping the FDA and promoting pharmaceutical safety,” the editorial states, adding, “Litigation can ferret out crucial information about drug company deception and risky drugs.” The editorial recommends that the Supreme Court “let the suits proceed,” with a requirement that plaintiffs “demonstrate that a company deliberately deceived the FDA or knowingly failed to warn about the risks of its medicines.” The editorial concludes, “That should both protect the drug companies and help keep them honest” (USA Today, 4/25).

Diane Bieri, USA Today: “For 70 years, Congress has charged FDA with ensuring that medicine labeling adequately warns about potential side effects,” but today “lawyers are trying to second-guess FDA’s expertise regarding the way to warn about potential drug risks,” Bieri, senior vice president and general counsel for the Pharmaceutical Research and Manufacturers of America, writes in a USA Today opinion piece. According to Bieri, in the event that plaintiff attorneys “are successful” in the Supreme Court case, the “companies researching and developing medicines could face massive damages” in product liability lawsuits filed in state court — “even after they discussed potential risks with FDA scientists and they required different warnings” — which “would be unfair and would hinder the development of lifesaving treatments.” Bieri writes that such lawsuits “would weaken FDA further because it no longer would have adequate authority to control safety warnings we all depend on” and “would effectively weaken FDA’s power to protect patients.” In addition, the “opinion of lawyers and juries would replace the judgment of FDA’s scientists and doctors,” she writes. Bieri writes, “Federal pre-emption is not about providing blanket immunity for pharmaceutical companies,” adding, “Simply put — pre-emption is about allowing FDA scientists to do their job and protect patients” (Bieri, USA Today, 4/25).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading