From the Washington Times
FDA panel backs first pill to block HIV infection
Must be taken every day to work
by Matthew Perrone
SILVER SPRING, Md. (AP) — The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.
In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.
The FDA is not required to follow the panel's advice, though it usually does. A final decision is expected by June 15.
Gilead Sciences Inc. , based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.
While panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug's effectiveness in women, who have shown much lower rates of protection in studies.
Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn't take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.
“The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine,” said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. “I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits.”
Panelists stressed that people should be tested to make sure they don't have HIV before starting therapy with Truvada. Patients who already have the virus and begin taking Truvada could develop a resistance to the drug, making their disease even more difficult to treat. The experts grappled with how to protect patients while avoiding hurdles that could discourage them from seeking treatment.
“If we put up too many hoops to jump through, there will be people who don't make it through those hoops,” said Daniel Raymond, the panel's patient representative.
Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.
Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.
But Truvada's groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada 's supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security, and encourage risky behavior.
During the meeting's public comment period, FDA panelists heard from more than two dozen doctors, nurses and patients who said patients would not take the drug as recommended — every day, in addition to using condoms.
“Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won't happen,” Karen Haughey told the panel. “In my eight years, not one patient that I've cared for has been 100 percent adherent.”
Other speakers worried that wide scale use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.
“Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies,” the group states in a petition to the FDA.
The FDA is legally barred from considering cost when reviewing drugs. Medicare and Medicaid, the nation's largest health insurance plans, generally cover all drugs approved by the FDA and many large insurers take their cues for coverage from the government plans.
An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to breakdown, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.
The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. But with no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.
Nick Literski , a federal worker in Seattle, has been taking Truvada for HIV prevention for more than a year. His partner is HIV-infected and his doctor prescribes the drug as a precautionary measure, even though it is not yet FDA -approved for that use. Literski pays a $40 monthly co-pay for the once-daily pill.
FDA approval of the drug for prevention would be “a huge step forward” in the fight against AIDS, he said in an interview Thursday. But he said rejection would be devastating, threatening gay relationships like his that involve one partner who is HIV infected and one who isn't.
“Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner,” Literski said, and he worried about that happening to him before he started using Truvada.
From the Department of Justice
Assistant Attorney General for the Civil Rights Division Thomas E. Perez Speaks at the Maricopa County Press Conference
Phoenix ~ Thursday, May 10, 2012
Today, the Department of Justice did something it has done only once before in the 18-year history of our civil police reform work; we filed a contested lawsuit to stop discriminatory and unconstitutional law enforcement practices. In our police reform work, we have invariably been able to work collaboratively with law enforcement agencies to build better departments and safer communities. Maricopa County, the Maricopa County Sheriff's Office and Sheriff Arpaio have been a glaring exception. Attempts to forge solutions to address the serious civil rights and public safety concerns have proven elusive.
In June 2008, the Department of Justice began its initial inquiry into allegations that the Maricopa County Sheriff's Office and Sheriff Joseph Arpaio were violating the constitutional rights of people in Maricopa County. In September 2010, following repeated unsuccessful efforts to obtain MCSO's and Sheriff Arpaio's voluntary compliance with its legal obligations to provide information in connection with our investigation, the department took the virtually unprecedented step of filing a lawsuit to force MCSO to comply. This lawsuit successfully caused MCSO to meet its legal obligations and it was settled in June 2011.
Six months later, in December 2011, the department issued its letter of findings detailing the results of our investigation. Our investigation found that there is reasonable cause to believe that MCSO and Sheriff Arpaio engage in: 1) a pattern or practice of discriminatory policing of Latinos, 2) discriminatory jail practices against Latino prisoners with limited English skills, and 3) a pattern or practice of unlawful retaliatory behavior against perceived critics of MCSO through baseless criminal charges, unfounded civil lawsuits and meritless administrative actions.
After we issued our findings letter, we tried to reach a negotiated settlement. The United States is not seeking, and has never sought, monetary damages or attorney's fees in connection with our case, though Title VI authorizes the termination of federal funding. Rather, we sought, and continue to seek, to accomplish one important goal: to fix the problems identified in our investigation and ensure that the necessary policies, practices and oversight are in place so that MCSO and Sheriff Arpaio comply with the Constitution and laws of the United States.
We traveled to Phoenix in early February and met with lawyers for MCSO and Sheriff Arpaio as well as with the county attorney, where we discussed the parameters of a potential settlement. We made it clear, orally and in writing, that a settlement would require an independent monitor. Later that month, we gave MCSO and Sheriff Arpaio a 128-page draft settlement agreement, which we hoped would serve as the framework for further discussion. Unfortunately, these further discussions were brief, and negotiations broke down, primarily because MCSO and Sheriff Arpaio would not agree to any settlement that included an independent monitor.
A monitor, in general, and specifically in a case of this nature, is not a new requirement. Monitors have been critical components of our settlements in other police cases, from Los Angeles to Pittsburgh to Cincinnati, and they play an important role in ensuring that reforms are carried out in an effective, fair and sustainable fashion. Ronald Reagan was correct: trust but verify. Monitors do not usurp the function of sheriffs; in fact, there was a provision in the proposed agreement that stated, “The monitor shall not, and is not intended to, replace or assume the role or duties of the defendant, including the Sheriff.” Monitors work collaboratively with sheriffs' offices, police departments, courts, communities and the Justice Department to provide necessary support and assistance to ensure that the problems are fixed in a sustainable fashion. Unfortunately, this provision was unacceptable to the Sheriff and MCSO and they ended negotiations.
Left with no choice, earlier today we filed a civil complaint in the United States District Court against Sheriff Arpaio, the Maricopa County Sheriff's Office and Maricopa County.
The police are supposed to protect and serve our communities, not divide them. At its core, this is an abuse of power case involving a sheriff and sheriff's office that disregarded the Constitution, ignored sound police practices, comprised public safety, and did not hesitate to retaliate against perceived critics. Constitutional policing and effective policing go hand-in-hand. Our complaint alleges that the defendants' actions were neither constitutional nor effective.
There are three categories of claims in the complaint. First, the complaint alleges that MCSO's police practices unlawfully discriminate against Latinos in violation of their constitutional and statutory rights. It is Sheriff Arpaio's prerogative to set law enforcement priorities for his agency. Whatever his priorities, he must carry them out in a manner that is consistent with his constitutional and statutory obligations. Law enforcement agencies cannot cut constitutional corners in the pursuit of their objectives, and the complaint alleges that from at least 2006 to the present, MCSO officers have unlawfully discriminated against Latinos and violated their constitutional rights in a number of ways, including racial profiling of Latinos in traffic stop settings; unlawful detention, searches and arrests of Latino drivers and passengers; and unlawful targeting and illegal detention of Latinos during home and worksite raids.
The complaint further alleges that MCSO failed to adopt basic policy, training and internal oversight practices to monitor these police activities, examine their effectiveness, and prevent unlawful activities. For instance, despite the fact that the traffic operations have very low “hit rates,” and very high rates of stopping Latino U.S. citizens and legal residents, the specialized units receive little oversight and inadequate training. If you looked Latino, you were all too frequently fair game for MCSO officers.
The second category of claim in the complaint is that MCSO's correctional practices violate the constitutional and statutory rights of Latino prisoners in MCSO jails who have limited English skills. It is essential as a safety matter and as a civil rights matter for officials who administer a jail to ensure that employees can effectively communicate with prisoners who have limited English skills. MCSO recognizes this obligation. In a position statement of June 14, 2010, MCSO noted the importance of providing language assistance to LEP prisoners, stating that such assistance is “essential to the overall operation of the jails and the safety of the prisoners and officers.”
The complaint outlines how MCSO failed to put this into practice in its jails. MCSO and Sheriff Arpaio routinely failed to provide necessary Spanish language assistance to Latino prisoners with limited English skills. As the complaint outlines, MCSO detention officers routinely issue commands only in English. In some instances, when Latino prisoners with limited English skills failed to follow a command given in English because they could not understand, the detention officers placed an entire area of a jail in lockdown. This incites obvious and unwarranted hostility toward the inmates, potentially placing prisoners and officers alike in harm's way.
In other circumstances, MCSO detention officers have forced Latino prisoners with limited English skills to sign key legal documents printed in English, in which they forfeited key rights.
MCSO's failure to provide effective language assistance services is a violation of the civil rights of Latino prisoners with limited English skills, and is a substantial departure from generally accepted correctional standards.
The third category flows from Sheriff Arpaio and MCSO's pattern or practice of retaliating against perceived critics of MCSO practices. The complaint outlines a number of instances where MCSO and Sheriff Arpaio have targeted a range of people, including judges, lawyers, and community leaders who made statements or took actions that they either disliked or perceived were critical of MCSO or the Sheriff.
A hallmark of our democracy is freedom of expression. It is equally important that dedicated public servants are able to carry out their responsibilities without fear of unlawful, retaliatory reprisals. The complaint outlines a series of retaliatory actions by MCSO and Arpaio, designed to silence and punish perceived critics, with the added effect of chilling would-be critics. Retaliatory activities were directed at public officials, judges and private citizens engaged in lawful protests. For instance, the complaint quotes from a recent opinion arising out of an ethics complaint filed against the former County Attorney and two of his assistants, which found the Sheriff and others to be involved in “a concerted effort to wrestle power from [the Maricopa Board of Supervisors], County officials and Superior Court judges, and to instill fear in the hearts of those who would resist.”
Nobody is above the law, and nobody can misuse the legal process to silence those with different opinions.
Leadership starts at the top, and all of the alleged violations outlined in the complaint are the product of a culture of disregard for basic rights within MCSO that starts at the top and pervades the organization. The complaint alleges that MCSO employees frequently use derogatory terms such as “wetback” and “Mexican bitches” to refer to Latinos. Such words and actions exemplify the culture of bias that contributes to the unlawful actions.
In terms of next steps, the matter will now be assigned to a federal judge, and we will follow the Court's direction. Our goal remains the same: we want to fix the problems and work collaboratively with the defendants, the community, and the court, to devise and implement a comprehensive blueprint for sustainable reform. We recognize the hard and dangerous work law enforcement officers do every day. Our work is intended to make their work more effective and safer.
I would rather fix the problem than debate the existence of a problem. It was ironic that yesterday, the same day that the defendants received our letter informing them that a lawsuit was imminent, Sheriff Arpaio released a 17-page document entitled, “Integrity, Accountability, Community.” We see these 17 pages as largely an admission of the problem. As our complaint states, MCSO's failure to ensure integrity and accountability has led to a crisis of confidence within the community. While it is noteworthy and perhaps heartening that a number of these changes appear to be taken from the 128 page proposed settlement agreement that we provided back in February, this too little, too late document cobbled together beyond the 11 th hour, is no substitute for meaningful reform.
It is time to forge comprehensive, sustainable solutions that include meaningful, independent oversight. Unfortunately, today's complaint, and the time-consuming path that will follow, is the only way forward.
From the FBI
New IC3 Internet Crime Report
Wouldn't it be nice if there was an easy, centralized place to report cyber fraud?
There is, and it's called the Internet Crime Complaint Center, or IC3, jointly run by the FBI and the National White Collar Crime Center.
Today, IC3 released its latest annual report, covering all the relevant and telling statistics of 2011. Overall, the center fielded more than 300,000 complaints for the third year running, adding up to losses of nearly a half-billion dollars. The total number of complaints last year rose by 3.4 percent.
Just some of what the report includes:
- A rundown of the yearly complaint totals since IC3 opened in May 2000;
- Lists of the top 10 states for complaints by volume (California was #1) and by population rate (Alaska was the highest);
- Victim dollar losses in many categories with breakdowns by gender;
- The most frequently report Internet frauds and detailed stats on each; and
- Scam alerts issued by IC3 during the year.
We welcome your complaints and use your reports of potential or actual cyber fraud individually and in aggregate as intelligence to fuel our investigations. And they help us get our arms around the latest and most common scams so we can then report that information back to you, along with tips on how to avoid being victimized. (You can find such tips in the report in Appendix I.)
Read the full report for more details. To report a cyber scam, go to http://www.ic3.gov/.
Department of Homeland Security
Readout of Secretary Napolitano's Participation in the 33rd Annual Washington Area Police Memorial Service
Release Date: May 7, 2012
For Immediate Release
Office of the Press Secretary
WASHINGTON—Secretary of Homeland Security Janet Napolitano today joined Washington, D.C. Mayor Vincent Gray, Metropolitan Police Department Chief of Police Cathy Lanier and members of the local law enforcement community to participate in the 33rd Annual Washington Area Police Memorial Service, honoring the service and sacrifice of law enforcement professionals who gave their lives in the line of duty.
“The loss of these brave individuals is another reminder of the dangers the men and women of law enforcement often face while on the job, the risks they so willingly take, and the sacrifices they make for us, our communities, and our nation,” said Secretary Napolitano. “It is because of their service and sacrifice that our nation remains safe today and we continue to enjoy the freedoms and liberties that we all cherish.”
The annual service recognizes the members of the Washington area law enforcement family who have given their lives in service to their communities. In 2011, three local officers lost their lives in the line of duty.
For more information, visit www.dhs.gov.
Arson Awareness Week May 6-12, 2012
Prevent Youth Firesetting
Download the 2012 Arson Awareness Week Poster (PDF, 723 Kb)
Download Sample Arson Awareness Week Letter, Proclamation (PDF, 23 Kb)
Download Focus on Fire Safety Poster: Prevent Youth Firesetting (PDF, 658 Kb)
Watch/Share Youth Fire Prevention Public Service Announcement (PSA)
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“Fire in the hands of children is devastating - regardless of a child's age or motive. It is imperative that we do everything possible to prevent youth firesetting to protect the nation's most valuable resource, our children.”
Ernest Mitchell, Jr., U.S. Fire Administrator
The U.S. Fire Administration (USFA) is pleased to partner with the International Association of Arson Investigators (IAAI); Safe Kids USA; USAonWatch; National Volunteer Fire Council (NVFC); and the National Association of State Fire Marshals to announce the theme for the 2012 Arson Awareness Week (AAW): "Prevent Youth Firesetting."
USFA and its partners will use the week of May 6–12 to focus public attention on the importance of a collaborative effort with fire and emergency service departments, law enforcement, mental health, social services, schools, and juvenile justice to help reduce the occurrence of juveniles engaged with fire.