MorganRants

Things I am passionate about. Injustice, stupidity, intolerance, bigotry and small-mindedness. Oh and there might just be some humor to offset the whole thing.

Archive for March, 2008

Gunfire in the cockpit

Posted by morganwrites on March 31, 2008

When airline pilots lobbied Congress in 2002 for permission to carry guns, their fear was that hijackers might breach even the new reinforced cockpit doors installed after the 9/11 attacks. Now it appears there might be another danger: a gun accidentally discharging during flight, as happened Saturday in the cockpit of US Airways Flight 1536 on approach to the Charlotte airport.

The pilot’s gun went off, sending a bullet through the left side of the cockpit and out of the Airbus jetliner, according to the Transportation Security Administration (TSA). The co-pilot was flying the plane at the time, and no one was injured. Thankfully. The flight carried 124 passengers and a crew of five.

To keep things in perspective, this was the first time a gun has discharged accidentally in flight since pilots began carrying them in 2003. Pilots get training before they can carry a gun, and stringent rules require that they keep the gun holstered during flight.

Further, government and aviation experts say it’s unlikely a single shot in the cockpit could cause a catastrophic accident. And that familiar movie scene, where a gunshot blasts a hole in a jet, sucking objects and passengers from the cabin and sending the jet plunging to earth? Well, it’s worth recalling that in 1988, a Boeing 737 landed safely after losing about one-third of its roof near Hawaii.

But the risk of a less spectacular tragedy is undeniable. Where there are guns, there’s a risk of accident. In 2005, the last year counted, there were 789 “unintentional firearm” deaths in the USA and 15,388 injuries — a rate of more than five for every 100,000 U.S. residents, according to the Centers for Disease Control and Prevention.

On a plane, a stray bullet could hit a crewmember in the cockpit or pierce the wall between cockpit and cabin, the TSA concedes. Perhaps that’s why TSA and the airlines opposed letting pilots carry guns when the pilots and the National Rifle Association pushed the idea through Congress in 2002.

Regardless, the question now is how to minimize the risk.

The TSA, which says it is still investigating, has declined to reveal how the gun went off in the US Airways cockpit. Nor will US Airways talk about it. The longer they delay, the more likely the Hollywood image will linger in passengers’ minds.

For now, just this much is clear: Guns in holsters don’t just go off by themselves. Something went very wrong on US Airways 1536, and the flying public deserves an explanation.

Holy Shit.

Advertisements

Posted in Fire in the hole! | Leave a Comment »

Updates to Prezista (Darunavir) Tablets Labeling

Posted by morganwrites on March 30, 2008

(TBP) – Updates have been made to Prezista (darunavir) tablets labeling to reflect significant new risk information. Changes have been made to the CLINICAL PHARMACOLOGY section to include data from 6 pharmacokinetic, drug interaction Phase 1 trials, and to the WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS sections of the package insert to include hepatotoxicity information. Other updates include those made to PRECAUTIONS, updates to DOSAGE AND ADMINISTRATION, and changes to Table 11 to include information regarding a potential drug-drug interaction with rosuvastatin.

In the WARNINGS section, the following has been added:

“Hepatotoxicity
Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) has been reported with PREZISTA/rtv. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/rtv. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities including severe hepatic adverse events.

Post-marketing cases of liver injury, including some fatalities, have been reported. These have generally occurred in patients with advanced HIV-1 disease taking multiple concomitant medications, having co-morbidities including hepatitis B or C co-infection, and/or developing immune reconstitution syndrome. A causal relationship with PREZISTA/rtv therapy has not been established.

Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/rtv and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of PREZISTA/rtv treatment.

If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/rtv, interruption or discontinuation of treatment must be considered.”

The PRECAUTIONS section has been changed to read as follows:

“Patients with co-existing conditions
Hepatic Impairment: No dose adjustment of PREZISTA/rtv is necessary for patients with either mild or moderate hepatic impairment. There are no pharmacokinetic or safety data available for subjects with severe hepatic impairment, therefore, PREZISTA/rtv is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Hepatic Impairment and DOSAGE AND ADMINISTRATION).”

Table 11, Established and Other Potentially Significant Drug Interactions, has been modified, under HMG-CoA Reductase Inhibitors, to include rosuvastatin, indicating increased concentration of rosuvastatin, with the following clinical comment: “Use the lowest possible dose of atorvastatin, pravastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as fluvastatin in combination with PREZISTA/rtv.”

The following sentence has been added to the CLINICAL PHARMACOLOGY section, under Absorption and Bioavailability: “In vivo data suggests that darunavir/ritonavir is an inhibitor of the p-glycoprotein (p-gp) transporters.”

The following has been added under: Special Populations

“Hepatic Impairment: Darunavir is primarily metabolized by the liver. The steady-state pharmacokinetic parameters of darunavir were similar after multiple dose co-administration of PREZISTA/rtv 600/100 mg b.i.d. to subjects with normal hepatic function (n=16), mild hepatic impairment (Child-Pugh Class A, n=8), and moderate hepatic impairment (Child-Pugh Class B, n=8). The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been evaluated (see PRECAUTIONS, Patients with co-existing conditions, Hepatic Impairment and DOSAGE AND ADMINISTRATION).”

In addition, there are updates to Table 4: Drug Interactions Pharmacokinetic Parameters for Darunavir in the Presence of Co-administered Drugs, and Table 5: Drug Interactions: Pharmacokinetic Parameters for Co-administered Drugs in the Presence of Darunavir/Ritonavir.

The last paragraph of the ADVERSE REACTIONS section now reads: “Patients co-infected with hepatitis B and/or hepatitis C virus: In subjects co-infected with hepatitis B or C virus receiving PREZISTA/rtv, the incidence of adverse events and clinical chemistry abnormalities was not higher than in subjects receiving PREZISTA/rtv who were not co-infected, except for increased hepatic enzymes (see WARNINGS, Hepatotoxicity). The pharmacokinetic exposure in co-infected subjects was comparable to that in subjects without co-infection.”

In addition, the following has been added:

“Additional adverse reactions identified in clinical studies, occurring in less than 1% of the patients, are listed below by body system:

Hepatobiliary System: acute hepatitis, cytolytic hepatitis, hepatotoxicity, hyperbilirubinemia

Skin and Appendages: erythema multiforme, Stevens-Johnson Syndrome [this duplicate information was deleted from the Skin and Appendages section under the treatment-emergent adverse events occurring in less than 2% of de novo subjects]”

Changes were also made to DOSAGE AND ADMINISTRATION, to include the following: “Hepatic Impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. There are no data regarding the use of PREZISTA/rtv when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/rtv is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Hepatic Impairment and PRECAUTIONS, Patients with co-existing conditions, Hepatic Impairment).”

The new label will be posted soon at DailyMed to replace the 08/2007 version.

Just another example of our medical establishment at the very best!

Posted in adverse reactons, dosage, drug-induced hepatitis, precautions, Prezista | Leave a Comment »

Jewish Voters Must Say No to Obama

Posted by morganwrites on March 30, 2008

(TCV) – Little more than 24 hours after Senator Barack Obama (D-IL) stepped to the microphones to address the anti-Semitic, anti-American and anti-white rage of his ‘spiritual advisor’ and pastor, Rev. Jeremiah Wright, many Jews are taking a second look at the junior Senator and Democratic frontrunner.

By Wednesday the Obama campaign was trying to make Jews understand that his 20-year relationship with a preacher and church that gave an award to Louis Eugene Walcott (sorry, Louis Farrakhan, do all racists change their names?) and who blamed America for everything from the AIDS virus to the terrorist attacks of September 11, 2001 was just a relationship of a man sitting in the pew of a preacher from the “old black school.”

Unfortunately for Obama he did not talk until the controversy was out of control and when that happens it is far too late. As of this writing I know Jewish leaders and Israeli politicians who are willing to say that an Obama Administration would be “the worst for Israel” of all the candidates and that Obama was “unacceptable” to the Jewish population not only in Israel, but the Diaspora abroad.

Jewish voters give their votes anywhere between 25 and 27% to Republicans – the balance of Jewish voters in strongholds like New York and California vote in a huge Democratic bloc. Even more than counting on Jewish votes to get Democrats over the top it is almost equally important to get Jewish money. Obama now has a problem: why would any Jew give money to a man who associates with a pastor and a church that awards anti-Semites and bigots?

It is a bit more difficult to tally Jewish money in politics since there is no record kept of the faith of the voter. But, taking the afternoon to compare the directory of membership at my synagogue with records of political contributions it is clear that Jewish political contributions are equally important to Democrats.

So did Obama go far enough in his flag draped explanation about his relationship with a preacher who is willing to honor an anti-Semite and treat Israel like a dirty word? And why all the flags for a guy who won’t wear a flag on his lapel for fear of looking like he was pandering?

Instead of explaining with a condescending “it’s a black thing” and “we all disagree with our pastors” (no we don’t) not quitting his church he brought out of the woodwork people like the Black Panthers and other black separatists who admire anti-Semitism. They also believe that America is a bastion of evil where whites and especially Jews cause there to be inequity in America not unlike that seen during the 1950s in the south.

With friends like Wright, Farrakhan and the Black Panther Party on his side Obama does not need any enemies. The relationship with Wright puts him in the pantheon of black separatism and worse than that is Obama raised more questions than answers when he gave his address. His campaign called his remarks courageous, but courage would have been taking the anti-Semite to task; not telling us that he is like our crazy uncles.

Truth be told I probably would not have voted for Obama whether or not the highlights of Wright’s hate-filled sermons came to the public record or not, but I was willing to give Obama the benefit of the doubt with regard to his judgment. It is that judgment that Obama is using as his only qualification to be Commander-in-Chief and the leader of the free world – a world that has enemies throughout and enemies that would love a person in the White House who did not care if Israel was wiped off the map.

Obama has not explained how in 20 years of sermons, personal contact and experience that he never heard an utterance of an inappropriate or anti-Semitic nature by his own pastor. I’ve not been an adult for 20 years, but in the time I’ve been an adult I would remember well sermons, particularly those during High Holy days, that involved hatred for America or the kind that paint Israel as a demon.

The worst part of Obama’s non-explanation was that he gave it with the hope that it would end the questions concerning his pastor, but it hasn’t. In fact it gave us more to think about. How could a church release a “best-of” DVD of hate and Obama be oblivious to it? How could Wright blame America for everything from AIDS to crack and Obama be oblivious to it? How could Wright be the leader of Obama’s church and be part of his life for 20 years and Obama not be aware that he blamed Israel for the ills of the Middle East – including the fact that Wright and Obama believe that “cynicism” is the reason that there is not peace in the Middle East.

Cynicism? Does Obama, through Wright’s instruction, really believe that the people of Israel want peace so little that it is cynicism rather than the hatred of the Arab governments and people that surround her that keep peace from happening? If Obama misjudges the Middle East in theory – how will he do when he is in the Oval Office and is called upon to judge issues for real?

All Obama did on Tuesday was show just how poor his judgment is. His association with Wright’s church in Chicago may have made him a hero with the black left and helped in a segment of Chicago politics, but for someone that aspired to the highest office in America he should have known better.

Obama knew that Wright was a problem. When he announced his candidacy for the White House – the New York Times reported that Wright was “dis-invited” by an Obama staffer before his announcement. Obama’s knowledge that Wright was a problem a year ago makes it that much more difficult to believe that Obama did not know Wright was a problem ten years ago. That kind of bad judgment cannot be permitted in the White House – particularly when the only thing helping the Jewish vote make a decision is party affiliation.

The Jewish leaders and lay people that I talked to today are just as willing to vote for John McCain, who was at the Western Wall in Jerusalem today, as they would be willing to vote for either of the two Democrats. One unanimous thing that happened today is that I could not find one person in the Jewish leadership willing to say that they support Barack Obama’s run for the White House and it was not lost on Jewish leaders that while McCain was at the Wailing Wall in Jerusalem that Obama was trying to damage control for his association with anti-Semitic and anti-American people that he chose to associate with for two decades.

Jewish people need to examine Obama’s record much more closely and if Obama refuses to not only stand up and “renounce” or “repudiate” the comments and awards that he clearly knew were going on around him then the Jewish vote and Jewish money has an obligation to Israel to stay home or to go to McCain.

Barack Obama’s campaign has done little more than trot out supporters who happen to be Jewish elected leaders in order to explain and disassociate him from his preacher and his church. My microphone is open to the Obama campaign and I suggest that they take me or another Jewish broadcaster up on the offer because two days ago I was willing to go quietly if Obama was the Democratic nominee. Today I am unwilling to see him get to the White House and will do everything in my power to see that Jews are not only aware, but outraged, at his conduct and the pretense that he didn’t know anything untoward was happening right under his nose.

Posted in Anit-semetic comments, Barack Obama, Jeremiah Wright | Leave a Comment »

Democrat Turmoil And Liberal Dysfunction

Posted by morganwrites on March 30, 2008

(TCV) – Rush Limbaugh has been having a great time lately, fanning the flames of discord and confusion among the Democrats. But the ability to destabilize their party is hardly a dangerous manifestation of omnipotence on the part of the talk radio giant. Such turmoil could not be foisted on the Democrat Party from without, were it not already morally and philosophically rotting from within.

Consider all of the different fronts on which the Democrat Party lately finds itself in a total shambles. Along with the day to day revelations of the barnyard morality pervading the entire top echelon of New York’s state government, every new bit of news coming from the Democrat presidential race suggests an eventual crack up of the party no matter who wins the nomination.

In such a tainted atmosphere, it is highly unlikely that House Speaker Nancy Pelosi (D.-CA) will gain much traction to define the debate during this election cycle with her sanctimonious rants about a Republican “culture of corruption.” And more of the same is likely to come.

The latest controversy du jour is that of Barack Obama and his “former” pastor Jeremiah Wright, who has openly preached racism and hatred for America throughout his career. Yet Obama initially claimed that, while remaining a member of Wright’s church for two decades, he had not been in the pews to hear such venomous sermonizing.

In essence, he offered his own version of the “I smoked it but did not inhale” defense. Upon facing irrefutable evidence to the contrary, he has since resorted to the “inappropriate relationship” posture. His timing for this strategy is particularly bad, considering the candidate against whom he is competing for the Democrat Party nomination.

Moreover, were his claims of innocence even remotely believable, it would not speak well of the seemingly bright Illinois Senator to be so oblivious after twenty years to this malignant elephant in the room. Perhaps, having been married only fifteen years, he has not yet been made aware of the similarly angry anti-American sentiments held by his wife Michelle. And in light of all this, one has to seriously wonder as a matter of national security just how long it might take him to notice the threats posed to this country by the Islamists.

Interestingly, he seems to exhibit a slightly deeper degree of discernment, and a markedly faster reaction time, when assessing any comment from his political opposition that contains even the slightest suggestion of disparagement against his own ethnicity or culture. In this, he bears far more commonality than contrast with Hillary, whose “steel trap” memory can suddenly degenerate to “I do not recall,” the instant the topic shifts to any of the innumerable Clinton scandals.

It is extremely telling that, with all of the critical and potentially dangerous issues facing the nation, the bulk of energy between these two Democrat campaigns has degenerated to a series of estrogen/melanin wars. Nevertheless, in its current condition, America can glimpse the reality of liberalism.

Mrs. Bill Clinton has her own set of problems. While Obama has clearly benefited at times from the “race/victim” card, which he invokes at any affront so slight as even the mention of his middle name, Hillary Clinton is no less a caricature of every liberal feminist absurdity with her strategically timed crying episodes and reflections on the alleged difficulties facing her as a candidate strictly, we are told, because she is a woman.

Meanwhile, the Democrat Party machinery, behind closed doors, is no doubt panicking over the fact that according to its own thinking, Americans may not rally around either candidate, based on their competing minority subgroup statuses, in numbers sufficient to garner even a delegate majority within the party, let along a general election win. And having exploited the divisions in society for so many years along class, gender, and racial lines, the Democrats have set the stage for huge fractures and defections no matter who is selected as the nominee in the end.

America might indeed face widespread race riots in the event that the nomination is snatched from Obama’s grasp. But even that may pale in comparison the dire spectacle that America may witness if Hillary loses, and her sputtering feminist minions react with comparable outrage, many of them having reached the stage in life where bra burning could be construed as a “hate crime.”

Having proven himself to be the quintessential angry black separatist in sheep’s clothing, or at least someone who comfortably remains under the tutelage of that variety of “spiritual headship,” Obama is no more likely to appeal to a mainstream America that wants race to take its proper role in distant “back seat” behind character, than can Hillary distance herself from the sputtering ranks of embittered feminists.

In simple terms, this election has become extremely difficult for the Democrats to navigate. As a result of the candidates who have risen to the forefront, it is perhaps the first campaign where the different liberal subgroups are driving their respective races on a truly ideological basis.

In the past, the Democrat political sect has resulted from a conglomeration of disparate special interest groups, each of which is ultimately indifferent to the others, but all of whom can collectively benefit from the party’s successes.

It was in their common interests to further their agenda by thwarting those stodgy conservatives, who continually resist attempts to reinvent society’s morality and traditions according to the latest liberal fads. But of even greater importance is that with liberals in power, their various special interests, no matter how dissimilar in philosophy, can count on access to the public trough.

Thus, a totally mixed bag of anti-Christian, anti-American, anti-capitalist causes can, in normal years, rally to the party candidate and expect a continuation of their lifeline of federal funding. But with the ascendancy of pseudo feminist extraordinaire Hillary Clinton, and African American separatist sympathizer/national uniter Barack Obama, liberals are being forced into camps that overlap extensively when it comes to their usage of public funding, but contrast severely on their emotional appeal to the different “victim” groups.

On display here is the ugly reality of liberalism that for too long has remained hidden from real America, much like the appalling varieties of vermin which are present even in the best manicured gardens, but go unnoticed until somebody turns over a rock.

Ultimately, the similarities between the liberalism of Clinton and the liberalism of Obama, as reflected in their personal lives as well as their public lives, far outweigh any differences. And it is this grim truth about both potential Democrat nominees that should seriously concern America.

Were either compelled to face a real conservative in the general election, this race would already be over.

Posted in Barack Obama, Clinton Scandals, Democratic discord and confusion, Hillary's a caricature of liberal feminist, Islamists, Jeremiah Wright, Michele Obama's angry anti-American sentiments, Nancy Pelosi, Rush Limbaugh | 2 Comments »

Jet’s Door Falls Off During Takeoff

Posted by morganwrites on March 29, 2008

jet-planes-door-falls-off.jpg

GRAND JUNCTION, Colo. — Aviation officials said the main passenger door fell off a twin-jet business plane as it was taking off from Grand Junction Regional Airport, but no one was hurt.

Federal Aviation Administration spokesman Mike Fergus said the front left side door tumbled from the Bombardier Challenger CL-60 shortly before 4 p.m. on Monday, forcing the plane to make an emergency landing.

Fergus said the plane was “climbing” when the door fell out. It landed in a desert area west of the airport property, he said.

No one on the plane or on the ground was hurt. There were two pilots on board the aircraft but no passengers.

As emergency crews waited, the jet circled back to the airport and landed safely. It was flying from Grand Junction to Rifle.

Fergus said investigators will look into why the door detached from the jet. FAA investigators are expected at the airport Tuesday.

The plane’s registered owner is WFP Investments of Snowmass Village. No one answered the company’s phone after business hours Monday.

Airport officials said the plane was towed to Westar Aviation for inspection.

Posted in Uncategorized | Leave a Comment »

Vaccine Failure Is Setback in AIDS Fight

Posted by morganwrites on March 29, 2008

Test Subjects May Have Been Put at Extra Risk Of Contracting HIV

(WP) – The two-decade search for an AIDS vaccine is in crisis after two field tests of the most promising contender not only did not protect people from the virus but may actually have put them at increased risk of becoming infected.

The results of the trials, which enrolled volunteers on four continents, have spurred intense scientific inquiry and unprecedented soul-searching as researchers try to make sense of what happened and assess whether they should have seen it coming.

Both field tests were halted last September, and seven other trials of similarly designed AIDS vaccines have either been stopped or put off indefinitely. Some may be modified and others canceled outright.

Numerous experts are questioning both the scientific premises and the overall strategy of the nearly $500 million in AIDS vaccine research funded annually by the U.S. government.

“This is on the same level of catastrophe as the Challenger disaster” that destroyed a NASA space shuttle, said Robert Gallo, co-discoverer of the human immunodeficiency virus (HIV), which causes AIDS, and head of the Institute for Human Virology in Baltimore.

The recently closed studies, STEP and Phambili, used the same vaccine — made from a common respiratory virus called adenovirus type 5 that had been crippled and then loaded with fragments of HIV. Both studies were halted when it became clear the STEP study was futile and possibly harmful.

The results of the Phambili vaccine trial, which was conducted in South Africa, were revealed last month and only worsened the gloom. Although the number of new HIV infections in that study was far smaller than in STEP — and too few to draw firm conclusions from — those results, too, hinted at a trend toward harm among vaccine recipients.

Many researchers are questioning the scientific premises on which all those studies were based and are wondering, along with AIDS activists, what effect this near-worst-case scenario might have on tests of future vaccines.

The working hypothesis for what went wrong is that the vaccine somehow primed the immune system to be more susceptible to HIV infection — a scenario neither foreseen nor suggested by previous studies.

The National Institutes of Health, which funded the STEP and Phambili trials, is convening a meeting next week to reassess its AIDS vaccine program. But some respected scientists have already reached a verdict.

“None of the products currently in the pipeline has any reasonable chance of being effective in field trials,” Ronald C. Desrosiers, a molecular geneticist at Harvard University, declared last month at an AIDS conference in Boston. “We simply do not know at the present time how to design a vaccine that will be effective against HIV.”

He told a rapt audience that he has reluctantly concluded that the NIH has “lost its way in the vaccine arena” and that he thinks it should redirect its AIDS vaccine funds to basic research and away from human trials.

In this fiscal year, the NIH’s budget for AIDS vaccine research is $497 million. The STEP and Phambili trials were each expected to cost about $32 million. Pharmaceutical giant Merck & Co. has spent an undisclosed amount developing the vaccine and helping to manage the studies.

“We can’t afford to have any more trials like this,” said Mark Harrington, head of the activist Treatment Action Group and a longtime observer of AIDS research. “We have to stop and reassess and recommit to basic science, or people will begin to lose faith.”

At the moment, only two things are certain.

The first is that the vaccine, developed by Merck, could not have caused HIV infection because it contains only three proteins from HIV, not the entire virus. The second is that there are no obvious villains.

“I do not think that what happened in this trial is an example of scientists blindly rushing into dangerous things,” said John P. Moore, an AIDS virologist at Weill Cornell Medical College, who has criticized vaccine trials he considered futile. “In the general HIV-research community, I didn’t know anyone who said this was going to happen.”

Both trials recruited people who were at high risk of HIV infection through sexual activity. The STEP subjects included many male homosexuals; the Phambili volunteers were male and female heterosexuals. Half the people in each trial were randomly assigned to get three shots of vaccine, and half to get three shots of a harmless liquid containing no adenovirus or HIV proteins.

Each trial was to have 3,000 participants. STEP had finished enrolling subjects in North and South America, the Caribbean and Australia. Phambili (which means “moving forward” in the Xhosa language of South Africa) had signed up 801 by the time it was shut down.

While scientists hoped the Merck vaccine might prevent some infections, its chief purpose was to stimulate “cell-mediated” immunity to produce a less severe illness. Specifically, the vaccine was expected to lower the “viral load” of HIV in the bloodstream, which in turn would both prolong survival and lessen the chance the person would infect others.

Many experts are questioning the wisdom of that strategy, even if it had worked perfectly. Urging millions of people to take an AIDS vaccine that probably would not protect them from the virus, they say, would be a hard and confusing task, even in places where the epidemic still rages.

For the moment, that is an academic question. The vaccine failed to achieve any of its goals.

In both studies, people who got vaccine were more likely — not less — to become infected, with trends suggesting roughly a twofold risk. In the STEP study, which has many more cases to evaluate, nearly all that added risk was in people who had high levels of antibodies to adenovirus type 5 before they got their first shot — evidence they had been previously infected with that strain. Uncircumcised men in that group had the highest risk.

So how could this have happened?

The leading theory is that activation of the immune system, a cascade of events that occurs naturally when a person is infected with a virus or bacterium or gets a vaccine against one of them, in some way increased the risk of HIV infection.

Activation causes cells called CD4 T-lymphocytes (among many other things) to proliferate. CD4 cells are the targets of choice for HIV. In their activated state, they are coated with molecules called CCR5 co-receptors, which HIV needs to attach itself to a cell.

The hypothesis is that people who received the vaccine had greater-than-normal activation and consequently produced more and fatter cellular targets for HIV. That then increased their chances of becoming infected should they encounter the virus in unprotected intercourse.

Two things undercut this idea.

People have been suffering immune-activating infections and getting vaccines for years, and there has never been evidence that those events increased a person’s risk of acquiring HIV. These vaccine trials would be odd places to first notice such a thing. Furthermore, people in the STEP study who got the vaccine did not have more activated CD4 cells than people who got placebo — something that Merck vaccine executive Mark B. Feinberg called “kind of an interesting and unexplained observation.”

“There is something very, very peculiar” going on in the vaccine trials, said Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, which sponsored them.

The multiple surprises have reminded researchers how much they still do not know about HIV’s biology. It has also focused attention on questions they never asked.

For example, none of the monkey experiments with the Merck vaccine subjected animals to the kind of sexual exposure that people in the trial had — namely, repeated encounters with low doses of HIV, with no single exposure being especially high-risk.

Why not?

The researchers did not have any reason to believe the vaccine might be harmful (although they acknowledged it might not be effective), and in any case such a study would have required quite a large number of monkeys, which are expensive to acquire and maintain for research.

Instead, researchers vaccinated a relatively small number of monkeys with the Merck vaccine and then injected them with the monkey equivalent of HIV in a manner that guaranteed they would become infected. Those animals did much better over the long run than infected but unvaccinated ones.

That was once enough to move a vaccine into human trials. But it probably never will be again.

Can anyone remember Tuskegee?

Posted in AIDS, HIV, Merck, NIH, Phambili, Robert Gallo is an asshole | Leave a Comment »

Birth Control for Others

Posted by morganwrites on March 28, 2008

FATAL MISCONCEPTION :The Struggle to Control World Population.

By Matthew Connelly.

Illustrated. 521 pp. Harvard University Press. $35.

kristof-600.jpg

 

(NYT) – The first large-scale scientific test of family planning took place in Khanna, India, beginning in the early 1950s. Backed by the Rockefeller Foundation and the Harvard School of Public Health, researchers asked 8,000 villagers how often they had sex, whether they wanted to conceive and the details of the women’s menstrual cycles. The researchers met the villagers monthly and provided contraceptives, while closely monitoring another group that was given no contraceptives. After five years, the women given contraceptives had a higher birth rate than those who hadn’t received any assistance.

That initiative was an early warning that population policy can be very difficult to get right. In “Fatal Misconception,” Matthew Connelly, an associate professor of history at Columbia University, carefully assembles a century’s worth of mistakes, arrogance, racism, sexism and incompetence in what the jacket copy calls a “withering critique” of “a humanitarian movement gone terribly awry.”

Efforts to control population have long been ferociously controversial, and the United States under George W. Bush refuses to provide a penny of funding for the United Nations Population Fund because of its supposed (but in fact nonexistent) links to forced abortion in China. Critics of family planning programs will seize gleefully upon this book, and that’s unfortunate, because two propositions are both correct: first, population planners have made grievous mistakes and were inexcusably quiet for too long about forced sterilization in countries like India and China; and second, those same planners have learned from past mistakes and today are fighting poverty and saving vast numbers of lives in developing countries.

“Fatal Misconception” is to population policy what William Easterly’s “White Man’s Burden: Why the West’s Efforts to Aid the Rest Have Done So Much Ill and So Little Good” (2006) was to foreign aid: a useful, important but ultimately unbalanced corrective to smug self-satisfaction among humanitarians. Connelly scrupulously displays a hundred years of family planners’ dirty laundry, but without adequately emphasizing that we are far better off for their efforts. One could write a withering history of medicine, focusing on doctors’ infecting patients when they weren’t bleeding them, but doctors are pretty handy people to have around today. And so are family planners.

One of the movement’s early sins was a fondness for eugenics, the belief that contraception was perfect for “dull-minded natives,” as one enthusiast put it, or for curbing the share of melanin in the admixture of humanity. Activists sometimes seem to have had antifreeze in their veins. Connelly cites a crusader named William Vogt, author of a best-selling environmental diatribe called “Road to Survival,” who in 1948 described tropical diseases like sleeping sickness as “advantages” because they helped curb population growth and scolded the medical profession for believing it “continues to have a duty to keep alive as many people” — read: brown and black people — “as possible.” Margaret Sanger, who courageously pioneered the cause of birth control, icily promoted contraception “to be used in poverty-stricken slums, jungles and among the most ignorant people.”

In the 1960s, the United States began to pour money into population control, pushing nations to adopt family planning as a condition of foreign aid. One result was extensive campaigns to insert IUDs, with little or no follow-up care for the many women who developed pelvic inflammatory disease and other problems. When the manufacturer of the Dalkon Shield was hit with lawsuits over dangerous complications, it offered the device at a big discount (and unsterilized) to the United States Agency for International Development, which happily shipped it abroad to be used by less litigious dark-skinned women. As Connelly writes, “Scientists and activists worldwide had agreed that high fertility was to be treated as a disease, and that birth control for nations made individuals expendable.”

In fairness, while IUDs were dangerous, so was pregnancy. The planners reasoned that while many people would suffer or die from botched sterilizations or contraception, tens of thousands fewer women would die in childbirth. Unfortunately, they showed little interest in maternal health care, and they often mixed an admirable impulse to serve humanity with a blithe contempt for individual humans.

It didn’t help that the planners were virtually all Western men who had little understanding of life in the villages. At the 1974 World Population Conference, 127 of the 130 national delegations were led by men. The planners had far too much confidence in their own wisdom. Paul Ehrlich’s best-selling book “The Population Bomb” had warned that the world was on the verge of terrible famines and urged the United States to cut off food aid to areas beyond hope. At the World Bank, Robert McNamara discouraged financing of health care “unless it was very strictly related to population control, because usually health facilities contributed to the decline of the death rate, and thereby to the population explosion.”

Planners always assumed their programs would lower fertility. The reality, however, was more nuanced. Evidence from careful, randomized studies suggests that well-designed, intensive birth control programs can reduce fertility somewhat, but that simply shoveling pills or condoms at peasants has little or no impact. Poor and uneducated people often want lots of children, so to be successful, family planning has to focus as much on reducing desired family size as on curbing ovulation. “Even according to the most favorable contemporary studies,” Connelly writes, “family planning efforts explained less than 5 percent of fertility levels in developing countries.”

In 1983, the United Nations disgraced itself by giving its Population Award gold medal to Qian Xinzhong, head of the Chinese government’s brutal quasi-military campaign of forced sterilizations and abortions as part of a crackdown under its one-child policy. Yet gradually the population movement became aware that women had rights as well as uteruses. This awareness coincided with the rise of women in the movement in the United States and abroad, including the appointment of Nafis Sadik as head of the United Nations Population Fund in 1987. Under Sadik, a Pakistani gynecologist known for promoting women’s rights, the fund expanded its scope to tackling maternal mortality and the spread of AIDS. It has also become a huge positive force in China, taming coercive policies and pushing for replacement of the traditional Chinese IUD, which was ineffective and painful (but which the government favored because it was cheap). More broadly, planners have embraced education for girls — now recognized as the single most effective means of contraception in poor countries — as well as programs like microcredit that empower women and reduce fertility, too. They are also leading the fight to lower maternal mortality, which continues to take more than half a million lives a year.

It’s certainly fair of Connelly to dredge up the forced sterilizations, the casual disregard for injuries caused by IUDs, the racism and sexism and all the rest — but we also need to remember that all that is history. The family planning movement has corrected itself, and today it saves the lives of women in poor countries and is central to efforts to reduce poverty worldwide. If we allow that past to tarnish today’s efforts by family planning organizations, women in poor countries will be doubly hurt.

 

Just might have to read this book. It’ll probably get my blood pressure up in the dangerous range.

 

Posted in Columbia University, Family Planning, Fatal Misconception Matthew Connelly, Harvard School of Public Health, Incompetence, Mistakes Arrogance Racism, Rockefeller Foundation, Sexism | Leave a Comment »

A Boy the Bullies Love to Beat Up, Repeatedly

Posted by morganwrites on March 27, 2008

 

billy-wolfe-1.jpg
Billy Wolfe

FAYETTEVILLE, Ark. (NYT) – All lank and bone, the boy stands at the corner with his younger sister, waiting for the yellow bus that takes them to their respective schools. He is Billy Wolfe, high school sophomore, struggling.

Moments earlier he left the sanctuary that is his home, passing those framed photographs of himself as a carefree child, back when he was 5. And now he is at the bus stop, wearing a baseball cap, vulnerable at 15.

A car the color of a school bus pulls up with a boy who tells his brother beside him that he’s going to beat up Billy Wolfe. While one records the assault with a cellphone camera, the other walks up to the oblivious Billy and punches him hard enough to leave a fist-size welt on his forehead.

The video shows Billy staggering, then dropping his book bag to fight back, lanky arms flailing. But the screams of his sister stop things cold.

The aggressor heads to school, to show friends the video of his Billy moment, while Billy heads home, again. It’s not yet 8 in the morning.

Bullying is everywhere, including here in Fayetteville, a city of 60,000 with one of the country’s better school systems. A decade ago a Fayetteville student was mercilessly harassed and beaten for being gay. After a complaint was filed with the Office of Civil Rights, the district adopted procedures to promote tolerance and respect — none of which seems to have been of much comfort to Billy Wolfe.

It remains unclear why Billy became a target at age 12; schoolyard anthropology can be so nuanced. Maybe because he was so tall, or wore glasses then, or has a learning disability that affects his reading comprehension. Or maybe some kids were just bored. Or angry.

Whatever the reason, addressing the bullying of Billy has become a second job for his parents: Curt, a senior data analyst, and Penney, the owner of an office-supply company. They have binders of school records and police reports, along with photos documenting the bruises and black eyes. They are well known to school officials, perhaps even too well known, but they make no apologies for being vigilant. They also reject any suggestion that they should move out of the district because of this.

The many incidents seem to blur together into one protracted assault. When Billy attaches a bully’s name to one beating, his mother corrects him. “That was Benny, sweetie,” she says. “That was in the eighth grade.”

It began years ago when a boy called the house and asked Billy if he wanted to buy a certain sex toy, heh-heh. Billy told his mother, who informed the boy’s mother. The next day the boy showed Billy a list with the names of 20 boys who wanted to beat Billy up.

Ms. Wolfe says she and her husband knew it was coming. She says they tried to warn school officials — and then bam: the prank caller beat up Billy in the bathroom of McNair Middle School.

Not long after, a boy on the school bus pummeled Billy, but somehow Billy was the one suspended, despite his pleas that the bus’s security camera would prove his innocence. Days later, Ms. Wolfe recalls, the principal summoned her, presented a box of tissues, and played the bus video that clearly showed Billy was telling the truth.

Things got worse. At Woodland Junior High School, some boys in a wood shop class goaded a bigger boy into believing that Billy had been talking trash about his mother. Billy, busy building a miniature house, didn’t see it coming: the boy hit him so hard in the left cheek that he briefly lost consciousness.

Ms. Wolfe remembers the family dentist sewing up the inside of Billy’s cheek, and a school official refusing to call the police, saying it looked like Billy got what he deserved. Most of all, she remembers the sight of her son.

“He kept spitting blood out,” she says, the memory strong enough still to break her voice.

By now Billy feared school. Sometimes he was doubled over with stress, asking his parents why. But it kept on coming.

In ninth grade, a couple of the same boys started a Facebook page called “Every One That Hates Billy Wolfe.” It featured a photograph of Billy’s face superimposed over a likeness of Peter Pan, and provided this description of its purpose: “There is no reason anyone should like billy he’s a little bitch. And a homosexual that NO ONE LIKES.”

Heh-heh.

According to Alan Wilbourn, a spokesman for the school district, the principal notified the parents of the students involved after Ms. Wolfe complained, and the parents — whom he described as “horrified” — took steps to have the page taken down.

Not long afterward, a student in Spanish class punched Billy so hard that when he came to, his braces were caught on the inside of his cheek.

So who is Billy Wolfe? Now 16, he likes the outdoors, racquetball and girls. For whatever reason — bullying, learning disabilities or lack of interest — his grades are poor. Some teachers think he’s a sweet kid; others think he is easily distracted, occasionally disruptive, even disrespectful. He has received a few suspensions for misbehavior, though none for bullying.

Judging by school records, at least one official seems to think Billy contributes to the trouble that swirls around him. For example, Billy and the boy who punched him at the bus stop had exchanged words and shoves a few days earlier.

But Ms. Wolfe scoffs at the notion that her son causes or deserves the beatings he receives. She wonders why Billy is the only one getting beaten up, and why school officials are so reluctant to punish bullies and report assaults to the police.

Mr. Wilbourn said federal law protected the privacy of students, so parents of a bullied child should not assume that disciplinary action had not been taken. He also said it was left to the discretion of staff members to determine if an incident required police notification.

The Wolfes are not satisfied. This month they sued one of the bullies “and other John Does,” and are considering another lawsuit against the Fayetteville School District. Their lawyer, D. Westbrook Doss Jr., said there was neither glee nor much monetary reward in suing teenagers, but a point had to be made: schoolchildren deserve to feel safe.

Billy Wolfe, for example, deserves to open his American history textbook and not find anti-Billy sentiments scrawled across the pages. But there they were, words so hurtful and foul.

The boy did what he could. “I’d put white-out on them,” he says. “And if the page didn’t have stuff to learn, I’d rip it out.”

I have no words for this piece. No wonder maltreated children grow up to be miscreants.

Posted in beatings, Billy Wolfe, Fayetteville Ark., Gay Beatings, Harrasment, insanity | Leave a Comment »

A Third of Patients On Transplant List Are Not Eligible

Posted by morganwrites on March 26, 2008

(WP) – The list of patients waiting for organ transplants, which is widely used to promote organ donations, includes thousands who are ineligible for the operations, according to statistics kept by the national network that manages the allocation of organs.

More than a third of the nearly 98,000 patients on the list at any one time are classified as “inactive,” meaning they could not be given an organ if it became available because they are too sick, or not sick enough, or for some other, often unexplained, reason.

Although the need for organs far out paces the supply, critics say the large number of inactive patients on the list may signal that potential recipients are languishing in limbo too long and that including them could mislead potential donors, recipients and policymakers about the magnitude of the need.

Officials at the United Network for Organ Sharing (UNOS), which oversees the transplant system under a federal contract and provided a breakdown of its waiting list at the request of The Washington Post, defend the practice. Many patients are inactive for only short periods because of temporary complications or other issues that are often resolved, they say.

But critics note that a significant number of patients have been inactive for more than two years and may never become eligible.

“The wait list is dishonest,” said Donna L. Luebke, a nurse who said she was rebuked by UNOS officials when she complained about the list near the end of the three years she served on the organization’s board of directors. “The public deserves to know the true numbers.”

The revelation comes at a time when advocates of organ donation have come under fire for using increasingly aggressive strategies to obtain organs, justifying their efforts by citing the long and steadily growing waiting list.

“Part of the argument for the push to get more people to be donors, and for expanding the types of procedures that we do to get organs, is there’s all these people waiting for organs and dying in the meantime,” said Joan McGregor, a bioethicist at Arizona State University. “If the number is not accurate, that’s giving people the false impression that the situation is more serious than it is. It’s deceptive.”

The advocates, however, say that there are compelling reasons to keep many inactive patients on the list and that the continuing shortfall in organs overshadows any questions about them.

“Whether it’s 75,000 or 100,000, there are still far more people who need transplants than can get them,” said Robert Higgins, president-elect of UNOS. “None of this changes the fact that there is a significant number of people who die waiting.”

Of 97,772 patients on the waiting list as of Feb. 29, which officials said provided a representative snapshot, 32,014 — nearly 33 percent — were inactive.

The proportion of inactive patients varied with the type of organ, ranging from nearly 26 percent of those needing livers to nearly 69 percent of those waiting for a pancreas. Nearly 33 percent of those waiting for kidneys, the transplant most often sought, were inactive.

Most inactive patients had been ineligible for at least a year — and often for more than two years. More than 55 percent of the patients on the list for hearts, and nearly 49 percent waiting for livers, had been inactive for more than two years. Nearly half of those waiting for kidneys had been inactive for at least a year — and nearly a third for more than two years.

“I could expect people to be on there for months potentially,” said Arthur L. Caplan, a University of Pennsylvania bioethicist. “But more than two years? What’s that about?”

No information was available for a significant fraction because they became inactive before UNOS started collecting that information in 2006. In some cases, evaluations of patients’ suitability for a transplant were never completed. That was the case for more than 36 percent of kidney transplant candidates.

“This raises the question about whether the transplant centers are doing their jobs,” Caplan said. “If I’ve been on the inactive list for two years, my question is, ‘What has been done to either get me on the active list or take me off the list?’ “

UNOS officials said it is up to individual centers and doctors to track their patients’ status, a position that Caplan criticized as unacceptable. “You can’t just sit there and look at those numbers and dump responsibility back locally,” Caplan said. “UNOS is supposed to steward those patients.”

Higgins acknowledged that “there’s probably room to do a better job cleaning up the wait list.”

Critics say that overstating the need could have various negative consequences, including undermining public confidence in the system.

“The list is what they use for propaganda. It’s the marketing tool. It’s always: ‘The waiting list. The waiting list. The growing waiting list,’ ” Luebke said. “It’s what they use to argue that we need more organs. But it’s dishonest.”

The size of the list could be particularly important to people who are considering becoming a “living donor” by donating a kidney or a piece of their lung, liver or pancreas — a practice that has spurred intense debate over whether such donors are fully counseled about the risks.

Exaggerating the size of the list is also unfair to active recipients, said Luebke, who donated a kidney to her sister in 1994.

“It plays on the psyche of the person who’s on the wait list,” she said. ” ‘Am I up against 74,000 or 50,000?’ “

But officials defended the practice, saying that patients may become inactive for reasons that do not permanently disqualify them. They may develop an infection that temporarily makes them ineligible, for example. Keeping kidney patients on the list when they are not ready enables them to move up without denying anyone else an organ, they said.

“I don’t believe there is any reason to be concerned about this,” said James F. Burdick, who heads the division of transplantation at the federal Department of Health and Human Services. “I don’t think there’s anything that indicates that patients are not getting a fair shake.”

Others noted that the size of the list is often used in lobbying efforts to seek funding or to change organ-procurement policies. Donation advocates are campaigning to revise state laws to make it easier to obtain organs in ways some say may sacrifice the needs of dying patients and their families.

Isn’t this the most insane article you’ve ever laid your eyes on? Are we a third world country when it comes to our medical establishment? Appears so.

Posted in Debacle, Decpetive, Department of Health and Human Services, Hearts, Inactive Patients Causing Potential Recipients to Die, Ineligible for transplants, Kidneys, Livers, Lung, Organ Donor System is Broken, Pancreas, Patients Dying Needlessly, UNOS | 4 Comments »

Women ‘unprepared for childbirth’

Posted by morganwrites on March 25, 2008

(BBC) – Many women are going into labor vastly underestimating how painful it can be and overly optimistic that they will be able to manage without drugs, a study suggests. How has this happened?

Researchers at the University of Newcastle who looked at evidence from the UK and beyond found significant discrepancies between women’s expectations of labor and their actual experience.

In England around a quarter of women who give birth end up having an epidural, the spinal analgesia which eliminates the pain of contractions, although many did not plan on having one.

Growing emphasis on birth as an entirely natural process – which may be better carried out in your front-room than in a labor ward – also means many women feel they have somehow failed if they end up rapidly making their way through every form of pain relief available.

Campaigners fought hard for many years to “demedicalise” childbirth and reduce the number of unpleasant, invasive, and potentially unnecessary procedures many women were subjected to in the course of delivering their child.

But there are fears the pendulum may now have swung too far the other way, with the many advantages of modern medicine forgotten in the desire to take the process back to basics.

After all, you wouldn’t have your teeth pulled without an anesthetic, so why would you embark on something as major as childbirth simply preparing to grit them?

Holding hands

Much evidence suggests, however, that women who are well supported by midwives and partners throughout their labor and made to feel at ease are the ones who manage their pain the most effectively and require the fewest drugs.

But even with all the helping hands she may wish for, a woman needs to be aware that this is sometimes simply not enough, the Newcastle team concluded.

“Of course it is important to have hopes for how you would like your labor to be.

“But those involved in providing ante-natal sessions, while listening to these, need to make sure that women are aware of how things may go and help them construct realistic expectations,” says Joanne Lally, who led the research.

“You shouldn’t have to feel a failure because you’ve ended up with a lot of pain relief.

“The problem with some of the courses out there is that they concentrate so much on doing it naturally that inevitably women feel as though they’ve done something wrong when those techniques simply aren’t enough for them.”

‘Gladiators’

The National Childbirth Trust is one the major private providers of ante-natal classes in the UK, seeing perhaps as many as a quarter of all women preparing to give birth and also carrying out instruction on behalf of the NHS

The NCT classifies “normal” birth as one which does not involve anesthetic and would like to see a reduction in the use of epidurals, although it insists this does not mean it is against the use of pain-relief.

“We have campaigned for a long time for normal birth, and the bottom line is that we encourage women to have confidence in themselves and their bodies,” says Gillian Fletcher, a former president of the NCT.

“But that doesn’t mean we don’t talk about pain relief in our ante-natal sessions.

“We help women weigh up the pros and cons of every method. Of course epidurals are brought up – but we do make clear that if you have one you are two to three times more likely to end with a forceps delivery.”

“What’s crucial is that women are ready to negotiate with their midwife, and don’t find themselves lying flat on the bed, which we now know is a sure way to a more difficult experience.”

But regardless of the content of ante-natal sessions – be they provided privately or by the NHS – women themselves should perhaps be less competitive with each other about how they give birth, argues Anna Davidson of the Birth Trauma Association.

“Ante-natal sessions do need to be more realistic – perhaps including women who have given birth and had very different experiences. But mothers themselves need to stop being so gladiatorial about what they managed to endure.

“We sometimes seem to forget that while childbirth is natural, women in the past regularly died as a result of it, and we should be a bit more positive about the advances medicine has brought us.”

One obstetrician believes the tide is perhaps turning yet again.

“I have seen many women in the last decade with completely unrealistic expectations, who end up incredibly disappointed when they have not been able to give birth without significant pain relief,” says Patrick O’Brien, a consultant and spokesman for the Royal College of Obstetricians and Gynecologists.

“But I get the feeling that things have started to change, and more women realize there is only so much you can plan for.

“Find out about aromatherapy – but find out about epidurals too – and prepare to be flexible. I do think that message is getting through.”

Posted in Birth Trauma Association, Contractions, Drugs, Epidural, Labor, Midwives, National Childbirth Trust, Spinal Analgesia | 1 Comment »