Little Red Ribbon-Hood: April 2006: Archives

April 29, 2006

Former FDA Chief Under Investigation genre: Little Red Ribbon-Hood & Six Degrees of Speculation

Lester Crawford

Lester Crawford, the controversial former head of the Food & Drug Administration, is being investigated for possible false statements to congress and financial improprieties. Crawford, before his resignation last fall, had been accused of blocking the approval of the Plan B contraceptive drug. His nomination was put on hold at one point by Senator Hillary Clinton because of the delay by the Administration to issue a decision on the drug. During his tenure he was also accused of an improper relationship with a fellow employee. That investigation did not lead to Crawford's resignation. The New York Times reports:

Dr. Crawford resigned in September; fewer than three months after the Senate confirmed him. He said then that it was time for someone else to lead the agency.

The next month, financial disclosure forms released by the Department of Health and Human Services showed that in 2004 either Dr. Crawford or his wife, Catherine, had sold shares in companies regulated by the agency when he was its deputy commissioner and acting commissioner. He has since joined a Washington lobbying firm, Policy Directions Inc.

The criminal investigation was disclosed at a court hearing in a lawsuit over the FDA's actions on the emergency contraceptive Plan B, a subject of bitter contention during Dr. Crawford's tenure as acting commissioner and commissioner. After the pill's maker, Barr Laboratories, applied three years ago to sell the pill over the counter, the agency repeatedly delayed making a decision on the application.

According to the transcript, she said that Dr. Crawford was under criminal investigation and that the issue of his financial disclosures "is within the grand jury."

Crawford, during his time at the FDA was accused by many of making politically motivated decisions with regard to medical issues. Some felt his actions with regard to Plan B were consistent with the administrations favoring of abstinence programs and their fear that the approval of the drug would lead to promiscuous behaviors.

Obviously Crawford is innocent until proven otherwise. However, he seems to be one of many who take positions on morality with regards to sex but seemingly forget about morality when it relates to financial issues. It seems like an all too familiar pattern. I often wonder if the actual reality is that many of these people who become vocal advocates of sexual morality are simply using the issue as a vehicle to political power. Sadly, it seems to be an effective approach. As we approach the 2006 midterm elections, I expect to see the rollout of a number of moralistic wedge issues.

Daniel DiRito | April 29, 2006 | 8:15 AM | link | Comments (0)
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April 25, 2006

HIV Vaccine Update genre: Little Red Ribbon-Hood

The following HIV vaccine information is reprinted from Kaiser Netwrok which can be found here. More and more experimental vaccines are in the testing and trials pipeline. An available vaccine is still a number of years away even if one of the many candidates were to be found effective.

The Wall Street Journal on Monday examined a procedure developed by a research team from Harvard Medical School and the Dutch biotechnology company Crucell that might deliver experimental HIV/AIDS vaccines using a modified common cold virus. NIH and Merck have developed two experimental AIDS vaccines, currently in trials, that attempt to use a modified version of the cold virus Adenovirus 5 "like a shuttle rocket carrying a payload of AIDS genes to spark an immune defense," according to the Journal.

About 40% to 50% of people in developed countries and 90% of people in Africa have been exposed and are immune to the Ad5 virus, which could hinder the vaccine's effectiveness by "blocking the virus before it delivers its payload," the Journal reports. To circumvent this, researchers used a procedure that modifies Ad5 to resemble a similar virus, Adenovirus 48, to which few people are immune. The Harvard and Crucell team in a letter published in the April 16 online version of the journal Nature reported that the procedure led to positive immune responses in monkeys, according to study author Dan Barouch of Harvard Medical School and Beth Israel Deaconess Medical Center.

Crucell Chief Scientific Officer Jaap Goudsmit said the vaccine procedure could begin human trials by late 2007, adding that the procedure potentially could be modified for vaccines for other diseases such as malaria and tuberculosis. "The proof of the pudding is always what happens in humans, but this is a promising start in the attempt to get around the problem of pre-existing immunity," Anthony Fauci, director of NIH's National Institute of Allergy and Infectious Diseases, said. The research on the procedure is funded by a $19.2 million NIH grant (Chase, Wall Street Journal, 4/17).

Daniel DiRito | April 25, 2006 | 4:54 PM | link | Comments (0)
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April 21, 2006

Cardinal Supports Limited Condom Use genre: Little Red Ribbon-Hood

Cardinal Carlo Maria Martini, one of the potential frontrunners during the election of the current Pope, Benedict XVI, said today that the Catholic Church should consider allowing condom use in light of the AIDS epidemic. Read the entire article here. AIDS activists have long criticized the Church for it's apparent refusal to acknowledge the need for condom use in the fight against the virus, especially in third world countries where women are particularly vulnerable.

I personally feel that historians will view the Church's position on contraception, in light of the AIDS crisis, as misguided as their inexcusable silence during the Holocaust. The Church only recently apologized for their inaction at the time. I expect to see a future Pope making a similar apology regarding the AIDS epidemic. Highlights from the article follow:

"We must do everything to fight AIDS," said Cardinal Carlo Maria Martini, the retired archbishop of Milan, in Italy's L'Espresso newsweekly. "Certainly, the use of condoms can constitute in certain situations a lesser evil."

The 79-year-old Martini was considered a liberal alternative to Cardinal Joseph Ratzinger in the 2005 conclave that elected Ratzinger, now Benedict XVI, pope. Martini is one of the most prominent church leaders to call for an easing of the position on condoms.

Martini was responding to questions from the Italian scientist and bioethicist Ignazio Marino, who heads the transplant center at Jefferson Medical College in Philadelphia.

Martini agreed with the questioner that the church could consider condoms a "lesser evil" than the risk of the disease.

"There's also the unique situation of a married couple, one of whom is afflicted with AIDS. That one is obliged to protect the other, and the other must be able to protect him or herself," the cardinal said.

Martini repeated church teaching that opposes research on embryonic stem cells and also reiterated church opposition to abortion and euthanasia.

However, he acknowledged that in abortion, there were cases when the life of the mother was at risk where abortion might be considered the "lesser evil."

"In such cases, it seems that moral theology has always supported the principle of the legitimate defense and the lesser evil, even if it concerns a reality that shows the dramatic and fragility of the human condition," he said.

Daniel DiRito | April 21, 2006 | 5:54 PM | link | Comments (0)
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April 12, 2006

Novel HIV Therapy Being Tested genre: Little Red Ribbon-Hood

A new approach to build the immune systems of HIV infected individuals has been the subject of extensive speculation and guarded excitement. The procedure involves removing the a supply of the patients own stem cells and infecting them with a harmless mouse virus that has been altered to carry a ribozyme gene that produces the enzyme needed to protect the cell from the attack of the HIV virus.

Results of the study are not expected until next February but some participants have reported impressive results that may indicate the procedure is capable of building an alternate immune system that can fend off the virus. The research company is owned by Johnson & Johnson. The company has said very little given that the trial is ongoing. The following article is from the San Francisco Chronicle:

Michael DeLane is about to celebrate a rare anniversary. On Saturday, it will be one year since he stopped taking all his drugs for AIDS.

Many patients have experimented with breaks from their AIDS medications, and a few of these have been able to keep their virus levels in check for a year or more.

What makes DeLane's case important is that he is among a small group of HIV-infected men and women participating in an unusual experiment. Half of them have had their own blood cells modified with a gene that blocks the virus.

Today, the 41-year-old San Francisco man is in good health and fine spirits.

If the experimental therapy is proved successful, it could raise the prospect that infected individuals could control the virus and maintain their health without having to spend a lifetime taking costly and potentially toxic drugs.

"It's possible that the stars are lining up on this one,'' said Dr. Jay Lalezari, a UCSF researcher who conducts clinical trials for drugmakers and has enrolled patients in this study. But he cautioned that the experience of a single patient has little scientific meaning. "The technology has proven itself in various ways, but we won't know the results of this trial until February,'' he said.

The goal of this experiment -- which combines elements of genetic engineering, gene therapy and stem cell science -- is to create a kind of parallel immune system that is fortified against the AIDS virus.

Like the 73 other participants in the clinical study, DeLane does not know for certain whether he was among the half who received the modified gene or was given a placebo. What he does know is that his T-cell count -- a measure of infection-fighting white blood cells -- has more than doubled.

Although he remains HIV-positive, the level of virus in his bloodstream is currently undetectable.

"It was such a burden to be lifted, to be no longer connected to the pills,'' said DeLane, a former Greenpeace activist now working as an administrator for the UCSF Medical Group.

DeLane was among the first to participate in the experiment, which he learned about because he has closely monitored HIV science since he became infected in August 2002.

Similar experiments are being carried out at UCLA and in Sydney, where the technique was developed by a small research company owned by Johnson & Johnson, the New Brunswick, N.J., medical giant.

Although DeLane was among the first to participate, the researchers have only recently performed the treatment on the last of their volunteers. Preliminary results of the trial won't be ready until February.

Johnson & Johnson spokesman Marc Monseau declined to discuss the treatment. "The trial is ongoing, and we prefer not to comment about ongoing trials,'' he said.

The secret of this new gene-therapy approach to controlling HIV is an enzyme called a ribozyme. It is a custom-built chemical "scissors," designed by Australian researchers, that cuts up one of HIV's nine genes just as the virus tries to replicate itself. Certain types of white blood cells are the natural target of HIV. But researchers believe that if these same cells are equipped with this man-made enzyme, they cannot be infected.

Because the body does not naturally produce this ribozyme, researchers had to come up with a way to cause blood cells to manufacture it. The answer was found in the emerging science of stem cells.

The stem cells chosen for this experiment are not the controversial kind found in human embryos, but grow naturally in bone marrow and float about in the bloodstream. They are literally the mother of all blood cells -- they morph into the many kinds of white cells that fight infection -- and are the favorite target of HIV.

Participants in the gene therapy experiment follow a procedure developed by the Australian scientists, led by Johnson & Johnson researcher Geoff Symonds.

First, the volunteers spend two eight-hour shifts hooked to a machine that filters out stem cells and returns the rest of their blood to their arm.

Next, the harvested stem cells are infected in the laboratory with a harmless mouse virus engineered to carry the ribozyme gene. The genes are a blueprint that tell the cell how to make the enzyme. Three days after the gene is transferred to the stem cells, they are returned to the patient's bloodstream. In subsequent weeks, these stem cells produce a variety of infection-fighting white blood cells, each containing the ribozyme that can ward off HIV.

(In the experiment, only half the subjects receive stem cells containing the gene. The rest receive unaltered stem cells as a placebo.)

The hope is that when HIV attempts to infect these fortified blood cells, the virus will be destroyed. As time goes by, these fortified blood cells would eventually outlive the natural blood cells -- and the patient would be left with a rebuilt immune system resistant to HIV.

DeLane was infused with either the treated blood cells or a placebo at a Stanford University Medical Center clinic in June 2004. He strongly believes that he received the treated cells, because for several months after the procedure his blood counts fluctuated wildly, as if a battle were going on in his immune system. Forty weeks after the infusion, he stopped taking antiviral drugs.

The Chronicle has learned that DeLane is not the only patient in the stem cell study to maintain undetectably low levels of virus, although the number is a closely guarded secret.

Word that some participants were doing well has been circulating among AIDS activists for several months. DeLane's experience with the Stanford trial is the first to be publicized -- but only because he chose to share the test results with reporters.

Perhaps the most intriguing development in his case was in February when the level of virus in his bloodstream jumped into the detectable range -- the first sign that perhaps the therapy was failing. But in March, the so-called "viral load" test slipped back into the undetectable range -- suggesting that DeLane's immune system, newly fortified or not, beat back the infection without any help from AIDS drugs.

"It's a fascinating case,'' said Dr. Steve Deeks, a UCSF researcher. Deeks was not involved in the clinical trial, but is an expert on the reaction of the immune system in HIV patients who stop taking their medications.

Deeks said it is possible that DeLane is one of those patients who can naturally control the virus without drugs, and his encouraging results may have nothing to do with the therapy. "Long-term control of the virus in the absence of treatment is rare, but it does happen,'' said Deeks.

Scientists involved in the study remain cautiously optimistic. Dr. Ronald Mitsuyasu, director of the UCLA Center for Clinical AIDS Research, is running the study in Los Angeles and collaborated with the Australian team on the first pilot test of the new therapy. It showed that the procedure was safe, and that the anti-HIV ribozyme installed in stem cells turned up in the many white blood cells that derived from them.

Researchers have improved the technique of transferring the gene to stem cells so that 90 percent of the harvested stem cells are returned carrying the ribozyme.

The AIDS scientist said he does not believe this type of therapy will ever fully replace effective antiviral drugs. However, "if we are intelligent in how we use the drugs with these immune therapy approaches, it could lead to extremely effective control of HIV,'' Mitsuyasu said.

Daniel DiRito | April 12, 2006 | 7:33 AM | link | Comments (2)
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