Colorado says dentist put thousands at HIV risk from reused syringes

DENVER (Reuters) - A suspended Colorado dentist reused syringes and needles in his now-shuttered practice, potentially exposing thousands of patients to HIV and hepatitis infection, health officials warned on Friday.

The Colorado Department of Public Health and Environment sent letters to 8,000 patients of dentist Stephen Stein, urging them to seek tests for the diseases after learning of 'unsafe injection practices' at two Denver-area clinics he owned between September 1999 and June 2011.

Investigators found that Stein reused needles and syringes in several patients' intravenous lines at his oral surgery and dental implant clinics, in violation of standard medical protocol, the department said in a statement.

'This practice has been shown to transmit infections,' the statement said. It added that there had been no confirmed cases of anyone contracting the viral infections through Stein's clinics.

In the letters sent to Stein's former patients, the health department urged them to be tested for HIV, hepatitis B and hepatitis C, said Jan Stapleman, a department spokeswoman.

Stein's records were incomplete, so it is likely more people were possibly exposed than those already identified, she said.

A hot line established for Stein's patients to call was 'very busy' all day on Friday, Stapleman said.

Stein's lawyer, Victoria Lovato, said her client 'is cooperating with the state's investigation.'

Authorities said any patient who underwent any type of injection at the clinics, including sedation, might be at risk. They cautioned that if any patients of Stein tested positive for any of the viruses, there was no way to determine how they contracted the disease.

Stein's license to practice dentistry in Colorado was suspended for an unrelated matter, said Cory Everett-Lozano, spokeswoman for the state Department of Regulatory Agencies, which oversees medical licenses.

Until that probe is resolved, the reasons for Stein's current suspension are confidential, she said.

Lynn Kimbrough, a spokeswoman for the U.S. Attorney's Office in Denver, said Stein was already the target of a criminal probe for possible prescription fraud before the allegations emerged about reusing syringes. She said no criminal charges had so far been filed.

(Editing by Tim Gaynor and Peter Cooney)



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Can HIV Prevention Be Found in a Pill?

An antiretroviral HIV drug has shown effectiveness in reducing infection risk, but the medication could put up some hurdles for physicians and health experts.

Three studies released online this week in the New England Journal of Medicine looked at the efficacy of a combination drug called Truvada (emtricitabine and tenofovir disoproxil fumarate) among heterosexuals.

Truvada is currently used as a treatment for HIV, but an FDA panel recently recommended approving the drug for preventive treatment as well.

One of the three studies followed 4,747 couples, one of whom was HIV-positive. The other partner was randomly assigned to Truvada, tenofovir (another HIV treatment) or a placebo.

The Truvada group had a 75 percent reduced risk of HIV infection compared to those who took the placebo, and those who took tenofovir had a 67 percent lower risk compared to the placebo group.

In another study, among 1,219 HIV-negative Africans, those taking Truvada were about 62 percent less likely to get the HIV infection.

But the medication, although promising, presents some challenges. A third study done among women in Africa was stopped because too many participants stopped taking the drug.

An editorial that accompanied the studies acknowledged that the studies had "complex and disparate results" and that more studies are needed to understand the potential and pitfalls of the pre-exposure prophylactic HIV treatment.

The authors of the editorial pointed out that although the studies showed no increase in risky sexual behavior or a drop in condom use, care must be taken that use of the drug doesn't indirectly encourage those behaviors.

They added that concern over how the drug is managed shouldn't take away from its promise as a preventive treatment.

What more needs to be done to prevent the spread of the HIV virus? Let us know in the comments.

---

Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine | TakePart.com



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Circumcision ruling called threat to religion

BERLIN (AP) - A German court's decision that ritual circumcision amounts to criminal bodily harm threatens religious freedom in Europe, a group of European Orthodox rabbis said Thursday.

The ruling, handed down last month by a Cologne court, has prompted widespread criticism from Jewish and Muslim groups alike, despite German government attempts to allay fears that it could lead to a national ban on circumcisions.

Despite the government's assurances, the president of the German Medical Association this week recommended that doctors cease performing circumcisions for religious reasons until the law can be clarified.

Following an emergency meeting in the German capital of some 40 rabbis from across Europe to discuss the issue, the head of the Conference of European Rabbis, Pinchas Goldschmidt, called circumcision 'the foundation' of the Jewish faith.

Goldschmidt, the chief rabbi of Moscow, said that while the rabbis recognized the ruling does not set a nationwide precedent, it has raised fears among the Jewish community that members could be prosecuted if they circumcise their sons.

Goldschmidt cited France's ban on face-covering Muslim veils and Switzerland's ban on the construction of new minarets for mosques in saying the Cologne decision was part of a wider trend aimed at limiting religious traditions in largely secular Europe.

'I don't think that today there is a quasi-ban of circumcision in Germany, but it is an attack on circumcision - a big attack on circumcision - and I am here because I think that this is not only a problem for Germany but a problem for Europe,' Goldschmidt said.

'Germany is an integral part - one of the most important parts - of Europe, so we want to solve this problem here first.'

In a joint statement from Brussels earlier this week, a group of rabbis, imams and others said that they consider the ruling against circumcision 'an affront on our basic religious and human rights.'

In its decision, the court said that circumcising young boys on religious grounds amounts to bodily harm even if parents consent to the procedure.

The ruling came in the case of the circumcision of a 4-year-old Muslim boy that led to medical complications, and both German Jewish and Muslim groups have spoken out against it.

Avichai Apel, the chief rabbi of Dortmund, said he was in regular contact with Germany's bishops and imams on the issue.

'Circumcision is for us a duty, and the basis for a Jewish child to be a part of the Jewish people,' he said. 'Religious freedom is being curtailed, and that is something we cannot accept here in Germany.'

Following the decision, German Foreign Minister Guido Westerwelle was quick to offer assurances that it would not mean an end to the practice, saying 'the free exercise of religion is protected in Germany - that includes religious traditions.'

The German ambassador to Israel told lawmakers in Jerusalem on Monday that the government was looking into whether laws needed to be changed.

'For us the deadline is not tomorrow, but yesterday,' Goldschmidt said of possible changes to the law. In the meantime, however, 'we say to the Jewish community ... keep performing the brit milah, and have no fear.'

Justice Minister Sabine Leutheusser-Schnarrenberger told the Augsburger Allgemeine newspaper in an interview printed Tuesday that for her 'the best thing here would be a clear word from one of the high courts.'

'Circumcision has never been questioned in the past,' she said. 'It is about fundamental questions and different values. The question is what part of religious practice is also part of the right to physical integrity.'



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HIV Drug May Prevent Bone Marrow Transplant Complication

WEDNESDAY, July 11 (HealthDay News) -- An HIV drug significantly reduced the risk of graft-versus-host disease, an all-too-common complication in blood cancer patients following bone marrow transplants, new research finds.

Bone marrow is the spongy tissue inside the bones that contains immature cells, or stem cells. In an 'allogeneic' bone marrow transplantation, also called a stem cell transplant, a patient's own stem cells and immune system are wiped out by chemotherapy and radiation. Then, the patient receives the transplant, or bone marrow, from a closely matched donor.

The treatment is used for several types of blood cancers, including lymphoma and leukemia.

But a common complication of a bone marrow transplant is graft-versus-host disease. It occurs when transplanted immune cells attack patients' healthy tissue, a complication that can be minor or life-threatening.

'Graft-versus-host disease affecting the skin, liver, gut and other organs is a dreaded complication of allogeneic stem cell transplantation either from a related or unrelated donor,' said one expert, Dr. Jasmine Zain of NYU Langone Medical Center in New York City. 'The rates are 35 percent with related donors and up to 57 percent by day 100, even in reduced-intensity transplants,' added Zain, who is director of the Bone Marrow Transplant Program and assistant professor in the division of hematologic malignancies and medical oncology at the center.

The study was conducted by a team at the University of Pennsylvania's Perelman School of Medicine and included 38 patients with several types of blood cancers. The cancers included acute myeloid leukemia, myelodysplastic syndrome, lymphoma and myelofibrosis. All of the patients were given the drugs tacrolimus and methotrexate, which suppress the immune system and are a standard treatment to prevent graft-versus-host disease.

The patients were also given a 33-day course of the HIV drug, maraviroc, beginning two days before their transplant.

None of the patients treated with maraviroc developed graft-versus-host disease in the gut or liver within the first 100 days after their transplant. The liver and gut are the most serious locations for the complication, the researchers noted.

After six months, 6 percent of these transplant patients developed severe graft-versus-host disease compared to 22 percent of a group of similar patients who weren't treated with the HIV drug.

In addition, fewer in the group given the HIV drug developed graft-versus-host disease in their liver or gut compared to those given the standard treatment.

One year following transplant, about 15 percent of patients given the HIV drug developed severe graft-versus-host disease compared to 29 percent of patients who received standard therapy.

The study was published in the July 11 edition of the New England Journal of Medicine.

Researchers explained that the HIV drug redirects these immune cells without having to suppress patients' immune systems. Because their immune systems aren't compromised by the drug, patients should be less vulnerable to infections and to a relapse of their cancer.

'It appears that our new approach allows us to prevent some patients from developing [graft-versus-host disease] by redirecting immune cells away from certain sensitive organs that they could harm,' lead study author Dr. Ran Reshef, an assistant professor in the division of hematology-oncology, said in a university news release. 'This is a novel way for us to try to decrease treatment-related complications among bone marrow transplant patients without also reducing their new immune system's ability to attack their cancer.'

More research on the effects of longer-term treatment with maraviroc is needed, they added.

For her part, Zain called the study 'innovative.'

'There was no increase in the degree of immunosuppression, which is the usual approach to prevent and treat graft-versus-host disease but comes at a cost of increased infections and disease relapse,' Zain said. 'This makes this a novel and unique approach that should be investigated in a larger trial.'

More information

The U.S. National Library of Medicine has more about bone marrow transplants.

Studies Show Value of AIDS Drugs as Prevention

WEDNESDAY, July 11 (HealthDay News) -- Researchers have released the final results of two studies that suggest AIDS drugs can prevent exposed people in Africa from getting infected with HIV by their sexual partners. However, another study indicates that it's a tough job to convince African women who aren't at the highest risk to take preventive medications.

In the big picture, the studies show that 'we have a new HIV-prevention strategy, one that's quite powerful but also depends on adherence,' said Dr. Jared Baeten, an associate professor of global health at the University of Washington, in Seattle. 'The next step is figuring out how to motivate people to take it.'

The studies appeared online July 11 in the New England Journal of Medicine.

The general findings of the studies have been previously released, but only now has the research become available in a medical journal after going through a peer-review process.

Two studies offer promising details about the potential for the drugs to prevent -- although not all the time -- the transmission of HIV to heterosexual men and women from their infected partners.

One study in Kenya and Uganda looked at heterosexual couples -- almost all married -- in which one person was infected with HIV, the virus that causes AIDS. The uninfected partners were randomly assigned to take an inactive placebo or a once-daily dose of the drug tenofovir (Viread) or a tenofovir-emtricitabine combination (Truvada) for up to three years. Nearly 5,000 people completed the study.

Those who took Truvada had a 75 percent lower risk of becoming infected with HIV compared to those who received a placebo. The risk was 67 percent lower in those who took Viread compared to a placebo. Even in those who got the placebo, the overall risk of getting infected was low: 52 of 1,468, or a little more than 3 percent, did so.

Truvada treatment in the United States costs several thousand dollars a year, Baeten said, but the discounted price can be as cheap as 25 cents a day in Africa. The drug, which stops the AIDS virus from reproducing in people who are infected, appears to do the same thing in uninfected people who are exposed to the virus, he said. In their cases, the virus doesn't already have a foothold in the body so it dies off.

In this study, 10 percent or less of those who took the drugs reported side effects such as fatigue, diarrhea and nausea, and only in the first month.

The second study of 1,219 HIV-negative adults in Botswana looked at Truvada versus a placebo. Comparing the 33 participants who became infected during the trial -- nine people in the drug group and 24 people on a placebo -- the study found those who took Truvada were 62 percent less likely to become infected with HIV.

In this study, significant loss of bone mineral density was a side effect for participants receiving the drug, compared to those on a placebo.

Another study, in Kenya, South Africa and Tanzania, assigned 2,120 women at higher risk of HIV infection to receive Truvada or a placebo. However, there wasn't much difference in HIV infection rates between the two groups -- about 5 percent in both became infected.

Baeten explained the finding, saying many women stopped taking the drug, which prevented an accurate assessment of its effectiveness.

The next step in research into the use of the drugs to prevent infection is to 'figure out how to make them work in the real world, outside of an intensive research setting,' Baeten said. In the United States, for example, researchers are studying their use in gay men who are at high risk for infection.

As for condoms, another major player in HIV prevention, Baeten said the prevention drugs will add to their level of security or provide some protection in cases where people can't use condoms.

In an editorial accompanying the studies, two experts stressed that medications should never be viewed as a substitute for the condom.

'Although no evidence of increased risky sexual behavior or decreased condom usage was reported in these studies, we must ensure that pre-exposure prophylaxis does not indirectly encourage such behavior,' wrote Dr. Myron Cohen of the University of North Carolina at Chapel Hill and Dr. Lindsey Baden of Brigham and Women's Hospital, Boston.

They added that more research is needed to properly assess who stands to benefit most from these drug regimens, the best timing and dosage, as well as any potential side effects from long-term use.

More information

For more about AIDS, visit the U.S. National Library of Medicine.



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Pills to prevent HIV raise many questions: studies

Various trials examining the use of anti-retroviral drugs in healthy heterosexuals as a way to prevent HIV have shown drastically different results, research showed Wednesday.

The findings of three major studies in Africa, published in the New England Journal of Medicine, raise many questions about which groups would likely benefit and how to manage such treatments in the future, doctors said.

The approach is known as pre-exposure prophylaxis, or PrEP, in which healthy people take antiretroviral drugs -- the kind used to treat people with HIV -- in order to prevent getting the virus during sex with HIV-infected partners.

One study detailed in the journal which included heterosexual couples -- each with one HIV-positive partner, one HIV-negative -- showed a 67 to 75 percent reduced risk of getting HIV among uninfected partners taking the drugs.

The study, known as Partners PrEP, ran from 2008 to 2010 in Kenya and Uganda and included more than 4,700 couples. It randomly assigned the HIV-negative partners to once-daily tenofovir, a combination of tenofovir-emtricitabine, or a placebo.

Both treatments showed 'significant' and a 'similar magnitude' of protection for both men and women, the study said.

Adherence to the drug regimen was also high in this study, with 82 percent of samples from randomly selected participants showing detectable drug levels, and study authors estimating an overall 92 percent adherence rate.

Another study detailed in the journal however was stopped early in April 2011 because the group receiving the drug did not show any better level of protection than the group taking the sugar pill.

That study, known as FEM-PrEP, was a randomized trial of 2,120 women in Kenya, South Africa and Tanzania.

Thirty-three women taking the drug became infected with HIV, compared to 35 taking the placebo.

The study also showed a much lower rate of adherence to the medication regimen (40 percent) and a much higher rate of reported side effects such as nausea, vomiting and kidney or liver abnormalities.

Since many of the women in the study reported viewing themselves at low-risk for acquiring HIV, this may have contributed to their failure to take the drug regularly, the study authors said.

A third study, called TDF-2, enrolled 1,219 men and women in Botswana, and showed that pre-exposure prophylaxis had an efficacy rate of about 62 percent in sexually active heterosexual adults.

Previous studies on men who have sex with men have shown that the approach could reduce transmission of HIV by 44 percent overall, though much higher success rates were seen in men who took the pills most regularly.

'Why the results differ across the various studies reported to date is unclear,' said an accompanying editorial by Myron Cohen from the University of North Carolina and Lindsey Baden of Brigham and Women's Hospital in Boston.

Learning more through future study is important because PrEP is increasingly being seen as a part of an integrated HIV prevention approach, they wrote.

Also, an advisory panel to the US Food and Drug Administration earlier this year recommended approving the first ever pill for HIV prevention. A decision is expected in September.

Therefore, doctors need to consider how to manage such an approach with patients, the authors said.

Questions to consider include which populations are best suited, when to start and stop treatment, how to avoid the risk of drug resistance, what long-term side effects may include, and how to make sure the treatment does not encourage risky behavior such as unprotected sex.

'Concern about the management of pre-exposure prophylaxis of HIV infection should not detract from the potential importance of the intervention,' Cohen and Baden wrote.

'The health care provider who recommends pre-exposure prophylaxis needs a management plan that recognizes the effects of the intervention on the patient's sexual behavior, safety and well-being as well as the ramifications of the intervention for the health of the public.'

GSK's HIV drug beats Gilead market leader in study

LONDON (Reuters) - An experimental once-daily AIDS drug from GlaxoSmithKline and its Japanese partner Shionogi proved better than Gilead's market-leading Atripla in a late-stage clinical trial, increasing hopes for the product.

Dolutegravir, which could reach the market late next year, belongs to a novel class of drugs known as integrase inhibitors that fight HIV/AIDS by blocking the virus causing the disease from entering cells.

It should help British group GSK rejuvenate its HIV/AIDS business - an area it used to dominate but where it has fallen behind rivals, notably U.S.-based Gilead.

The stakes are high with Atripla, the leading HIV/AIDS treatment in the United States, raking in sales of $3.2 billion last year.

Dolutegravir's impressive result may also make a spin-off of GSK's HIV/AIDS business ViiV Healthcare more likely, analysts said. ViiV is currently run as a joint venture with Pfizer, with Britain's biggest drugmaker holding an 85 percent stake.

Dolutegravir's success against Atripla, taken as a single tablet, may impress clinicians as Gilead's own new Quad pill, which also contains an integrase inhibitor, only matched Atripla.

In the latest Phase III study, 88 percent of patients taking a regimen of dolutegravir plus two older drugs for 48 weeks had their virus suppressed against 81 percent for those on Atripla, GSK and Shionogi said on Wednesday.

The superior efficacy was driven by the fact that more patients taking Atripla dropped out of treatment, with 10 percent of those on the Gilead drug stopping due to side effects against 2 percent in the dolutegravir arm.

The result was the second positive final-stage clinical read-out for dolutegravir, following encouraging results against U.S. company Merck & Co's rival Isentress in April.

Two further Phase III trials are expected to report results by the end of the year and dolutegravir could potentially be filed for approval with regulators before the end of 2012, a company spokesman said.

That means the medicine may reach the market before the end of 2013, ramping up competition in the HIV/AIDS market.

GSK shares were up 0.7 percent by 1150 GMT, while Gilead was down 2 percent in pre-market Nasdaq trading.

GSK'S 40 PCT SHARE

Dolutegravir is viewed by analysts as a potential multibillion-dollar-a-year seller, as its once-daily dosing is likely to be attractive to patients. However, the financial gain to GSK will be diluted by its deals with Shionogi and Pfizer.

Income from the medicine will be shared 50:50 between ViiV and Shionogi, so GSK will receive only just over 40 percent after taking account of Pfizer's minority stake in ViiV.

The creation of ViiV in 2009 marked an unusual drug industry collaboration because of the way in which it pooled GSK and Pfizer's HIV/AIDS operations into a new business. There have been doubts, however, as to whether the joint venture would have a viable future, given uncertainty about its new drug pipeline.

The impressive results with dolutegravir will lay some of those worries to rest.

Mark Schoenebaum, an analyst at ISI Group, said the latest data was 'a bit better than expected', although it might not be enough to drive big shifts away from Gilead's drugs.

Citi analysts also noted that concerns remained about the cardiovascular safety of Epzicom, one of the older drugs used with dolutegravir.

Still, the findings are clearly an overall plus for GSK's HIV unit and could help make it a viable standalone business.

'Today's news may prompt further market discussion of a possible spin-off of ViiV as dolutegravir is much the most important pipeline product for this venture,' Deutsche Bank analysts said in a note.

GSK Chief Executive Andrew Witty said last year he had no immediate plans to spin off ViiV but was 'open-minded' about the unit's long-term future.

Merck's Isentress, which had sales of $1.4 billion last year, is currently the only integrase inhibitor approved by regulators, although Gilead's Quad pill containing its integrase inhibitor elvitegravir was recommended by a U.S. expert panel in May.

(Editing by Jon Loades-Carter)



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