Monthly Archives: September 2010

Patients sue Teva to release ALS drug trial data

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Patients can get impatient &mdash in this case when it involves data relating to a treatment they volunteered for. Three patients who participated in a clinical trial examining the efficacy of Teva Pharmaceuticals’ Copaxone, a multiple sclerosis drug, in treating amyotrophic lateral sclerosis (ALS, or more commonly, Lou Gehrig’s disease) are suing the Israeli drug giant, saying they were not given enough information about the treatment.

They’re demanding that Teva release the results of the trial, but the company has refused, saying that information falls under the umbrella of trade secrets. Teva has offered a compromise, under the terms of which the data would be released, but kept secret outside of the trial proceedings.

Copaxone is scheduled to go off-patent soon, but in an interview with Nature Medicine in March, Teva CEO Shlomo Yanai said he did not expect to see generic competition until 2014. It would be an interesting reversal for the company, which is the largest manufacturer of generic medicines worldwide.

Straight talk with … Rajiv Shah

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rajivshah.jpgBy Elie Dolgin

Rajiv Shah was less than a month into his position at the helm of the US Agency for International Development (USAID) when the catastrophic earthquake that hit Haiti propelled him to the frontline of an international relief effort. To meet the challenge, Shah relied on his previous experience in leadership roles at the Bill & Melinda Gates Foundation and at the US Department of Agriculture to help launch the largest urban food distribution effort in history and a vaccination campaign that reached more than a million people. With Haiti now in a state of long-term reconstruction, Shah’s focus is shifting toward meeting the Millennium Development Goals (MDGs), the eight major areas of international development that the world agreed to address by 2015. Ahead of the MDG Review Summit this month in New York, Elie Dolgin spoke to Shah about how he plans to make progress toward reaching the targets. (Click here to continue reading)

Image via AFP Photo

States relish in their stable stem cell funding

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Stem cell research is on again. Wait, no, it’s off again. Oh, who can keep track with all these back-and-forth court decisions? Wouldn’t it be nice just to have some stable stem cell funding in the United States? Fortunately, there already is a degree of constancy in many states around the country that had previously established their own stem cell agencies. And as the fallout from the US district court judge’s decision to temporarily halt all federal funding for human embryonic stem cell research drags into its third week, many of these states are feeling vindicated by their ability to keep the controversial research going without endless reversals and legal challenges.

“This is not going to go away,” Dan Gincel, director of the Maryland Stem Cell Research Fund, told Nature Medicine. “That’s why it’s so important to continue funding cutting edge research and to let the scientific peer review committee decide what projects should be funded, and not judges or lawmakers.”

After former President George W. Bush restricted taxpayer-backed funding for human embryonic stem cell research to just a couple dozen cell lines, a number of individual states — including California, New York, Massachusetts, Connecticut, Illinois, Wisconsin and Maryland — created government agencies to support stem cell work done within their state borders.

Those organizations were seen as life supports for the field throughout the Bush-era. But after President Barack Obama issued an executive order last year to expand stem cell funding countrywide, many critics argued that these state agencies were redundant at best and obsolete at worst. But the turmoil that the field has faced since the 23 August halt to federal funding — which a Washington, DC judge upheld earlier this week only to be temporarily overturned by a federal appeals court yesterday — should silence those critics.

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Line item cut threatens monitoring of more than West Nile virus

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mosquitocontrol.jpgDengue fever is lapping at America’s shores. In early August, Florida’s Department of Health confirmed that there had been 96 cases of the mosquito-borne disease in the state since the start of the year. More distressing was that 29 of those who fell sick contracted dengue locally. The mosquito-borne disease has established a firm foothold in Puerto Rico, with 1,000 cases reported by late July in that US territory alone. (Click here to continue reading)

Photo by Joe Raedle

Masterminds behind pharmaceutical fraud deserve prison time

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jailbars.jpgBy Jeb White

The US legal system has rightly constructed a high barrier to prosecuting individual corporate employees. However, when a person deliberately masterminds massive pharmaceutical fraud, he or she needs to be held accountable. Whistleblowers hold the key to building stronger, more viable cases against those who devise large-scale corporate criminal activity. (Click here to continue reading)

Image by recursion_see_recursion via Flickr Creative Commons

Monkeypox transmission scrutinized in Sudan

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Monkeypox.gifLast month scientists detailed how monkeypox has rushed to fill the niche left vacant in certain parts of Africa by the human eradication of smallpox. Now, a new report from Emerging Infectious Diseases documents a 2005 outbreak of monkeypox in the Sudanese state of Unity that hints at possible human-to-human transmission. There were ten confirmed cases and nine probable cases of monkeypox between September and December of 2005. No deaths occurred.

The disease presents symptoms similar to smallpox, causing swelling of the lymph nodes, fever, and a raised, bumpy rash. It has a mortality rate of 1-10% in Africa.

The particularly intriguing aspect of this outbreak is the evidence of possible human-to-human transmission. In this case, a traditional healer was linked to three of the four transmission chains in the outbreak. The healer had a confirmed case of monkeypox, and a number of the monkeypox patients were either children whom the healer had recently treated for illnesses or young adults who had gone to him for a tooth extraction procedure (removal of the incisors to signify passage into adulthood is a cultural tradition in this part of Sudan).

Usually most cases of monkeypox originate in rural areas, where the virus is spread through contact with infected animals (usually rodents, domestic animals, and, yes, monkeys). Though it is not unheard of, another instance of human-to-human transmission—if it proves to have indeed happened in this case—would heighten concerns about possible monkeypox outbreaks in urban areas.

Image via Wikimedia Commons

Personalized investigation

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personalinvest.jpgBy Elie Dolgin

Despite continued doubts about the clinical utility of direct-to-consumer genetic tests, tens of thousands of people have sent away tubes full of their saliva to learn more about their genetic profiles. Armed with such DNA data, a number of early adopters are showing how empowering—and beneficial to science—personal genetic information can be. Elie Dolgin reports on one company’s plans to make medical genetics more participatory. (Click here to continue reading)

The real war on drugs

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helicopter.jpgBy Cassandra Willyard

The murder of ten aid workers, including an optometrist and a surgeon, in Afghanistan last month refocused the world’s attention on the difficulties of providing health care in conflict zones. Beyond the dangers of delivering acute care such as surgery, dispensing medicines for chronic illnesses ranging from HIV to diabetes remains a challenge in areas affected by war. Cassandra Willyard looks at the lessons relief agencies have learned in recent years providing care amidst increasingly complex conflicts. (Click here to continue reading)

BP and NIH to examine health of oil spill cleanup workers

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oilspillworker.jpgBP’s effort to mitigate the damage done by the Deepwater Horizon spill&mdash both to the Gulf of Mexico and to the oil company’s reputation&mdash is in full throttle. Today, the company released documents relating to an internal investigation that shifted most of the blame to the contractors and employees of the rig.

Yesterday BP announced that it would contribute $10 million to a new US government initiative that will examine the health impacts of the oil spill. The money comes from a $500 million research program set up by BP called the Gulf Coast Research Initiative. The US National Institutes of Health (NIH) will foot another $10 million for the government program, which will focus on relief workers that were exposed to oil, oil byproducts, and dispersants used during the cleanup efforts.

A subsection of the NIH, the National Institute of Environmental Health Sciences (NIEHS), will be charged with conducting the research. The study’s lead researcher, Dale Sandler, chief of the Epidemiology Branch at NIEHS, said in an NIH statement that they’ll be enrolling workers involved in all aspects of the cleanup, both offshore and on land, as well as workers who were not exposed to oil, who will be used as controls.

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Lack of uptake threatens promise of HIV vaccines

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syringehand.jpgBy Elie Dolgin

The news out of Thailand last year that an experimental vaccine reduced the risk of contracting HIV by as much as a third reinvigorated hopes that a vaccine against the elusive virus was possible. But new research showing that large swaths of the public wouldn’t bother getting immunized against HIV, were such a vaccine available, calls into question the effectiveness of the approach in controlling the AIDS epidemic. (Click here to continue reading)

Image by Mel B. via Flickr Creative Commons