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Brazil's top court approves stem cell research
Biotech | 2008/05/30 09:27
Brazil's Supreme Court ruled Thursday that scientists can conduct embryonic stem cell research, which holds the promise of curing Parkinson's disease and diabetes but raises ethical concerns about the limits on human life.

Six of the court's 11 justices upheld a 2005 law allowing embryonic stem cell research and turned down a petition filed that same year by then-Attorney General Claudio Fontelles, who argued the law was unconstitutional because it violates the right to life.

The remaining five judges argued that while the 2005 law is constitutional, research should only be carried out "with restrictions" such as not allowing the embryo to be destroyed and submitting each case for the approval of an ethics commission.

The ruling drew immediate fire from church officials in the world's largest Roman Catholic country.

The National Conference of Brazilian Bishops issued a statement saying it "regretted" the ruling, comparing it to a death sentence. The bishops' conference said its position "is not a matter of religion, but of the defense of human life, beginning with conception."

The law opens the way for research with embryos resulting from in-vitro fertilization that have been frozen for at least three years.

Advocates have said that a favorable Supreme Court ruling could make Brazil Latin America's leader in stem cell research.

They praise Brazilian scientists for their work with adult stem cells for the treatment of cardiovascular diseases and Type 1 diabetes, and have said that similar breakthroughs could be achieved with embryonic stem cells.



Panel Seeks New Limits on Anemia Drugs
Biotech | 2008/03/14 03:58

A federal advisory panel, in response to mounting safety concerns, called on Thursday for additional restrictions on the use of anemia drugs by cancer patients.

The recommendation by a committee that advises the Food and Drug Administration could lead to an additional decline in sales for the drugs: Aranesp, made by Amgen, and Procrit by Johnson & Johnson.

But the two companies avoided the outcome they most feared: a recommendation that the drugs not be used by any cancer patients. That probably would have meant the loss of at least $1 billion in sales for each company.

“They dodged the really big bullet, but they still took some damage,” said Geoffrey C. Porges, a biotechnology analyst at Sanford C. Bernstein & Company.

Yaron Werber, an analyst with Citigroup, estimated that Amgen would lose about $125 million in Aranesp sales if the recommendations were enacted. That would be about 25 percent of Mr. Werber’s already reduced projections for 2008 sales to cancer patients in the United States. The meeting was held because eight clinical trials suggested that the drugs might make cancer worse for some patients or even shorten their lives. Cancer patients take Aranesp or Procrit to counter the anemia caused by chemotherapy.

The difficulty for the committee was that those eight studies involved high doses of the drugs. There was very little solid information on whether the drugs were dangerous at doses typically used by cancer doctors.

Faced with that information, the panel voted 13 to 1 in favor of recommending that the drugs remain available for use by many cancer patients.

But the committee then voted 9 to 5 in favor of recommending that the drugs not be used by patients with either breast cancer or head and neck cancer because the evidence of a risk was strongest for those types of tumors.

The committee also voted 11 to 2, with 1 abstention, to recommend that the drug not be used by patients being treated with the intent of curing their cancers. The definition of that category is vague, but it generally refers to patients with early-stage cancer who are undergoing chemotherapy after surgical removal of a tumor, in which the doctors hope the cancer has been eliminated. F.D.A. officials said after the meeting that most use of the anemia drugs was for patients with more advanced cancers.

The panel members also recommended that patients be made to sign consents in order to obtain the drugs. But the panel voted against carefully controlling distribution of the drugs.



Brazil Court Puts Off Stem Cell Ruling
Biotech | 2008/03/06 06:34
Brazil's Supreme Court postponed a decision on whether to permit embryonic stem cell research in Latin America's largest country after one justice asked Wednesday for more time to study the matter.

The court had been scheduled to rule on a 2005 petition by then-Attorney General Claudio Fontelles, who argued that a law passed that same year allowing embryonic stem cell research was unconstitutional because it violates the right to life.

The law opened the way for research with embryos resulting from in-vitro fertilization that have been frozen for at least three years.

The session was suspended, almost five hours after it began, when Justice Carlos Alberto Menezes Direito formally requested more time to consider the issue. He has 10 to 30 days to present his opinion during another session, according to the court's press office.

Before the adjournment, current Attorney General Antonio Fernando Souza and a lawyer for Brazil's Roman Catholic Church argued that embryonic stem cell research should be banned because the process involves destroying embryos, which they said ends human life.

Other attorneys representing the government and Congress defended the 2005 law, saying research with embryonic stem cells could lead to cures of diseases such as Parkinson's, multiple sclerosis and diabetes.

While embryonic stem cell research is currently legal, scientists have put most projects on the back burner pending the Supreme Court's ruling.



Mercury-Containing Vaccine Vindicated
Biotech | 2007/09/27 03:48

As federal health officials offer more evidence that the mercury-containing vaccine preservative thimerosal is safe, many vaccine experts say in retrospect that the U.S. Food and Drug Administration's decision to remove it from childhood vaccines may have done more harm than good by raising public fears.

And still others argue that research and funds still being spent on exploring the risks of thimerosal could be directed to more productive enterprises.

A new study published in the New England Journal of Medicine concludes that early exposure to thimerosal does not cause any neurological problems. Thimerosal, used in vaccines since the 1930s, has been a topic of controversy since the FDA banned it in 1999.

Some claim that the additive causes autism and other brain development disorders in children. But the latest study joins a growing body of literature that shows thimerosal is safe and causes no long-term negative effects on children's health.

Although no concrete evidence at the time showed that thimerosal was harmful, the Centers for Disease Control and Prevention and the American Academy of Pediatrics pushed for its elimination to quell the fears of parents who might otherwise not get their children vaccinated.



FDA Finds No Heart Risk With 2 Heartburn Drugs
Biotech | 2007/08/10 05:20

The popular heartburn drugs Prilosec and Nexium do not appear to spur heart problems, according to preliminary U.S. and Canadian probes announced yesterday.

The Food and Drug Administration and its Canadian counterpart, Health Canada, began reviewing the drugs, used by tens of millions of people, in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.

Those studies compared treatment of the chronic heartburn known as gastroesophageal reflux disease with either of the two drugs or with surgery, and tracked patients for five to 14 years. The initial analysis found that more patients treated with the drugs had had heart attacks, heart failure or heart-related sudden death.

The FDA followed up on those studies and found that they seemed skewed: Patients who underwent surgery were younger and healthier than those treated by drugs, suggesting that the heart link was a coincidence.

While the studies' designs make safety assessments difficult, many of the participants who developed heart problems had risk factors before starting the drugs, Health Canada said.

The FDA then looked at 14 additional studies of the drugs and found no evidence of heart risks. In a few studies where patients received either medication or a dummy pill, those who took the heartburn drugs had a lower incidence of heart problems.

Does African Dust Affect Atlantic Hurricanes?

Storm scientists are taking a closer look at whether giant dust clouds from the Sahara could join the El Niño phenomenon as a leading indicator of the ferocity of Atlantic hurricane seasons.

Scientists are intrigued by preliminary research showing a direct correlation between the sandy plumes and tropical cyclones.

"What we've seen is: more dust, fewer hurricanes," said William Lau, chief of the Laboratory for Atmospheres at NASA's Goddard Space Flight Center.

The busy and damaging hurricane seasons of 2004 and 2005, which rattled global energy and insurance markets, have heightened interest in storm forecasting and in research on factors that make tropical cyclones either spin into monster storms or wither and die at sea.

El Niño, a warming of eastern Pacific waters, has become a dominant storm indicator because it can flatten an Atlantic hurricane season by increasing the wind shear that can rip apart cyclones.

Cancer Drug Could Cure Dangerous Skin Disease

Four weekly injections of the cancer drug Rituxan may be enough to provide a long-term cure for a rare but potentially fatal skin disorder characterized by blistering lesions that do not heal, French researchers reported.

A study published last year showed similarly impressive improvement using a combination of Rituxan and immune globulin over six months. The new results, reported in the New England Journal of Medicine, suggest that Rituxan alone, over a one-month period, is effective.

The drug, known generically as rituximab, is made by the biotechnology companies Genentech and Biogen Idec, and approved for non-Hodgkin's lymphoma and rheumatoid arthritis.

The drug is sold by Roche AG as MabThera outside the United States, Japan and Canada. Roche sponsored the French study.



Anti-smoking drug Chantix works for alcohol too
Biotech | 2007/07/10 05:57

The drug varenicline is already on the market under the brand name Chantix to help smokers kick the habit but new preliminary research now suggests it could also be useful in helping heavy drinkers quit.

The research which was carried out on rats provided the rodents with intermittent access to 40 proof alcohol for four months and by varying the access to the liquor supply the rats were made to crave it.

The researchers say every time the rodents had access to booze, they upped their intake and drank all day and withdrawing the alcohol made them want to drink even more.

After months of this behaviour and a total of 37 binge-drinking sessions, all the rats cut their drinking in half when given varenicline.

When taken off the drug, the rats did not immediately imbibe more, a rebound effect that has affected other treatments.

Varenicline has been available as a smoking cessation aid for nearly a year in the U.S. and the European Union, and as well as being safe it does not suppress the appetite and is not metabolized in the liver.

Bartlett says this is a major plus because long term drinkers often have liver damage.

According to the researchers the drug targets a pleasure center in the brain and has the potential to be considered as a treatment for addictions such as gambling and painkillers.

Varenicline works by latching onto the same receptors in the brain that nicotine binds to when inhaled in cigarette smoke, an action that leads to the release of dopamine in the brain's pleasure centers; the drug blocks any inhaled nicotine from reinforcing that effect.

The new study suggests alcohol also acts on the same locations in the brain and varenicline, might be equally as effective for curbing drinking.

Selena Bartlett, a University of California neuroscientist who led the study says the drug has already proven itself safe for people trying to stop smoking and is now a potential drug to fight alcohol dependence.

Experts say smoking and drinking often go together and a single drug able to tackle both addictions is not surprising.

The researchers at the University of California along with the National Institute on Alcohol Abuse and Alcoholism, plan to conduct clinical trials in humans of the drug's effectiveness in curbing alcohol cravings and dependence.

The drug is already approved by Food and Drug Administration and this should speed the process up.

But skeptics warn that varenicline does not work for all smokers and it's highly unlikely it will work for all drinkers and some experts insist there is a common biological basis for addictions to both alcohol and tobacco.

Although drug company Pfizer provided the drug for the study it was not involved in the research and is apparently undecided whether to seek broader FDA approval for the drug.



Bush heads for showdown on stem cells
Biotech | 2007/04/11 17:10

The White House has threatened to veto a new bid to lift US President George W Bush's restrictions on federal funding of stem cell research as the Senate began considering the bipartisan bill. While the Democratic-led Senate seemed certain to pass the legislation as early as Wednesday, it was unclear if backers would have the needed two-thirds majority to override a veto. The bill, a 2006 Democratic campaign promise, would expand federal funding of human embryonic stem cell research, lifting restrictions Bush imposed in 2001.

In the first and only veto of his presidency, Bush rejected a similar measure last year.

The debate is emotionally charged. Advocates call stem cell research the best hope for potential cures for ailments like Alzheimer's disease, diabetes and spinal cord injuries. But the testing requires destruction of days-old embryos, and opponents say it is immoral.

"The administration strongly opposes Senate passage of (the bill), which would use federal taxpayer dollars to support and encourage the destruction of human life for research," the White House said in a statement threatening a veto.

Iowa Democratic Senator Tom Harkin, a chief sponsor of the bill, countered: "It's time we provide hope to millions and expand stem cell research."

Democrats won control of the US Congress from Bush's Republicans in November promising to expand federal funding of stem cell research, which is now restricted by Bush to batches available as of August 2001.

White House spokeswoman Dana Perino said Bush stood firm.

"The president weighed this issue very carefully back in 2001 and has thought about it since. And he believes that clear moral line that he established back in August of 2001 is a good place for the country to be," Perino said.

Stem cells are a kind of master cell for the body, capable of growing into various tissue and cell types. Those taken from embryos are especially malleable. Scientists hope to use the cells to repair tissue damaged by disease or injury.

In the 100-member Senate, backers and foes debated the measure as they counted votes and tried to determine if supporters could get the two-thirds majority needed in both the House and the Senate to override a Bush veto.

"It's going to be very close," Harkin said.

Earlier this year, the House passed a similar stem cell bill on a vote of 253-174 - about three dozen votes short of a two-thirds majority.

Another bill being considered would not lift Bush's restrictions and critics said it was inadequate. But with the backing of the White House, the Senate seemed certain to pass it this week.

That measure would encourage stem cell research using embryos that have naturally lost the ability to develop into fetuses. It would also support the creation of a bank of stem cells taken from amniotic fluid and placentas - two recently discovered potential sources.

"We are offering an opportunity to move the ball forward," Republican Senator Norm Coleman of Minnesota said.



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