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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.



Mass. gov. seeks stem cell rule reversal
Biotech | 2007/03/30 21:59

Massachusetts Governor Deval Patrick (D) said Friday he plans to reverse the restrictions placed on stem cell research by former governor and Republican presidential candidate Mitt Romney. Patrick emphasized during a meeting with the state Life Sciences Collaborative that "life sciences should be guided by science, not ideological politics."

He also announced his intention to ask the Massachusetts Public Health Council to revisit the stem cell policy it approved last August. The 2005 stem cell law, which banned embryo farming and prohibited district attorneys from charging scientists who conducted embryonic stem cell research, was vetoed by the former governor. Romney's subsequent restrictions placed additional limits on embryo research. Patrick said reversing Romney's stem cell limitations will restore the legislature's intent.



Biovail Fires Kasowitz Over Legal Controversy
Biotech | 2007/03/26 09:23
Kasowitz Benson Torres & Friedman LLP has been fired by Biovail Corp. Kasowitz is the law firm that filed its lawsuit claiming that several hedge funds worked together to bring down the drug company’s stock price, according to The AP.

The New York-based law firm is in the middle of a legal controversy over whether it willfully violated a protective order when it used information subpoenaed from New York-based Banc of America Securities in a shareholder suit in New York Federal court.

As reported, the information was used to draft Mississauga, Ontario-based drug maker's February 2006 complaint against SAC Capital Management LLC; Woodridge, N.J.-based Sigma Capital Management LLC; Scottsdale, Ariz.-based Gradient Analytics Inc.; Gerson Lehrman Group; former Banc of America Securities analyst David Maris and others.

Goldman Sachs Group Inc. downgraded Biovail from “neutral” to “buy” noting shares are up 28% since November and approaching target price, according to another Associated Press report.

Analyst Randall Stanicky reaffirmed his price target of $24, saying that while shares should see support from current levels, more meaningful gains will be linked to growth, the report stated.



Antibiotics overprescribed for sinus infections
Biotech | 2007/03/19 12:09

U.S. doctors may be over-prescribing antibiotics for sinus infections, which are often caused by viruses and not bacteria, according to a study released Monday.

A review of two national surveys of visits to doctors and recommended treatments found antibiotics prescribed for about 82 percent of acute sinus infections and nearly 70 percent of chronic sinus infections, researchers at the University of Nebraska Medical Center in Omaha said.

That "far outweighs the predicted incidence of bacterial causes. The literature repeatedly shows that viruses are by far the most frequent cause of acute rhinosinusitis," the study, published in this week's Archives of Otolaryngology-Head & Neck Surgery, said.

The infections are considered acute when symptoms persist up to a month. They become chronic when they last for three months or more.

Overuse of antibiotics, which are useless against viruses, is causing the evolution of drug-resistant bacteria that must be treated with the most expensive new antibiotics.

But many patients with sinus infections demand an antibiotic, Dr. Hadley Sharp and colleagues said. As many as one-fifth of antibiotic prescriptions for adults are written for a drug to treat sinusitis.

The high level of antibiotic use may partly come from doctors treating secondary infections, Sharp's team said.

"The vast use of these agents makes the statement that they seem to be effective ... or they would have been abandoned," the researchers wrote.

It is also possible that many sinus infections will simply clear up on their own, the researchers added.

"While keeping the goals of treatment in mind, there are concerns about the overuse of antibiotics and the resultant problems, including drug resistance and increasingly virulent bacteria," they wrote.



Ruling favors Merck in next Vioxx trial phase
Biotech | 2007/03/05 15:44

Merck & Co. won't have to defend against claims that the painkiller Vioxx caused a Wisconsin man's fatal heart attack during the second phase of a trial that begins today.

Judge Carol Higbee in Atlantic City on Monday rebuffed a request by Brian Hermans' family to let jurors consider whether Vioxx caused the accountant's death. The jury ruled on Friday that Hermans had been adequately warned of the drug's risks.

 
The jury also found that Merck, the third-largest U.S. drugmaker, didn't properly warn another man, Frederick Humeston. Humeston's attorney will present evidence in the trial's second phase that Vioxx caused his client's September 2001 heart attack. Merck faces 27,000 lawsuits over Vioxx, which was pulled from the market in 2004.

"We're pleased with the judge's decision," said Kent Jarrell, a Merck spokesman. "We are preparing for the second phase of the trial, where we believe the evidence will show Vioxx did not cause Mr. Humeston's heart attack."

Merck, based in Whitehouse Station, has won eight verdicts and lost four on the question of whether Vioxx caused patients' heart attacks. In the latest Atlantic City trial, jurors found that Merck warned Hermans of the risk by changing Vioxx's label in 2002.

The panel also concluded in both the Hermans and Humeston cases that Merck misrepresented the risks in marketing Vioxx, and that its handling of the drug violated New Jersey consumer laws, entitling the families to triple reimbursement for their expenses for Vioxx, plus payment of legal fees.



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