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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 warns of fatal risks with Cephalon pain drug
Consumer Rights | 2007/09/27 03:48
U.S. drug regulators on Wednesday issued a public health advisory warning of the potential for a deadly overdose of a pain drug for cancer patients made by Cephalon Inc. The U.S. Food and Drug Administration warning comes after Cephalon earlier this month warned doctors about several patient deaths related to inappropriate prescribing of the drug, called Fentora.

Fentora is approved to treat cancer patients whose pain is not sufficiently controlled by conventional painkillers like morphine or other powerful drugs.

The FDA said it is crucial for doctors to precisely follow prescribing instructions to avoid fatal overdoses of the drug, which should not be used for short-term management of migraines or headaches.

"FDA is monitoring this issue very closely," Steven Galson, the head of the agency's Center for Drug Evaluation and Research, said in a statement.

Doctors can prescribe drugs for uses outside their approved labeling, a practice known as "off label use." Cephalon is seeking FDA approval for use in a broader group of pain patients.

Last year, a probe by the Connecticut attorney general found that Cephalon promoted some drugs for uses for which they were not approved, a practice that is illegal.

Cephalon earlier this month detailed three deaths of patients on Fentora, which it said were due to inappropriate use of the drug.

The company on Wednesday said it is working with the FDA to finalize a new label to reflect new safety messages about the drug, which comes in pill form.

FASTER ACTING

In its letter to health professionals dated September 10, Cephalon said patient deaths were due to improper patient selection, dosing or product substitution. It also warned that Fentora should not be used as a replacement for a similar painkiller sold by Cephalon called Actiq.

Fentora delivers more medication to the blood than Actiq, and substituting the same dose for Actiq can be fatal, the FDA said.

Dr. Scott Fishman, past president of the American Academy of Pain Medicine and professor at the University of California in Davis, said a big issue is that doctors are not trained in pain management, especially with faster acting painkillers like Actiq and Fentora.

"There are a host of patients out there that need relief quickly. Doctors will feel compelled to use whatever works," Fishman said in an interview.

Fentora is made from fentanyl, which in raw form is 80 times stronger than morphine. Cephalon officials said once it is processed, the difference is much less.



Top job at US law firm for Goldsmith
Legal Careers News | 2007/09/27 02:51

The former Attorney-General, Lord Goldsmith, QC, is joining a top American law firm today to lead its European litigation practice.

Lord Goldsmith, who retired from Government in June after six years – just before be was expected to be sacked – has landed a job with Debevoise & Plimpton.

He will take on a wide range of work involving litigation, investigations, arbitration and public interna-tonal law. Within months he will qualify as a solicitor, while remaining a barrister, and become a partner within the firm. Last year its partners each made annual earnings of $1.8 million (£890,000).

The move is a big coup for the firm, which in the past four years has ranked top of the American/inter-national law firms that have bases in London. Lord Goldsmith said: “I am delighted to be joining one of the world’s leading international law firms and to be heading up Debevoise’s high-quality global litigation practice from Europe.” He said that he had received several “very tempting offers”.

It is known that top commercial chambers, as well as a number of leading British law firms, tried to lure him to join. Top of those disappointed with his choice is likely to be his old chambers at Fountain Court.

Lord Goldsmith, who will be based in London, said that the global work of Debevoise, coupled with its public service work, had enticed him to the post. His post of European chair of litigation will involve him in all aspects of global litigation, including advocacy in British courts.

Lord Goldsmith resigned in June after six years as Attorney-General, where he had a mixed record. Widely praised for his work in boosting the Crown Prosecution Service, his reputation diminished over the legal advice that he gave on the war in Iraq; and subsequently over the dropping by the Serious Fraud Office of the investigation into BAE Systems.

His refusal to stand aside from any decision – ultimately made after he had left the post – over the “cash-for-honours” investigation prompted the current inquiry into whether the post of Attorney-General should be reformed or broken up.

Lord Goldsmith, 56, said that he had to obtain official clearance for taking up the post from the committtee on business appointments, chaired by Lord Mayhew of Twisden, and that he was told that it was “entirely proper” once three months had elapsed. He declined to comment on his earnings but added that they would not “be as much as they would have been at the Bar”.

Debevoise & Plimpton was named “America’s best law firm” in the yearly rankings for 2004, 2005, 2006 and 2007, compiled by the magazine American Lawyer.



Japan's NEC says Nasdaq to suspend US shares
Securities | 2007/09/26 23:24
NEC Corp., Japan's largest personal- computer maker, will be suspended from the Nasdaq Stock Market tomorrow, pending a delisting, after failing to submit an annual report to the Securities and Exchange Commission. Holders of the American depositary receipts, which account for 2.9 percent of NEC's outstanding stock, can trade the securities over-the-counter or convert them into common shares, according to a statement from the Tokyo-based company.

A withdrawal from the Nasdaq would hurt the company's ability to attract investors in the world's biggest economy. More than 27 percent of NEC shareholders are non-Japanese.

"It's not positive for NEC as a delisting may hurt foreign investors' trust in the company," Naoki Fujiwara, who helps oversee $3.24 billion at Shinkin Asset Management Co. in Tokyo. "It will have little effect on Japanese investors though."

Shares of NEC fell 2.5 percent to 541 yen on the Tokyo Stock Exchange. The stock slid 4.9 percent this year, compared with a 4.6 percent drop in the Nikkei 225 Stock Average. The ADRs, equivalent to one share, rose 3 percent to $4.87, or 559 yen, yesterday on the Nasdaq.

"`The suspension will have little effect over our operations," said Hideyuki Nakajima, a NEC spokesman. "We've taken all possible measures to protect ADR holders and we'll keep improving our accounting practices."

NEC missed a deadline yesterday to submit a report with the required analysis of software, maintenance and service sales under U.S. accounting standards. The information is needed for the auditor to finish consolidated financial statements for the fiscal year ended March 31, 2006.



Mutual-Fund Suit Vs Citigroup Dismissed
Business | 2007/09/26 23:15

A federal judge in New York on Wednesday dismissed a lawsuit against Citigroup Inc. that alleged it didn't disclose to mutual-fund customers millions of dollars in savings allegedly pocketed by its asset-management business. In an order Wednesday, U.S. District Judge William H. Pauley III in Manhattan dismissed claims by investors in the Smith Barney family of funds against Smith Barney Fund Management LLC and Citigroup Global Markets Inc., which are part of Citigroup Asset Management. The judge gave the investors the right to replead some claims by Oct. 19.

The judge also dismissed claims against Thomas W. Jones, the former chief executive of Citigroup Asset Management, and Lewis E. Daidone, the former treasurer and chief financial officer of the Smith Barney family of funds.

"It is undisputed that defendants disclosed the amount of fees paid by the funds. Thus, plaintiffs were in possession of all material information, i.e., they knew the value of the funds," the judge said in a nine-page opinion.

The consolidated lawsuit alleged that Citigroup's asset-management business took most of the benefit of a discount from using an affiliated transfer agent for itself, pocketing more than $90 million, rather than passing on those savings to the mutual funds and their customers.

In February, another federal judge in Manhattan dismissed a similar case brought by the Securities and Exchange Commission against Jones and Daidone. Citigroup itself settled the SEC's charges in May 2005 and agreed to pay $208 million to affected mutual-fund customers. In settling, the financial-services company didn't admit or deny wrongdoing.

A lawyer for the investors and a Citigroup spokesman didn't immediately return phone calls seeking comment Wednesday.



High court to review lethal injection
Law Center | 2007/09/26 09:01
Facing near legal chaos in states that use the death penalty, the U.S. Supreme Court's decision Tuesday to review a Kentucky lethal injection case signals the justices are prepared to try to settle the issue for California and other states. The Supreme Court's brief order to review the appeal of two Kentucky death row inmates marks the first time the justices will consider the constitutionality of an execution method since 1879, when the high court upheld Utah's firing squad.

The Supreme Court will now examine whether a fatal three-drug cocktail most of the states use to execute inmates may violate the ban on cruel and unusual punishment.

Among the four key questions the justices will consider is whether states can execute an inmate if there is a "substantial risk" of pain and suffering through lethal injection.

By taking the Kentucky case, the justices are expected to provide a road map for judges across the country, including in California, where a San Jose federal judge has been reviewing the issue for more than a year.

"They decided to take the bull by the horns," said Ronald Matthias, a senior assistant attorney general in charge of California's death penalty appeals. "It is a very significant development, and we expect a very far-reaching and important decision which we'll obviously be bound by."

The Supreme Court review is likely to further delay California's effort to resume executing death row inmates.

Matthias would not speculate whether the court's intervention would halt the ongoing challenge in California by death row inmate Michael Morales, whose case has prompted Gov. Arnold Schwarzenegger to overhaul the state's lethal injection procedures.

U.S. District Judge Jeremy Fogel is scheduled to hold additional hearings on the Morales case in December and to tour a newly constructed death chamber in November. But some legal experts now expect the case may wait until the Supreme Court makes its ruling.

California has put executions on hold since early 2006 while Fogel has been reviewing Morales' lawsuit, which maintains the state's lethal injection method poses an undue risk of an inhumane execution for the more than 650 inmates on the state's death row.

John Grele, one of Morales' lawyers, said he would need to review the Kentucky case more closely to determine its effect on the California litigation.

But legal experts agreed the decision to hear the Kentucky case would have broad implications for states across the country, particularly given the scattershot results that have come from different courts asked to review the arguments of death row inmates.

In some states, executions have been put on hold, whereas other states have kept executing people despite nearly identical challenges pending in their courts.

The Supreme Court's decision to take the Kentucky case is "huge news" that should lead to a "de facto moratorium" on executions nationwide, Douglas Berman, an Ohio State University law professor and leading expert on the issue, said on his law blog. Berman does not expect a ruling until the end of the court's next term, in June.

Elisabeth Semel, head of the death penalty clinic at UC Berkeley's Boalt Hall School of Law, said the case is crucial to settling questions surrounding lethal injection but cautioned that the justices do not necessarily have to settle them all.

"The court is taking a bite of the apple," she said. "But how big a bite is not known."

"It puts Judge Fogel and other judges in the middle of this process in a position where they have to step back," she added.

A Supreme Court review of lethal injection has been brewing for years. Most states with a death penalty have turned to the method after similar legal challenges of alternatives, such as the gas chamber and the electric chair.

A federal appeals court declared California's gas chamber unconstitutional in the mid-1990s, prompting the switch to lethal injection.

In recent years, the Supreme Court has been repeatedly asked to review challenges to various states' lethal injection procedures but has steered clear of the central constitutional issue. The justices did make it easier for condemned inmates to file challenges, prompting a number of cases to unfold in states such as Missouri, Tennessee and Kentucky.

A federal judge in Tennessee recently put executions on hold there after concluding that the state's lethal injection method was too flawed. Fogel, in the California case, called this state's execution procedures "broken" but fixable.

In the Kentucky case, the state courts rejected challenges from death row inmates Ralph Baze and Clyde Bowling Jr. after a trial was held in 2005 to review Kentucky's execution method. It was the Baze and Bowling case the Supreme Court agreed Tuesday to hear.

Kentucky uses the same three drugs to put an inmate to death as California -- sodium thiopental to sedate the inmate, pancurium bromide to paralyze the muscles in breathing and potassium chloride, which stops the heart.

Lawyers for death row inmates say pancurium bromide conceals an inmate's suffering and masks the potential of the third drug, causing a searingly painful death.

One of the four issues the Supreme Court may address is whether it is unconstitutional to use those three drugs if other chemicals are available that pose "less risk of pain and suffering."

But legal experts say the court's ultimate ruling may focus more on how a state administers those drugs, rather than what drugs are used.

The Supreme Court, experts say, can instead clarify the standard for what amounts to a cruel and unusual execution and the obligations of states to administer the fatal drugs with proper safeguards.



Vonage Gets Another Black Eye
Business | 2007/09/26 09:00

For Vonage, things have gone from bad to worse. On Sept. 25, a jury found that Vonage infringed on Sprint Nextel's patents. It asked Vonage to pay $69.5 million in damages and a 5% royalty rate for future use of the patented technology. Sprint may also seek an injunction against Vonage; Vonage say it will appeal. So, what does this mean for Vonage? Basically, Vonage will need to find its way to break even faster now, as its cash has taken a major hit, and it can't afford to lose money for much longer.

Here're some back-of-the-envelope calculations. Vonage will have to pay some $69.5 billion in damages to Sprint. In addition, since spring, it's placed into escrow or issued a bond for some $90 million related to a patent-infringement case it lost to Verizon (a decision on an appeal is expected any day now). That adds up to $159.5 million. Plus, Vonage is obviously paying lots of legal fees. And Vonage is still losing money: It lost $34 million in the second quarter alone.

So, let's look at Vonage's cash. At the end of the second quarter, the company's cash and equivalents totaled $344 million, which included $66 million of restricted cash used as collateral for the Verizon bond. If we subtract from that the various royalty payments and jury awards/restructed cash, Vonage has about $184.5 million in cash and equivalents to work with.

Assuming Vonage continues to lose money at the current rate of $34 million per quarter, the company can last for a little over five more quarters.

This is a very rough estimate, of course: Vonage's expenses will rise as it starts making royalty payments to Sprint. The outcome of the Verizon case can tip the scales one way or another. Thanks to recent staff cuts, overall expenses may fall. But one thing is clear: Vonage will have less financial flexibility now, after the Sprint loss.



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