Vanda Pharmaceuticals suspends development, cuts staff

Washington Business Journal - by Tierney Plumb Staff Reporter

Pesticide, fertilisers linked to decline of amphibians: study

1 day ago

PARIS (AFP) — A pesticide compound commonly used in the United States is linked to the growth of tiny parasites that sicken and kill frogs and also harms the amphibians' immune defences against infection, according to a study published Thursday.

The impact of this chemical is boosted in the wild by phosphate fertilisers, the investigators believe.

Runoff from fertilisers into ponds encourages the proliferation of snails that are a natural host to the flatworm parasites, they say.

The flatworms, called trematodes, are notorious for causing limb malformations, kidney damage and sometimes death in several species of frog.

The new study points the finger at atrazine, an active ingredient in several herbicide products manufactured by a Swiss-based company, Syngenta.

Atrazine was banned in the European Union in 2004 after the chemical showed up in drinking water, but has over the last 15 years become a leading farm chemical in the United States, especially in corn-growing regions.

In a field survey led by Jason Rohr of the University of South Florida, scientists measured more than 240 variables in 18 Minnesota wetlands that could account for the rate at which frogs are infected by trematodes.

The strongest link by far was with atrazine concentrations, which accounted for more than 50 percent of the likelihood that the amphibians would become diseased.

When the presence of atrazine was combined with traces of phosphate fertilizer -- runoff from nearby agricultural plots -- the rate of diseased frogs went up to 75 percent.

Seeking to find out more, the researchers raised tadpoles for four weeks in several 290-gallon (1,100-litre) tanks containing snails, leaves and insect larvae, to approximate a natural environment.

In tanks where atrazine was added in concentrations found in wetlands, four times as many snails grew compared with the population that was in water free of the herbicide. The population of the parasitic flatworms exploded too.

Green frogs used in the experiment showed significantly higher levels of trematode infection, while pickerel frogs experienced high rates of mortality.

"The wetlands survey was highly suggestive that atrazine was causing the increase in larval trematode load," Rohr told AFP by phone.

"The follow-up experiment really demonstrated that it was indeed a causal link."

He cautioned, though, that these findings did not by themselves explain a massive slump in American frog populations, a fall that began in the mid-1990s and is mirrored by shrinking populations of amphibians elsewhere in the world.

Global warming, inflicting a loss of wetland habitat, has been blamed as one of the causes.

Syngenta, asked to reply by AFP, said in a statement: "50 years of use and a vast amount of research has shown that (atrazine) can be used safely with no long-term detriment to ecosystems."

The concentrations of the chemical in wetlands reported in the Rohr study were well below the "level of concern" thresholds established by the US Environmental Protection Agency (EPA), it noted.

Rohr added that there could be other chemicals in addition to atrazine and fertilizers that affected disease risk.

"Many chemicals can be immuno-suppressive, and standard toxicity tests used to register chemicals in the United States and Europe are conducted on isolated individuals, ignoring interactions with other species, such as their parasites.

"Thus, our findings are likely the tip of the iceberg for pollution-induced disease emergence in both humans and wildlife."

The study was published on Thursday in the London-based journal Nature.

Rohr said that a senior biologist from the EPA, Thomas Steeger, had requested a copy of the study.

In its latest evaluation of atrazine, the EPA concluded in 2006 that the product posed no threat to human health.

Report: FDA officials opposed drug suit policy

By KEVIN FREKING – 1 day ago

WASHINGTON (AP) — Top scientists and career employees at the Food and Drug Administration opposed agency regulations that weaken consumers' ability to sue drug makers, congressional investigators said Wednesday.

At issue is language in a drug labeling rule from 2006 that effectively limits when people can sue in state court over injury claims involving medications. The FDA contends federal regulations prevail when there is a conflict with state law. This concept is called pre-emption.

Internal agency documents showed that career officials opposed this approach, according to a report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee. In the past, the agency had viewed private suits as an additional layer of protection against unsafe drugs, the report said.

"Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis," the report quoted Dr. John Jenkins, who oversees FDA's new drug reviews, as saying. "We know that such an assumption is false."

Patients injured by drugs have won suits against drug manufacturers for failing to warn against certain dangers.

In a case to be argued before the Supreme Court on Monday, a Vermont woman sued Wyeth after she lost her right arm below the elbow following a high-volume injection of the drug Phenergan. The injection accidentally punctured an artery, prompting gangrene to set in. Levine argued that the company had a duty to warn consumers that such injections could have devastating consequences. The state courts agreed, awarding her nearly $7 million.

Wyeth appealed, saying it was protected from such suits. It argued a state court cannot overrule the FDA's judgment on label warnings.

FDA scientists had weighed the risks and benefits of Phenergan, used to treat nausea and allergies, when it approved the prescribing literature, or label, as a guide for doctors. The FDA was aware of risks associated with injecting some forms of Phenergan, but the label did not specifically warn about the technique used with Levine.

The FDA said in its 2006 rule and in a 2008 rule that state suits could encourage drug makers to propose unnecessary labeling. Such labeling could result in scientifically unsubstantiated warnings and less use of beneficial treatments.

Waxman's staff obtained documents rejecting that warning. Jane Axelrad, an associate director for policy at the agency, wrote: "We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary," she said. "To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information."

The report said the FDA has yet to provide a complete set of documents that would show communications between the White House and the agency, but some documents suggested the agency and the White House would not go forward with a rule on labeling until the pre-emption changes were included.

• House Oversight and Government Reform Committee: http://oversight.house.gov

(New throughout)

WASHINGTON, Oct 29 (Reuters) - Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) used a misleading brochure to tout its kidney disease drug Sensipar to patients, U.S. health officials said in a letter released on Wednesday.

"This piece is false or misleading because it omits and minimizes the risks associated with the use of Sensipar and broadens the indication," the Food and Drug Administration said in a letter to Amgen.

The agency asked Amgen to immediately stop using the brochure.

The approved uses of Sensipar include treatment of secondary hyperparathryoidism, or excessive production of the parathyroid hormone, in patients undergoing dialysis for chronic kidney disease.

Amgen said it is working closely with the FDA to address their concerns about the Sensipar patient education brochure.

"We immediately ceased distribution of the brochure. Amgen is committed to responsible marketing that reflects the benefits and risks of our medicines," the company said in a statement.

The FDA letter was posted on the agency's Website here

(Reporting by Lisa Richwine and Deena Beasley; Editing by Bernard Orr)

(Recasts, adds company and congressional comment, updates shares to close)

By Susan Heavey

WASHINGTON, Oct 28 (Reuters) - Two over-the-counter Bayer AG (BAYG.DE: Quote, Profile, Research, Stock Buzz) aspirin products that contain dietary supplements have not been proven to work and are being sold illegally, U.S. health regulators warned on Tuesday.

Claims made about the products, Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium, also mislead consumers, the U.S. Food and Drug Administration said.

"These are not FDA-approved products," agency spokeswoman Rita Chappelle said. "They are selling products that are illegal."

The FDA stopped short of calling for the pain relievers to be removed from store shelves but urged the company to take "prompt action" or else face legal action.

But Bayer defended the medications and its right to market them.

"We stand behind both products and all marketing claims made in their support," the German drugmaker said in a statement.

The company added that its advertisements tell buyers to check with their doctors before taking the combination aspirins. Bayer Aspirin with Heart Advantage also tells consumers the drug does not replace cholesterol-lowering medication.

Bayer Aspirin with Heart Advantage contains plant sterols and claims on its packaging to help control cholesterol, while Bayer Women's Low Dose Aspirin + Calcium claims to help strengthen bones and prevent osteoporosis.

"These statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used," the FDA wrote in an Oct. 27 warning letter to the company released on Tuesday.

FDA officials gave Bayer 15 days to respond to the warning. To comply, the drugmaker could stop selling the products or conduct clinical trials and seek FDA approval.

If the company does not take proper action, the FDA could seize the product, seek an injunction or take other legal steps. Bayer said it was reviewing the agency's letter.

The drugmaker's marketing of its Heart Advantage aspirin is also the subject of a congressional investigation.

Earlier this month, the U.S. House of Representatives Energy and Commerce Committee began probing whether Bayer misled the public by marketing the combination product directly to consumers. "Our investigation will continue," committee Chairman John Dingell, a Michigan Democrat, said.

In its letter, the FDA confirmed Bayer's actions violated the agency's policies.

Unlike drugs, supplements such as vitamins and herbs do not have to be proven safe and effective before they can be sold in the United States. But adding them to already-approved drugs makes them entirely new products that must be subject to FDA review before being sold, the agency said.

At the same time, the FDA has approved a variety of health claims for certain foods and supplements that manufacturers can include on their product packaging, such as the impact of plant sterols in reducing heart disease.

Bayer earlier told the agency it was within its rights to market its Bayer Heart Advantage, the FDA said citing a separate Aug. 18 letter from the company.

In it, the drugmaker said the FDA and the U.S. Federal Trade Commission support public education about aspirin's heart benefits, "and that a ban on cardiovascular claims in consumer labeling for Bayer Heart Advantage would violate Bayer's rights under the First Amendment," according to the FDA.

But the agency rebuked that argument, saying the U.S. Constitution does not protect speech that is false, misleading or concerns illegal activity.

It is the agency's duty to scrutinize new products because otherwise consumers could waste money and "more importantly, rely to their detriment on a drug product which did not go through the requisite regulatory review, and could prove harmful," it said.

The American Herbal Products Association, which represents supplement manufacturers, has been seeking FDA guidance on the marketing of combination drug-supplement products, but criticized the agency's action.

"FDA could have developed a streamlined science-based policy to control the introduction of health promoting products, rather than forbid all combination products," the group's president, Michael McGuffin, said.

After the FDA warning, Bayer shares trimmed gains to close up about 1 percent on the German exchange. (Editing by Dave Zimmerman and Andre Grenon)

Posted: Oct. 27, 2008

The Wisconsin Medical Society's board has come out against doctors accepting gifts, speaking fees and other payments from pharmaceutical and medical device companies.

The new policy ranges from the ubiquitous pens and pads found throughout doctors' offices to the controversial practice of paying doctors to give talks about a company's products.

It also includes the free lunches and other food that pharmaceutical sales representatives bring for doctors and their staffs on sales calls.

The Wisconsin Medical Society's policy goes beyond the guidelines of the American Medical Society and most state medical societies.

"We have chosen to take a firm stand," said Steven Bergin, president of the Wisconsin Medical Society. "This makes a statement."

The Wisconsin Medical Society has about 12,000 members, or roughly two-thirds of the state's doctors.

Pharmaceutical and medical device companies spend an estimated $19 billion a year on gifts, grants and other payments to doctors. The policy comes at a time when the ties between the companies and the doctors who prescribe or use their products is drawing increased scrutiny and criticism.

Several states have passed laws that limit gifts and other payments or that require pharmaceutical companies to disclose them. Minnesota, for example, bars pharmaceutical companies from giving doctors food or other gifts worth more than $50 a year.

U.S. Sens. Herb Kohl (D-Wis.) and Chuck Grassley (R-Iowa) also have introduced a bill that would require companies to report gifts and payments and establish a national online database disclosing the information for each doctor.

Arthur Derse, a professor of bioethics and emergency medicine at the Medical College of Wisconsin, described the Wisconsin Medical Society's new policy as courageous. "They are out in front of the majority of their members on this," Derse said.

A survey published in the New England Journal of Medicine last year found that 83% of doctors received food and beverages from pharmaceutical sales representatives.

Some health care systems already have policies prohibiting their employed physicians from accepting gifts from pharmaceutical and medical device companies.

Studies have shown that the practice of giving doctors pens, coffee mugs and other small gifts makes doctors more likely to prescribe certain drugs. "They don't know they are being influenced," Derse said, "and the drug companies know they are."

Studies also have shown that accepting even a small gift creates an obligation to return the favor.

"There is an obligation - either conscious or unconscious - to return that gift," said Michael Oldani, a former drug representative and now a medical anthropologist and assistant professor at the University of Wisconsin-Whitewater. "The entire informal economics of the pharmaceutical industry is based on gift exchange."

The Pharmaceutical Research and Manufacturers of America, or PhRMA, said in a statement that it does not believe small items and modest meals influence doctors, and that the Wisconsin Medical Society's new policy is not needed given the trade group's new voluntary guidelines that prohibit the giving of non-educational items.

PhRMA's new guidelines also reaffirm that interactions between company representatives and health care professionals should be focused on providing scientific and educational information and supporting medical research and education.

But pharmaceutical and medical device companies have ties to doctors that go beyond lunches for the staff and small items.

Many companies pay doctors to give talks about their products to other doctors, typically after an expensive meal in a fine restaurant.

The Medical Society of Wisconsin's policy states that doctors should not participate in speaking bureaus for pharmaceutical companies.It also recommends that:

•  Doctors not accept payments from pharmaceutical and medical device companies for participating in online courses for continuing medical education.

• Drug samples should be limited and, when possible, should be replaced by a system of vouchers.

•  Doctors who have a commercial relationship with pharmaceutical companies should not serve on formulary committees that recommend which drugs doctors should use.

Doctors can still consult and do research for pharmaceutical companies under the policy.

Thousands of cancer patients could be denied a new drug

A cancer drug which could prolong the lives of thousands of patients, has been ruled not cost effective by the NHS drugs watchdog.

The drug lenalidomide, marketed as Revlimid, can extend the lives of patients with an aggressive cancer of the bone marrow by up to three years.

But draft guidance from the National Institute of Health and Clinical Excellence has said it is not cost effective and the estimate of three years of extra life was disputed.

It costs £36,000 per patient per year and breaches the cost effectiveness threshold used by Nice more than twice over.

Myeloma is an incurable bone marrow cancer that cuts the production of red and white blood cells. An estimated 20,000 people in the UK have the disease and each year around 3,800 new cases are diagnosed. The cancer has a high mortality rate, claiming more than 2,400 lives a year.

Charities are now calling for the drug companies and the Department of Health to broker a deal so the Revlimid can be used on the NHS.

A so-called risk sharing scheme is already in place for another multiple myeloma drug, Velcade, where the NHS only pays for the treatment in patients who can be shown to respond and where it does not work the treatment stopped and the cost refunded by the manufacturer.

Revlimid maker, Celgene could agree to a sliding discount which increases the longer a patient survives, offer of one or two free courses of treatment or a price cut.

Professor Gareth Morgan, consultant haematologist at the Royal Marsden Hospital in London and Surrey and president of Myeloma UK, said: "This decision will have a devastating impact on patients with multiple myeloma as it could result in patients being denied additional years of life.

"Revlimid offers new hope for cancer patients as it represents a major step forward in turning the blood cancer, multiple myeloma, into a chronic and manageable disease rather than the death sentence it has been until now."

Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: "The independent advisory committee did not accept the manufacturer's claim that lenalidomide is cost effective because it felt that they had over estimated the extension to life expectancy gained with lenalidomide treatment.

"If these treatments were provided on the NHS other patients would lose out on treatments that are both clinically and cost effective. The Institute will consider any pricing scheme proposed by the manufacturer once they have been reviewed and considered suitable for the NHS, by the Department of Health."

Wyeth has high commercial hopes for Prevnar-13, which is designed to protect against six more disease-causing types of the bacteria streptococcus pneumoniae than does Prevnar. Streptococcus causes pneumococcal disease, which can lead to ear infections, pneumonia and meningitis.

Vaccines been a bright spot for the Madison, N.J., company, which also makes small-molecule drugs and biologics. Its pharmaceuticals division has faced generic competition to a significant heartburn drug, Protonix, and delays on new drug approvals.

In contrast, Wyeth reported last week that Prevnar grew 13% in world-wide sales in the third quarter and it has generated revenue of more than $2 billion year to date. It is the only pneumococcal vaccine currently approved for use in young children world-wide.

The data on Prevnar-13 come from findings from four European studies, including a 604-infant trial conducted in Germany, which will be part of the package to be submitted to the U.S. Food and Drug Administration when the company files for approval of the vaccine in the 2009 first quarter.

The results appear to show that the amount of working antibodies produced by Prevnar-13 is comparable to the strength of response with Prevnar. Safety and tolerability aren't significantly different between the two, according to the new data. In addition, the vaccine doesn't appear to react negatively with other common immunizations that children receive in the countries studied.

The current version of Prevnar has decreased the incidence of invasive pneumococcal disease in children 5 and under by nearly 80% in the U.S. as of 2006, according to the Centers for Disease Control. The company expects Prevnar-13 to increase prevention to 92% in the U.S. and Canada.

The new vaccine, which involves a more complex manufacturing process than the original Prevnar, appears to protect against several types of the bacteria that are particularly common in developing countries, markets where Wyeth hopes to expand. In addition, Wyeth expects to seek approval to treat older adults, who are also at increased risk of developing invasive pneumoccocal disease.

Of the additional types of the bacteria that Prevnar-13 protects against, one called 19A is the most important, according to Emilio Emini, head of Wyeth vaccine research and development, because it is responsible for the most severe form of pneumoccocal disease. In addition, about half of this type in the U.S. is antibiotic-resistant, making it hard to treat.

The company is looking at whether kids who have already been inoculated with Prevnar should get reimmunized with the new version once it becomes available, and has already begun discussions with the CDC's Advisory Committee on Immunization Practices, which writes vaccine administration guidelines, says Jim Connolly, head of Wyeth's vaccine business unit. Millions of children have been immunized with Prevnar since it was approved in 2000 by the FDA.

"Prevnar-13 is critical for us," says Mr. Connolly. "It expands coverage to address some of the remaining unmet need from the pediatric perspective."

Originally submitted at Oneida

Set includes: Baby Fork, Baby Spoon, Feeder Spoon, Child Knife, Child Fork and Child Spoon

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(legalese)

• OCTOBER 24, 2008

Drug Industry Adapts to Democrats' Mounting Clout

By T.W. FARNAM, ALICIA MUNDY and BRAD HAYNES

The ad campaign thanks the legislators for supporting a children's health-care bill vetoed twice by President George W. Bush in 2007, but the bill carried few financial implications for the industry. The group running the campaign says it singled out the lawmakers for praise because they were under pressure to switch their votes. Some of them could also play key roles in shaping bills that pose serious hazards for drug makers.

The warm and fuzzy ads were produced by the nonprofit America's Agenda: Health Care for Kids. The group was started last month and says Pharmaceutical Research and Manufacturers of America, the main drug-industry trade group, is its sole funder.

PhRMA has also been collaborating with other one-time foes. For about two years, it has been working with unions through another America's Agenda group to push universal-health-care bills in states and cities across the country. And after years of donating overwhelmingly to Republicans, the pharmaceutical industry is now splitting campaign contributions between the political parties.

"They've been very supportive of everything we've been trying to do in every state," said Doug Dority, the president of both America's Agenda groups. "They've been involved certainly as much as all of the unions have and it's very encouraging to see."

Five of the Democratic senators lauded by the ads aren't up for re-election this year. Over images of smiling children, the narrator tells constituents to call their lawmakers and "tell them to keep fighting to insure our kids."

Many of the 28 lawmakers support efforts opposed by the drug industry. All of the Democrats mentioned want the government to negotiate a lower price for prescriptions through the Medicare program, and the lawmakers largely support the importation of less-expensive drugs.

Some are in critical positions to influence legislation. Sens. Susan Collins (R., Maine) and Byron Dorgan (D., N.D.) co-sponsored a bill to reimport Canadian drugs. Sen. Max Baucus (D., Mont.) is chairman of the Finance Committee, which would consider proposals for Medicare price negotiations.

Mr. Dority, the former president of the United Food and Commercial Workers union, said he first met with PhRMA representatives about two years ago, shortly before the 2006 midterm elections, when Democrats recaptured control of Congress. This summer he started a campaign to push for expansion of the State Children's Health Insurance Program, commonly known as SCHIP, which many thought would come up for another vote again this fall. PhRMA answered his call for donations.

"I think they realize that the only way to have any serious respect by the vast population of people is to start working toward solving the health-care problems," Mr. Dority said.

PhRMA's president, former Rep. Billy Tauzin of Louisiana, has been trying to restore the drug industry's tarnished image. His efforts include a TV ad campaign touting programs to help needy patients pay for their medicines; hurricane hotlines for drug supplies; and the syndicated TV show "Sharing Miracles," in which survivors of chronic diseases tell their stories to Mr. Tauzin, a cancer patient himself.

PhRMA officials say the latest ads praising the legislators are part of a political strategy separate from the public-relations campaign. "The SCHIP ads are about good policy," said Ken Johnson, a senior vice president at PhRMA. "We are trying to promote programs that encourage greater access to health care."

Democratic leaders' agenda also includes limiting drug makers' direct-to-consumer advertising and strengthening consumers' right to sue drug makers for damages. One pending bill would change regulations that affect imported drugs and make the Food and Drug Administration a more powerful regulator.

"We are constantly confronted with a lot of difficult challenges," Mr. Johnson said. "Many critics, including some politicians, unfairly demagogue our industry."

The two companies that arranged the ads are run by Democratic consultant Steve McMahon, former top aide to Democratic National Committee Chairman Howard Dean, and by Republican strategist Alex Castellanos, who has worked for Bob Dole and George W. Bush. The company of Mr. McMahon, the Democrat, got about $12 million and Mr. Castellanos, the Republican, got about $1 million.

Write to Alicia Mundy at alicia.mundy@wsj.com and Brad Haynes at brad.haynes@dowjones.com

Consumer groups call on FDA to test Chilean salmon

1 day ago

WASHINGTON (AP) — Environmentalists and consumer advocates urged the government Thursday to increase testing of farm-raised salmon from Chile after authorities in Germany detected banned chemicals in Chilean fish.

"We obviously have a problem, at least according to German government data," said Urvashi Rangan, a senior scientist with Consumers Union, a nonprofit consumer advocacy group. "Some of these banned substances are potentially carcinogenic, and the only way to find out how widespread it might be is for the Food and Drug Administration to get out there and start testing."

Salmon is one of the top seafood items on American menus. Most of it is farm-raised as part of a global industry, and Chile is a leading supplier. The $2-billion-a-year Chilean industry is in crisis over an outbreak of a virus that can kill salmon but is harmless to humans.

Earlier this month, a German consumer protection agency detected antifungal and antiparasitic chemicals that are banned in Europe and the U.S. in samples of Chilean salmon. Environmentalists are also concerned about the use of antibiotics to keep penned-in fish from getting sick.

Last year, the FDA tested only 40 samples out of 114,320 tons of salmon sent from Chile, the Pew Environment Group said.

GSK to publish level of doctors’ advisory fees

By Andrew Jack

Published: October 22 2008 19:54 | Last updated: October 22 2008 19:54