First Genetically Altered Drug from Goats Approved by FDA

Drug from genetically altered goats approved by U.S. regulator

The U.S. Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.

GTC Biotherapeutics said regulators cleared its drug ATryn, which is made using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.

The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists.

Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be sold in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals.

About one in 5,000 people don't produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death.

Clots threaten placenta

Pregnant women with the disorder are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.

Patients with hereditary antithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval.

ATryn is only approved for use when patients are getting surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.

To make the drug, scientists at GTC put DNA for the human antithrombin protein into single-cell embryos of goats.

Goat embryos with the gene were then inserted into the wombs of surrogate mothers, who gave birth to baby goats that produce the protein-charged milk.

Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic.

Amid growing questions about the technology, the FDA last month issued guidelines for how it will regulate products made from genetically altered animals.

FDA said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The agency's panel of blood product experts recently concluded ATryn was safe and effective.

But consumer groups said the FDA's long-awaited policy will not require all genetically engineered foods to be labelled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment — particularly if some escape and begin to mate with animals in nature.

The drug received European approval in 2006.

Shares of GTC Therapeutics rose five cents, or 5.5 per cent, to 87 cents in midday trading.

Source: CBC.ca

Peanut Snack Bar Recall

Peanut snack bar added to Canadian recall over salmonell

Canadians should not eat a brand of chocolate-dipped honey peanut bar, the latest salmonella-linked product that's part of a growing recall of peanut products in the United States.

The Canadian Food Inspection Agency said it has expanded a voluntary recall to include another snack food made in the U.S.

Isagenix's Chocolate Dipped Honey Peanut IsaLean Bar in 2.29 oz or 65 gram size contains peanut butter or peanut paste recalled in the U.S. by Peanut Corporation of America, CFIA said.

The bars may have been distributed nationally, the agency said.

No reported illnesses are associated with consumption of the bars.

Investigators in the U.S. have traced the outbreak of Salmonella typhimurium to a peanut processing plant in Blakely, Ga.

More than 400 kinds of cakes, cookies, ice cream, other snack foods, Asian-style sauces and dog biscuits have been recalled in the outbreak.

Company 'devastated'

More than 500 people in the U.S. have fallen ill in the outbreak, which may have contributed to eight deaths.

On Wednesday, the Peanut Corp. expanded its recall to all peanut products produced at the Georgia plant since Jan. 1, 2007, as a precaution.

"We have been devastated by this, and we have been working around the clock with the FDA to ensure any potentially unsafe products are removed from the market immediately," Peanut Corp. of America president Stewart Parnel said in a statement late Wednesday.

Company officials are co-operating with state and federal officials, he added.

'One of the largest recalls we've had'

There have been calls for a criminal investigation into the company, but the U.S. Food and Drug Administration has said that is premature and the agency's investigation continues.

"We feel very confident that it's one of the largest recalls we've had," said Stephen Sundlof, head of the FDA's food safety centre. "We're still in the process of identifying products, but it certainly is among the largest."

The expanded recall includes contamination with salmonella strains not associated with the current outbreak, Sundlof told a telephone briefing with reporters.

"The additional salmonella strains discovered at this plant underscore that this plant was shipping adulterated product, but as for now we are not aware of any illnesses connected to any other salmonella strains shown at this facility," Michael Rogers, head of FDA's field investigations, told reporters.

FDA inspection reports showed problems including live cockroaches, mould and signs of a leaking roof at the Georgia plant.

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Source: CBC.ca

Beware FDA Changes to Guidelines

Change in FDA's ethical guidelines for clinical trials troubling: Lancet

The Lancet medical journal is reporting that the United States Food and Drug Administration is abandoning the Declaration of Helsinki as an ethical foundation for international clinical trials.

The declaration was drafted in 1964 by the World Medical Association to provide binding ethical standards for medical research involving humans.

Many basic patients' rights are enshrined in the declaration. Sections of it also govern business and environmental practices of the researchers.

The FDA is instead adopting the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP), which allows less stringent ethical standards for overseas research.

In a commentary published in the Jan. 3 issue of the Lancet, medical research experts Jonathan Kimmelman of McGill University, Charles Weijer of the University of Western Ontario and Eric Meslin of the University of Indiana call the move "troubling."

The authors urge the incoming U.S. administration of president-elect Barack Obama to stick to the original declaration pending a review of the implications for American research overseas should the new guidelines be adopted.

"The FDA regulates the largest drug market in the world, and we worry that its replacement of the Declaration of Helsinki with a less morally authoritative document may cause others to follow suit, thereby undermining international ethical standards for research," they write.

In October 2008, the FDA formally stopped requiring that foreign clinical studies supporting applications for drug licensing comply with the declaration.

The authors point out several important requirements that the declaration contains but the GCP lacks, including:

* Investigators must disclose funding, sponsors and other potential conflicts of interest to both research ethics committees and study participants.
* Study design must be disclosed publicly (e.g., in clinical trial registries).
* Research, notably that in developing countries, must benefit and be responsive to health needs of populations in which it is done.

Source:CBC.ca

Mommy's Bliss Cream Recall

Mommy's Bliss Nipple Cream. Mommy's Bliss Nipple Cream is promoted as an all-natural product to help soothe and heal dry or cracked nipples. The U.S. Food and Drug Administration has warned that the product contains the preservatives chlorphenesin and phenoxyethanol, which could cause serious side-effects, including difficulty breathing and dehydration, if ingested by nursing infants.
Source: Health Canada

Gardasil Marketing Machine Silenced by FDA

FDA bars Merck from marketing cervical cancer vaccine to women age 27-45

Drug maker Merck & Co. said Wednesday that the U.S. Food and Drug Administration has rejected expanding the use of the cervical cancer vaccine Gardasil to include women ages 27 to 45.

The federal agency cited "issues that preclude approval" within the expected time frame for a review, Merck said.

Gardasil was approved in 2006 for girls and women between nine and 26 years old to prevent cervical cancer caused by the human papillomavirus, or HPV. The agency's current action does not affect this population's use.

The FDA decision bars Merck from marketing Gardasil to women ages 27-45, but does not prevent those women from getting the vaccine from their doctors.

Merck said that the agency identified several issues related to the application in a "complete response" letter, including stating that the data submitted does not support extending Gardasil's use to include non-vaccine HPV types.

Merck also reaffirmed its goal of attaining compound annual growth in its businesses of between four per cent and six per cent from 2005 through 2010.

Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market. It is outselling another vaccine, Cervarix, from GlaxoSmithKline PLC, in worldwide sales, analysts said, garnering over $1 billion in sales since its June 2006 U.S. launch.

"This is clearly not what Merck wanted. It reflects the painstakingly slow process that the FDA has in approving anything," WBB Securities analyst Steve Brozak said. "I think this is one where they would rather err on the side of getting another 23 pounds of documents."

New Jersey-based Merck said it has already had discussions with the FDA and plans to respond next month.

In afternoon trading Wednesday, its stock was down eight cents, or 0.2 per cent, to $36.95 US in New York.

Gardasil is approved in Canada for use in women aged nine to 26.

Source: CBC.ca

Dental Fillings Pose Risk - FDA

Mercury fillings pose health risks, FDA warns

Mercury in dental amalgams may pose health risks to children, fetuses and pregnant women, the U.S. Food and Drug Administration is warning.

The FDA issued a statement, on its website Wednesday, about the potential dangers of dental amalgams.

As part of a legal settlement reached Monday, the federal agency has agreed to release a new ruling on the safety of dental amalgams in July 2009, and alert consumers about potential related hazards. Consumer advocacy groups, including Moms Against Mercury, called for a ban on the fillings in the U.S.

"Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," the FDA said.

"When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapour. Mercury vapour is also released during chewing."

The FDA says consumers should not have amalgam fillings removed.

Health Canada says that while amalgam has been shown to release mercury in the body, the levels are not serious enough to cause adverse health effects.

The federal agency says current data does not support hypotheses linking mercury exposure with Alzheimer's disease, amyotrophic lateral sclerosis, multiple sclerosis and Parkinson's disease.

But the federal agency notes patients with kidney disease and pregnant women should avoid dental amalgams given that mercury has been shown to cross the placental barrier and weaken kidney function at sub-clinical levels of exposure.

Sweden and Norway have banned the use of dental amalgams, citing health concerns.

Source: CBC.ca

Ban Demand: 8 Dyes Linked Problematic Child Behaviour

Consumer group calls on FDA to outlaw food dyes

A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colourings in food because the additives may cause hyperactivity and behaviour problems in some children.

Controlled studies conducted over three decades have shown that children's behaviour can be worsened by some artificial dyes, says the Center for Science in the Public Interest. The group noted the British government is successfully pressuring food manufacturers to switch to safer colourings.

Over the years, the FDA has consistently disputed the centre's assertion. The agency's website contains a 2004 brochure that asks the question: "Do additives cause childhood hyperactivity?"

"No. Although this hypothesis was popularized in the 1970s, well-controlled studies conducted since then have produced no evidence that food additives cause hyperactivity or learning disabilities in children," the agency said.

Julie Zawisza, an FDA spokeswoman, said Tuesday that color additives undergo safety reviews before approval for marketing and that samples of each artificial colouring are tested. She said the agency reviewed one of the studies the centre cites in calling for a ban.

"[We] didn't find a reason to change our conclusions that the ingredients are safe for the general population," Zawisza said. "Also note that the European Food Safety Agency has a similar view as FDA's."

Dyes are used in countless foods and sometimes used to simulate the colour of fruits or vegetables. The additives are particularly prevalent in the cereals, candies, sodas and snack foods pitched to kids.

"The purpose of these chemicals is often to mask the absence of real food, to increase the appeal of a low-nutrition product to children, or both," said Michael F. Jacobson, the centre's executive director.

"Who can tell the parents of kids with behavioural problems that this is truly worth the risk?"

The centre's petition asks the FDA to require a warning label on foods with artificial dyes while it mulls the group's request to ban the dyes outright.

The colourings the centre seeks to ban are:

• Yellow 5
• Red 40
• Blue 1
• Blue 2
• Green 3
• Orange B
• Red 3
• Yellow 6
  

Source: CBC.ca

Potential Psych Warning On Flu Drugs - FDA

FDA mulls psych warning for 2 flu drugs

U.S. Food and Drug Administration staff have recommended new warnings about psychiatric side effects seen in some patients taking Tamiflu and Relenza, according to documents released Friday.

An FDA advisory panel will review the recommendations for the anti-viral influenza drugs at a meeting next week.

It based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

In the case of Tamiflu, "the number of cases continues to increase," FDA staff wrote, in one of several documents posted ahead of the meeting.

The panel meeting will be the third public meeting on the safety of Roche Holding AG's Tamiflu, originally prompted by reports two years ago of a dozen deaths of children in Japan who had been taking the drug.

Experts then found no evidence of a direct connection between the drug and the deaths, although the FDA did ultimately update Tamiflu's label to add a caution urging close monitoring of patients for abnormal behaviour such as delirium or self-injury.

In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened further to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

Consumer group Public Citizen chided the agency for failing to note the reported adverse events earlier on the label.

"What is the justification for not warning people for these adverse events that have clearly occurred?" said Dr. Sidney Wolfe, head of Public Citizen's health research arm.

"Japan has said, 'stop using the drug if these things occur.' In [the U.S.], we haven't even mentioned that deaths have occurred."

Hallucinations, delirum seen in Relenza patients

In March, Japan warned against prescribing Tamiflu to young people aged 10 to 19 as more than 100 individuals, mostly young, showed signs of abnormal behaviour after taking the drug.

Earlier this year, Japan broadened its probe of Tamiflu to look at amantadine and GlaxoSmithKline Plc's Relenza.

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behaviour" observed in some patients taking the drug.

The current Relenza label has no label warning related to psychiatric events.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

It will present the advice to the advisory panel of experts meeting on Tuesday. The agency typically takes the advice of these panels but is not bound by them.
Source: CBC.ca