Danny... killed by ProHeart 6The Food & Drug Administration is allowing a drug known as ProHeart 6 to be placed back on the market, after reports that the drug (first introduced in 2004) has killed 400 dogs and caused adverse reactions and illness in thousands of others. Isn't it great to know that the FDA has our interests in mind? Never mind that in order to obtain this drug, veterinarians will have to register with Fort Dodge (the company responsible for the drug) and take a web-based training program. The drug will be available only through prescription (ie, it will cost a lot more money for you and make a lot more money for the vet), and you (the consumer) will have to sign a form stating that you will not hold the company liable for the death or injury of your dog should something bad happen when you dog takes the medication. Golly... where do I sign up?? This sounds like a great bargain! Let's see... buy a drug at an exhorbitant price, run the risk of killing my dog in the process, tell the company that they don't need to be responsible... all to eliminate a parasite that I can eliminate with a 25 cent dose of cattle ivermectin that I can buy at Tractor Supply... the FDA (and Fort Dodge) must think that dog owners are COMPLETE MORONS. But, then again, maybe we are... the drug, which has been on the market in Europe now for a couple of years, has a 42% market share in Italy. (sure am glad I'm not a spinone!) Oh well... another story to add to my collection of "How the government screws the people while sleeping with corporate America."
Here's some excerpts from the Wyeth Corporation website... they own Fort Dodge...
Mission, Vision and Values
Mission
We bring to the world pharmaceutical and health care products that improve lives and deliver outstanding value to our customers and shareholders.
Vision
Our vision is to lead the way to a healthier world. By carrying out this vision at every level of our organization, we will be recognized by our employees, customers and shareholders as the best pharmaceutical company in the world, resulting in value for all.
We will achieve this by being accountable for:
Leading the world in innovation through pharmaceutical, biotech and vaccine technologies
Making trust, quality, integrity and excellence hallmarks of the way we do business
Attracting, developing and motivating our people
Continually growing and improving our business
Demonstrating efficiency in how we use resources and make decisions
We bring to the world pharmaceutical and health care products that improve lives and deliver outstanding value to our customers and shareholders.
Vision
Our vision is to lead the way to a healthier world. By carrying out this vision at every level of our organization, we will be recognized by our employees, customers and shareholders as the best pharmaceutical company in the world, resulting in value for all.
We will achieve this by being accountable for:
Leading the world in innovation through pharmaceutical, biotech and vaccine technologies
Making trust, quality, integrity and excellence hallmarks of the way we do business
Attracting, developing and motivating our people
Continually growing and improving our business
Demonstrating efficiency in how we use resources and make decisions
Values
To achieve our mission and realize our vision, we must live by our Values.
QualityIntegrityRespect for PeopleLeadershipCollaboration — "Teamwork"
Quality
We are committed to excellence — in the results we achieve and in how we achieve them:
Do our jobs right every time
Focus on what's important
Raise the bar and deliver continuous process improvement
Innovate and execute flawlessly
To achieve our mission and realize our vision, we must live by our Values.
QualityIntegrityRespect for PeopleLeadershipCollaboration — "Teamwork"
Quality
We are committed to excellence — in the results we achieve and in how we achieve them:
Do our jobs right every time
Focus on what's important
Raise the bar and deliver continuous process improvement
Innovate and execute flawlessly
Integrity
We do what is right for our customers, our communities, our shareholders and ourselves:
Operate ethically
Take responsibility for our actions
Follow through on commitments
Communicate in an honest and authentic manner
Respect confidentiality
We do what is right for our customers, our communities, our shareholders and ourselves:
Operate ethically
Take responsibility for our actions
Follow through on commitments
Communicate in an honest and authentic manner
Respect confidentiality
Respect For People
We promote a diverse culture and commitment to mutually respect our employees, our customers and our communities:
Treat others with dignity and respect
Embrace and encourage new ideas
Cultivate individual talents
Celebrate achievements
Foster an environment of trust
Encourage open and honest dialogue
Embrace diversity to drive business results
Treat others with dignity and respect
Embrace and encourage new ideas
Cultivate individual talents
Celebrate achievements
Foster an environment of trust
Encourage open and honest dialogue
Embrace diversity to drive business results
Well... I must admit... they ARE following through with their commitment to "growing and improving our business."
For additional info...
Here's a copy of the text from CNN News...
FDA Allowing Heartworm Drug For Dogs Back In US
June 05, 2008: 06:01 PM EST
By Jared A. Favole
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a reformulated version of a Wyeth (WYE) heartworm drug for dogs back into the U.S., sparking a powerful U.S. senator to question the agency's decision.
Wyeth unit Fort Dodge Animal Health pulled the drug from the market in 2004 amid reports that 500 dogs died while taking it. The FDA's handling of the situation sparked congressional inquiry after an FDA safety officer said the agency tried to silence her when she raised concerns about the drug.
Sen. Chuck Grassley, R-Iowa, fired off a letter to FDA Commissioner Andrew von Eschenbach on Thursday expressing concerns about how the agency came to its decision to allow the drug, called ProHeart 6, back in the U.S.
Grassley, ranking member on the Senate Finance Committee, said the agency has had 18 meetings and 85 phone calls about ProHeart 6 since it was withdrawn, but doesn't know if any of the meetings involved FDA safety officials.
"I have also learned that FDA may be relying on safety studies for ProHeart 6 that were performed with guinea pigs," Grassley said, according to a statement Thursday.
Grassley said he wants a response from the FDA by June 19 about whether any safety officials were involved in the meetings, and if any of the studies involved dogs.
When asked about whether the company's tests involved dogs or guinea pigs, Wyeth spokesman Doug Petkus said the company conducted all the safety tests in compliance with the FDA's specifications. He added, "You have to remember this [ drug] has extensive field experience with millions of dogs and has been proven as a safe and effective product to treat heartworm around the world."
Heartworm is a parasite that affects millions of dogs, and Fort Dodge officials said in a conference call Thursday that many veterinarians called the company asking them to get the product back in the U.S.
Rami Cobb, a senior vice president at Fort Dodge, said extensive testing and international use of the reformulated drug makes the company "confident" the drug is safe for dogs in the U.S.
The FDA, however, is restricting distribution of the drug and required revised labeling to include more safety information. The FDA said the new label warns people not to give the drug to dogs within a month of receiving a vaccination.
"While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions," said Bernadette Dunha, director of the FDA's Center for Veterinary Medicine, in a statement.
ProHeart 6 was the first product approved by the FDA to be administered every six months. Most other drugs need to be given monthly, and Cobb said test show the new drug results in about one adverse event for every 10,000 dogs that take it.
Prior to the new formulation, studies showed two to three adverse events for every 10,000 dogs that used it, Cobb said.
Adverse events associated with the original form of the drug included seizures, difficulty walking, jaundice (a yellowish appearance), bleeding disorders, convulsions and death.
The new form is free of certain residues that caused the majority of the allergic reactions in dogs.
Company officials couldn't comment on how much the drug would cost or how much they expected to make from it.
Vets who want to use ProHeart 6 will have to register with the company and participate in a Web-based training program. The drug is already marketed in Europe, Japan and Australia. Cobb said ProHeart 6 has a 42% market share in Italy.
The FDA said few adverse events have been reported with the new drug, but urged anyone who suspects his or her dog is experiencing an adverse reaction to immediately contact a veterinarian and call Fort Dodge at 1-800-533-8536.
-By Jared A. Favole, Dow Jones Newswires
June 05, 2008: 06:01 PM EST
By Jared A. Favole
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration on Thursday said it will allow a reformulated version of a Wyeth (WYE) heartworm drug for dogs back into the U.S., sparking a powerful U.S. senator to question the agency's decision.
Wyeth unit Fort Dodge Animal Health pulled the drug from the market in 2004 amid reports that 500 dogs died while taking it. The FDA's handling of the situation sparked congressional inquiry after an FDA safety officer said the agency tried to silence her when she raised concerns about the drug.
Sen. Chuck Grassley, R-Iowa, fired off a letter to FDA Commissioner Andrew von Eschenbach on Thursday expressing concerns about how the agency came to its decision to allow the drug, called ProHeart 6, back in the U.S.
Grassley, ranking member on the Senate Finance Committee, said the agency has had 18 meetings and 85 phone calls about ProHeart 6 since it was withdrawn, but doesn't know if any of the meetings involved FDA safety officials.
"I have also learned that FDA may be relying on safety studies for ProHeart 6 that were performed with guinea pigs," Grassley said, according to a statement Thursday.
Grassley said he wants a response from the FDA by June 19 about whether any safety officials were involved in the meetings, and if any of the studies involved dogs.
When asked about whether the company's tests involved dogs or guinea pigs, Wyeth spokesman Doug Petkus said the company conducted all the safety tests in compliance with the FDA's specifications. He added, "You have to remember this [ drug] has extensive field experience with millions of dogs and has been proven as a safe and effective product to treat heartworm around the world."
Heartworm is a parasite that affects millions of dogs, and Fort Dodge officials said in a conference call Thursday that many veterinarians called the company asking them to get the product back in the U.S.
Rami Cobb, a senior vice president at Fort Dodge, said extensive testing and international use of the reformulated drug makes the company "confident" the drug is safe for dogs in the U.S.
The FDA, however, is restricting distribution of the drug and required revised labeling to include more safety information. The FDA said the new label warns people not to give the drug to dogs within a month of receiving a vaccination.
"While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions," said Bernadette Dunha, director of the FDA's Center for Veterinary Medicine, in a statement.
ProHeart 6 was the first product approved by the FDA to be administered every six months. Most other drugs need to be given monthly, and Cobb said test show the new drug results in about one adverse event for every 10,000 dogs that take it.
Prior to the new formulation, studies showed two to three adverse events for every 10,000 dogs that used it, Cobb said.
Adverse events associated with the original form of the drug included seizures, difficulty walking, jaundice (a yellowish appearance), bleeding disorders, convulsions and death.
The new form is free of certain residues that caused the majority of the allergic reactions in dogs.
Company officials couldn't comment on how much the drug would cost or how much they expected to make from it.
Vets who want to use ProHeart 6 will have to register with the company and participate in a Web-based training program. The drug is already marketed in Europe, Japan and Australia. Cobb said ProHeart 6 has a 42% market share in Italy.
The FDA said few adverse events have been reported with the new drug, but urged anyone who suspects his or her dog is experiencing an adverse reaction to immediately contact a veterinarian and call Fort Dodge at 1-800-533-8536.
-By Jared A. Favole, Dow Jones Newswires
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