Cavandra Posted June 19, 2008 Author Share Posted June 19, 2008 Just thought i would add this to the thread............showing the corruption involved! If you want to look at the links you will need to cut & paste them to your browser. _http://blogs.usatoday.com/oped/2008/06/our-view-on-dru.HTML#more_ Our view on drug safety: FDA vet tracks dog deaths, gets smeared in the Process Tale of ProHeart 6 raises questions about who calls the shots at agency. _ProHeart 6_ (http://www.proheart6.com/) — a controversial heartworm drug For dogs — came back on the market last week, almost _four years after it was Pulled_ (http://www.senate.gov/~finance/press/Gpress/2008/prg060508.PDF) When hundreds of dogs died and thousands more suffered adverse reactions. Ordinarily, this might be of interest mainly to pet owners and veterinarians. But This is much more than a dog story. (Photo - Hampshire: Questioned heartworm shot / Leslie E. Kossoff, AP) During the process that took ProHeart 6 off the market, the drug's maker _investigated and denounced a Food and Drug Administration scientist_ (http://www.usatoday com/money/industries/health/drugs/2005-12-05-FDA-wyeth-probe_x.htm) Who gathered the damning data. And instead of protecting its scientist, the FDA booted her off the case and tried to have her criminally prosecuted. It's a disturbing tale for anyone who relies on pharmaceutical companies and The FDA to ensure that medicines for animals and humans are safe, one that Raises questions about the conduct of a major corporation and its federal Regulator. The story begins in 2001, when ProHeart 6 came on the U.S. Market. It was Regarded as a breakthrough. Veterinarians could inject it once every six months, Replacing the once-a-month pill people gave — or often forgot to give — Their dogs to ward off potentially deadly heartworms. Though many dogs did fine On ProHeart 6, others had dangerous complications. Eventually, the FDA says 500 to 600 dogs died and there were "adverse" reactions, including seizures And uncontrolled bleeding, in 5,500 to 6,000. In 2004, the FDA pushed ProHeart 6 manufacturer Fort Dodge Animal Health, a Subsidiary of pharmaceutical giant Wyeth, to _remove the drug from the Market_ (http://www.FDA.gov/BBS/topics/answers/2004/ans01312.HTML) . Wyeth argued That the drug was safe but agreed to remove it. Then it fought back. The company _targeted Victoria Hampshire_ (http://www.whistleblower.org/content/press_detail.cfm?press_id=1302) , a veterinarian and FDA safety officer Who collected and analyzed the adverse drug reports on ProHeart 6. Wyeth hired Investigators who dug up information on Hampshire's home, her tax records and A veterinary website where a handful of her friends and veterinary clients Could buy drugs and pet supplies. (It's not uncommon for FDA's vets to Practice medicine part-time in their off hours.) Wyeth executives then alleged that Hampshire had a conflict of interest. Without telling Hampshire what was going on, the FDA took her off the ProHeart 6 case and began an internal investigation that culminated when FDA Investigators asked the U.S. Attorney in Maryland to criminally prosecute her. It Took one day for the U.S. Attorney to sort through the flimsy referral and Refuse to press charges. The FDA _eventually exonerated Hampshire_ (http://www.msnbc.MSN.com/id/18137930/) , and she now works at the agency in a different Job. ProHeart 6, meanwhile, is back on the market. The manufacturer and the FDA Say the drug is safe, free of the solvent residue thought to have caused the Earlier problems. But the drug is being administered under a strict "_risk Minimization_ (http://www.FDA.gov/cvm/Documents/Proheart6RiskMAP.PDF) " plan that Applies to only a small number of FDA-approved drugs for animals and humans We know much of this story not because Wyeth or the FDA disclosed it Voluntarily, but because a persistent _investigation by Sen. Chuck Grassley_ (http://finance.senate.gov/press/Gpress/2008/prg020608.PDF) , R-Iowa, dragged it out Of them. The probe revealed that Wyeth officials had easy, undocumented Access to the FDA to lobby for ProHeart 6 and attack Hampshire. FDA managers Seemed more interested in placating Wyeth than in dealing fairly with one of its Scientists. The most troubling aspect of this is the effect it will inevitably have on Other FDA safety officers. After seeing what can happen when someone gathers Evidence that a drug is unsafe, what safety officers wouldn't think twice about Risking their careers by antagonizing powerful companies? That's a terribly dangerous way to run a drug safety process that can ultimately mean life or death to animals and humans alike. Posted at 12:22 AM/ET, June 17, 2008 in _Animals - Editorial_ (http://blogs.usatoday.com/oped/animals_editorial/index.html) , _Drug abuse - Editorial_ (http://blogs.usatoday.com/oped/drug_abuse_editorial/index.html) , _USA TODAY editorial_ (http://blogs.usatoday.com/oped/usa_today_editorial/index.html) Link to comment Share on other sites More sharing options...
Guest Tess32 Posted June 19, 2008 Share Posted June 19, 2008 Terrible. And the amount of vets will giving it at vaccination time also....is just revolting. Link to comment Share on other sites More sharing options...
Jey Posted June 19, 2008 Share Posted June 19, 2008 I got my dog the annual heartworm injection because it was such a drama feeding him the heartworm tablets. Is there only one type of heartworm injection? At least I now know to ask more questions of the vet. If the dog was ok initially, is there a chance of risk throughout the year? If the dog was ok the first time, will he be ok the second time? Link to comment Share on other sites More sharing options...
Guest Tess32 Posted June 19, 2008 Share Posted June 19, 2008 The effect can be cumulative, so yes it's still dangerous to give it again. Link to comment Share on other sites More sharing options...
stormie Posted June 20, 2008 Share Posted June 20, 2008 (edited) Interesting that there's nothing on the SR-12 labels, nor have the reps etc mentioned anything about not giving it within 1 month of vaccination. It's possible that Fort Dodge have added this to proheart 6, so that people cannot claim a vaccine reaction is a proheart 6 reaction. Edited June 20, 2008 by stormie Link to comment Share on other sites More sharing options...
sausy.dog Posted June 20, 2008 Share Posted June 20, 2008 Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read. Link to comment Share on other sites More sharing options...
Cavandra Posted June 20, 2008 Author Share Posted June 20, 2008 Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read. They say this because they are talking about a dog suddenly becoming ill or dying suddenly after having it done.....that is rarely the case..........What it does is causes things like seizures months later.........Ask your Vet how many dogs they have on their books that have "epilepsy"....then ask how many have the heart worm shot! Wonder how many clients they have lost because the customers dog did die, or did have a reaction at the time & they blamed that Vet rather than the drug itself & so changed Vets & never told them why they changed Vets....get my drift............Australians in general believe everything the Vet tells them, Many Americans dont, and that is why all our reactions (whether Vaccine, heartworm, anaesthetic, drug related ) never get reported here !!! Many dogs never show any signs of distress, death, seizures etc. ....what about the ones that do though, and just because a dog has had it 5 years in a row doesnt mean it wont die from it the next year..........the death will be presumed to be from something else of course........ Link to comment Share on other sites More sharing options...
sausy.dog Posted June 20, 2008 Share Posted June 20, 2008 Both vet practices in our country town say they have never heard anything about proheart side effects. I asked the vet at a consult where I usually take my dogs and she said she would do some reading but had never heard of it causing any problems. When I took Elly to puppy preschool - run by the other clinic - the vet nurse was telling us we should get it done and when I queried it she also said that their clinic gives it routinely without any adverse reactions. I am not sure, I haven't done enough reading on it, but I am not happy to give it to my dogs on what I have read. They say this because they are talking about a dog suddenly becoming ill or dying suddenly after having it done.....that is rarely the case..........What it does is causes things like seizures months later.........Ask your Vet how many dogs they have on their books that have "epilepsy"....then ask how many have the heart worm shot! Wonder how many clients they have lost because the customers dog did die, or did have a reaction at the time & they blamed that Vet rather than the drug itself & so changed Vets & never told them why they changed Vets....get my drift............Australians in general believe everything the Vet tells them, Many Americans dont, and that is why all our reactions (whether Vaccine, heartworm, anaesthetic, drug related ) never get reported here !!! Many dogs never show any signs of distress, death, seizures etc. ....what about the ones that do though, and just because a dog has had it 5 years in a row doesnt mean it wont die from it the next year..........the death will be presumed to be from something else of course........ I understand everything you are saying and I agree. I think a lot of vets are just not informed about this drug - either because they don't actively seek info or they aren't given it - and its a real worry. I suspect that in our area there would have been little or no alarm bells ringing by linking seizures etc with proheart because few people actually treat for heartworm here - it is not in our area at the moment. I know it is only a matter of time but until large numbers of people start treating for it with proheart then there will be very little to link adverse reactions to proheart that the vets will pick up on which is possibly why they are still ignorant about it. Link to comment Share on other sites More sharing options...
stormie Posted June 20, 2008 Share Posted June 20, 2008 The problem is, there is no scientific evidence to say the drug causes problems. No one can say that the dogs who developed seizures and other issues, wouldn't have had these problems anyway. Link to comment Share on other sites More sharing options...
Miss B Posted June 20, 2008 Share Posted June 20, 2008 I got my dog the annual heartworm injection because it was such a drama feeding him the heartworm tablets. Is there only one type of heartworm injection? If the daily tablets are a bit of a drama, and you don't want the heartworm injection - you could try something like the monthly 'Heartgard' chews - they are pretty palatable and most dogs will happily eat them. My dogs love them Interesting that there's nothing on the SR-12 labels, nor have the reps etc mentioned anything about not giving it within 1 month of vaccination.It's possible that Fort Dodge have added this to proheart 6, so that people cannot claim a vaccine reaction is a proheart 6 reaction. I was thinking the same thing. The Fort Dodge promotional posters actually use wording such as "Simple yearly injection, can be given at the same time as your dog's annual health check and vaccination" or something to that effect. As with anything though, there are good vets and there are bad vets and I do not believe they should all be tarred with the same brush. I would never support a vet who promoted the breeding of designer dogs Obviously they are all about the money, and squeezing as much as possible out of their clients. Thankfully not all vets are like this. I'm lucky enough to work for a wonderful clinic owned by vets who genuinely care about their patients and clients and are not 'all about the money' :D Link to comment Share on other sites More sharing options...
Jey Posted June 20, 2008 Share Posted June 20, 2008 If the daily tablets are a bit of a drama, and you don't want the heartworm injection - you could try something like the monthly 'Heartgard' chews - they are pretty palatable and most dogs will happily eat them. My dogs love them :D I made a mistake; it was those monthly chews that were a drama. The vet nurse would have to force them down his throat. Next year I might give crushing up the tablets in his food a go. Is there only one type of annual vaccine? Link to comment Share on other sites More sharing options...
rose of tralee Posted June 20, 2008 Share Posted June 20, 2008 It's very good that this is being discussed, vets who can balance the bottom line with animal welfare have nothing to fear. Link to comment Share on other sites More sharing options...
stormie Posted June 20, 2008 Share Posted June 20, 2008 It's very good that this is being discussed, vets who can balance the bottom line with animal welfare have nothing to fear. Even if SR-12 eventually is proved to be harmful, its not going to be the vets who get done, it will be the company. Vets rely on information they receive, which usually includes scientific studies and evidence to show products to be effective and safe. Just because there are websites out their stating these products to be harmful, until a properly done study shows that moxidectin is causing all these problems, it's still going to be used. Rather than having a go at vets, why not target the companies that make them. Link to comment Share on other sites More sharing options...
dogbesotted Posted June 21, 2008 Share Posted June 21, 2008 From my perspective given the fact that as the company itself acknowledges that a small % of dogs have adverse reactions to the proheart.. why on earth would anyone run the risk that their dog may be one of the few and that the drug ( it is NOT A VACCINE) remains active for at least 12 months. cheers H Link to comment Share on other sites More sharing options...
morgan Posted June 21, 2008 Share Posted June 21, 2008 My vet stopped using it after several cases of autoimmune haemolytic anaemia occurred after the shot. He said that it is supposed to be a 1 in 10,000 occurrence, but he only vaccinated a few hundred dogs. This link has been posted in almost every Proheart thread, but here it is again for those who have not seen it. http://www.wyethah.ca/pdfs/Canine/EngLetterMarch16.pdf The boxed warning on the caution section of the label is as follows - BECAUSE OF ITS POTENTIAL FOR SERIOUS ADVERSE DRUG REACTIONS AND THEABSENCE OF IDENTIFIABLE RISK FACTORS ASSOCIATED WITH THOSE REACTIONS, PROHEART 6 IS ONLY INDICATED FOR THOSE DOGS IN WHICH ALTERNATIVE PREVENTATIVES CANNOT BE EFFECTIVELY ADMINISTERED.* As far as I'm concerned, vets should be showing this label to their clients and giving them the ability to make an informed choice. Link to comment Share on other sites More sharing options...
stormie Posted June 22, 2008 Share Posted June 22, 2008 The boxed warning on the caution section of the label is as follows -BECAUSE OF ITS POTENTIAL FOR SERIOUS ADVERSE DRUG REACTIONS AND THEABSENCE OF IDENTIFIABLE RISK FACTORS ASSOCIATED WITH THOSE REACTIONS, PROHEART 6 IS ONLY INDICATED FOR THOSE DOGS IN WHICH ALTERNATIVE PREVENTATIVES CANNOT BE EFFECTIVELY ADMINISTERED.* As far as I'm concerned, vets should be showing this label to their clients and giving them the ability to make an informed choice. I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12 Link to comment Share on other sites More sharing options...
morgan Posted June 22, 2008 Share Posted June 22, 2008 I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12 Go figure - Proheart 12 has 3 times the active ingredient of Proheart 6. Obviously different labels for different countries :rolleyes: Link to comment Share on other sites More sharing options...
stormie Posted June 22, 2008 Share Posted June 22, 2008 (edited) I still can't work out why this is on the label of proheart6, but not on the label of proheart SR-12 Go figure - Proheart 12 has 3 times the active ingredient of Proheart 6. Obviously different labels for different countries :rolleyes: Surely the suspension the moxidectin is in must be different, otherwise the SR-12 would all be absorbed in 6 months. There must be something different about it to make it be absorbed slower. It wouldn't just be because there is more of it being injected, because otherwise the size of the dog would determine how long it lasted, if that makes sense. Which could potentially be why the proheart6 has had more problems, because the chemical is being absorbed much faster. Definitely something I'm going to question the FD reps on when they next come by... Edited June 22, 2008 by stormie Link to comment Share on other sites More sharing options...
Cavandra Posted June 23, 2008 Author Share Posted June 23, 2008 Surely the suspension the moxidectin is in must be different, otherwise the SR-12 would all be absorbed in 6 months. There must be something different about it to make it be absorbed slower. It wouldn't just be because there is more of it being injected, because otherwise the size of the dog would determine how long it lasted, if that makes sense. Which could potentially be why the proheart6 has had more problems, because the chemical is being absorbed much faster. Definitely something I'm going to question the FD reps on when they next come by... Trouble is that if it were this simple the yanks would have adopted Proheart 12, and they never have.........why not I ask ????? My theory is that due to drug companies having zero ethics, so long as they are "getting away with it" they will continue, Australia is a far easier target as we dont sue over everything like Americans do, and we are more gullible.... JMO Link to comment Share on other sites More sharing options...
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