Effient: FDA May Approve Blood Thinner That Causes Internal Bleeding
The Food and Drug Administration may be on the verge of approving an ELil Lilly blood thinner a consumer group says causes internal bleeding.
The drug in question is prasugrel (to be advertised as Effient), which watchdog Public Citizen and Johns Hopkins research director Dr. Victor Serebruany say wasn't tested at a proper dosage by Lilly. The result, Public Citizen argues, is an unsafe drug potentially harmful in the long term may be released to the public.
This is a high-stakes issue because the drug, as a competitor to Plavix, could earn Lilly a billion dollars a year, an Associated Press story says.
The drug prevents more heart attacks than Plavix, but it also causes more internal bleeding, according to a study of over 13,000 patients conducted by Lilly.
But consumer watchdog Public Citizen says that study did not give an accurate comparison of prasugrel versus Plavix.
In a letter Wednesday, the group notes that the dose of prasugrel studied by Lilly was about 2.5 times more potent than the dose of Plavix. The scientists say that the higher dose accounted for the excess bleeding seen with prasugrel. The letter said some patients on prasugrel actually stopped forming blood-clotting platelets completely, putting them at increased risk of hemorrhages.
The story says a panel of outside advisers recommends the FDA approve the drug, because it cured 24 heart-related problems for every 10 cases of bleeding it caused. The department is mulling things over and has already missed two target dates for the drug's review.
Consumer group wants halt on review of Lilly drug [AP]
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Comments:
How about Consumer blogs allow scientists and regulators to judge a drug? Amateur activists will destroy the health of hundreds of lucky patience in their insistence that drugs carry no risk or side effects. Medication is always a utilitarian gambit where the FDA must weigh the danger of a drug with its benefit. Given the lethality of these heart issues I want less uninformed quibbling from blogs and activist doctors, please. This kind of nonsense is why the FDA exists - it's a shame that agency has so effectively destroyed its reputation that many consumers would rather trust internet commentary.
Yah, that is a risk with all anticoagulant. That's why you need to report any bleeding with an unknown origin ASAP! It will probably be used for patients who can't use aspirin, heparin, or coumadin..
As far as I'm concerned, as long as the information about bleeding risk is put out there in the open, let the Dr. and their patient decide whether the risk/reward ratio is good enough to use it.
Blood thinners are insanely dangerous, generally. I'm surprised this got approval considering that when my father was on warafin sodium, he went to the doctor four times a week to get his INR levels checked. I wonder if this drug's use is going to be limited to people being treated as in-patients at hospitals?
@Jessica O'Dowd: Yes. The main issue with blood thinners is that they require A TON of follow up by doctors and patients. That's why heparin is pretty much only used by patients in a hospital and coumadin is followed very closely. I do worry about bad doctors not following the dosing protocols or checking the INR levels and patients not being aware that blood thinners are fairly dangerous (but often necessary) drug.
It's completely unreasonable to expect a treatment to be entirely without side-effects. Medicine is an odds game - is the risk of the side effect greater than the risk of not taking the drug? Almost certainly not.
Spinning this as profit-mongering is really out of line.
@nova3930: You beat me to it. If a doctor has a patient that he evaluates at being at a very high risk to have a heart attack, it seems reasonable to prescribe this medication initially to get things under control before going to a less potent medication.
Why take it out of the toolbox?
These types of drugs should be prescribed very cautiously due to the dangers. However, our prescription happy culture will gladly write scripts for new drugs over older, less risky alternatives due to some advertising campaign. I'm not blaming doctors 100% here, but a combination of doctors and idiots who see a commercial on TV and demand a prescription for the new drug...
/I would like to see this drugs effecacy on masking EPO and CERA, though...
@Jim Topoleski: Yeah, I was also under that impression. You can't really thin blood without reducing the body's ability to clot and increasing the chances of internal bleeding.
Thank you Unsolicited Advice. Very well said on all counts.
@Unsolicited Advice: This is always my argument when I talk to people about vaccines causing autism. I will take medical advice from my doctor, not Jenny McCarthy and Jim Carrey, thank you. I'm sorry that your child is autistic, I truly am, but there is zero scientific evidence that autism is caused by vaccines. The fact that most children get lots of vaccines at the same time that signs of autism begin to appear does not imply causation.
Maybe a one-armed man can convince Dr Serebruany that the drug is indeed safe.
@CRNewsom: I've always wondered about the effect of advertisement for prescription drugs. Can a patient actually "demand" that a doctor prescribes a specific drug?
@nataku83: I suffer from internal bleeding and consistently low blood counts and all I take is my normal aspirin regimen as far as thinners are concerned.
@HiPwr: It happens all the time. "I want Provasic!" Of course, the doc isn't required to prescribe the drug, but if the patient asks for the more expensive, newer drug that (supposedly) does the same thing as the old one, why does the doctor care? They are still getting the treatment, just paying more for it.
@Jim Topoleski: Right, but how much internal bleeding? If it's 90% of people bleeding out to the point of hospitalization, that's different than .2% have a little blood in their urine but otherwise being fine.
@zarex42: Agreed. I don't really understand what the issue is here. It's not like there was any deception involved. The drug was tested at a certain dosage level, which had a certain level or rewards versus risk, and all this info is publicly available. If the FDA decides to approve it, then, well, they're the FDA, and that's their prerogative.
What I don't understand is the group's argument that the study "did not give an accurate comparison of prasugrel versus Plavix", with the former being more potent. Isn't like that saying that comparisons of the benefits of Extra-Strength Tylenol to Regular Tylenol are inaccurate because they have different compositions?
@Hil-fish: I feel the same way about people who rage against anti-depressants. Maybe they don't work for you but they get me out of bed so I'm going to keep taking them
On one hand: agreed, the community of Tubes can not, and should not, affect the outcome of a review by experts. And experts will always disagree, and it boils down to a matter of risk.
On the other hand: I value these posts as an alert to me; if I were to go to my doctor and he suggested taking Effient (assuming it gets approved), I would now have plenty of questions to ask him about the risk of internal bleeding and how he's going to monitor that and what to do if I see signs of it...
@humphrmi:
The risk is that less credible sources enter a complicated conversation, causing patients to engage in sub-optimal behaviors that endanger their health. You need only look at the immunization crisis caused by misguided autism correlationists to realize that the danger is very real. Measles, mumps, rubella, and other diseases thought forgotten are killing kids because of celebrity activism with a grain of truth - the influence of blogs can be extremely similar. Not to say Consumerist isn't credible, it is, but I have real concerns about the potential behavioral impact for less-critical thinkers.
The FDA needs to be a strong, credible organization and it needs to protect Americans.
Do you mean Eli Lilly?
@Unsolicited Advice: Bingo! How many people have died as a result of the FDA's reluctance to allow patents to take life saving drugs? If me or my hypothetical child has a life threatening disease, I'll risk the unknown side-effects if there is a chance the new drug can save a life.
@Trulymadlyme: It hasn't yet - but it should. Blood thinners are crazy dangerous, but they prevent even more dangerous diseases. It's a balancing act. Healthy people should not take them. However, if someone needs them, they should have access to them - it should be the doctor's and patient's call, not the FDA's (when the potential benefits for some subset of the population outweigh the risks for that same subset).
Part of the FDA's responsibility is to protect you from making distressed decisions to use untested or unconventional therapies that could worsen an illness. Your argument and mine are a bit different. The FDA should be reluctant, in my opinion - but that reluctance should be trusted, and blogs should stop making hay out of drug industry FUD.
@rpm773: And that's why you don't delay approval of blood thinning medication!
Oh wait, wrong one-armed man.
@HiPwr: Reading the modern Hippocratic oath, there's no real language saying whether or not to let the patients wishes override the doctor(s).
This article is irresponsible and unethical of the Consumerist. It has no basis for bringing this up and jeopardizing the health of the many people that might benefit from this drug. The FDA's decision should be uninfluenced by outside unqualified opinion. It should weigh the risks and benefits of the drug on its own merits, not what a community of people on the internet thinks.
@Unsolicited Advice: Having worked for a government contractor for years I'm pesimistic of any and all government foot dragging, very little of it adds any value.
Lets see, some internal bleeding or massive heart attacks. Hmmm. Well I think if I have to choose I'd go with the former.
@humphrmi:
Maybe it's just me but I don't need warnings like this. Any drug I take, I make sure to look it up and do the research first. It's not like it's hard nowadays with the plethora of easy information. Back in the dark ages, we just had to hope and pray that our drugs were right and weren't going to screw us over. At least nowadays we can double check. Well, some of us anyway. I don't think it's all that difficult to comprehend drug information but maybe it's different for others.
@henwy: No one is saying whether people should or shouldn't be able to take it. But the safety issues of the drug militate some caution on its use outside of being in the hospital or being see by the prescribing doctor nearly 3 or 4 times a week (which is extremely cumbersome on the part of the practicing doctor.).
@Jim Topoleski: I was once a juror on a malpractice case where blood thinners were used when a clot formed around a stent that had been put in the patient earlier in the day (this sometimes happens) and caused a heart attack in the patient. There had been a small perforation made to the artery, so when the thinners got into his system, he started bleeding out and died. There are all sorts of things that can kill you when trying to help you.
@saintpetepaul: Man, I thought you were being snarky before I realized that there's a commentor with that name now.
On one hand: agreed, the community of Tubes can not, and should not, affect the outcome of a review by experts.
@humphrmi: But how likely is it that it would? Does the Consumerist have that much clout that our comments would actually affect what the FDA will do? I don't think we should worry about discussing an AP news article because the FDA might listen to use instead of the experts.
I just don't think that it's a legitimate concern.
I don't think either of us is worried about the FDA. The problem lies with individuals who will potentially refuse a drug due to loaded headlines like "Blood Thinner Causes Internal Bleeding." Heart disease is more likely to kill you, and that is why we take medicine, but Consumerist has elected to form the impression for readers that this drug is a dangerous killer that will bleed you out. Phil links to some pretty crappy analysis here and this story is akin to passing on an urban legend.
@Unsolicited Advice: So we are to stop questioning our all-knowing government? Take what they say is good for us and shut the hell up? That sounds smart.
@unpolloloco: In what way is this irresponsible or unethical? Because you say so? Because we have no right to understand the scope of testing that occurred on the drugs we take? Because we aren't all doctors? If anything, not questioning our government's decisions, particularly as regards health, is unethical and irresponsible.
You know how they say that there are no stupid questions? They're lying. "Questions" based on specious evidence can be deadly when it comes to medication. I hate to belabor the autism vaccination bit but it's killed children, and all because some rather stupid people have found a way to publicize an influential argument that convinces some parents that vaccines are unsafe. The FDA should be trusted to consider those risks and activists should not perpetuate baseless conjecture.
My wife has been on a blood thinner regimen for the last 5 years (she's 26) started off with coumadin (see warfarin/rat poison) but whenever we fly, or she throws a clot, she's got to get lovonox shots in an alcohol suspension (so it burns like a mother). Luckily, she's found a great hematologist that's gotten her off the rat poison, kids are out of the question though. Blood thinners are insanely dangerous to start with, because you're countermanding what the body naturally does.
Asking the question "How do we answer the question of this drug's safety based on the conflict surrounding FDA testing procedures?" doesn't seem to be the process implied by the headline. The headline is telling me this drug is going to give me internal bleeding.
There's a subtle but important difference between muckraking and spreading crap around.
Dont all blood thinners cause internal bleeding in rare cases though?
I am pretty sure all the ones I have seen give that as a possible side effect, even Plavix.