Adverse drug reactions often appear idiosyncratic. Some drugs have powerful effects and everyone experiences the side effects (e.g., cancer chemotherapeutic agents). Others, however, seem to disagree with only a few people, although that disagreement can be major. Obviously drug companies would rather not have to contend with the fallout that occurs when their customers become collateral damage. Much of the controversy over drugs like Vioxx is how much the companies knew about that damage and what they did with that knowledge. Big Pharma would rather the blame the drug failure on the victim than the company. Maybe that's too cynical a view of a new initiative just started by five of the world's biggest drug companies. On the other hand, when it comes to drug companies, can any view be too cynical?
The companies started the International Serious Adverse Events Consortium to study genetic causes of bad drug reactions, according to a statement today by the nonprofit group. The first two projects, in partnership with university researchers and the U.S. Food and Drug Administration, will examine why some people suffer liver damage or life-threatening skin reactions to drugs.President George W. Bush is expected to sign legislation within days giving the FDA more power to police drug safety. The agency has been examining the role that individual genetics may play in dangerous drug reactions under a program begun in 2004 to modernize how products are developed and evaluated.
[snip]
About 90,000 people in the U.S. suffered adverse drug reactions in 2005 that caused death, disability or hospitalization, almost triple the number from 1998, according to a report this month in the Archives of Internal Medicine.
Last month, the FDA told doctors that genetic testing may help identify which patients on the blood-thinner warfarin are more susceptible to deadly bleeding, and which nursing mothers may have a higher risk of dangerous reactions to the painkiller codeine. (Bloomberg)
The idea is to pool genetic data gathered from patients who had bad reactions and compare it to patients without adverse effects. One goal is to allow drug companies to design clinical trials with better chances of success, presumably by screening out via genetic testing subjects who will have bad reactions. But unless the ultimate consumers of these drugs will have similar genetic testing, the only effect will be to have the clinical trial look better than it really is by improving the risk benefit trade-off. The idea that the fault for a catastrophic drug failure rests in the patient rather than the drug is also an idea the companies would find congenial.
Meanwhile the major cause of liver failure in the US remains Tylenol ingestion. Maybe that's the fault of some (fairly common) genetic variation. But maybe it's also caused by the combination of Tylenol with other factors in the diet, environment or over the counter or prescription drugs taken simultaneously.
Or maybe it's even because most of the American public thinks Tylenol is a perfectly safe drug. I wonder where they got that idea. Maybe they were genetically predisposed to believe it.
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Revere,
I'm afraid I have to agree with the drug companies on this one.
I had the opportunity of caring for my 81-year-old father-in-law from January to April after his surgery. His children had taken over dispensing his medications the previous fall after an accicental overdose. He was very non-compliant and still, on occasion , tries to skirt the system we have set up for him. Like asking his "friend" to sneak Tylenol PM up to his hospital room. Like stating just yesterday that he'd like to take a sleeping pill before dialysis so he can just sleep through it.
We are always on alert. His "friend" argued with his children over the medications and interfered with them getting a handle on why he overdosed. She said he doesn't like to take medicine. I have found out through her own admission that they trade prescriptions and think nothing of it. I could go on, but I think I've made my point.
Look at patient compliance, and see through the lies they tell their doctors and families, and you will get a different picture than the above study. There may be a genetic component to non-compliance coupled with addictive behavior. This 81-year-old was a heavy drinker, and is still smoking a pack a day.
We, as a society, are too dependent on pharmaceuticals, and I don't see this trend abating at all.
Love,
Library Lady
LL: The drug company strategy won't affect your father in law's situation. They aren't looking for a "gene" for non compliance (any more than a gene for blogging or commenting on a blog). The study discussed in the post has nothing at all to do with compliance.
Revere:
I know. That's not what I meant. I should have said "non-compliance as a result of addictive behavior". Look for addiction genes and a co-relation with adverse events.
Love,
Library Lady
Two things Revere... First is the Tylenol thing. When baby boy was sick several years ago and he had to be hospitalized I walked into the room where he was on his back and running a 103 fever. Mom of course was there and the nurse came in and took his temp. She left and came back with a bottle of liquid Tylenol the dropper kind.
She proceded to give him dropper load after dropper load. At number five I said, "STOP!" Looking at me like I was nutz she said is there a problem and I told her that five is more than enough and not to give him any more. This was an RN and about 30'ish so she couldnt have been out of school very long. She said we had to get his fever down and that, "Its only Tylenol, you can give them as much as you need to get the fever down." I told her again not to do it an said get the doctor to call.... In 24 hours he according to his chart had two big bottles of this stuff. The doctor called and I told him what had happened and that unless they wanted a bunch of dead kids in a certain childrens hospital they had better get their act together. He called the desk, confirmed what I had read and called back. In checking he found that one particular nurse was uneducated to what you could do with this stuff. When a doctor wrote Tylenol as needed didnt mean give them the pharmacy load. It was to mean within the limits of the normal dosing on the bottle. Dumbass!
Next morning a big rash on the belly and a little jaundicey. That cost me and the insurance company another four days in the hospital until he cleared up.
Only Tylenol huh....?
The other thing.... Who, what and how are they going to collect genetic data and do I really want a pharma company having my genetic data? How is it going to be used afterwards? If it ever gets into the hands of insurance companies they will use it to deny or raise the rates on people based upon genetic dispositions for "pre-existing" conditions as they are born. It becomes a Gregor Mendel gene experiment and who in the Hell is going to maintain and keep secure samples and the database. I can see it now, someone comes in off of a hummer of a weekend and is doing the testing, slips, contaminates a sample. Two months later I or someone else gets a letter in the mail saying that my insurance is being cancelled or raised because I have a predisposition to develop sickle cell anemia and I am Nordic white.
I write this on every test sheet of any kind that is done on my family that all data, information, tissues, excrement, or discharges are to be destroyed in every instance after testing and that they may only be used for the immediate test requested by the doctor. No subsequent use for any other testing may be done under any circumstances.
Might be a little anal now, maybe not in ten or fifteen years.
MAXIDEX WARNING
I had eye surgery and in the post-op pack was MAXIDEX)dexamethasone) drops by ALCON LABS.
Two days later I was BLIND
Use Google and enter EPOCRATES MAXIDEX to verify