Here is a finding that will likely unnerve drugmakers. A team of researchers used search tools to review queries made by six million people over a 12-month period and were able to identify evidence of unreported side effects that were caused by interactions between drugs before they were detected by the FDA.
Specifically, the researchers used automated software to identify searches for info on the Paxil antidepressant, the Pravachol cholesterol drug or both pills during 2010. And they found evidence that the combination of these drugs caused high blood sugar. The study was published in the Journal of the American Medical Informatics Association (here is the abstract).
Two years ago, the researchers had previously culled adverse events reported by physicians to the FDA and found the risk of developing hyperglycemia was greater than the risk of hyperglycemia from taking either drug individually. The latest study was designed to access a faster way of gaining such insights.
"Historically, it's been really hard to detect synergistic effects of drug combinations that aren't necessarily side effects of any of the drugs alone," Russ Altman, a Stanford University professor of bioengineering, of genetics and of medicine, and co-author of the study, says in a statement.
The researchers first identified individual searches for the drugs and the calculated the odds that people in each group would search for hyperglycemia — or almost 80 of its symptoms or descriptive terms, such as "high blood sugar," "blurry vision," "frequent urination" or "dehydration."
They found that, among people who searched for Paxil, which has the chemical name paroxetine, about 5 percent also searched for hyperglycemia or a related phrase. For Pravachol, or pravastatin, the rate was below 4 percent. But for those who searched for both drugs - suggesting they used both pills - the search rate was 10 percent.
To verify the accuracy of their analysis, they examined 31 drug-drug interactions already known to cause hyperglycemia, and 31 interactions known to be safe. Overall, the drugs with known interactions led to more search queries on hyperglycemia.
"But the results also suggested that around 12 percent of users searching for drug combinations known to have no interactions also had an unusually high rate of hyperglycemia searches, which would lead researchers down dead ends if they pursued them," according to the Stanford statement.
The researchers believe that combining search history data with other sources of information — such as social media, patient support forums and information from medical records and doctors - will improve the false-positive rate.
"I believe patients are telling us lots of things about drugs, and we need to figure out ways to listen," says Altman. "This is just one way of listening and one application."
59 Comments
Nice review. One thing -- This research was done in conjunction with MICROSOFT, not GOOGLE: "The Microsoft team developed automated tools for mining anonymized data from 82 million drug, symptom and condition searches performed by 6 million Internet users who had agreed, when they installed a Microsoft browser plugin, that the company could use their search history for research purposes."
So, your Dummy book may be better titled "Bing for Dummies"
I kinda thought Bing alone would not be used by enough people to yield any scientifically meaningful results :-)
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm
Become more informed and maybe you'll become more of a fan.
I aagree with Nopharmafan - it's long overdue for the FDA to put up a site where consumers could post side effects (plus seeing what side effects others were having). With 100,000 people in the U.S. dying every year of prescription drug side effects, you'd think we'd be doubling down on this national tragedy.
Thanks for the note and point taken. I hoped the graphic would illustrate the larger point, but perhaps I should have viewed that differently. But thanks for the close read.
ed
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Insulin kills about 1750 people each year. Of course if you take it off the market, about half a million American type 1 diabetics will die within 12 months. What's your suggested date for withdrawing this drug?
Thaldomid and Revlimid kill a couple thousand more each year. But the average patient taking these drugs has a 16 month extension of freedom from multiple myeloma and dies 3 to 5 months later. How soon should it be pulled?
Interferon, which has been shown not only to reduced relapses but also to slow the rate of disability progression in MS, kills about 2000 each year. What decision will you make on behalf of the 300,000 patients with MS?
3500 or so deaths are attributed to Enbrel and Humira each year, drugs which delay disability progression and joint damage in patients with severe RA. What's your decision?
The anti-epilepsy drugs valproic acid, lamotrigine, and phenyltoin have about 500 deaths each attributed to them annually. What is your decision on behalf of the 2.2 million Americans with epilepsy, some of whom experience seizures hourly when off meds?
For extra Bonus Points, how will you handle privately owned swimming pools, which don't extend anybody's life or postpone disability, but are involved in about 700 drowning deaths each year?
One of the great ironies is how hard pharma works to dilute any efforts to improve prescription drug safety labelling or strengthening the FDA's hand in this regard. Why oh why could this be?
We all remember PDUFA 2007 - all the safety improvement language stripped out at the eleventh hour. Wonder how that came about?
Long term antipsychotic use in schizophrenia reduces mortality risk: http://www.ncbi.nlm.nih.gov/pubmed/19595447/ and lower risk of rehospitalization. http://www.ncbi.nlm.nih.gov/pubmed/21362741/
Reduced risk of mortality with continued treatment with antipsychotics in schizophrenia http://www.ncbi.nlm.nih.gov/pubmed/23112292
Antipsychotics reduce mortality in schizophrenia; http://www.ncbi.nlm.nih.gov/pubmed/20923917
Antipsychotics associated with lower suicide and all cause mortality http://www.ncbi.nlm.nih.gov/pubmed/18327869
But go ahead and keep flailing away. You'll continue to be ignored as you have been in the past, because of your unwillingness to familiarize yourself with the data.
"With 100,000 people in the U.S. dying every year of prescription drug side effects, you’d think we’d be doubling down on this national tragedy."
And when I listed some of the drugs that were responsible for these deaths and the consequences of taking them off the market, you responded that I was cherry picking, which would seem to imply that you believe there are other ones that should be taken off the market.
I'm glad we agree that the vast majority of the industry's products have a favorable risk/benefit ratio. I thought you were implying something different.
I'll pass on the book. I prefer the primary scientific literature to summaries written by people who present only the side of the story that supports their point of view. If I find myself in the mood for sensationalism and half-truths, I'll pick up a copy of the National Enquirer and read about Taylor Swift's plans to get a boob job.
One can pick this or that article out of the scientific literature but the "little" problems of ghostwriting, paying big bucks to "opinion leaders" in medicine and the like make many of the journals little more than shills for industry. And, as for the FDA, thanks to pharma it is, sadly, a weak sister where prescription drug safety is concerned. Probably couldn't even get a warning label on thalidomide these days.
Good for your niece for walking away. Others do this as whistleblowers. I hope she found honest employment elsewhere.
At some point, the next generation of kids, grandkids, nieces, nephews, neighbors and BFF will, out of necessity, need to take over the SCIENCE of medical research since 20 years of breaking apart the process of standing on the shoulders instead of stepping on the toes will heave people back 10,000 years to the hands of snake oil salesmen and shamans who will profit greatly from using the magic of internet technology to turn gossip and who-knows-what-else "data" into the next billion $$ thing that might only kill a couple hundred thousand.
Walking away to another "career" won't be an option. Neither will "whistleblowing" since that is NOT protected by the First Amendment or even internally at the FDA.
I GARONTEE you they will come crawling back on their hands and knees begging the OII and John2 to reopen our doors for business.
So who's doing God's work inside Wall Street's b-tch?
Tell me the difference between Anesthetic amnesia causing stimulant antidepressants and Cocaine? or Alcohol? They act on the same receptors. The person acts drugged up and out of it and they have no emotional connections to anyone.
WE don't need an adverse side effects website we need the drugs taken off the market and drug reps out of the doctors offices. You are killing innocent people and destroying innocent families. Antidepressants don't bring out Manic Episodes. They cause Manic Episodes that last months.
In the event of perceived negative comments what would prevent an enity or organization from taking steps to keep real or perceived negative information from surfacing?
Whatever the self-appointed internet experts have been telling you, the overwhelming majority of studies have found that antidepressants reduce or have no effect on violence.
http://www.nber.org/papers/w15354
http://www.ncbi.nlm.nih.gov/pubmed/21070110
http://www.ncbi.nlm.nih.gov/pubmed/19422623
http://www.ncbi.nlm.nih.gov/pubmed/19389333
As I suggested previously, if you want to be a pharma critic, it would be good to at least try to learn a few basic facts.
It is good to bear in mind that the people that most need to report may be very ill. I like the idea of open reporting of side effects. The data could be assessed for what it is observational and may be the driver to take a closer look at a product generating a lot of complaints.
If in fact there was publication and reporting of all trials and this data was publicly available with de-identifiers etc in place perhaps some of these crisis could be solved before an intervention ever gets to market. http://www.ithinkwell.org/all-trials-all-trials-registered-all-results-reported
PS: do you *really* just park cars? What happened?
Kudos as well.
Anyway, the current passive system will always be behind the 8-ball. Private pollsters and marketers show what is possible in outreach, and the FDA should be doing some thinking and trials along these lines in this age of instant communication.
http://www.monkeytime.org/lakey.html
FYI, an n-value refers to the *NUMBER* of subjects in the study. If you remember, MCRPH loves to refer to studies with about 20 volunteers (ie, n=20) and call it conclusive.
Of course you never clicked on my links...they werent for youtube.
Anyone cal call to report anything.
http://www.pharmalot.com/2013/01/and-now-for-some-more-pharma-layoffs/#comments
By the way most people just use "n" when refering to sample size. "N-value" comes up more when referring to a work hardening exponent.
Come on girlfriend - what do you do for a living? We are dying to know.
On another note here is a tip for millennial job applicants: when I see a bunch of “u” for you and “r’s” for are in your cover letter and your email address is pharmagoddess@xyz your stuff goes right into the trash.
MCRPH-IDIOT SAID: "By the way most people just use “n” when refering to sample size. “N-value” comes up more when referring to a work hardening exponent."
Ooooh wo000w. Now you're a statistician too, huh?
I wonder how the pharma industry could have ever let a "peach" like you go.....Oh wait,,,, werent you "downsized?"
That's the point I already made, IDIOT.
"LMFAO HAHAHAHAHHA"
the number is 1-800-FDA-1088. :)
I used a study with an n of 20 to support my opinion - didn't say it was conclusive. Still waiting for your proof that hydrocodone has less abuse potential than oxycodone or are you still waiting for the DEA to help you? You can work to switch the oxy junkies to hydro and trumpet that you cured drug addiction.
What is that you do again? Still too fearful to answer, eh? Not surprising girlfriend.
Since you insist in living in the past and are apparent unable to read English: I have already answered that in a previous thread. I even pasted the answer in *several places* within that thread!!!! one is a C3 the other is a C2. Different schedules for different compounds with different safety/abuse potentials. If you dont like the different scheduling, take it up with the DEA.
A study with n=20 is _literally useless_ when you are suggesting changing the scheduling of a drug that has been around for as long as you have been alive. I would expect a 1st year nursing student to know that
MCRPH: all kidding aside, you sound mentally unstable and possibly illiterate.
Are you off of your own meds?
You are not a statistician?? NO KIDDING????
Help me understand this: both plain oxycodone and oxycodone/apap are CII. plain hydrocodone is CII while hydrocodone combination products with less than 15mg are CIII. Does the apap in Vicodin make the hydrocodone less likely to be abused? THIS MAKES NO SENSE AND IS UNSCIENTIFIC.
Still afraid to tell us what you do?
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