I opened the most recent edition of Journal of the American Medical Association (JAMA) and found a striking full-page ad from the FDA.
It’s unclear if this is the first ever such advertisement. I have been unable to find a similar one on the Internet at least. Has anyone seen such ads before?
The JAMA ad sternly warned docs on the dangers of the use of foreign drugs. In fact it threatens potential criminal charges if providers enable patients to use foreign non-FDA approved drugs.
I can see both sides on this issue.
On the one hand, medicines in the US are far too expensive and many patients cannot afford them. In fact, a significant number of patients do not take the proper doses of medicines because they are too expensive. This clearly has substantial potential for negative health consequences.
On the other hand, foreign medicines could in principle be dangerous to consumers as they could contain contaminants, be of the wrong dose, or be the wrong medicine. I wonder how often that happens though.
More broadly, is this big ad reflective of a new approach for FDA for getting the word out on key issues?
More FDA ads to come?
If so, will we see a similar JAMA ad targeting physicians that says essentially:
“Note to Physicians. Do not put your patients, yourself, or your practice at risk by purchasing or administering unapproved biological drugs such as more than minimally manipulated stem cells.”
Frankly, I’m not sure this is the best way for the FDA to communicate these kinds of messages.
But they do need to communicate more often to a large audience using clear language, which this ad does.
Paul, this subject I’m sure hits home with many people. In my families case, my in-laws wintered in South Texas with a whole group of retires from their home town in Kansas. There literally hundreds of these small retirement communities down there. Almost everyone is on a fixed income. Being able 2 go into Progresso, Mexico and get all their scripts for minimal cost is huge bonus! They also get all their dental work/dentures, their eye exams/glasses etc… You get the picture! What in the world is wrong with this picture that our aging population has had 2 come 2 the point of seeking medicines and medical treatment in another country! You and Barbara are absolutely right this is a giant mess with no good solution in sight! Pharmacy orders being placed by Americans to Canada and Mexico I assume are at an all time high!
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I would love to think this is done out of the “kindness of their hearts” in protecting people who must take pharmaceuticals. Unfortunately, this is only
a business decision. The pharmaceutical industry is in the black and they won’t be able to compete much longer with biotechnology driven compounds and techniques. The rest of the world seems just fine taking pharmaceuticals made outside of the US.
Maybe I am missing something here. But we have lived for the past 15 years south of the border. Occasionally we have taken medication in these foreign countries. Some of it required an RX from a physician in the foreign countries. In other cases, the medication was available without prescription but would have required one in the U.S. The drugs come from retail pharmacies locally and are packaged mainly in material that says that it was made by internationally known drug makers. The stuff is much cheaper than the identical product in the US. It also WORKS based on our use of it. This warning would seem to indicate that all foreign drugs are suspect and dangerous under any circumstances. It would also seem to indicate that Americans should not take any drugs in “foreign” countries and instead skip them unless they return to the drug-sanctified environs of the US. Or maybe I am all wrong about this warning.
One way to perceive FDAs message is the one from a ‘medical ethics’ point of view. The most important principle for a physician is to ‘do no harm.’ Though the two opposing views present valid points, there are always going to be many uncertain anomalies.
Thus it is important for a physician to err on the side of caution. They should always keep safety a priority.
Brian – I agree with you 100%. I also agree with Paul’s statement, “medicines in the US are far too expensive and many patients cannot afford them. In fact, a significant number of patients do not take the proper doses of medicines because they are too expensive. This clearly has substantial potential for negative health consequences.”
Purchasing from foreign pharmacies is their lifeline, but the FDA doesn’t care. A good example is a drug I use called Advair. The cost is well over $250 to buy it in the U.S. The cost from a reputable source that I know of overseas is $35.00.
The FDA fails to mention that many drugs they have approved have horrible side effects, have caused death and are ineffective. It’s quite obvious that this is an agency that is protecting Big Pharma while trying to make the public believe otherwise.
Barbara,
It’s a mess.
Regarding the “protecting Big Pharma” allegation, what do you say to the $2B fine for J&J, at least in part because of FDA issues with the company?
http://money.cnn.com/2013/11/04/news/companies/johnson-and-johnson-settlement/
Paul – There are far too many incidents over the years where the FDA has protected Big Pharma, however, your example of the J & J fine levied is an example of the right course of action being taken. The whistle blowers are to be commended as well.
I have an even worse example of the outrageous cost of some drugs. There is an inhaler called Xopenex for those with COPD. If it is not covered in one’s insurance plan or you don’t have insurance, the cost I was quoted was $600.00. I can get the same thing from a reputable foreign pharmacy for about $15.00. I agree with you – It’s a mess!!!
Could it be related to this story from yesterday?
http://www.cbsnews.com/8301-505263_162-57611023/ranbaxy-whistleblower-reveals-how-he-exposed-massive-pharmaceutical-fraud/
It seems to say that this large company that makes generic drugs is not meeting FDA standards for some common prescription drugs. Maybe the FDA is worried that they will reach the US anyway through other countries with less oversight.
FDA dictates are a poor alternative to thinking for yourself
http://www.sciencedaily.com/releases/2013/06/130606154706.htm
Too much power is in the hands of a singular organization with too much self-interest.
I look forward to the day that medical doctors take out full page advertisements warning the public about some of the more obvious deficiencies of the FDA.