The FDA Fails to Prevent Traveler’s Diarrhea

by on January 11, 2017 at 7:37 am in Food and Drink, Law, Medicine | Permalink

I’ve been getting lots of vaccinations in preparation for my sabbatical in India. A Canadian friend recommended Dukoral. Dukoral is a vaccine for cholera, a very serious disease although one that’s rare for travelers even in undeveloped countries. (It’s roughly comparable in prevalence to Japanese encephalitis, however, which most travel physicians recommend vaccinating for.) As a side-effect, however, Dukoral is also quite effective (60%) against the most common cause of traveler’s diarrhea, that caused by enterotoxigenic E. coli.

Dukoral was approved in the European Union in 2004 but it has not been approved in the United States (a different cholera vaccine was approved late last year but it is not yet widely available). Moreover, Dukoral is available without a prescription in Canada (and also I believe in New Zealand). It’s a big seller in Canada and widely used by Canadians abroad.

It has long been my position that if a medical drug or device has been approved in another developed country then it ought to be approved in the United States. If it’s good enough for the Canadians then it’s good enough for me.

Never let it be said that I don’t follow through on my beliefs. I arranged for someone to buy me some Canadian Dukoral and ship it over the border. Unfortunately, my “connect” is not as practiced in the art of evading U.S. customs as would be ideal and in a fit of regrettable honesty wrote “gift, diarrhea medicine” on the package. The ever-vigilant U.S. Customs intercepted and confiscated my package, thus saving me from the dangers of FDA-unapproved medicine. So I am out $150 (2 doses) and will be less than fully protected on my trip.

If my son or I become “indisposed” in India, I will know who to blame.

1 Jonathan January 11, 2017 at 7:44 am

Fascinating. I’m going to India soon and was trusting the CDC website to give me all the necessary information. Aside from having well-travelled friends, do you have any other medical resources for travelers?

2 cowboydroid January 11, 2017 at 9:36 am

I’m just fascinated that you trusted the CDC to give you “all the necessary information.”

3 Bill January 11, 2017 at 7:44 am

histoire
“THE CANADIAN TRAGEDY
Thalidomide was synthesized in West Germany in 19541 by Chemie Grünenthal. It was marketed (available to patients) from October 1, 1957 (West Germany) into the early 1960’s. Thalidomide was present in at least 46 countries under many different brand names. (See The many faces of Thalidomide for a partial list of those names.)

Thalidomide became available in “sample tablet form” in Canada in late 1959. It was licensed for prescription use on April 1, 1961. Although thalidomide was withdrawn from the West German and United Kingdom markets by December 2, 1961, it remained legally available in Canada until March 2, 1962, a full three months later. Incredulously thalidomide was still available in some Canadian pharmacies until mid-May 1962.”

http://www.thalidomide.ca/the-canadian-tragedy/

4 Roy LC January 11, 2017 at 7:55 am

That was 55 years ago, a lot of things have changed, for example Canada had a different flag back then not to mention a different drug approval process.

5 Bill January 11, 2017 at 7:59 am

I know who to blame if a drug is approved in the US that damages me or others, but tell me what rights I have as a US citizen to vote in the Canadian election so that I could kick out of office some politician who permitted a poor drug approval process.

6 Bill January 11, 2017 at 8:04 am

By the way, here is a list of withdrawn drugs by country and date. https://en.wikipedia.org/wiki/List_of_withdrawn_drugs

7 Derrie January 11, 2017 at 9:42 am

“I know who to blame if a drug is approved in the US that damages me…”

And just who do you blame if the forced non-availability of an effective (non-approved) drug … causes damage to you ??

Who should ultimately decide what you ingest/inject/inhale into our own body ?

There’s a much larger principle in play here.

8 Bill January 11, 2017 at 1:25 pm

Yes, there is a larger principal involved here. There is an externality from having a regulator oversee what gets introduced into the prescription drug market. I doubt you have the ability to judge the efficacy or safety of a drug; I do not either. Information provided by a regulatory agency, and its approval, ensures that people will take their drugs and be informed of the risks and benefits. If you do not have this trusted and verifying organization, people will not take their medicine, and will not undertake the search cost, and will instead rely on what a news advertisement says.

In case you forgot this feature of an information market and externalities, I suggest you not take a Prevagen, but instead do some reading on the economics of information.

9 Wendt January 11, 2017 at 3:27 pm

“If you do not have this trusted and verifying organization, people will not take their medicine…”

And just how do we know with certainty that the individual government regulators are trustworthy all the time? They posses no unique nobility or knowledge that is unavailable in the general population; legal coercion is their sole distinguishing characteristic. All the genuine drug expertise is in the private sector and consumer information is widely available.

The private sector is highly vulnerable to market forces and civil/criminal penalties for bad products and faulty information; FDA employees operate in a protective bubble– with no consequences for their actions or inactions… no matter what harm they cause.

10 cowboydroid January 11, 2017 at 9:38 am

A rant against the FDA wouldn’t be complete without some troll blurting out “Thalidomide!”

11 Bill January 11, 2017 at 5:36 pm

I always like the Libertarian responses to this because they choose to ignore history.

For every government regulation, there was an antecedent case of no regulation. If you thought the world without regulation in this sphere were ideal, you would not be so afraid of raising examples of failures to regulate.

Ever heard about Upton Sinclair?

Ah, the good old days without regulation.

12 cowboydroid January 13, 2017 at 11:52 pm

The irony of citing a work of fiction to support your argument of a less than ideal past did not go unnoticed.

13 Dan Lavatan-Jeltz January 11, 2017 at 12:23 pm

This misuse of the word “Incredulously” suggest the link is machine-generate propaganda designed to sell ads. Just because pregnant people shouldn’t take it doesn’t mean it should be restricted for the rest of us.

14 prior_test2 January 11, 2017 at 7:54 am

‘I will know who to blame’

Faceless bureaucrats, of course.

And this might come as a shock – that same ever-vigilant U.S. Customs will also intercept and confiscate lower priced Canadian medicine that is approved by the FDA, though using their discretion.

‘The savings can be dramatic. A 30 tablet supply of the drug Abilify costs $199.70 from an online Canadian drugstore, but $711.83 if ordered at Walgreens. One 10 capsule dose of Tamiflu sells for $112.20 in the U.S. and less than $50 in Canada. (Note: these are 2013 prices.)

But is it legal to buy medications from Canadian pharmacies? The answer is, technically no, but U.S. officials are allowing it to happen.

Under the Prescription Drug Marketing Act of 1987, it is illegal for anyone other than the original manufacturer to bring prescription drugs into the country. However, federal officials have decided to exercise “enforcement discretion” in dealing with prescription drugs brought across the border, provided the drugs are not narcotics or other controlled substances. This means that as long as a person brings back no more than a three-month supply for personal use, border officials generally look the other way, Thomas McGinnis, director of pharmacy affairs for the U.S. Food and Drug Administration (FDA), told the Milwaukee Journal Sentinel in March 2001. Patients generally may order refills in amounts up to a three-month supply without interference.

What about ordering over the Internet? Prescription drugs cannot be legally mailed into the United States by foreign “e-pharmacies.” But here again officials are employing “enforcement discretion,” preferring to use limited resources to crack down on large commercial drug supplies and narcotics, not prescription-drug shipments for personal consumption. Thus, customs officials allow the companies to mail up to 90-day supplies of medications.’ http://www.elderlawanswers.com/buying-prescription-drugs-from-canada-legal-or-illegal-1204

15 odeboyz January 11, 2017 at 9:36 am

A conservative overtly Christian economist with a world-wide reputation promoting smuggling? And then moaning when it goes wrong seems surreal to me. Perhaps Tyler has been watching the Dallas Buyers Club once too often.

16 Gil January 11, 2017 at 10:34 am

Alex not Tyler

17 Urso January 11, 2017 at 3:08 pm

wtf at “overtly Christian.” Precisely the opposite.

18 the opposite January 11, 2017 at 3:25 pm

Tyler is precisely the kind of atheist that only a Protestant can ever be.

19 Sigivald January 11, 2017 at 1:51 pm

Alex knows exactly why that is prohibited.

Because undercutting the prices kills drug development – the US basically underwrites an entire planet’s worth of drug discovery and development by actually charging people the money it costs during the patent term.

20 carlospln January 11, 2017 at 2:38 pm

Bull Shit

You can’t/won’t manage spend on BigPharma

The End.

21 Cliff January 11, 2017 at 4:10 pm

The U.S. won’t because lives matter more than politics

22 Zach January 11, 2017 at 8:08 am

Please CORRECT SPELLING IN THE HEADLINE diarrhea diarhea …

23 dearieme January 11, 2017 at 9:12 am

Please CORRECT SPELLING IN THE HEADLINE: diarrhoea

24 dearieme January 11, 2017 at 9:13 am

Please CORRECT CORRECTED SPELLING IN THE HEADLINE: diarrhoea

25 Sigivald January 11, 2017 at 1:51 pm

We’re not in the Commonwealth.

There’s no “o” in diarrhea, and only one “i” in aluminum.

26 dearieme January 11, 2017 at 5:08 pm

I think I know a thing or two about diarrhoea, I suffer from it routinely as a consequence of too much BBC

27 JC January 11, 2017 at 8:19 am

Have you asked people in India if the vaccine is available there? If so, get your shot as soon as you arrive in India because it’s very unlikely you will get the disease after one or two nights there…

28 Decimal January 11, 2017 at 8:21 am

Probably quite a bit cheaper there as well.

29 Ian January 11, 2017 at 9:17 am

I took Dukoral before a three month trip to Southeast Asia, and managed to avoid traveller’s diarrhea. Unfortunately, you need to start taking it two weeks before a trip, so buying it in India won’t be an option. Also, it’s not a shot – it comes in powder form that you mix with water and drink.

30 Dan Lavatan-Jeltz January 11, 2017 at 12:27 pm

You really don’t need anything. I drank the water everywhere in South America without taking anything or getting sick. The water in the cities is probably chlorinated anyway and there is a reason people have immune systems.

31 Roy L January 11, 2017 at 12:46 pm

South America is not India.

32 byomtov January 11, 2017 at 1:25 pm

Nor is South America when there is no cholera outbreak the same as South America when there is one.

33 Axa January 11, 2017 at 8:20 am

There’s capable people in India. They developed a cholera vaccine (Shanchol) with 5 years immunity instead of the 2 years of Dukoral. It costs 324 Rs or ~5 USD. https://www.1mg.com/drugs/shanchol-oral-vaccine-237557

The WHO has a stockpile of Shanchol to deal with Cholera outbreaks. Perhaps the health of rest of the world is not an FDA issue. http://www.who.int/cholera/vaccines/Briefing_OCV_stockpile.pdf

34 Brandon Zaharoff January 11, 2017 at 9:02 am

Try DiaResQ – Passport Health in the US recommends it for exactly these cases. Developed by Microbiome scientists and actually works. There are separate versions for kids and adults too if you are travelling with your children.

http://diaresq.com/

35 Jan January 11, 2017 at 9:03 am
36 Decimal January 11, 2017 at 9:18 am

Nicely said. Personal responsibility…. isn’t that libertarian?

37 Bill January 11, 2017 at 9:19 am

Jan,

Did you expect Alex to be a pharmacist?

Nah, he just looks for unapproved drugs and ignores approved drugs that are better than a two dose unapproved drug.

Well, at least he is experiment with himself and his children.

And,

Not with you.

38 Jim January 11, 2017 at 10:08 am

Alex mentions this in the post!!!

39 Bill January 11, 2017 at 1:32 pm

Jim,

Alex says he tried to get a friend to get the Canadian drug and then goes on to his spiel on foreign approvals. He does mention another drug, but then tried to get his friend to buy the Canadian drug for him. He must be some pharmacist to measure the safety and effectiveness of one unapproved drug against an approved drug.

40 Cliff January 11, 2017 at 4:11 pm

He explained pretty clearly why one is better

41 Jan January 12, 2017 at 7:44 am

He edited the post after my comment.

42 Turkey Vulture January 11, 2017 at 10:12 am

Taking a quick look I’m not sure that vaccine has the same beneficial side effect of protecting against diarrhea.

43 GeorgeNYC January 11, 2017 at 9:26 am

Has the manufacturer of Dukarol tried to obtain approval in the US and failed or been delayed?

So basically if a drug company can bribe a regulator in a “developed” country to get approval you are good with that?

44 albatross January 11, 2017 at 9:41 am

Is it possible to go to Mexico or Canada, see a doctor there, and get the vaccine?

45 GoneWithTheWind January 11, 2017 at 9:54 am

As I understand it YOU can physically goo to Canada and buy medicines for your own use and bring them back yourself. You cannot ask someone else to do it for you. You can also have Canadian pharmacies fill legitimate prescriptions for medicine. I would be careful about evading these laws.

I do think that Americans would benefit by a more streamlined FDA approval of medicines. 6 months to a year max and if they miss the deadline the medicine becomes legal by default. More people will be helped by getting good medicines into doctors hands faster.

46 Boonton January 11, 2017 at 10:06 am

Why does the maker not apply the FDA for approval in the US? Certainly the US must offer a larger market potential than Canada?

47 Jon Murphy January 12, 2017 at 12:20 pm

They probably have, but the approval process can take over a decade.

48 Turkey Vulture January 11, 2017 at 10:13 am

Did Alex confess to a crime here? I don’t know the relevant laws, but I would keep the discussion at a more theoretical level out of an abundance of caution. But then again I am paranoid.

49 John Mansfield January 11, 2017 at 10:50 am

The American regulations that make this drug unavailable are part of the same culture that also makes this drug unneeded within the United States, though the drug is apparently useful for those leaving the United States to go to places where the drug is freely available.

50 RPLong January 11, 2017 at 11:06 am

I took Dukerol when I lived in Canada before a big trip abroad. It was interesting stuff. It dissolves in a glass of water and tastes like raspberry soda. I have no idea why it isn’t approved in the USA, nor why the people at US Customs would confiscate it at the border. Just because something isn’t approved to be sold or prescribed doesn’t mean it’s illegal to possess or to take.

51 mulp January 11, 2017 at 1:55 pm

1) FDA can’t approve a drug where no application has been made.
2) FDA can’t address patent issues for drugs with no application for US customs – drug patents granted by PTO have a bunch of exceptions to the normal patent expiration rules based on when the FDA approval is granted.

Dukerol uses a US patent from 1994 which might be expired, but maybe not if the FDA approves a drug dependent on the patent. According to Google, SBL VACCIN AB, SWEDEN paid the 12th year fee in 2005 soon after the EU approval for Dukerol.

We the People speak and act through Congress in calling for protection of Intellectual Products and thus we have mandated US Customs act to police IP theft, “piracy”.

And We the People elected Donald Trump who ran on building walls to keep out both people and products. But how many doses would a factory producing Dukerol sell just in the US?

52 Gordon Blewis January 11, 2017 at 12:41 pm
53 Ian Matthews January 11, 2017 at 12:50 pm

Try LiveLeaf it works great. (full disclosure former employee) http://liveleaf.com/

54 byomtov January 11, 2017 at 1:23 pm

Not a bad idea to take some oral rehydration salts with you.

You can buy packs of these at outdoors stores like REI. As I understand it (I am not a doctor, so check this out) cholera kills you because the diarrhea dehydrates you and you can’t retain liquids. If you dissolve the ORS in water and drink that you will retain the water. It’s not much different than Gatorade, actually.

I’ve heard that a long time ago Indians discovered that drinking rice water can work also.

55 mulp January 11, 2017 at 1:31 pm

The “world government” WHO calls cholera vaccine essential and places “The cost to immunize against cholera is between 0.1 and 4.0 USD.”

Given Canada has cheap drugs, how can you be out $150?

And given the active ingredient costs the same as that in the Epipen, why haven’t US drug makers paid for FDA review so they can charge $800 for something that costs a buck like they are doing with Epipen and and will soon it seems be charging for naloxone.

It sure seems that economists have been totally wrong on manufacturing economies of scale – higher manufacturing volumes and more experience in producing a product seems to increase the unit costs exponentially based on the economic of US drug manufacturers.

56 mulp January 11, 2017 at 1:39 pm

Why not just buy the FDA approved single dose Vaxchora-vaccine?

https://www.blinkhealth.com/vaxchora-vaccine

$76.72 via blink health deal with pickup at CVS, etc after you call your primary doctor office and get a prescription sent by the electronic prescription system. Faster and more reliable than phoning a friend in another country.

57 Angus January 11, 2017 at 2:35 pm

“If it’s good enough for the Canadians then it’s good enough for me.” Spoken like a true Canadian!! We are building the wall in the wrong place!

58 carlospln January 11, 2017 at 2:41 pm

A tempest in a tea cup.

Canuck Version.

59 Urso January 11, 2017 at 3:10 pm

Blame your own weak constitution. A true libertarian would accept the verdict of nature, red of tooth & claw, not ask a nanny pharma company to protect him.

60 Jeffery Mewtamer January 11, 2017 at 3:37 pm

While I think it’s good to have regulatory bodies like the FDA screening things for safety and effectiveness, I can’t say I’m on board with such bodies serving as gatekeepers to the market, especially if the approval process is cost or time prohibitive.

Personally, I say keep the FDA, streamline the FDA approval process, and remove the requirement for FDA approval to enter the US market and let individual doctors decide whether they’re okay with prescribing non-FDA approved drugs, individual pharmacies if they’re okay with selling non-FDA Approved drugs, individual insurance companies if they’re okay with paying for non-FDA approved drugs, and individual patients if they’re okay with taking non-FDA approved drugs.

Also, in general, I see no reason to trust the FDA’s decisions more than the decisions of the FDA’s Canadian, Japanese, or European counterparts.

Also, I consider customs examining the contents of parcels to be a violation of both the sender’s and recipient’s privacy.

61 AlanG January 11, 2017 at 5:52 pm

“Personally, I say keep the FDA, streamline the FDA approval process, and remove the requirement for FDA approval to enter the US market and let individual doctors decide whether they’re okay with prescribing non-FDA approved drugs, ”

LOL big time. Most MDs have no clue about the FDA approved drugs they prescribe these days. They don’t know the adverse event profile, sometimes never check with the patient to see what other drugs he/she is taking, or whether the drug is the best for the patient’s particular condition. And you want to let them prescribe unapproved drugs? Didn’t the US go through this with the patent medicine craze in the early 1900s? Oh yes, that’s what led to the FDA in the first place.

62 Mogden January 11, 2017 at 4:25 pm

Silly Alex. Why would you think you know better than a technocrat?

63 Bill January 11, 2017 at 5:39 pm

Alex is a pharmacist and has his degree in pharmacology.

Isn’t that what a Ph.D stands for. Pharmacy Doctor?

64 Ray Lopez January 11, 2017 at 6:32 pm

Dr. Alex Tabarrok, illegal drug user.

65 Tom T. January 12, 2017 at 12:00 am

I initially thought the accompanying picture represented a radical new delivery device for a diarrhea drug, resembling some sort of brush or even plug that was to be inserted into one’s nether opening.

66 Jon January 12, 2017 at 6:09 am

Alex left out critical information. How effective is the drug? Which specific germs is it most and least effective against?

67 Sam January 12, 2017 at 10:59 am

Read the post

“As a side-effect, however, Dukoral is also quite effective (60%) against the most common cause of traveler’s diarrhea, that caused by enterotoxigenic E. coli.”

68 Jon January 12, 2017 at 6:15 am

An irony: One of the key examples cited by libertarians of lives lost due to FDA delay is Beta-blockers–a drug to lower blood pressure that had fewer side effects then existing alternatives. However, more recently it has been found that Beta-blockers are far less effective at preventing the harms from high blood pressure than the blood pressure measurements suggested. I guess that example goes down the drain, as well as the complaint that the FDA is too rigid about getting results from actual health outcomes vs proxies.

69 Euripides January 12, 2017 at 11:47 am

Canadians!! there is an expression in the South for them “bless their hearts”!

70 edwardseco January 25, 2017 at 8:40 pm

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