FDA still overcautious on meningitis vaccine after student dies

posted at 3:21 pm on March 21, 2014 by Kevin Glass

Drexel University student Stephanie Ross died last week from Meningitis B, a straing of the bacteria that has been seen in recent outbreaks on college campuses. It’s thought she had contracted the bacteria while visiting friends at Prinecton University. Approval for a Meningitis B vaccine has languished, waiting approval from the Food and Drug Administration.

Jared Meyer of Economics21 points out that Princeton and the University of California, Santa Barbara have been granted special exemptions to vaccinate their students, and that the meningitis B vaccine has been used safely in the United States and around the world:

The FDA is responsible for creating an environment where a vaccine that has been proven safe and is approved for use in Canada, Australia, and the European Union cannot help Americans. Companies know the immense financial costs, time commitment, and regulatory uncertainty associated with getting the FDA’s approval for a drug. Because of this, they often hesitate at the barriers to bringing a drug to market—to the detriment of consumers.

Surprisingly, the FDA admits the vaccine against type B meningitis is safe. The vaccine is referred to as an “investigational new drug.” If the FDA agrees that the drug is safe, and has approved it for the entire Princeton and UCSB campuses, why is it still not available for widespread legal use in the United States? The answer boils down to an institutional problem that causes specific harm, and even death, to Americans.

It’s pretty universally recognized that the FDA is too slow to approve new drugs. College students are often required to be vaccinated before attending school – but none are vaccinated for meningitis B because the FDA has yet to approve the drug. These outbreaks are entirely preventable and these problems can be traced directly to the FDA.

FDA reform is something that not enough Americans get exercised about, but their archaic procedures probably impact more people on a day to day basis than most government regulations. For more on the subject, read the FDA Review, a project of the Independent Institute, which catalogues the FDA’s malpractice and options for reform.

Update, 3/25 (Ed): Meningitis B is a meningococcal disease, which is caused by bacteria and not a virus as the post originally indicated. The correction has been made above; thanks to reader Chris C for the correction.


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It’s next in priority after the Keystone pipeline.

/s

PolAgnostic on March 21, 2014 at 3:23 PM

College students are often required to be vaccinated before attending school

So, where do all the special little snowflakes go whose mommies don’t want them vaccinated?

DublOh7 on March 21, 2014 at 3:26 PM

FDA reform is something that not enough Americans get exercised about, but their archaic procedures probably impact more people on a day to day basis than most government regulations. For more on the subject, read the FDA Review, a project of the Independent Institute, which catalogues the FDA’s malpractice and options for reform.

.
People would get excited if they new the flip side of the coin … how lax the FDA is in its oversight of pharamceutical companies meeting safety standards related to public health.

Combined with the FDA’s ability to generate unenforceable regulations, they WILL kill a bunch of people one of these days.

They don’t enforce the standards plants were built to meet while they are busy dreaming up new standards that would require new plants.

PolAgnostic on March 21, 2014 at 3:28 PM

So, where do all the special little snowflakes go whose mommies don’t want them vaccinated?

DublOh7 on March 21, 2014 at 3:26 PM


Home to Jenny McCarthy?

;->

PolAgnostic on March 21, 2014 at 3:29 PM

On the other hand maybe it’s not such a bad thing after all, FDA is notorious also for approving all sorts of under-researched drugs/medicines (following half azz/incomplete or inconclusive clinical trials) that turn out to be controversial at least, side effects and all…

jimver on March 21, 2014 at 3:34 PM

Archaic review process.

Thats cuz none of the drug companies are bribing the FDA leadership to fast-track something for them.

If there was profit potential here, it’d be done already.

BobMbx on March 21, 2014 at 3:35 PM

I work in the pharmaceutical research field. Specifically I work in Data Management which is the group that sets up and monitors the databases that capture the data from clinical trials.

I have some stories… oh boy do I have stories – that would make you literally want to run like hell from anything that’s “approved” by the FDA.

Defenestratus on March 21, 2014 at 3:42 PM

The FDA is too big.

It should be split up and streamlined.

workingclass artist on March 21, 2014 at 3:44 PM

People would get excited if they new the flip side of the coin … how lax the FDA is in its oversight of pharamceutical companies meeting safety standards related to public health.

PolAgnostic on March 21, 2014 at 3:28 PM

Holy crap. You don’t even know.

Dude there are three letters you never mention around my office for fear that they’ll be summoned.

“Oversight” isn’t the correct word. When the FDA comes to audit your operation, you already know that the bill is in the mail.

Lax is not the word I’d use for it. Terrifying. Intimidating. Career-destroying. Product-killing. Those are the words I’d use for them.

And yes, I work on the front lines of this industry.

Defenestratus on March 21, 2014 at 3:46 PM

Fun Fact #1435

On any document that does into the Trial Master File, you cannot put a drop of red ink on it. Why? Not because its ugly or offends the senses.

No.

Its because the FDA still apparently has photocopiers that cannot pick up red ink.

Defenestratus on March 21, 2014 at 3:47 PM

The FDA is at once both crushingly slow and negligent at the same time. Typical, really.

antisense on March 21, 2014 at 4:19 PM

College students are often required to be vaccinated before attending school – but none are vaccinated for meningitis B because the FDA has yet to approve the drug.

Meningitis vaccine is not one of the mandatory vaccines required….at least it wasn’t when I went. When I was at school they gave the free meningitis vaccinations at the beginning of the semester, but it was voluntary…and that was only because someone had died from it the previous semester.

Pablo Honey on March 21, 2014 at 4:23 PM

Personal story, for two different years at college I took a vaccination for bacterial meningitis. In one of those years, a kid in my dorm died from the disease.

I guess this vaccine is for viral meningitis, which is something else. It doesn’t seem to make sense that the vaccine’s approval is not facilitating its wider availability.

22044 on March 21, 2014 at 4:28 PM

Ohio State has an outbreak of mumps infecting at least 32 people. Why? People not vaccinating their kids. The close proximity at this huge school really, really calls for FDA streamlining of various vaccine approvals.

antisense on March 21, 2014 at 4:36 PM

My son will be attending Auburn Univ. in the fall. The only vaccines they require is the Tuberculin Skin Test (PPD) and measles (MMR). If these tests/vaccines are not done within 6 months of entering school then you will not be able to attend at all. My pediatrician has recommended a meningitis vaccine as well just to be on the safe side.

KickandSwimMom on March 21, 2014 at 4:38 PM

The FDA has lost sight of its mission.

It banned my fragrance free hand soap, for instance, in what I think was at the behest of a competitor. Why else would they?

A friend sold his chemical company because he was sick of various FDA guys contradicting each other about whether or not he could go forward. A doctor reported that her application to investigate a new “drug” (stool samples for FMT) weighed 22 pounds, and that’s just the start of it.

I think they got tons of money from Obama and now like the EPA are regulating everything and anything.

PattyJ on March 21, 2014 at 5:16 PM

This is par for the course with the FDA. They are a beauracratic nightmare within a buearacratic nightmare. As an example (not a comparison to their responsibility in this young girl’s death), they will not approve a blood glucose meter that can connect to a phone via bluetooth. There are a couple of oddball ones that have overcome the hurdle, but, c’mon, it’s something that should be on every blood glucose meter.

The FDA must be reformed, just like the EPA, the Dept. of Education,………ad infinitum

NOMOBO on March 21, 2014 at 5:16 PM

One class of people are exempt from FDA processes and review. Any medication showing any promise at stage two testing is immediately made available to HIV positive people. It is also the law that HIV positive always get brand name drugs rather than generic drugs, the cost generally paid for by the government.

The American left always uses Europe as a model but in Europe they make drugs available quicker and easier. Many drugs are available without prescription at pharmacies upon consultation with a pharmacist.

Viator on March 21, 2014 at 6:13 PM

he American left always uses Europe as a model but in Europe they make drugs available quicker and easier. Many drugs are available without prescription at pharmacies upon consultation with a pharmacist.

Viator on March 21, 2014 at 6:13 PM

Is this due to a more efficient health care system, or because it takes forever to see a doctor?

BobMbx on March 21, 2014 at 8:00 PM