In a post I put up last September, I asked “What Is Going On With The FDA??”

Thanks to a couple of articles I figured it out.

There’s a reason it takes so many years for the FDA to take action against “dangerous” drugs like children’s cold meds, Rocephin, and Haldol. These drugs have all been on the market for more than 15 years and in just the past six months, the FDA came to the conclusion that they were all a threat to American lives.

Enter the GAO.

In a New York Times article, government investigators have just reported that the FDA is woefully understaffed. The article stated that at the FDA’s current staffing level, it would take more than 13 years to check every foreign drug manufacturing plant, and more than 1900 years to check every foreign food manufacturing plant. No, I didn’t have a nervous twitch on the “0″ key. The article states “one thousand nine hundred” years to check all the foreign food manufacturing plants. In fact, the FDA computer systems are so bad that they can’t even create a list of which plants have been inspected and which have not.

A Wall Street Journal article reported that the FDA can’t even keep up with inspection of domestic manufacturers of medical devices (like defibrillators and contact lenses).

A former lawyer for the agency stated that “This is a fundamentally broken agency, and it needs to be repaired.”

So it isn’t like Big Pharma is paying off the FDA to approve drugs while they are on patent and then put danger labels on them when they are off patent (and no longer earn the drug cartels companies any money). It’s just that the FDA is so overworked that 15 years is about how long it takes until they can review a drug’s safety profile.

Doesn’t that make you feel better?

Hat Tip to ACEP‘s Emergency Medicine Today

According to a front page article in the Washington Post, an FDA panel voted 13 to 9 to recommend against the use of over the counter cold medications in children less than age 6.

Is there some genetic transformation between the 2190th and 2191st day of life that makes someone less likely to have adverse effects from these medications? Or is the panel just drawing arbitrary lines in the sand at age 6?

I think the reason they made this arbitrary age is because everyone on the panel has kids that are older than age 6, so they don’t have to worry about treating colds in their kids any more.

Here’s an interesting factoid: According to the Washington Post article, Mary Tinetti, MD of the Yale School of Medicine is the doctor who chaired the FDA panel. Mary Tinetti is also Chief of the Division of GERIATRICS at Yale. She is the Director of the Claude D. Pepper Older Americans Independence Center. Her interests are in fall injury risk prevention and geriatric health problems. All of this is obviously germane to the effects of children’s cough and cold medications. In fact, she must have a lot of experience with 6 year olds — maybe when they come to their grandparent’s doctor’s appointments and are all strung out on cold medications.

If I were asked to be on a panel with Dr. Tinetti’s qualifications, I would decline because of a lack of experience with the subject matter. Why did she accept the appointment?

If your kids are sick this winter and you want to get an FDA expert’s opinion, you can contact Dr. Tinetti at the link above.

No, I haven’t been watching the movie “Conspiracy Theory” too much.
No, I don’t believe that Big Pharma is coming to get me (yet).
But within the past week, I’ve received two warnings via e-mail about how I should stop using medications I’ve used all my career. Suddenly, they’re a threat to the life and well-being of my patients.
First, it’s an FDA ALERT about haloperidol (Haldol). After 18 years, now we must put all Haldol patients on an EKG monitor. I was thinking about that during one of my rant manic phases. Does that also mean that we can bill the government more for taking care of these patients since we are providing a higher level of care?
The latest warning is another FDA ALERT regarding ceftriaxone (Rocephin). If Rocephin is given within 48 hours of anything containing calcium, it can form a Rocephin-calcium complex in the lungs and could KILL YOU! There are case reports that prove this, you know. At least that’s what the FDA says. So I went to PubMed and looked for them.

One small study from 2004 stated that Rocephin may cause small sized asymptomatic renal stones when administered in children.
Another small study from 2000 stated that Rocephin can cause transient biliary stones in children that typically disappear in less than 2 months.
Another case report from 2000 showed a 5 year old girl that developed symptomatic pseudolithiasis during treatment with “Rocephalin” (maybe it was another medication – Rocephin’s evil isomer). The symptoms disappeared within a few days after changing antibiotics.
Several studies from 1990, 1992, and 1991 discuss how Rocephin can complex with calcium and cause biliary sludge. One patient allegedly developed pancreatitis from Rocephin.

But I’ll be darned if I can find one case of a patient developing the dreaded lung Rocephin complex. And no case reports I found had anyone dying from Rocephin – at least in any of the studies published on PubMed. Maybe these are top secret government studies that are off limits to the public. Secret Squirrel, we need your help.

But now, if your kid drinks milk, you better not give him Rocephalin for 48 hours because he could develop kidney stones in his lung and could die. And whatever you do, if you’re taking Rocephin, DON’T HYPERVENTILATE. You could increase the ionized calcium in your system, it could bind with Rocephin and you could kill yourself.

What’s my beef?
First, why did the FDA wait for 18 years to now suddenly declare this drug a threat to human life? If kids really did die from receiving Rocephin and calcium together, these rocket scientists at the FDA should be held responsible for delaying their FDA ALERT for so long.
Second, Rocephin went off patent in July 2005. Another FDA attack on a generic drug. Ceftazidime and cefotaxime are two other generic injectables in this class of antibiotics. I’m just waiting to see how long it takes before these medications get FDA ALERTS, too. Then physicians will be pushed into prescribing the high-priced but “safe” brand name injectable antibiotics.
Third, what’s so magical about 48 hours between calcium and Rocephin? Has the FDA not heard about protein binding? Or does that only occur with drugs that are off-patent?

I’m going to go take a couple of aspirin, now. But I’m only taking them with water. Filtered water. From a spring in a small town in northern France.

The FDA just came out with an FDA ALERT warning healthcare providers about the use of Haldol.
Based on an Italian study in 2005, there may be a link between Haldol and Torsades de Pointes/QT prolongation. In addition, there were “at least 28 case reports” of Torsades and QT prolongation with Haldol use. Knock me over with a feather.

Now there is a recommendation that EKG monitoring be performed on anyone receiving IV Haldol.

Haldol was approved by the FDA in 1988. Nineteen years and probably tens of millions of doses later we are able to come up with a whole 28 case reports that may link Haldol to prolonged QT syndromes? Impressive.
Notice how the ALERT states

Based on case reports alone, we are unable to estimate the frequency with which QT prolongation or TdP occur following administration of these drugs.

Doesn’t matter. Just blast this medication the same way you blasted Droperidol with no scientific basis.

So now I have some questions.
If the FDA was so concerned for patient safety, why did it wait for two years before posting its FDA ALERT? The study which forms the basis for its ALERT was published in 2005.
Did anyone notice that the Italian study cited used Haldol decanoate – the long-acting version of the drug? No one gives that IV.
Did anyone notice that the study cited by the FDA was sponsored by Johnson & Johnson? Janssen Pharmaceuticals is one of Johnson & Johnson’s partners and makes a product named Zyprexa that competes with Haldol. Zyprexa has sales of more than $2 billion per year. Don’t suppose that sales of Zyprexa will be hurt by the FDA’s shock statement about Haldol usage.

Interesting NY Times article from 2003 showing how these antipsychotic drugs are a huge moneymaker for pharmaceutical companies. The article notes that

For the price of treating one person with Zyprexa at $303 for a month’s prescription, he said, or two on Risperdal, at $159 per month, the state could treat 8 or 10 people with Haldol at $35 per month.

Zyprexa and Risperdal have been linked to early onset diabetes and DEATH, but there is no “FDA ALERT” that we have to do Hemoglobin A1c levels or blood glucose levels before giving them. Risperdal is also linked to strokes, but there is no “FDA ALERT” that we have to do a CT scan on every patient before we give it. Why all the fuss about Haldol?

Want me to stop using Haldol? Here’s my proposal to patients:
Stop coming into my emergency department as an angry drunk or a combative drug abuser. Stop trying to assault me or my staff. Cooperate with us while we try to help you. Then I won’t have to use Haldol on you and everyone will be happy – except maybe Johnson & Johnson.