I can tell you everything that’s wrong with the drug approval process in one word: Tamiflu.
But the biggest problem with the drug isn’t what we know from the research. It’s what we don’t know — because the company that makes the drug, Roche, has refused to release some of the most important details on patient outcomes.
Now, they’re taking some big-time heat for it. The editor of BMJ, Fiona Godlee, published a scathing editorial practically demanding the data. And one leading researcher went even further.
Peter Gotzsche, head of the Nordic Cochrane Centre, called on the European Union to sue Roche to get back every penny — or every euro — of the billions spent stockpiling the drug based on those half-released studies.
But why would those health officials sue for that data when they didn’t demand it in the first place, before they actually approved the drug?
And that’s exactly the problem here, because this approve-first, ask-questions-later approach isn’t limited to Tamiflu. Drugs for everything from cancer to cholesterol are often given the OK based on limited and conflicted data, and long before we know everything we need to know about them.
In Tamiflu’s case, even what we know so far from those partially released studies is thoroughly unimpressive: The drug may shorten the duration of the flu by as much as a day or so, but only if the flu patient takes the drug within 36- 48 hours of the onset of illness.
And who does that?
Most people spend the first 24 hours thinking they just have a cold, and the next 24 hours wondering if they should call the doctor.
By the time they get into the clinic, two or three days have passed — and by then, it’s too late for Tamiflu (although that little detail hasn’t stopped doctors from prescribing it anyway).
There’s no other benefit to the drug, by the way. There’s no evidence that it stops the spread of the disease, and some researchers have even concluded it doesn’t lower the risk of flu complications, hospitalization, or pneumonia.
And it’s linked to a ton of side effects, from the just plain nasty — think stomach pain, nausea, and vomiting — to serious psychological problems and bizarre behavior, especially in kids.
That’s why I’ve never prescribed this drug to my patients. I’ve never even been tempted to, since there are already safer and more proven ways to limit the damage of the flu.
Start with N-acetylcysteine. With a name like that, it almost has to be abbreviated — so expect to find it sold under the name “NAC.”
Take 600 mg twice a day during flu season to avoid the disease. If you manage to get sick anyway, up the dose to between 2,000 mg and 3,000 mg a day for a week. Unlike meds, studies have shown NAC really can reduce both the duration and severity of the flu.
And for more on how to beat the flu without a drug or vaccine, read my free special report, “Beat the flu without a shot.” And if you’re in the Southern California area, visit my clinic for a personalized regiment that can give your immune system the power it needs to fight off just about anything that might come its way.
Dr. Mark Stengler