Category Archives: Pharmaceuticals

What The FDA Isn’t Telling You

Traci Johnson was discovered hung on February 7, 2004 in an Indianapolis laboratory run by Eli Lilly. She had been involved in a clinical drug trial on the antidepressant duloxetine, and investigators from the Food and Drug Administration were there to investigate, coming up with inconclusive results. This left plenty of people wondering, was the drug safe or not?

Was Johnson’s death that one off situation? Now, more recently, researchers have been able to nail down differences between different types of depression from blood and urine test. They have determined that some types actually respond badly to traditional antidepressants, as Johnson did, whereas some others respond well. So what stopped them from looking for the differences before running this test?

Eli Lilly focused on the idea that this was nothing more than an isolated incident, and when any drug company chooses not to publish or reveal these types of results, it leaves the public at large partially uninformed, and in a way, if it is an isolated incident, it protects us from throwing away possibly great drugs because of those one offs.

If you read off the side effects on virtually any common antidepressant, suicide is one of the possible side effects, but only in extreme situations of course. Maybe that’s their way of revealing these types of results in an obscure way. However, the FDA claims their silence is due to the idea that some data in clinical trials is considered trade secrets or commercially protected information. In other words, if somebody dies, they hide behind trade secrets.

To be fair, the same thing can be said about measured effectiveness, and yet it’s different. Because our body chemistry is so different and we respond so differently, it’s difficult, if not impossible to find any antidepressant that is going to be effective for everybody. We’ve all been through our share of failures and side effects in trying to find the right drug.

The market is littered with stories similar to that of Johnson’s. Marketers are afraid, whether or not their product is riskier, and they don’t want you to know about these incidents, and apparently, neither does the FDA.

Eli Lilly officially lists no suicides and 2 deaths among patients who were enrolled in clinical trials for Cymbalta, which actually had suicides documented. The website now lists 10 clinical trials of Cymbalta and 5 for a drug called Yentreve, where they disclose 1 suicide and 5 deaths combined. There are 5 suicides allegedly left out of the FDA results.

Does this mean that you should swear off your antidepressants and never trust another thing your doctor says about FDA approved drugs? Not at all. Frankly, there have been many helped by antidepressants that may not work or even cause problems for others. But it does mean that you should take the FDA’s word with a grain of salt, and if you find yourself having negative side effects or things like suicidal thoughts, take them seriously and listen to yourself.

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Can You Cure Crohn’s Disease?

Just try getting a correct diagnosis. Let’s jump that hurdle first. If you have a digestive disorder, a lot of them look virtually identical, and many times, it takes a few attempts with the doctor to actually get the right one. If you have Celiac disease, in a way, you’re lucky as it’s all about dietary changes, and it can be fixed. However, with Crohn’s disease, it could very well be the most severe and tragic of digestive disorders, especially when diagnosed improperly.

This said, one can live with Crohn’s disease. In fact, some are even talking about a cure. Some have started to use fecal transplants for this (among other digestive disorders). Personally, I just can’t stomach the idea of someone else’s feces going into my body, regardless. However, some have talked about truly miraculous results there.

There are others though who say that they have been cured of Crohn’s disease in other ways. My question is, is it like the cure for AIDS, which as it turns out is not a cure at all. AIDS has reemerged in those who were thought to be cured.

When it comes to Crohn’s, it is a mix of medications according to some, specifically for TB and leprosy. Like fecal implants, the idea is that Crohn’s disease is actually caused by a germ in the digestive system, and if you get that germ out or overwhelm it with good germs, then you can eliminate the problem and the plethora of symptoms that come with it. According to proponents for this treatment, you have to follow a certain diet, and in most treatments for digestive disorders, they recommend following a healthier diet free of certain trigger foods, such as spicy foods for example.

As of right now, the evidence is based on case reports. There are no large, overwhelming studies. So there is some fair speculation about if this is actually legitimate. It’s fair to say though that some have benefited from it, and of course, the ones experiencing the medical miracles are more willing to be loud about it than those who simply saw no results either way. So what is this plan?

The Diet

This diet is a bit more extreme and particular than many others suggested for digestive disorders. Something called MAP (otherwise known as Mycobacterium avium subspecies paratuberculosis) has been found in many dairy products. In other words, we get into the hormones put into foods and animals. Proponents suggest that MAP is part of the problem, and if you eliminate foods with MAP in it, that is one of the first steps to kill and prevent the bacteria’s regrowth. Some people are also extending this MAP free diet to other digestive disorders. Articles about Mycobacterium avium subspecies paratuberculosis have permeated many of the natural magazines and even other scientific publications. Granted, if you talk to your gastroenterologist, chances are they are going to brush it off, especially with some of the sources who have become slightly obsessed with it.

The Borody Protocol

Some patients have been started on what’s called the Borody protocol. This consists of clarithromycin, rifabutin, clofazimine and ethambutol. This is more medically supported in some circles. Since the beginning, some have stopped taking ethambutol due to the fear of side effects while clofazimine was discontinued in the US. It was instead donated to agencies that treat leprosy, generally through the World Health Organization. Patients have then reduced it to a combination of rifabutin, clofazimine, and clarithromycin. Within a few months, there have been reports that all symptoms have virtually disappeared.

Are People Cured?

There are people who have gone a number of years without more symptoms, but do we dare say that they are cured. Many are understandably approaching this with a large degree of caution. Crohn’s disease has negatively affected a number of people, and it is a daunting disease. We don’t want people to stop using good medications or for that matter do things that will allow/force the disease to progress.

Nobody is really sure how this will go forward. There are some who are trying to conduct more studies and do more research. We don’t know if this is really a cure, and there are plenty of critics of this for strong reasons. At this point, we will see how things move forward, and if it turns out to be a cure, then we’ll talk about that then.

Are Prescription Drug Studies Reliable?

Prescription drug companies capitalize on the idea that they are FDA approved and natural or alternative treatments are not. They brag about all of these big studies and other proof, and yet some have accused drug reps of using false studies! If they had so many legitimate ones, why in the world would they have to lie, right? Apparently though, they are, and there’s nothing the US government can do about it. That’s a little scary.

In the US Court of Appeals in New York, they have ruled that a drug salesman pedaling this false information was just practicing free speech. Yes, his employers should have been smarter, and yes the doctors should obviously be doing their own research. But he can basically say what he wants when it comes to the uses and studies about a drug meant to treat narcolepsy.

pharmaHe told doctors that it could be used to fight insomnia, chronic fatigue, and other related conditions that the FDA has not approved. If the Supreme court does not overturn this, it’s also scary for the consumer. Obviously, if you’re using something that is not actually meant for your condition, that could be harmful, but there are worse things. Companies will benefit from this decision by paying fewer multi-billion dollar fines, and unnecessary and useless healthcare spending will actually increase! In other words, more money goes out of your pocket and into the pockets of big pharma.

Maybe the US Court of Appeals hasn’t heard of false advertising. They get natural companies for that same act all the time. They prosecute weight loss companies who they say don’t have FDA approved studies to show that their drugs promote weight loss. They prosecute companies who say their drugs will fight joint pain. But when it comes to a drug rep pedaling a prescription drug, lying about the uses of that drug and the studies surrounding it is “free speech.” I’m not big for lies in general, but it seems a bit hypocritical and makes it harder to trust a doctor unless you know he’s taking the extra time to do the research himself. What happens if the sites are doing the same thing? More specifically, your doctor may go to the company’s website to do his research. Are the sites subject to the same “rights to free speech” ultimately leading to complete mirepresentation?

So far, this decision only affects 3 states including New York. The FDA understandably aims to appeal. If they do and the Supreme court rules against them, this could affect the whole country, not just 3 states.

What are the big implications for drug companies? Just think about GlaxoSmithKline, who paid out $3 billion in July to settle 3 separate indictments. 2 of the indictments were leveled because they were marketing anti-depressants for off label and unapproved uses. In just the past 4 years, companies like Pfizer, Johnson & Johnson, and Abbott and Eli Lilly have individually paid over $1 billion for the same basic reasons.

Frankly, big Pharma is held to a higher standard, or at least they’re supposed to. In some cases, they are talking about real studies. The problem is these are often biased, shoddy, and completely unreliable. Hence, the FDA has not approved those uses. Do you really want your doctor prescribing useless drugs that are extremely expensive (even after insurance payout) based on the word of a drug rep? I don’t.

One of the scariest of these studies was released by Paxil. They pulled together shoddy studies suggesting that Paxil could treat depression in teens and minors. The problem is the study wasn’t valid, and actual numbers showed it would likely increase suicide risk. Just think. You get your teen a drug to help them fight their depression, and next thing you know, you’re in the hospital because an otherwise non-suicidal teen just attempted suicide after taking their drug. This kind of ruling could also negate the parents’ ability to sue both doctors and drug companies.

Obviously, this kind of behavior is financially appealing. The more prescriptions they can get doctors to write out, the more money they make. The problem is that it comes at major cost to you, the consumer. It comes at major cost to the healthcare industry that take care of you as a whole.