February 27, 2009

Court Case: How One Drug Company "Buried" Evidence Showing Its Drug Caused Diabetes

If you have a strong stomach, take a look at this news story:

AstraZeneca Seroquel Studies ‘Buried,’ Papers Show.

The data is coming out ten years after the malfeasance described here which resulted in the information being hidden from doctors that the expensive new drug, Seroquel, was less effective than older, cheaper drugs, and that there was solid evidence that it caused both weight gain and diabetes.

As many of you have learned the hard way, the diabetes that the atypical psychotic drugs like Seroquel causes may be irreversible. It is probably not caused by the weight gain experienced in people who take these drugs, as the story suggests. Instead, as is so often the case, the weight gain probably occurs after it breaks something that causes blood sugars to rise high enough to increase insulin resistance.

What's really tragic here is that people took Seroquel because the company hid the data suggesting it was less effective than halperidol, an older drugs whose problems were well understood.

But my reason for highlighting this study is not just because of what it shows us about how Seroquel was marketed, but because it alerts you, once again, to the techniques that have been used by all the drug companies selling expensive new drugs and makes you aware of how far they are willing to go to convince doctors to prescribe these new drugs to you even when they have internal documents warning that these drugs may not be effective and that they may do patients harm.

Because it takes at least a decade for the real problems with widely prescribed drugs to become evident enough that drug makers are forced to surrender internal documents to the court, it will be another 8 more years until the public learns about the mismarketing of today's new drugs. Between now and that time, hundreds of thousands of people will experience irreversible, life-altering side effects from ineffective drugs that in some cases will end their lives prematurely and in others, as is the case with Seroquel, will add other chronic disorders to their health burden.

But because so much ugly truth has leaked out about the drugs of a decade ago, there is a change in how drug companies are operating. Today's drug company will commit errors of omission rather than squelching of results. If you don't do a study looking into something that a reasonable scientist would assume should be investigated, given how a drug affects the body, you won't end up with a result you have to hide.

So you won't be seeing studies looking to see if people taking Januvia have a higher rate of cancer if they keep taking this drug longer than the 18 months that acceptance trials lasted, even though the mechanism by which Januvia works is known to shut off tumor fighting genes. This is true, even though there was a slight hint in acceptance testing that even in 18 months cancers were rising in people taking Januvia. The company cleverly spun the way it reported tumors so that this finding was obscured.

Several non-drug company researchers who work with DPP-4, the protease suppressed by Januvia, have told me that this is a valid concern and one that should be investigated. But given the role drug company money pays in research today, no university is going to sponsor research of this kind. They are too dependent on that drug company money which would be shut off were they to blow the whistle on this highly profitable new family of drugs.

You have only to look at how the maker of Avandia threatened the university that employed the researcher who tried to blow the whistle on Avandia's relationship to heart attack, to see the power of this threat. Avandia's heart attack risk stayed hidden and the researcher was muzzled. Few universities can afford to defend lawsuits threatening $4 billion dollar damages.

Read about the $4 Billion Law Suit Used to Muzzle the Avandia Whistle Blower HERE.

By the same token, you won't find much new research looking into the incidence of blindness in people who took Avandia or Actos for more than a decade, though we now know it increases macular edema. You won't find studies that follow people who took Avandia or Actos for 15 years to see how many of them end up in nursing homes with broken hips, though we know these drugs increase the incidence of serious osteoporosis in older women.

Drug companies pay for most drug studies, and they have learned from what happened to Avandia to avoid doing any studies of already successful, approved drugs that might turn up anything troubling.

And even when they do conduct studies they are careful to avoid asking any questions but those where they already know the answer. When testing the effects of powerful new statins, for example,they don't include measures of cognitive function, before and after people spend five years on the drugs, because if they were to do so, they'd have to let you know that whatever benefits these drugs have are countered by their tendency to cause cognitive problems in older people.

Bottom line: Be wary. Don't believe everything you read in published studies because the data has often been analyzed in ways that obscure important findings, or the study design itself or the selection of study subjects may have been tinkered with to provide a result that would boost sales. Remember that negative studies often do not get published.

Take as few pharmaceutical drugs as you possibly can. When possible take older drugs that have survived the test of time, whose real side effect profile is known, and which are out of patent so that there is no financial motivation for companies to promote them with tricks.


ItsTheWooo said...

One comment regarding seroquel and diabetes...

It amazes me that there is this irrational and unfounded assumption that lithium has horrible/intolerable side effects, when the reality is that antipsychotics (that is, dopamine blocking medication) have worse side effects in any dose, of any kind of AP (typical or atypical). Drug companies have perpetuated this myth that lithium is a drug you don't want to be on, when the reality is it's probably the better tolerated of any medication used for psychosis/mania. Lithium doesn't make you hugely fat, it doesn't cause diabetes, the only valid risk is that which is is associated with hypothyroidism and kidney damage related to lithium salts (but these are long term changes on high doses). As far as metabolic consequences go lithium is way way way better than any dopamine blocker.

It angers me that the majority of people receiving psychiatric care think lithium is a bad choice because of how they've been brainwashed.

Antipsychotics have a place in medicine, for the acutely and severely psychotic. In a state hospital, yea, you want your haldol and what not, trust me as someone who works in health care, uncontrolled severe psychosis is by far a worse fate than diabetes.

So I'm not against antipsychotics, but what we have instead is this terrible, almost criminal tendency to give people with mild mental illness antipsychotic medication! (e.g. bipolar II, depression that may be suspected bipolar) and it's just frigging irrational because the side effects of the medication are worse than the disease itself. And doctors are encouraged not to use more gentle medicines which can be very effective, like lithium, because there is no money in these older/natural medicines like lithium (my sister pays, what, 4 dollars a bottle?)

When I did research on lithium after my sister started taking it I was shocked to discover that lithium used to be used for psychosis, severe aggression, it pretty much works for everything related to craziness... but there is this myth that it "only works for type 1 bipolar disorder with euphoric mania". It's just not true at all, it kinda works for everything. And you have these patients out there brainwashed to believe seroquel is a better drug because "it helps depression" or "it works in people with non-classic bipolar whereas lithium does not" or "it works with mixed episodes whereas lithium does not". None of this is true.


Cassini said...

Hi there,

I myself have been dealt the loving hand of Seroquel and have had both the weight gain and I am now Type2 Diabetic. I have been taking Seroquel for approx 4 years now, my highest dosage was 800mg/day, at this dose the weight was piling on.
I was ( mis-) diagnosed with bi-polar disorder to begin with. I have a lot of other psychiatric "labels" as well. It was also 'scripted for off label use in my clinical depression and anxiety.

There are a couple of other sad things involved with this. First being I contacted AstraZeneca with my diagnosis of Diabetes (Sept'08), after a few weeks, they did respond with an email saying they are sorry to hear of my plight and have passed the email on to their internal investigation sector. I have not heard another word from them since.
Second, which really should be first, I am STILL taking this nefarious medication! I am in the process of weaning off of it with Doctors care, but as I take less and less, I am down to 100-125mg/day. I am feeling worse in the depression area.
I do see my PsychDoc tomorrow in fact and am going to ask him to get me OFF this permanently, even if it means taking something else instead.
The fact of the matter is this, I do suffer from some mental illnesses. I am now also ill physically. Diabetes is not going to go away. Ever. It is and has already started to cause erosion of other parts of my body, my kidneys are now under the care of a Nephrologist, my vision has been affected.
The worry associated with these ongoing and progressive illnesses just adds more to my already stressed psyche, needing more meds to deal with an already heavily medicated body and mind.
And what do I have to look forward to in the future? Nothing from Seroquel makers, that is for sure. Do I thank them for not having enough information on the handout sheets in the box? No point in that.
I am very frustrated by all of this and look forward to some bleak issues to deal with.
I truly hate AstraZeneca.
Helen In Canada

Unknown said...

I took Actos for 2 years. I am almost blind. I have had to have 21 shots of steroids in the eyes, ctaract surgery in both eyes, Shingles in both Corneas and now floaters so bad I cannot see to even read. All over the last two years and due to a drug I didn't need. And I am only 52. During those two years I was in great control of My diabetes. A1Cs from 5.7 to 4.8. After stoping the three times a day Actos plus met, I lost 42 pounds within the next few months. The retinas are still trying to heal. I want to sue, i just don't know where to start.
thanks for listening