July 13, 2010

No. I Am NOT Paranoid about Drug Company Evildoing

The drug companies will do whatever it takes to keep their blockbuster drugs selling, and often what it takes is deliberate hiding of research results that point to the dangers of the drug.

I urge you to read this New York Times article published today in full:

NYTimes: Diabetes Drug Maker Hid Test Data on Risks Files Indicate

But keep in mind that the media know Avandia is a dangerous drug because the company ran one study too many--one that demonstrated that it was killing people. They do not have a clue about the dangers of other drugs, even those that are already well documented (like the way that Actos causes heart failure and serious osteoporosis with long term use). Nor do the people who write about health in the media do any research beyond printing up press releases and interviewing a few high profile doctors who are inevitabley highly paid as "consultants" by the big drug companies.

And, of course, the media know nothing at all about the many other drugs whose makers have been more successful than Glaxo at hiding the research that turned up serious problems connected with their drugs.

Which is why you really DO have to be paranoid--very paranoid indeed--about any new drug. And if you have diabetes the drugs you really need to be paranoid about are the "gliptin" drugs that lower blood sugar by impeding the action of the gene that makes an enzyme, DPP4, that degrades GLP-1. Januvia (sitagliptin) and Onglyza (saxagliptin) are the two "gliptins" that have been approved for use. There are others in the pipeline.

The problem with these drugs is this: while inhibiting DPP-4 does, in fact, boost GLP-1 levels and lower blood sugar, the body uses DPP-4 for many OTHER functions besides getting rid of GLP-1. The most important of these function is this: the immune system uses DDP-4 to kill cells that have become malignant--i.e. those first cells that left alive turn into dreaded cancers including melanoma, lung cancer, ovarian cancer and prostate cancer.

All of us develop cancerous cells as we go through life. But our immune system recognizes them and kills them. It is only the rogue cells that escape this process that go on to kill us. DPP-4 is one of the tools the body uses to kill these cells before they can grow into tumors.

And here is why you need to be paranoid about the gliptin drugs: Though the function of DPP-4 as a tumor suppressor is well known, the drug companies have never revealed that they have done a single research study to examine what happens to the body's ability to defend against these cancers when DPP-4 is inhibited.

The tests that are required as part of the FDA drug approval process will not answer this question. The cancer-related testing is made up of only two kinds of tests.

One is a test tube study, The Ames Test, that only can tell if the drug damages DNA. The DPP-4 inhibitors do not damage DNA. They don't cause cancer, either. They just turn off the enzyme that destroys cells that have become cancerous before they can do harm.

The other required test that is part of the approval process is the rodent test. These tests check whether large doses of the drug give cancer to short lived rodents. This is not a useful test for a drug that promotes human cancers that may take years to develop. How many rodents live long enough to get prostate cancer? Nor is it helpful for melanoma, which is not a problem for fur covered animals.

The acceptance trials for these drugs are very short--no longer than two years--and because they are so short they aren't likely to show the increased cancer risk in those taking them if the cancers take four or five years to become evident. Even so, the acceptance trials for Januvia did show a slight rise in cancers in the people taking Januvia--a fact that was obscured by the way that the company chose to report tumors--mixing together both benign and cancerous lesions.

I have documented this issue extensively here: Januvia. I urge you to read it carefully. Keep in mind the same issues cited for Januvia also apply to Onglyza.

It took a long term study (intended to find something else that would have sold much more of the drug) to reveal that Diovan raises the incidence of cancer. (Note that this story was carried almost entirely by the business press that worried that this finding would harm drug company profits!)

It was a long term study intended to find something else that would have sold more Avandia that showed the world that Avandia was killing people. You can be sure that the drug companies have learned their lesson--and it isn't to test their drugs more carefully. These experiences have taught the drug companies this: Don't run long term studies of drugs that are earning you millions.

The New York Times article points out that though the drug companies are now legally required to publish the results of all trials they run, they are doing so, in the words of the New York Times in postings that "are often little more than cryptic references."

But rather than just obscure the results of studies, smart drug company executives will merely avoid running studies in the future that could kill their golden geese.

I find it very unlikely that the makers of Januvia, Onglyza, and the not-yet-approved other "gliptin" drugs are unaware of the fact that their drugs turn off a cancer fighting gene. And that is why it is certain they've learned from the Avandia fiasco that the easy way to avoid exposure is to avoid conducting long term studies of a profitable drug.

Meanwhile, tens of thousands of people with diabetes will die of unnecessary cancers. Their doctors will tell them, "People with diabetes are known to have a higher risk of cancer"--which is true. But they'll ignore the fact that they gave these people with diabetes a drug that turns off a cancer fighting gene.

Doctors are very ignorant about how the drugs they prescribe work. They know only what the drug companies tell them which is often highly oversimplified if not actually misleading.

if you doubt this, ask your doctor what else DPP-4 does besides lower blood sugar. It is very unlikely he will know. In fact, if you ask him how DPP-4 lowers blood sugar, it is possible he won't know that either--it does it by slicing up the GLP-1 molecule. I have heard from many dozens of cancer survivors who, like me, were prescribed Januvia by doctors who had no clue what DPP-4 was or what its relationship was to cancer. When their patients asked them about it, the doctors' response indicated that they they trusted that these drugs had been tested to eliminate the possiblity that they caused cancer during acceptance testing.

They weren't. And because of the Avandia lesson, they probably won't be the subject of the long term testing that could reveal this.

Stick with drugs that have been around for more than fifteen years and you are much more likely to avoid unpleasant surprises.

 

12 comments:

Michael Barker said...

You, to your credit, had this pegged a long time ago.

And as they say, "Just because you're paranoid does not mean they aren't out to get you."

Mike

Steve Parker, M.D. said...

Jenny, you make a good indirect case of government funding of long-term drug safety studies.

Government funded the study earlier this month that found higher adverse cardiovascular event rates with rosiglitazone versus pioglitazone.

You and I would both agree that low-carb eating helps control blood sugars enought that some drugs can be avoided altogether.

-Steve

Janet Volkman said...

Jenny, You are the best. You've been warning about Avandia for years. I am incredulous that they left it on the market if for no other reason than the company covered up negative findings. Isn't that punishable in some way?
Once again, profits before people!

Janet Volkman

Jenny said...

The FDA's thinking must be that if they took every drug off the market whose utility was supported by dishonestly conducted and deceptively reported studies, there would be no drugs left on the market at all.

Priscilla said...

When a former supervisor of the drug safety office at the FDA (who resigned after being disciplined for recommending stronger warnings against Avandia) says the leadership at the FDA needs to be 'looked at' the question for me becomes.......who can I trust with my health? The answer is that, since I can not comfortably trust my Dr.'s, Pharma, or even the drug safety office of the FDA, the responsibility becomes mine. Thanks to you, Jenny, for sharing the vile information contained in this article and for offering a path away from these potential dangers.

Priscilla

Laura in Arizona said...

Jenny,
Excellent article. Thanks for all you do to help us make better choices for our health.

@Priscilla
Very well said. I came to the same conclusion: my health is MY responsibility.

Laura

renegadediabetic said...

A pattern of fraud and deception is definitely emerging. There was also the ENHANCE fiasco where they sat on the results for two years that Vytorin did no better than Zocor alone. All this makes me wonder what else are they NOT telling us about statins and other drugs for that matter.

There are new regulations for clinical trials after the Vioxx fiasco. Here is an article pointing out that recent statin trials, after the new regulations, are showing negative results. They question the positive results of previous studies and even make the bold suggestion that it's time to fully reappriase the cholesterol hypothesis.

http://www.jstage.jst.go.jp/article/jln/19/1/65/_pdf

Anne said...

It has been disclosed that at least one panel member who wants to keep Avandia on the market has direct ties with Glaxo.

Dr. William Davis said...

Great post, Jenny.

I don't believe that your concerns with these drugs are misplaced or exagerrated. I wish they were!

In their eagerness to achieve revnue milestones and outdo their competitors, they are so eager to release new drugs before there are satisfactory data to demonstrate long-term safety for anything beyond the primary indication.

Radhakrishna said...

Jenny, would I be asking too much if I requested a translation (into English, or Hindi or Malayalam, whichever of these three languages you are most comfortable with) of the Chinese (or Japanese?) comment if the comment is really an interesting one? ;-)

Regards,
Rad

Jenny said...

Rad,

Thanks for calling my attention to that comment which was approved by accident. I get a ton of these and they are spams or worse. It's gone now.

Lisa E said...

I totally agree. Deaths caused by prescription drugs happen every year, and plenty of them too (4.4 % per 100,000 people) according to www.naturalnews.com. Having endometriosis I'm all too aware of the side effects of the commonly prescribed medication Lupron.

And yes, they don't do long term studies at all. Long term is considered one whole year. But that's not long term in my opinion as patients often need these medications for many, many years.