Are Your Medications Safe?

[DeSwiss]

[font size=4]Are Your Medications Safe?[/font]
The FDA buries evidence of fraud in medical trials. My students and I dug it up.

By Charles Seife

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.

The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

Much of my research has to do with follies, foibles, and fraud in science, and I knew that the FDA wasn’t exactly bending over backward to correct the scientific record when its inspectors found problems during clinical trials. So as part of my investigative reporting class at New York University, my students and I set out to find out just how bad the problem was—and how much important information the FDA was keeping under wraps.

MORE

See also:

• FDA lets drugs approved on fraudulent research stay on market

• The FDA - Hazardous To Your Health?

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[Holly_Hobby]

1. Lots of class-action drug injury lawsuits...

Zofran, Lipitor, Actos, various popular antibiotics, Benicar, Zarelto, Marena, and that's just the first page of http://topclassactions.com/

I've seen most of those drugs on tv commercials and in magazines. I think drug advertising should be illegal, like cigarettes. Maybe they should spend the ad money on better research.

[Logical]

2. Well, I don't trust lawyers more than drug companies. What we need is the FDA to do their job. nt

[Orrex]

30. I'll tell my friend that she can throw away her insulin.

Since her aphasia and coma are merely symptoms of diabetes and exist to bring her body back to balance.

Ditto for my friend who foolishly received a tetanus shot after he stepped on that rusty nail. Full-body tetani and death are symptoms meant to bring him into balance.

They'll be so relieved!

[DeSwiss]

9. We are allowing ourselves to be poisoned for profits.

“There will be in the next generation or so a pharmacological method of making people love their servitude and producing dictatorship without tears, so to speak, producing a kind of painless concentration camp for entire societies so that people will in fact have their liberties taken away from them but will rather enjoy it.”

~Aldous Huxley

[daredtowork]

40. I think it used to be illegal

But then it became legal under Reagan or Bush Sr.? The idea was if the patient had "direct access" to the drug then there would be more competition and they would become cheaper...?

[djean111]

3. This is why I just have to snicker at those who insist that those of us who do not

trust the FDA or Monsanto or Big Pharma are just anti-science. I am not anti-science, I an anti the kind of science that lies and twists and omits in the name of profits.

[DeSwiss]

8. Agreed.

Logic would dictate that the system that oversees all medicine (e.g. - vaccines) and food cannot be trusted once collusion, corruption, theft, incompetence, lying, and falsification of data has been discovered within it. The so-called oversight agencies that are couched within the system (Inspector's General Office) are completely ignored by Congress because the majority of them are bought and paid for by these same corporations.

And we know this.

- It would seem that those whose voices are the loudest against those of us who question authority in these matters either have a vested interest or, they're the kind of person who loves the scientific method until it doesn't do what they want it to.

[marions ghost]

12. Ditto ^^^^

me too.

[Orrex]

17. In my entire time on DU, I have never seen anyone...

never seen anyone criticized as "anti-science" for not "trust(ing) the FDA or Monsanto or Big Pharma." If the person is criticized for being anti-science, it is invariably because the person demonstrates a hostility to the scientific method and the concept of peer review.

If you can find me, say, three examples of someone being called "anti-science" specifically because they "do not trust the FDA or Monsanto or Big Pharma are just anti-science," then I will be happy to challenge those who make that false accusation.

[djean111]

18. Oh, find and read threads about GMO labeling.

Those of us who do not trust Monsanto and/or the FDA on this, and want labels, are always sneered at as anti-science.

[Orrex]

25. You're conflating two different things, modifying your original complaint.

I've been in a great many of those threads, and the anti-science propaganda is indeed quite thick. Over-reliance on "internet authorities" and scare-tactic meme-photos are hallmarks of anti-science, for instance. Linking to NaturalNews is anti-science. Summarily lumping HFCS and CCD and GMO crops into one category--treating them all as equal evidence of Monsanto's evil--is anti-science.

In short, if you can't produce the evidence for peer review, and if you reject calls to do so, you are by anti-science definition.

Many studies have demonstrated the safety of GMO foods, for instance, independent of Monsanto. These studies are long-term and are peer-reviewed, so trusting in the conclusions of those studies has nothing to do with trusting Monsanto or the FDA.

However, questioning the need for labels is not at all the same as demanding that you "trust Monsanto and/or the FDA," and it's intellectually dishonest to equate the two.

[djean111]

26. I will just continue to skip foods that may be GMO. Thanks for the typical response!

No further discussion is necessary, really.

[Orrex]

28. Ironically, your response is symptomatic of an anti-science mentality

No further discussion is necessary, really.

Your unwillingness to consider a view that differs from your own is an explicit rejection of peer review. That is, you've formulated your conclusions in the absence of evidence, and no one can convince you that your conclusions might be faulty. That's about as anti-science as you can get, no matter how much you insist that you're not anti-science.

Rather than engage rationally with the subject, you react emotionally to what you identify as "the typical response," implying some kind of plot by Monsanto and the FDA to corrupt your precious bodily fluids or whatever.

When you simply close your eyes, jam your fingers in your ears and wail about the evils of Monsanto, you look and sound like an anti-science crank. Show your evidence and let us discuss it.

Otherwise, accept that you're pushing an anti-science agenda, and move on.

[djean111]

29. I really do think an "anti-science mentality" is quite okay, when it comes to eating food.

And taking whatever prescriptions my doctor gives me, with no regard for side effects or whose salesperson is most persuasive. Since I eat a very simple diet, I have had no prescriptions since 2002, and that was just for extra-strength Advil.
I see no reason, really, to care if you think I am a crank. I just would like better labeling on food. But it is easy to avoid things, so I can live with that. I do find it weird that anyone would be insisting I eat any particular foodstuff at all, though.

I do get emotional about what I put in my body. And I am well-qualified for Mensa. I did not just jam my fingers into my ears, I can assure you of that.

[Orrex]

31. You're not being consistent.

I see no reason, really, to care if you think I am a crank.

No? Well, I can live with that. However, your first complaint was this:

This is why I just have to snicker at those who insist that those of us who do not trust the FDA or Monsanto or Big Pharma are just anti-science.

Your snickering demonstrates very clearly that you do care whether people think you're a crank. You also care enough to start a sub-thread about it here in this discussion, for instance, and you care enough to try to impress me with your Mensa-qualified super-smarts.

If your next inclination is to insist that you don't care whether or not I'm impressed, then I have to wonder why you felt the need to mention it.

I do get emotional about what I put in my body. And I am well-qualified for Mensa.

Get emotional about whatever you want--that's up to you. Of course, it has nothing to do with science, so I don't know why you mentioned it here. For that matter, just about everyone I know is well-qualified for Mensa, myself included. My local library is more selective, for pity's sake.

I did not just jam my fingers into my ears, I can assure you of that.

Your assurances mean nothing, especially when they are overpowered by your actions, specifically your refusal to reconsider your conclusions.

[djean111]

33. Not trying to impress you with anything, just explaining my position.

Characterizing me as jamming my fingers in my ears, etc., is, IMO, childish and an attempt to marginalize. Whatever.
We are at opposites, and I am content to leave it there, no need for dime-store psychiatry.
Have a really great day!

[Orrex]

36. Then there was no reason to mention your Mensa qualification

Except in an (unsuccessful) effort to impress. Otherwise, why did you bring it up at all?

Characterizing me as jamming my fingers in my ears, etc., is, IMO, childish and an attempt to marginalize.

To be honest, you are marginalized by your mistrust of science, all the more so when you prattle about the nefarious plots of Monsanto and the FDA.

Whatever. We are at opposites, and I am content to leave it there, no need for dime-store psychiatry.

You accuse me of dime-store psychiatry while you simultaneously presume to analyze my characterization of your anti-science position. Interesting.

[NuclearDem]

20. I don't trust Big Pharma or Monsanto either.

But that position doesn't affect how I feel about the legitimacy of pharmacology and genetic modification.

[djean111]

23. So where is your line on eating GMO foods?

I also believe in the legitimacy of pharmacology and genetic modification, but I do not think that ALL of it is good for people and animals, and I cannot bring myself to trust Big Pharma and Monsanto about this. In the absence of labeling, I just don't buy anything that might be GMO. That is easier than it seems, because I have always followed a low carb diet, and most of my food is pretty basic, not processed.

[NuclearDem]

32. I have no more qualms with eating genetically modified food than any other food.

[djean111]

34. Cool. I just wish, since I do have qualms, it was easier for me to tell which foods have GMOs.

The non-qualms folks seem to be telling the qualms contingent - too bad! Life will go on!

[Avalux]

4. Helping the Republicans denigrate the FDA isn't doing anyone any good.

The FDA has a purpose, and it's a good one. We need regulations to be enforced, transparency, and more FUNDING so that inspectors can do their jobs effectively.

I am a researcher and I've never falsified data. Everywhere I've worked, we've made sure human safety is paramount. It's not realistic to think all outfits are ethical of course, because there's a lot of money to be made in clinical research, but most are in my 27 years experience.

We have good laws governing clinical research and an agency to enforce them. BUT - the effectiveness of the FDA in protecting public health is only as good as lawmakers allow it to be.

[DeSwiss]

10. Thanks for your openness.

But I disagree. History speaks for itself. If scientific efforts and research were carried out in our country in an environment devoid of the corrupting influences of capitalism then I'd probably be more supportive and trusting of it. However, as has been said previously, those who forget history are condemned. And I trust no system wherein the outcomes can be purchased, nor those overseeing those processes.

I believe that it may be that you're too close and involved in the process, and vested in it to view it objectively. You see your area as only beneficial to mankind, ignoring the dangers that also are a part everything in life.

Unfortunately these matters can have a tremendous affect upon others. So at this point your ''area of interest'' becomes my business. I get to decide what's in my best interest. Not science, and not society -- both of which are nothing more than a constructs. Ideas. Processes. Granfalloons.

- I'm real.

[Avalux]

14. I'm real too, and here's how I see it.

First, I do not believe what I do is only beneficial to mankind, there are risks, and part of that involves the unpleasantness of money and profits. But without people like me who are a part of the system and conduct ourselves ethically, what would happen? I do the best work I can within a not-so-perfect system.

You can't throw the baby out with the bath water. If FDA regulations and GCP guidelines governing clinical research didn't exist, we'd go back to the days of snake oil salesmen and experimenting on people without their consent. Is that how you want it?

[DeSwiss]

38. Yeah.

Pretty much.

I'm looking for the creation of a whole new paradigm.

Because this one's spent.

We keep trying to improve it.

To make it impervious to manipulation.

But it can't be fixed.

- Capitalism corrupts everything. Forever, if we allow it.

If one definition of insanity is doing the same thing over and over and expecting a different result. Then the definition of political naïveté must be expecting a corrupt system and the corrupt people running it to commit acts of honesty and pass fair and honest legislation.

~DeSwiss

[KentuckyWoman]

5. NO medication is safe. There is no such thing.

All medicines are poison. ALL OF THEM.

If you need it then inform yourself of the downside to taking it. There will always be a downside and you have to weight the potential benefit against the risks. This is why the lies and deceit from the very people tasked with informing doctors and patients is so heinous.

[Grammy23]

6. And might I add to your comment that much of the advice we

Have gotten pertaining to fat in our diet has been wrong and yet that misinformation continues to be dispensed by doctors and dietitians to this day. We have followed the guidelines of reducing the fat in our diet while increasing the carbohydrates at the same time. The result is that we have soaring rates of diabetes and a thriving drug industry that is inventing more and more pills to compensate (or at least they are advertised to "fix" the problem) for the results of following that dietary advice.

The standard recommendation regarding our diet has no real scientific evidence to back up the claim that reducing the fat while increasing the "complex carbs" will work to control our weight, cholesterol and overall heart health. None. But our real life experiment carried out by millions of people following the advice of their doctor or the Food Pyramid has demonstrated the flaw in that advice. Slowly but surely the tide is changing as the Low Fat Myth is losing favor but not before a huge number of people suffer the consequences of following that dietary plan and then compounding the error with drugs that don't work and that, in fact, may be fatal.

[Hekate]

7. You mean like the insulin my cousin injects ever since she went into a coma at 12 y.o.?

All poison?

[djean111]

13. My brother had juvenile diabetes, and my daughter-in-law lost her pancreas in a truck accident

when she was 12, so, yes, I know that insulin is life-saving if your pancreas cannot produce it.

What I am talking about is the way Americans have been boondoggled into eating more and more carbs in the nefarious name of "low fat". And then the health care INDUSTRY fattens itself on the resulting obesity and all the treatments. And then the treatments spawn side effects that require even more treatments.

I used to work in Japan. Nothing as eye-opening as the first day back here, after a month or two in Tokyo, and going to the grocery store. The huge people, and the huge shopping carts, full of processed carbs.

I see no reason to blindly trust the food industry or the health industry. Their profits depend on stuffing us and then treating us for the results of that. Aren't we told that Capitalism is a GOOD thing? Well, this is what happens with unregulated capitalism - the profits become vastly more important than people. If I don't know where to draw the line on what I put into my body, because of insufficient labeling, and secrecy - then that line becomes pretty exclusive of most things. That is my RIGHT, to do that. People who don't want labeling are really saying that I have no right to know exactly what I am eating. Fuck that.

[DeSwiss]

11. It all started with those billboards back in the 1950's.....

- And then the cellophaning of babies sealed it. We were doomed to a life of chemicals from then on......

[NuclearDem]

21. Wow, that might be one of the most ignorant posts I've read recently.

[KentuckyWoman]

42. no examples?

You can't give me insulin. It naturally occurs in the body. Though even that used improperly can cause harm.

Used correctly in the right circumstances medicines are lifesaving. But all have negative side effects. We balance the benefit versus the downside of sticking a bit of poison in the body. We need good science in order to decide.

But hey, if you think your multivitamin isn't toxic go swallow a whole bottle and let me know how that works for you. I suggest you don't.

[MindPilot]

15. Doctors seem reluctant to acknowledge the presence of drug side effects.

That is based solely on my own personal experience.

It usually goes something like this:

Me: "Doc, I think these new BP meds are affecting my vision."

Doc: "Try taking more frequent breaks when you're on the computer."

(based on a real conversation)

[Grammy23]

16. And the glossing over of side effects like weight gain

Which has happened to me. I take three medications for my blood pressure. One of them has a side effect of making you tend to gain weight or make it difficult to lose weight. I didn't realize how pervasive this problem is until I mentioned my frustration trying to lose weight to a cousin. She urged me to check out how many others face the same issue while taking this drug (Toprol XL). After I started looking on line I found many others who have this problem. My cousin also has the problem and informed me that no matter what she did to lose weight, nothing worked. Se said she had tried a variety of diets, increased her exercise, you name it. All to no avail.

My experience has had similar results. In addition to that, I saw my mother-in-law, a woman who never weighed more than 118-125 lbs for decades start to gain weight once she started taking this drug for her BP. Nothing else has changed for her. She pretty much eats the way she has for the 45+ years I've known her. She is baffled by the increase in weight and especially the stomach area getting larger.

I've talked to my doctor about this problem but she pretty much dismissed it as a major factor in my weight issues. I think because my blood pressure is in more normal range she is reluctant to tinker with the drugs. She ended up recommending a standard Low calorie diet and discussed serving size. Since I've already done that with minimal success, it was hard for me to follow that advice and in fact, I did not.

So I've basically given up on losing weight as long as I take this drug. I just wish doctors were more willing to admit that the drug CAN do this so patients can stop blaming themselves for not losing weight no matter what they do.

[Mimosa]

19. Statin drugs

Statin drugs (which were pushed hard on patients with 'high cholesteral') and Metformin for the resulting diabetes have made 2 men I know way fatter than they would have been otherwise.

Neither of the two men I'm describing had obesity in their families. Nor do they overeat. Personal Injury lawyers are advertising for female plaintiffs who have diabetes as a result of having been prescribed statin drugs. But I know two men with no diabetes type med histories who probably got in from statin Rxs. I'm glad I never fell for the statin B.S.. Weight from Type 2 diabetes appears near impossible to lose.

[greatauntoftriplets]

24. Instead they shoud blindly listen to you?

[DeSwiss]

39. Most doctors I know are owned by Big Pharma.

- Or long-term leased. Here's the results.....

[greatlaurel]

35. This article has problems, the reference to the European Medicines Agency about 700 drugs is false.

I clicked through the link and read through the list and many of the problem drugs are the same drug just listed repeatedly by the member countries that have banned the drugs. This leads me to be very concerned about the veracity of the article. It certainly was not very well researched or edited.

While I do not trust Monsanto any farther than I can throw them and I have issues with the accelerated approval process of new drugs, this article has little in the way of facts and seems more interested in bashing government regulations than in actually advocating for better consumer protections for the public.

Please find a more reliable site about drug problems which are real, but this article lacks credibility.

[DeSwiss]

37. I don't particularly care for Slate......

...but it is considered as reliable as any of the other MSMs out there. However, as for your request, well the thing is..... I don't give guarantees nor respond to quality-control requests. It's a personal proclivity of mine. So I'm sorry but you'll have to muddle through the muck like the rest of us.

- I guess that's why it's called ''free speech.''

“Journalism is printing what someone else does not want printed: everything else is public relations.”

~George Orwell

[greatlaurel]

41. False flag, my dear DeSwiss. This article is not journalism, it is right wing propaganda.

Another issue in this article, is how the writer complains how the FDA did not tell reviewers of the drug trials about problems the FDA had with the trials. The writer does not explain what the FDA protocol is for calling for independent review of a drug trial they have concerns about. Did the FDA violate their protocol? I suspect not, as it makes sense the FDA would want to see if independent reviewers would find the same problems as the reviewers from within the agency.

I believe the Slate article does indeed reach the public relations category from George Orwell. Great quote, but the quote proves my point even more. The article is pushing with very questionable pretzel logic an anti-government regulation and anti-medical science view. Slate is owned by the Graham Publishing Company, a subsidiary of the Washington Post.

[woo me with science]

43. K&R