FDA scientists complain to Obama of 'corruption'

[Robbien]

Source: AP


WASHINGTON (AP) — In an unusually blunt letter, a group of federal scientists is complaining to the Obama transition team of widespread managerial misconduct in a division of the Food and Drug Administration.

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency's Center for Devices and Radiological Health letterhead.

. . .

The FDA declined to publicly respond to the letter, but said it is working to address the concerns.

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices...have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

A copy of the letter, with the names of the scientists redacted, was provided to The Associated Press by a congressional official.

"Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around," the scientists wrote.



Read more: http://www.google.com/hostednews/ap/article/ALeqM5gfVw6WQl1LXeJz_XEnJRGuHAzTVwD95J8N980

---

A spokeswoman said the Obama transition team had no comment.

[xxqqqzme]

1. 'no comment' but certainly not surprised either.....I hope.

[Lorien]

2. They may not have a comment, but I hope they have a plan of action

to clean up the FDA and make it function for the well being of the people-not just the corporate bottom line-again.

[Robbien]

8. Ex-FDA head Jane Henney is being considered for the FDA by Obama

http://www.bloomberg.com/apps/news?pid=20601202&sid=awl2h_OIPsio&refer=healthcare

In her prior term she was well known to not only reduce the drug approval process but also made it more flexible for manufacturers. Oh goody. Get the untested drugs to us even faster than the fast track they are on now. That's the ticket.

She also feels it is okay for drug companies to heavily market their product to doctors and that it is up to the doctors to make sure their patient's safety is protected. Overworked doctors gate-keeping the drug companies. Nothing can go wrong with that.



Doesn't look promising.

[No Elephants]

29. Wow. Thanks for that. I hope Obama does NOT appoint her.

[MetaTrope]

30. And Sanjay Gupta says everything is hunky-dory!

[Delphinus]

49. Physicians for a National Health Plan

have four reasons they are in opposition to him


Among our concerns are these:


He has very little background in public health, preventive medicine or administration.


He has openly opposed progressive health reform, going so far as to cite false information to denigrate single payer (e.g. in his error-laden attack on Michael Moore's film "Sicko") and parroting the health insurance lobby's distortions of single payer.


As a media figure, he has been disturbingly cozy with Big Pharma. He co-hosts Turner Private Networks' monthly show "Accent Health," which airs in doctors' offices around the country and which serves as a major conduit for targeted ads from the drug companies. Another example: In 2003, despite mounting evidence to the contrary, he publicly downplayed concerns about the dangers of Vioxx. It was removed from the market a year later by its manufacturer, Merck.


In the 2008 election campaign, his reporting on John McCain's health proposals was misleading and implicitly positive, giving undeserved credence to McCain's claims that buying private health insurance on the open market is a financially viable option for most Americans.

[Joe Bacon]

61. Gupta is a Pre$$titute.

That liar has no business being Surgeon General

[ronnie624]

71. Industry insider for sure.

Henney serves on the boards of the health insurer Cigna Corp., drug distributor AmerisourceBergen Corp. and drugmaker AstraZeneca Plc.

Just more of the same.

[truedelphi]

86. I try to be optimistic about the future, but I find it harder each passing day.

[Jefferson23]

3. Excellent, the frustrations of those under Bush ready to spill the beans...more to come.

[Kolesar]

73. Phones will be ringing, come inauguration day

I don't think the newspapers are going to be able to keep up with all of the stories.

[pnwmom]

4. Thanks for posting. I'm going to recommend and hope that some of the FDA

apologists around here read this.

[GentryDixon]

5. It is about time.

There is not been an official recall of the generic for Toprol XL (Metoprolol). I was changed to the generic last Feb/Mar time frame from the Sandoz labs. My blood pressure immediately sky rocketed to over 200/160, I was dizzy, nauseous, and lethargic. It took me about a week to realize it was the change in the BP meds. I was switched back to Toprol. It has been almost a year and I am still waiting for a resolution to this problem.

The FDA did issue a letter: http://www.fda.gov/foi/warning_letters/s6891c.pdf. It has never been updated with an official recall, and yet there are still problems being reported on various websites.

My insurance has changed to punish users of name brand drugs versus generic. I have no choice until this has been resolved. I will be paying over double what I paid for the name brand last year until something is done to force the FDA to do their jobs to protect the American people.

[ekwhite]

23. That is a pretty bad one for a tablet manufacturer

Part of my job is to keep up on FDA warning letters at work, and I remember reading that one. Some of the things they were cited for struck me as pretty bad practice. The citations around dissolution, especially concern me. Your problem may have been that the tablets weren't dissolving adequately in your digestive system. What is interesting is that Sandoz, Inc. is part of Novartis, a major pharmaceutical manufacturer, not a fly-by-night operation.

[Lasher]

39. Active ingredients should be identical in generics.

But coatings and fillers can be different. You have an interesting theory about the tablets dissolving properly.

[ekwhite]

63. My guess would be they have a compression problem...

but I am a parenteral expert, not a tableting one.

Edit: The active ingredients have to be chemically identical, but they don't have to be sourced from the same supplier.

[bjobotts]

40. FDA is totally "pay to play" under the repuke corruption. Question is...

[bjobotts]

42. How long will it take to de-nazify our agencies after Bush/Cheney and Liberty U

[Enthusiast]

57. Sarah Palin will be in office before it's done. nt

[whistle]

6. Correct do you know what seafood you are eating? Does anyone know for sure?

google "deceptive seafood practices"

[antimatter98]

7. I hope this is 'just the start' of an outpouring..and that Obama will move on it. n/t

[santamargarita]

9. Bush has literally screwed up every part of Government!

[ChairmanAgnostic]

12. no, not literally. D E L I B E R A T E L Y

[Enthusiast]

58. They set out to prove government doesn't work.

And they were successful, the Bush government was a complete failure.

[Still Sensible]

76. Bingo, this is perhaps the most significant

failure of the entire GOP philosophy. They believe that government is wasteful, inefficient and ill suited for any task other than managing the war machine and they set about to prove it every time they are in charge.

Of course, this fits well in their midset, right along side Laissez Faire (let the greedy bastards screw everybody but other greedy bastards) approach to markets and Trickle Down (read piss on) economics.

[Enthusiast]

82. Send them to prison for life! nt

[goforit]

81. Yes! I am convinced (with my Tinfoil on), that he, his dad and Cheney were KGB!

[aquart]

43. That portrait is so good it should hang in the White House.

[BootinUp]

10. I is shocked I tells ya!

/sarcasm

[stevedeshazer]

11. The mere thought of Republicans/BushCo appointees in charge of the FDA is bad enough...

...but to have scientists come forward saying this scares the crap outta me.

:scared:

[ihavenobias]

13. K & R, good info. n/t

[Lint Head]

14. The head of the government for 8 years set the example.

Bush made it acceptable to be a criminal and take actions that led to the deaths of human life. Whats new?
:dem:

[bluesmail]

15. FDA has been poisoning and ripping us off for , I'll start with 8 years

Who really knows what's in "Generic'? Now I'm going to say something about 'our brands' in the grocery store. Same thing. If you can afford local food Buy It.

[defendandprotect]

27. "Poison" is right and I'm amazed at the harm done already ---

and that it isn't even more!

[MidwestTransplant]

16. I am sure any number of agencies could write the same thing. I hope they do.

[Auggie]

17. In other words, "Dear Mr. President-Elect...

PLEASE KICK SOME ASS!!!"

[D-Lee]

18. Problems with medicines too

The review standards for required research for medications have also been modified downward.

The problem is not only with medical devices ...

Read the book "Our Daily Meds" for background. Here's an Amazon link for the book: http://www.amazon.com/Our-Daily-Meds-Pharmaceutical-Prescription/dp/0374228272
It is an amazingly quick read and the author has a real talent for consolidating and presenting information in a cogent fashion.

[defendandprotect]

28. Absolutely . . .!!!

Thanks for recommendations and link --!!

[brentspeak]

19. Hopefully, the corrupt ones within the FDA get outed

[spanone]

20. the bu$h* legacy is in full bloom

katrina/fema is indicative of every department under bu$h*

[jberryhill]

21. Dang - No Wonder My Kinoki Foot Pads Don't Work

[tabatha]

24. yep, the whole concept is fraudulent

[jberryhill]

25. Not only that...

But the foot pads removed all of the active ingredients of my penis enlargement pills from my bloodstream.

There was no interaction warning on the package.

[Lasher]

41. So are your feet bigger now?

All that enhancement had to go somewhere.

[jberryhill]

68. The ladies don't call me "Bigfoot" for nothin' ya know /nt

[tabatha]

90. ha ha

like it removes anything

[Laura PourMeADrink]

50. roflol!!!! you are a riot !

[CubicleGuy]

78. Makes you wonder

As I waited in the checkout line at the local Walgreens this morning, I spent my time perusing the "last moment items" display conveniently situated on the counter next to the line, and I saw the Kinoki foot pads sitting there along with the "Airborne" anti-cold tablets, and I just wondered how much else of what was in the display was fraudulent.

How many other snake-oil products are being pushed at the local drug stores?

[ekwhite]

22. I hope Obama pays attention to these scientists

As an industry insider, I am all too aware of the problems the scientists are talking about. Right now, the FDA is serving neither patients or reputable manufacturers well. Political influence trumps science all too often when companies make submissions.

[Pryderi]

26. I'm so fucking sick of these cowards.

Maybe if all the scientists, justice department officials, cia staff, fbi admins, military leaders had raised their voices 4 years ago, our nation and the world wouldn't be so fucked up!

COWARDS!

[Enthusiast]

55. Whistle blowers were

slapped down everywhere during the Bush Administration. That is very obvious.

[bonito]

31. The FDA is the regulatory authority here in the US only

and we know about the close relationship with big Pharma, I would advise to see what the rest of the world uses, unless one thinks their the top of the heap :sarcasm:

[ekwhite]

64. I would limit that to what Europe, Canada and Japan use

Much of the rest of the world relies on FDA approval of the drug, with only pro-forma registration. Europe, Canada, and Japan have strong regulatory agencies.

[sce56]

32. I wonder how many people have died as a result of the Cronyisim at the FDA

If it is proven can we charge shrub with those MURDERS ALSO along with the Millon + in Iraq.

[RollWithIt]

33. So much to fix.... 2.5 years to do it.....

How much can be passed?

[Laura PourMeADrink]

51. so right. It's things like this that make you say, "We here were right

Our intuition told us that bush had corrupted the entire system" - you could just smell it - even if we didn't always have hard evidence.

I bet we will see lots more whistleblowers - because Obama's teams are doing intense reviews of all agencies and he will be able to sniff this stuff out. We thought we had it bad - just think about how demoralized the "honest" federal employees have been feeling for 8 years.

[Enthusiast]

56. Yup, you said it, Laura PackYourBags, lol.

Love your handle. :fistbump:

[Laura PourMeADrink]

67. need a new one - Yey!! How about Ba-bye Laura

[Enthusiast]

70. Sounds good. nt

[farmboxer]

34. Kevin Trudeau Was Correct about the criminal FDA

and the drug companies. His book "Natural Cures They Don't Want You To Know About" tells it like is is.

[davidthegnome]

46. Kevin Trudeau is a well known

criminal liar. I would suggest caution in any and all dealings with him. His book is nothing but an advertisement for his site, which offers only so much snake oil, garbage and nonsense.

Oh he may very well have been right about the FDA - I'd go so far as to say that, in my opinion, he was. That doesn't change the fact that he's a criminal out for his own profit and nothing else. What we have here is the pot pointing at the kettle and telling us it's black. It (Kevin) used advertisements and clever gimmicks to demonstrate this fact. For what purpose? His own profit. Nothing more. Pay no attention to that man behind the curtain...

He's a well known fraud in business circles. Hell, maybe you've even heard of ITV ventures, a program that, not surprisingly, he had a great deal of involvement with. Guess what? It crashed, the affiliates were screwed, yet I doubt good old Trudeau was effected much by it. He has a well known history of fraud and scandal, all of it well earned.

Don't be fooled by fakes like Kevin. I'm sure there are some authentic, decent people out there who are telling the truth and trying to help the consumer because they give a damn. Kevin is not one of them.

[Laura PourMeADrink]

53. Yes, you are right. I think one of the biggest scams is blood pressure medicine

not because it doesn't work - because it does - but because they put millions of people on it - for years and years at $100 (?) mo - without any plans whatsoever about finding ways to get the patient off. This just smacks of someone making a fortune.

[ekwhite]

66. Don't count on those 'natural cures'

I follow the FDA website, and they have forced recalls on a number of so-called 'dietary supplements' that actually contained undeclared drugs in them.

[NM Independent]

35. Great. Everything I put in my mouth is now questionable.

Not only that, but everything my Doctor might do to help me (surgeries, equipment, etc) is now suspect, too.

Another notch on W's Legacy stick.

[orleans]

36. k&r. n/t

[farmboxer]

38. It's all about the profit

Human lives mean nothing to those criminals.

[davidthegnome]

37. Heh. Who knew?

Seriously. The FDA is corrupt? OMG. We never would have imagined, would we?

[bitchkitty]

44. Damn!

I wonder what stopped them from coming forward before now? Or who stopped them...

[ronnie624]

72. The working atmosphere for a principled individual must be stifling and frustrating. n/t

[blendermax]

45. Ship them off to China for a trial.

where some actual justice might take place.

[Enthusiast]

59. No way! China has benefited

by making many raw ingredients for the big pharmaceutical companies.

[datasuspect]

47. political corruption is usually widespread in fascist, totalitarian governments

[Laura PourMeADrink]

54. why is that?

[machI]

48. Bush sends soldiers to die in order to enrich big oil.

Bush also enriches the medical industry with the death of American citizens.

Bush needs to go to prison

[Enthusiast]

60. Right you are, mach1

Has any criminal, ever, so richly deserved a prison sentence? Bush really really really really really should be in prison.

[No Elephants]

52. Am I the only one who read Reply # 8?

[Enthusiast]

62. I read it. I HOPE we will not

continue the status quo under Obama. I take quite a number of meds each month, mostly for elevated BP. I had hopes that Obama would be different. My fear is he is not *that different*.

[ShadesOfGrey]

69. Thanks for that, I missed it...

I am becoming very disillusioned by Obama's choices.
I'm starting to wonder what the "change" is going to be... so far, it's looking like more of the same.

[No Elephants]

87. He needs to step away from the DLCers. Enough already. www.change.gov

[pleah]

65. K&R n/t

[OneBlueSky]

74. Bush's legacy can be summed up in two words . . .

NOTHING WORKS! . . . not the FDA, not FEMA, not the SEC, not the FCC, not NCLB, not the military -- NOTHING! . . .

in a mere eight years, Bush has done more damage here and abroad than all of his predecessors combined . . . and for an illiterate, uninformed, incurious boob who has failed at everything he's ever tried in his sorry life, that's one hell of a legacy . . .

heartiest congrats for a job well done, you dipshit! . . . we'll be paying for your greed and incompetence for generations -- assuming the human race can survive that long . . .

[Uncle Joe]

75. I believe after eight years of Cheney/Bush,

finding a department that hasn't been corrupted will be the exception rather than the rule.

[blackbart99]

77. this is a good sign...

But why did they wait so long? I know people fear for their jobs and all but when it comes to public
safety and THAT is your job, then there is a moral obligation to come out and say something.
Bravo for them doing it now, they probably feel a little safer since the big O gets sworn in soon.
I hope that more an more come out the woodwork and tell the American people just how bad it got
during the Bush Dark years of moral and ethical obfuscation. Check my spelling on that $400 word.

[Nothing Without Hope]

79. A DUer, Time For Change, has given a FIRST-HAND ACCOUNT of FDA corruption. Links:

Here are some archived threads where Time For Change has discussed this:

My Personal Experience with “An Inconvenient Truth”
http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=364x1461671

10-5-05 Time for Change} Why Are Silicone Breast Implants about to Be Approved by the FDA?
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=104&topic_id=4980295

11-20-05 Time for Changwe re JAMA editorial} The Politicization of the Food and Drug Administration (FDA)
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=132&topic_id=2264993

[Time for change]

83. Thank you Hope, I'm glad you had those on hand to post

Here's my latest one on the subject:
http://www.democraticunderground.com/discuss/duboard.php?az=show_topic&forum=389&topic_id=4547844

It talks more broadly about the Civil Service in general, but there's a section on the FDA in there, though probably some overlap with the other ones.

Actually, I'm right now in the midst of what may be another good example. There is a clinical trial going on, dealing with a device that is supposed to reduce potentially fatal arrhythmias. However, the control group is doing much better than the group who received the device, which suggest that the device is actually causing the arrhythmias.

I suggested terminating the clinical study and pulling the device until we can investigate this further, but I'm encountering a lot of resistence. I don't know whether this is being done as a favor to the industry, or whether the people I'm dealing with just don't understand the issue.

[Realityhack]

89. thanks for the links n/t

[goforit]

80. Well thank you Folks, But stepright up in the longest line of corruption scandles!!!

There just aren't enough courts to handle them all at least until we have a complete turnover in
the most incompetent Congress ever.

[Nothing Without Hope]

84. I think the problem with Congress is even more CORRUPTION than incompetence.

Not just for their personal use, but we now have a system in which the cost to be elected and re-elected is so astronomical that there is a strong pressure to sell favors for campaign funds, as Governor Blag did. He just got CAUGHT because of an honest and courageous whistleblower who made the investigation possible. He is far from alone in his escapades, though he is stupider than most.

Meanwhile, there is a lot of bribe money to be made in the FDA from the companies whose profits and sometimes even existence rides on fast FDA approval by the FDA. Clinical trials are enormously expensive and take time, and rejection can sink a company. Lots of money involved there. Lots of opportunity for corruption.

[noiretextatique]

85. i was interviewed for a story related to this by a NY Times reporter

she saw my posts here in the cancer support forum and contacted Skinner who contacted me.

Mammosite is a newish brachytherapy (high dose radiation) procedure for breast cancer radiation, but my radiologist (the one i consulted for a second opinion) convinced me it was not the best treatment for me.

if i didn't get that second opinion, i might have opted for Mammosite because my surgeon and the first radiologist i saw really tried to "sell" Mammosite as the only option.

the reputable radiologist told me Mammosite is being marketed directly to women via magazines because it only takes 5-7 days to complete. traditional beam radiation takes 1-2 months to complete. tha manufacturer is also marketing Mammosite to surgeons because it's quick, easy money. she also told me most radiologists are not interested in Mammosite because it hasn't been through enough clinical trials. finally told me that my cavity was too large for the procedure and there was a risk of a higher dose of radiation to my heart and lungs via Mammosite vs. beam radiation.

i was really angry after talking to the second radiologist because she told me the exact opposite of what the doctor who was pushing Mammosite told me. my surgeon was new to the hospital, and apparently not familiar with standard breast cancer treatment. he should have referred me to a medical oncologist before doing anything else. the issue for him was the Mammosite balloon has to be inserted before the wound heals, so there's only a 4 week window to insert the balloon after lumpectomy.

i did beam radiation last February and i am fine now. i don't know what might have happened if i didn't get that second opinion. always get a second opinion. it may be a hassle, but it just may save your life.


http://www.nytimes.com/2008/10/27/health/policy/27device.html

[DeepModem Mom]

88. K&R. A criminal act. nt

[peacetalksforall]

91. I learned to despise and hold NO respect for Sanjay Gupta because I could

not believe some of the things he said, BUT MOSTLY BECAUSE I believed he was A BLATANT PARTISAN for the right wing and because he was paid by corporate TV.

I ANGRILY OPPOSE and DEPLORE OBAMA's CHOICE.

I try to see through the logic that Obama may be applying. The number of people being brought in offend and appall me. I cannot believe my ears.

The thoroughly expansive and cohesive partisanship displayed by this vile regime extends out. The five Republican networks existed to kiss Cheney and his sidekick.

How could Obama pick that propaganda artist pimp for corporations and the Cheney White House and do this to us? Tell me why?