Was German Regulator Fired To Appease Pharma?
15 CommentsBy Ed Silverman // March 1st, 2010 // 7:03 am
The German government has sacked the head of the Institute for Quality and Efficiency in Health Care (IQWIG) to placate the drug industry, a German MP and professor alleged in an interview with the BMJ.
In January, the board of directors of IQWIG, which the BMJ notes is the German equivalent of the United Kingdom’s National Institute for Health and Clinical Excellence (NICE), agreed to dismiss Peter Sawicki saying, “The excellent work of the institute should not be burdened with discussions about irregular administrative procedures.” Sawicki had been accused of irregularities over his expenses claims, including the use of his business car and gas for his lawnmower (BMJ 2010;340:c499, 26 Jan, doi:10.1136/bmj.c499).
Karl Lauterbach is certain, however, that the real reason for Sawicki’s dismissal is pressure from drug makers in Germany and from abroad (to read more, please go to the BMJ, although payment is required).
Hat tip to PharmaGossip
FDA Whistleblower
Dear readers,
If you want to know what really goes on between the FDA and the drug companies it’s imperative that the whistleblower protection act be passed in a format that actually protects whistleblower rights. However the Senate Committee on Homeland Security and Governmental Affairs has reported out a version that contains certain ‘poison pills’ that will make it impossible for any whistleblower to ever bring a case and keep their career.
More importantly the bill has been being “hotlined,” a process by which legislation can be passed through unanimous consent, without any debate or a roll-call vote.
“Hotlining” requires unanimous consent, which gives us a unique opportunity to ensure this bill does not pass as is. Every Senator, regardless of committee assignment, has the opportunity to weigh in on this legislation.
It only takes one Senator’s demand that these issues be fixed in order to stop this Trojan horse from destroying existing whistleblower protections. That Senator can be yours. Please TAKE ACTION and contact your Senator today!
For more information on the specific clauses including sending an auto e-mail to your senator (personal is better) please see.
http://capwiz.com/whistleblowers/issues/alert/?alertid=14705986
Otherwise we will continue to be harassed, threatened and retalilated against with no recourse for simply trying to not only do our jobs but for even protecting our own lives and the lives of our families.
FDA Whistleblower
M. Black
I’m in.
FDA Whistleblower
Thank you Mr. Black.
It’s been disappointing that with all the comments here about FDA and Pharma corruption that you are the only one who responded.
The drugs that we deal with can earn companies 10’s of billions of dollars over the life of the drug and for certains classes (such as psych or cancer or diabetes drugs) 100’s of billions. Those of us try to do our jobs ethically place our careers on the line daily, and for the whistleblowers in some cases we have literally placed the the lives of our family on the line just as the Pfizer whistleblower did. (Yes similar things happen to FDA employees). Unfortunately thanks to President Bush and his executive orders we cannot say anything at all publicly without guaranteeing that we will never work again, (or even being prosecuted and winding up in jail in retaliation). It’s only by taking the risks and openly speaking to congress and hoping that we will eventually have our day in court for whistleblowing that we can even hope to have things see the light of day. Unfortunately the WPA as it has come out of the Senate committee will guarantee that will never happen. Some of us have been with the FDA 15 or 20 years and have worked on many of the drugs (or in some cases multiple therapeutic areas) that are discussed here. We know the true inside stories and we know where the skeletons (and documents are buried). It’s a shame that people here seem to only want to speculate and not find out the truth (and believe me there is a lot worse that has not come out yet), or even do something constructive rather than just talk.
In all honesty if the public (especially those who have an interest) aren’t willing to speak to their representatives. Then in my estimation they are simply guaranteeing Pharma running the FDA and many more people dying. For when reviewers en masse or even single reviewers are threatened in front of others reviewers and then physically escorted from the building under armed guard simply to approve unsafe and ineffective drugs the other reviewers know that they have no alternative but to turn a blind eye, put up with the harassment by those who are corrupt, and simply pray they can make it to retirement.
FDA Whistleblower
patrons99
Count me in, too. Thanks, FDA-WB!
Justice in MI
Onward. In a thread about a week ago, I listed the likely results of the Supreme Ct’s gutting of campaign finance reform in the context of discussions here Two of the six items were the erosion of incentives for whistleblowing and the further erosion of whistleblower protection.
Point being–you are not forgotten.
drpete
A similar thing happened in Australia: against medical profession’s advice, a rep. of a drug company was put onto the government’s national purchasing board. The result: lots of hysteria-filled marketing driven subsidisation decisions as pharma works out how to manipulate this latest channel.
German Twits
When is someone going to discuss and investigate German / American products made in part in Germany, in part in America, and/or one or the other? Confused? Fentanyl was the fourth highest in adverse patient occurances. The transdermal patch form is made at a company whose parent company is in Germany, and whose sister site is down the road in West Caldwell. Unfortunately, said German parent company are a group of rootin’ tootin’ cowboys, and the sister is missing a chromosome or two. Other products directly effected are: Nicotine Transdermal (use the gum. trust me), Excelon Transdermal (Alzheimers), Parkinsons Transdermal, Listerine Oral Products (breath strips and whitening strips). The Germans in Germany that I’ve worked with have shown NO regard for US regulations with the philosophy that they shouldn’t need to because the FDA is “not down the road as it is in West Caldwell”. Why West Caldwell? If I said that, it would take all the excitement in figuring this out for yourselves. Something needs to be done with them. In as immediate a fashion as humanly possible. Focus should be on the contract manufacturing firm that specializes in the transdermal and oral film manufacture. A term used in QA “out of control” was written for this place. If a consent decree (an environment that I’ve worked in myself) is deserved I’m some firms, and it does not for this one, the Feds are in someone’s pocket. Where is ORA? This is a mess and a FAILURE IN OUR SYSTEM.
I suggest immediate regulatory action, since it’s more than needed.
M. Black
Whistleblower,
What can I do, and how do I go about doing so?
~ M. Black
M. Black
Whistleblower,
I feel your same sentiment. People should stop their bitching and whining and DO SOMETHING to make a positive difference.
I have no respect for perpetual whiners who stay hidden in the shadows. There are so many of you that once a few come out, the floodgates would open.
Decide whether or not you care. If you do, act. If you don’t, go find yourself another cause to boost your perception of self-worth.
Put your cowardly stance aside, or keep your mouth shut altogether. I’m sure you could find other ways into fooling yourselves into thinking that you’re making a difference by posting blogs.
~ M. Black
M. Black
They would be doing themselves a favor in providing protection in an age where a pen or a good quality cell phone can capture the blatantly illegal shenannigans (for lack of a better term - perhaps “bullshit” would be ok too).
“Better be careful, his bowtie is really a camera”
-Simon and Garfunkel
Technology will bury those that deserve to be buried alive. With consideration to how quickly new technologies are created and cheaply, I’d be crapping my pants if I were “one of those” that frankly should be behind bars for committing the worst type of white collar crime out there.
Not going to happen if people shut their mouths. More and more are coming out, and I forsee an avalanche about to flush the detritus from the pharma industry. They could practice their corruptive ways in the banking industry. Or go sell boner pills, shamwows, and snuggies.
~ M. Black
The Judge
If protection for whistleblowers somehow deteriorates, all that would accomplish would be the old “cloak and dagger” style means of getting information to the proper authorities (more like proper groups of authorities) including the media. If rights erode, audio and perhaps video recorders will simply be relied upon to provide evidence of unsafe conditions, illegal practices, etc. The ones on the recording are the important ones. If it needs to be sent out in quadruplicate to four entities anonymously, oh well.
The end result will be very similar if not identical. If it is what it is, then it is, and that’s all.
Technology. Protect yourself. Hit that record button if you are being harassed or being pressured to do something YOU KNOW is illegal or unethical. Even if you PERCEIVE it to be illegal or unethical. They have a personnel file on you from day one, and ANYTHING that may someday be able to be used against you is recorded. You have every right to protect yourself in any way you can.
The issue is that many managers suck rotten eggs. And that is likely on account of said managers putting their head on a chopping block for their previous managers, and performing actions that are illegal or unethical as asked of them by their managers. If we allow this type of “reward system”, take a few minutes and think about how that will effect an industry already mired in scumbag practices.
Anon.
I can’t figure out what M. Black’s true sentiments are. The last post is effectively telling WB’s to go slit their own throats. How successful does he think whistleblowers are going to be in trying to get some reporter or lawyer in a congressional office to even understand complex scientific issues covering thousands of pages of data. Even with simple smoking gun e-mails maybe 1 whistleblower in a 1000 can actually get the media interested and even then it’s a small story in some off-beat little publication that few people pay attention to.
The last post is effectively telling people to go public so they can be prosecuted for revealing government documents illegally. What about their legal bills in fighting. Who’s going to put food on the table for their children. Who will hire them at the time or even later. How are you going to pay for lawyers and actually getting at the corrupt parties. Don’t you realize that with corruption of science that dumping a few documents openly will actually work against you in the long run.
Anyone who is thinking about whistleblowing should get advice from people who’ve actually been there and the advice is always don’t do anything illegal. It destroys your credibility. It’s always better to have things come out in court legally. That’s what happened with tobacco and cancer. Jeffrey Wigand will tell you the best thing that happened to him was not having any documents and forcing him to subpeona them. Even then the tobacco industry fought with a scientific disinformation campaign. Don’t you think that the pharmaceutical industry and FDA won’t do the same.
No we need the courts. That’s why the whistleblower protection act in its current form is less than worthless. The people who are really stroking their egos are the ones who simply want to throw documents around without any thought to the big picture and how to make the biggest and most lasting impact.
The Judge
I wasn’t implying to start throwing documents around. Let me ask you a question Anon: How many petitions have you forwarded for consideration thus far? I never said that we don’t need protective laws, but in the case that the laws are weakened, this will have no effect on the actions of the conscientious employee. If you’re sloppy about it, well, that’s something you need to figure out.
M. Black
I’ve forwarded the petition to 100+ people today. Is that legally effective enough for you? Go do the same before wasting my time any further.
~ M. Black
Thanks Judge. Keep me posted.
M. Black
You realize, I assume, that by a very large majority most whistleblower issues are seen as a petty cost of business operations, don’t you? This cost is NOT EFFECTIVE in straightening out the crooks - I
hope and I assume you are aware of that.