Locker room talk at CDC and FDA

Grassley simply should subpeona the ombudsmen and Gerberding.

Its rare that I TOTALLY agree with Revere, but on this one I do. Rich's idea is dead on and should be done immediately.

Be advised I hear the Gerberdinator is leaving in August.

Randy, you don't seem to have links to any of the claims you make. Here on the Web, links equal credibility. You don't have much.

Politics called threat to CDC
Ex-directors say integrity, morale at risk

By JEFF NESMITH
The Atlanta Journal-Constitution
Published on: 04/04/07

Washington Former directors of the Centers for Disease Control and Prevention warned Tuesday that morale problems and questions of scientific integrity at the agency pose a challenge to the centers' future role in U.S. public health.

"Science is nothing without people," said Dr. William Foege, who ran the CDC from 1977 until 1983, "and there's a perception now that politics trumps science and truth.

Dr. William Foege, director of the Centers for Disease Control and Prevention 1977-1983, makes a point at a symposium of former directors of the Atlanta agency. "Science is nothing without people," Foege said, "and there's a perception now that politics trumps science and truth. This is not just with FDA decisions or climate change or at EPA. We see this in public health as well."

"This is not just with FDA decisions or climate change or at EPA," he said. "We see this in public health as well."

Citing an example of politics dictating CDC decisions, Foege said that in April 2004, the World Health Organization requested the participation of CDC scientists at a conference on HIV/AIDS, and the office of then-HHS Secretary Tommy Thompson insisted on clearing the participants in advance.

"CDC acquiesced in that, and politics trumped science in a way that I never thought would happen," Foege said.

Foege appeared with four other former CDC directors at a symposium sponsored by the George Washington University School of Public Health. It was a rare public discussion of their concerns since most of them privately sent a letter to director Julie Gerberding more than a year ago.

Responding to a question about challenges faced by the center in the 21st century, Foege said that it is hard to keep top-flight scientists when "people debate the efficacy of condoms or the need for vaccinations."

"I think the role of science that has always characterized CDC needs to be strengthened," he said.

Former CDC directors Jeffrey Koplan (1998-2002), David Satcher (1993-1998), William Roper (1990-1993) and James Mason (1983-1989) also appeared at the symposium. Dr. David Sencer, who headed the agency from 1966 until 1977, was unable to attend.

In comments relayed through Koplan, Sencer said morale and retention of top officials are serious problems at the CDC.

Koplan said Sencer told him "bright young scientists are the lifeblood of the agency" and expressed some concern at its ability to attract them in the current setting.

Gerberding, whose leadership has been criticized by many CDC employees for an exodus of top leaders and scientists and for deteriorating morale, was not a panelist.

The former directors were asked to describe what they viewed as the Atlanta-based agency's main "challenges," and Foege and Koplan both said they included scientific integrity and professional morale.

Morale problems and the exit of several top administrators prompted Gerberding last summer to appoint two ombudsmen, both temporary contract employees, to hear employee complaints.

"Maintaining public trust in scientific integrity at a time when there is a perception of political ideology intruding into public health decisions and public health policy" is one of the major issues faced by the centers, Koplan said.

Koplan is vice president for health affairs at Emory University Health Sciences Center, and Foege is professor emeritus of public health at Emory.

Roper said the agency has suffered from its own prominence. "The closer it is to the political process, the harder it is to function as a world health agency," he said.

"I think that this has turned out to be an anti-science age in the government," Foege said. "I can't imagine that we ever would have debated whether condoms were effective when I was there."

Satcher, director of the Center of Excellence on Health Disparities at the Morehouse School of Medicine, said getting sufficient funds and dealing with health disparities were among the CDC's top challenges.

In an interview after the symposium, Satcher said he thought a recent reorganization had much to do with the morale problems.

"I have been reluctant to criticize Julie," he said, referring to Gerberding, "but I think a lot of the senior people who left were unhappy about the way it was reorganized."

Thanks for the interesting post Melanie. It is clearly obvious that politics cause disaster whenever they enter the science fields. Everything seems to have gone downhill since the year 2000. Scary, huh?

First Melanie, is that because YOU say so? Thats a load of crap. It is the direct responsibility of Congress to oversee the Federal government and its agencies. Its very well contained in their responsibilities in the constitution of the US... Perhaps you would like a link to that?

"Congressional oversight refers to the review, monitoring, and supervision of federal agencies, programs, activities, and policy implementation. Congress exercises this power largely through its standing committee system. However, oversight, which dates to the earliest days of the Republic, also occurs in a wide variety of congressional activities and
contexts. These include authorization, appropriations, investigative, and legislative hearings by standing committees; specialized investigations by select committees; and reviews and studies by congressional support agencies and staff. Congresss oversight authority derives from its implied powers in the Constitution, public laws, and House and Senate rules. It is an integral part of the American system of checks and balances"

So its POLITICS whether you agree or not because the Congress is a political body.

I guess like everything else when someone exercises their responsibilties as part of their job, someone who doesnt understand something gets bent out of shape and comes out with yet another diatribe article or says oh you have to link on the internet.. Is that the case here Melanie? You obviously didnt read the Constitution recently. You must have been linking to something at the time.

Mind, the changes in the CDC were long in coming. Streamlining is the term I heard used on more than one occasion and the choice of Gerberding is like Healy at Red Cross. Both are political hacks, both were and are total screwups and Revere has this one down to a fine science at CDC. I agree with him totally. I will say that she was a poor choice and her landing in there was like a bomb going off, and the budgets were cut. In light of current events they should have shown the door to some, and then brought in bigger guns and paid for it. We ARE in deep kimche here. They should either fund it to fix it, they obviously need a departmental head change and barring that, get rid of it and try something else.

Her style and manner, the budget cutting has been laid out more than once here. It might not occur to you Mel that Grassley might actually want to INCREASE their budgets. All of the people that have left did so of their own accord and those that will come back in will also. It will be the system as we know it before, during and after and it doesnt change one thing and that bothers me. I didnt feel safe before the changes, during or especially now after. What do these people do anyway that is clearly beneficial? We know about the AIDS deal, blame it on ________ insert Reagan, Nixon, Ford if you like. Or how about Carter bringing the loads of Haitians in that were infected? Did anyone stand up and go to the President and ask for a declaration of emergency? Nope, they whined that their budgets were being cut and that they didnt have enough then either. Some of the people are in your cite above. Who do I see about that Melanie?

This agency is part of the federal government, thus it is subject to the scrutiny of the Congress. Anyone who doesnt think so is plain flat wrong. It gets its funding from the Congress and not the President. It is an agency that as best I can tell hasnt done just too terribly much since its inception. Cant tell that the health of the nation or the world has bettered since then. They maintain a really good database on all the things that screw humans but do little with it. You know, none of those guys before, during or after your insightful article in their tenure improved the public health or took on any president since its inception in '46. Koop was the only guy I have seen who waded into the fray and beat up both sides of the aisle and he was only the surgeon general. Cut their budgets and send it to the states or fix the damned problem. They are more fixated on Gerberdinator than fixing the problem and thats bullshit too.

Put yourself on a lecture tour.

Gee, Randy, do you ever read the news?

CDC nixes ombudsmen briefing for senator

By ALISON YOUNG
The Atlanta Journal-Constitution
Published on: 03/23/07

The Centers for Disease Control and Prevention has refused a U.S. senator's request for a briefing by the agency's new ombudsmen about efforts to improve employee morale at the Atlanta-based agency.

The refusal prompted U.S. Sen. Charles Grassley to send a blistering letter Thursday to CDC Director Julie Gerberding that lectures her on federal laws against interfering with a congressional inquiry. It also questions the Atlanta-based agency's rationale for denying his briefing request and the credibility of the ombudsmen with CDC staff.
Text of letters (PDFs)

Gerberding letter declining ombudsmen briefing
Grassley letter in response

"I fully intend to exercise my oversight responsibilities to ensure the success and integrity of the Ombudsman effort," wrote Grassley, the ranking Republican on the Senate Finance Committee. Grassley has been investigating whether poor morale and an exodus of high-profile scientists have damaged the agency's ability to respond in a major public health crisis.

The letter calls the refusal of a briefing "troubling" given that the new ombudsmen were supposed to be a cornerstone of the agency's efforts to improve morale.

In a March 5 letter to Grassley, Gerberding said the two contract employees CDC has hired to serve as interim ombudsmen believe that briefing the senator would violate standards of practice for ombudsmen and render them unable to continue to do their jobs effectively.

"While I am respectful of your desire to get further information, I am also sensitive to these principles especially because CDC's Ombudsman Office is in a critical stage of development," Gerberding wrote.

Grassley's letter questions the validity of the ombudsmen's reasoning, stating that he is neither the subject of the ombudsmen's inquiries "nor a potential cause of employee angst at CDC." He notes that the ombudsmen have met and briefed Gerberding. Many employees blame Gerberding and her leadership for problems at the agency.

"Dr. Gerberding, am I missing something here?" Grassley asked in his letter. "Why would two individuals claim preserving their objectivity as Ombudsmen requires refusing to brief Congress, but allows meeting with you to discuss their findings?" Grassley wrote, adding that he's not surprised that few CDC employees have "felt comfortable approaching these two men to seek their help on their problems with CDC management."

CDC spokesman Tom Skinner said Friday it was the decision of the ombudsmen not Gerberding to refuse Grassley's request for a briefing. Gerberding did not influence their decision, Skinner said.

CDC's interim ombudsmen, Joseph McDade and Gerald Naehr, did not immediately respond to a request for an interview Friday. They have not responded to any interview requests in the past.

Grassley was not immediately available for comment.

McDade and Naehr are former CDC employees who now work for Carter Consulting of Tucker. CDC hired them to be the agency's first ombudsmen last fall on a one-year, $250,000 contract.

In January, after meeting with Gerberding, McDade and Naehr issued a brief e-mail report to CDC employees saying that at that time their office had received 26 inquiries, but gave few details of what issues were of greatest concern or what the ombudsmen were doing to address them.

Gerberding, in her letter, told Grassley she's happy to continue to provide him progress reports on the ombudsman's office and its efforts. "Approximately 50 persons, or less than 1 percent of CDC employees, have contacted their office since September 2006," Gerberding wrote. "Given the limited information collected to date and the broad array of concerns initially raised, specific trends cannot yet be identified."

The idea for the ombudsmen came in part from discussions five former CDC directors had with Gerberding a year ago, after they sent her a rare, joint letter of concern that poor morale and the departure of key leaders were putting the agency's public health mission at risk.

Skinner said on Friday that CDC had just received Grassley's letter and would be responding.

"We have and will continue to cooperate with Senator Grassley's office and if there's any impression on the senator's part that Dr. Gerberding is stonewalling, nothing could be further from the truth," Skinner said.

It's unclear what the next move will be in the clash between CDC and Grassley, a senior Senator known for his dogged oversight of federal agencies.

"In the long run, it's foolish for anyone to refuse a request from a member of Congress for a briefing, said Jeff Levi, executive director of the Trust for America's Health, a Washington-based nonprofit public health policy organization.

Grassley's letter asks that CDC officials distribute his letter to employees so they are aware of their rights to contact his office with their concerns. Skinner said he's not aware of any immediate plans to distribute the letter, but that he believes a lot of CDC employees are aware of his interest and willingness to listen.

Skinner said that the low number of CDC employees who have sought help from the interim ombudsmen is likely due to the office being new. He adds that the primary role of the interim ombudsmen is to go on fact-finding missions to other ombudsmen's offices, create a CDC ombudsman's office, and eventually hire a permanent ombudsman. Greater marketing of a permanent ombudsman's office is likely to draw attention from employees, Skinner said.

And your point would be?

Exactly my point. Republican Co-Chair is demanding the Gerberdinator provide the information or she will face a subpoena. Does anyone think he is joking? So thats my point. She doesnt have the right to say no except in where the 5th is involved. She could always step down but might still have to testify. Hey if she's gone I am not going to cry.

I hear that the CDC is a brain trust of some of the best bug people in the business. Generally speaking those kinds of people like Revere are what I consider to be fucking brilliant for the lack of a better term. In my biz, I have had the same kind of terminology applied to me before. May or may not be true. But there is a price to pay generally around those kinds of people and they like to lead, tell people to get out of my way and dont forget the budget. Pass the bucks please. Okay, so JG was a POOR choice but as a person who fully believes that this is the system as we know it, she had better stop obfurscating the process or she could find herself in Club Fed. I would be the first to get the rope to hang her if she violates the law. That process starts with the subpoena.

Its not the CDC thats standing in the way of the Federal investigation, its her. Thats a big time stupid move on her part and yes I read the above I think two weeks ago or more. She is trying to preserve her job is all this is and stalling so she can bail with her tail.

If they subpoena her and the FBI gets involved and this is my part of it, the statements just as Gonzalez can be misconstrued as obstructon. The tip-over point for obstruction is very, very low and especially if you have appointed Federal prosecutors. Look GWB aint near as dumb as the left makes him out to be. They serve at the pleasure of the president. No one said jack-shit when Janet (Liberty City, Waco Texas) Reno fired everyone of the Reagan/Bush1 appointees. So yeah I do read up every day.

Maybe I am missing what you are trying to say so just put it out there and I'll read the Atlanta Constitution Journal next time I am in town.

And by the way, I dont give a crap about morale and their integrity being jeopardized from post one. I want them to do their jobs and improve the health of this country and the world. If it takes money then fine, but dont tell me that when they appoint an idiot to be the boss that you cant still do your job. We have all had jerks for bosses before. Me, I had colonels who would send you in knowing full well you only about a 10% chance of making. Now there's a morale buster.

Randy, I take it you've never worked in a tech-centric company.

I pretty much have to conclude that, because if you had, for more than maybe five years or so, you would never have said what you just did say.

Randy, a "bad boss" can single-handedly sink a technical operation - which the CDC indisputably is - right to the bottom. ALONE.

I know because I've seen it, up close and personal.

In the case I'm referring to, I was just about the last hard-core techie to jump ship. The company was bought a few months after I left by some stock fraudsters pretending to be businessmen. End of story.

The guy who played Russian Roulette with the company, with all six cylinders loaded? The Ops Manager.

I second what Charles Roten said -- I've seen a bad boss sink a tech company too, one that I used to work at. My ex-boss, the company principal, wasn't malicious, just couldn't get his act together for long enough to take care of the day-to-day running the company stuff. He was so caught up in long, speculative flights of fancy about what he was going to do next and how he was going to grow the company that he let the major client rack up tens of thousands of dollars in unpaid invoices. All the rest of us were still doing what we'd been paid to do, but the paycheques started coming later, and later, and eventually, they just stopped coming at all. I got laid off, and then about three months later, the company went out of business.

Grandiose claims, but at the end of the day, just doesn't have the cash? Does that sound familiar to anyone else?

Not any different here Charles or Interro. If its tech-centric then you had more than one dumb boss. One that was over you, and the other one or two that were stupid enough not to rectify the situation.

Combat zones demand results and whatever the mission is stated as. Colonels who dont perfom dont get more than one chance to get it right. I worked in aircraft engineering for Fedex which required the integration of literally hundreds of systems on aircraft that were in refits from pax to freighters. Yep, we had our obstructionists and fiefdoms all over that corporate monster. 120,000 people now and it was 38,000 when I worked there. Why did I leave? Because I realized I was smarter than the next three guys above me. I made them look good. When I left, 1 got fired, 1 demoted, the other shifted to another division to reduce "his stress level." But as I said it was a free choice to stay or go. I decided to go after five years. Now I make more money than any of those guys, and I get to tell people what to do, and they love me. Money breeds adoration believe me. Not many people on any airport that can walk away with a car note for just showing up for an hour or so. Its a good business I am in.

But to be serious here. That dumbass Gerberding has to go. If for no other reasons than to stop the brain burn over there. If it continues Charles I think they'll be contracting bug research out and the entire agency to the private sector (Revere put your application in, theres going to be an opening soon). I say another thing too. If she is trying to hide something which its pretty much evident to me then she is going to get toasted. The tolerance of this Congress is either far left, deep middle or just slightly right. If she is screwing with researchers then thats the dumbest thing she could be doing. Quirky lot at best. Give them money and food and throw away the clocks because they like being in those little dark rooms with the geeky glasses. By the same token, you dont piss of the guys who have your purse strings either meaning Congress. We are only six months from the next election and that could pull up the margin just a bit on either side. Grassely is senior to everyone but not in the majority in Congress. If Gerberdinator continues this "I'll get back with you crap" then the majority leader should issue the subpoena jointly. That subpoena could have a report to our office date too.

She plays this one fast and loose then she is going to be in a lot of hot water. Rove should be on her like super glue. Fact is he might already be. Perhaps a hunting trip with Cheney would bring her into the right state of mind.

I have a question for Revere here though and its serious. In light of what she has done at CDC, can you explain why in any good conscience she WOULD be doing it. Those people have powerful contacts and mostly at the Atlanta Constitution that nobody reads outside of Atlanta but Melanie. But the point is that to go in and make that many waves it just doesnt make sense. Cutting an already strapped budget? No way. There aint that much to get outta them for Iraq. So I just dont get it. If she was going in to do a hatchet job on the place it had to be for a reason. Good or bad. You have contacts, what have you heard?

erm.. Kruger, they've been pretending for years that government is "inefficient" (although they don't say in which aspects nor from whose perspectives). Surely, the instructors in bootcamp mentioned sabotage.

Greg, you didnt read it or understand it. Its either inefficiency, pissed off about Al "We are all gonna die" Gore, money for Iraq, public funding of irrelevant crap that flows out of there (a lot of that right now), people who dont see eye to eye with her, and on and on. I havent heard of any firings, just people leaving so its not a prosecutor and Gonzalez thing. If they fired people then we would have some flesh to sink our fingers into .

But, I havent seen anything anywhere other than the powers that used to be are no longer in charge of the little fiefdoms and realignment of depts were underway. No one likes change but is it change, or deliberately trying to get people to leave. Fed retirement system aint so bad you know.

Doesn't really matter... It's like the Hydra, you lope off a head, Congress is supposed to have control, but wait! Bush comes in with another recess appointment.

I vote for a headectomy. Since managers these days don't seem to have enough sense to fall on the sword, I suggest bringing the sword "to" them.

Crime and Punishment: Enough for Corporate Wrongdoing?
(Pharmaceutical Industry)

Corporate crime should not be a new concept to many. However, it has evolved into more troubling ways- not only in regards to its severity, but the methods of deterrence now being implemented against corporations- involved in the health care industry in particular. So it may be becoming progressively worse for U.S. citizens as a result.

Rather than speak of all corporations, what will be discussed is government health care fraud. Fraud basically is deception with the potential to harm others. In the case of pharma companies, this may include improper promotion and marketing, meaning that such tactics are or may be deceptive misconduct that may be illegal. In addition, there are the crimes of kickbacks and lesser crimes of misbranding products. Probably more methods of wrongdoing as well do in fact exist and happen. Yet the point is that drug companies should not engage in such wrongdoing to enrich their faceless existence with profiting off those who are ill in illegal ways.

How is such conduct discovered? Typically by whistleblowers who worked for the described pharma company, and such people are rare for a number of reasons. The whistleblower then seeks legal agents and files what is called a qui tam false claims act with a district attorneys office (Boston or Philadelphia, if you want prosecutors to take you seriously). After the case is filed, the whistleblower verbally acknowledges the charges and evidence to the chosen prosecutors and others.

Such cases usually take years for unclear reasons, yet in the past two years, the settlements from such cases has approached 2 billion dollars after investigations ended that took years, which is tax dollars returned to the American public with these settlements.

So, what has been happening once a pharma company is busted. Criminal indictment by the district prosecutor? Hardly, yet appropriate. Usually, the prosecutors objective is to dismiss the case, but give the impression that such activities will not be tolerated by our government. So Corporate Integrity Agreements are mandated to the pharma company, but not really taken seriously, as some have more than one of these agreements active still. Its an invisible ankle bracelet. A pharma company can and have committed equal or worse crimes while under such an agreement. This Agreement is issued after the deferred or non prosecution agreement is sentenced to the law-breaking corporation, which basically is a pre-trial diversion. Essentialy, its just parole, which is supported by the DOJ and the administration. The criminals admit wrongdoing, but not guilt. And they pay a settlement in the neighborhood of hundreds of millions of dollars. Not that shocking, if you consider the income of big pharma companies. These agreements are relatively new and partially a result of suggestions from what was known as a Thompson memo, which basically was created by a DOJ guy as commandments for prosecuting corporations and variables to consider when doing so, which ultimately offered responses as to why a greater degree of punishment was not enforced.

We are one of three countries in the world with the most prisoners behind bars, yet those that do similar if not greater harm to others get out of jail free. Double standard, I would say. Is this behavior by our legal system towards corporations an effective deterrent? Most think not. It rather seems like tacit approval of their conduct. And health care fraud may be more damaging than other types in other industries, yet lack of regulation allows such crimes to continue.

Citizens should make the laws in our country. Justice would then finally exist. Utopic concept, clearly.

Corporations cannot commit treason, nor be outlawed, nor excommunicated, for they have no souls.
---- Edward Coke

Dan Abshear