CORRUPTION JUST CONFESSED BY FDA SCIENTISTS


Dr. Betty Martini, D.Hum.
Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
Telephone: 770-242-2599
E-Mail: BettyM19@mindspring.com



Posted: 09 January 2009


Group of FDA Scientists sent letter to President-elect Barack Obama's transition team "pleading with him...managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law"!!!!!!!

Comment from Martini: Easy way to clean up this mess. Here's when it happened: http://www.mpwhi.com/the_new_fda.htm Dr. Arthur Hull Hayes was responsible when he over-ruled the Board of Inquiry that had revoked the petition for approval of aspartame, the deadly addictive excitoneurotoxic carcinogenic drug that interacts with virtually all drugs and vaccines due to damage to the mitochondria. Note the article about the "new FDA". We need to bring back the "old FDA". Ken Stoller, M.D., Pediatrician, would be willing to accept the position of FDA Commissioner and clean up this mess. From the aspartame documentary, Sweet Misery: A Poisoned World, http://www.soundandfury.tv. Here is James Turner, Atty, explaining how all this was caused by Donald Rumsfeld: http://www.soundandfury.tv/pages/rumsfeld.html

In this movie you will also see Arthur Evangelista who worked for the FDA and left because of this corruption back in the early 1990's. At the time the FDA were already manipulating data. Let's send him back with Dr. Stoller. He will get rid of aspartame which is costing this country trillions in medical care and stop the suffering of those with aspartame cancer and all the diseases listed in the 1000 page medical text, Aspartame Disease: An Ignored Epidemic, http://www.sunsentpress.com by H. J. Roberts, M.D. Over 100, 000 people have died just from drug interaction.

The FDA also serves above the law. The law states a Citizens Petition must be answered in 180 days. My petition for ban was sent certified mail over 6 years ago and remains unanswered. The imminent health hazard amendment which is required to be answered in a week or ten days was sent over a year ago. The FDA simply violates the law. FDA toxicologist, Dr. Adrian Gross, told Congress in 1985 that aspartame (NutraSweet/Equal, etc.) violated the Delaney Amendment because it caused brain tumors and brain cancer, and if the FDA violated its own law who is left to protect the public? Read it on the front page banner of http://www.mpwhi.com Is somebody now listening?

Read on below my signature.

Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: BettyM19@mindspring.com
http://www.wpwhi.com
http://www.wnho.net
http://www.dorway.com

Aspartame Toxicity Center: http://www.holisticmed.com/aspartame


ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

Underscoring a crisis of Confidence among FDA senior scientists, the Wall Street Journal reports (below) that a group of FDA scientists sent a letter on Wednesday to President-elect Barack Obama's transition team "pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law."

The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.

"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.

The letter will likely increase pressure on Tom Daschle, Mr. Obama'schoice to head the Department of Health and Human Services, to make sweeping changes at the agency. The scientists' main concerns are with FDA's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."

Adding insult to injury, another report in the WSJ (below) describes how FDA's $1.5 million PR contract with the Center for Professional Development, Inc (CPD)is being spent to promote FDA's Deputy Commissioner, Janet Woodcock, PhRMA's choice for Commissioner, as a "visionary leader."

In essence, CPD is providing promotional services to create an illusion of excellence about the FDA and its top brass--much as it does for its pharmaceutical company clients. The strategy is to divert attention from serious safety issues that cause preventable deaths with promotional puff pieces, such as an "inspirational" FDA slide presentation. See: http://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jpg

The slide presentation is in the same genre as Merck's notoriouspower point slide presentation to its Vioxx sales staff, captioned "The Payoff" in which "Bonus," appeared on a slide, showing a sales representative holding a glowing bag of money.

The fact that Deputy Commissioner, Janet Woodcock, MD, is a serious contender for the FDA Commissioner slot is an indication that the Obama team has, until now been unaware of the agency's failing grades on detecting and averting drug safety catastrophes.

Dr. Woodcock, as some of you may recall, has been a major playersiding with drug industry interests when these clash with consumer safety issues. Indeed, Dr. Woodcock staunchly defended the agency's decision to keep Vioxx on the market even as Merck withdrew the drug. On Nov. 14, 2004, she stated:"There was more bleeding with naproxen, and more cardiovascular events with Vioxx. If you look at the numbers, it's a wash." She said the FDA and its outside experts decided the balance of gastrointestinal benefit and heart risk justified keeping the drug on the market. [1] http://www.iol.co.za/index.php?sf=31&set_id=1&click_id=31&art_id=qw110053998

Evidence of a cover-up was documented in a November 1, 2004 article in the Wall Street Journal, citing internal company e-mails and marketing materials. [2] On November 5 2004, an article posted on the Internet site of the British medical journal, The Lancet reported that by 2000, scientific evidence existed of an increased risk of heart attacks and strokes due to use of Vioxx.

"The record indicates that the actions of both Merck and the US Food and Drug Administration (FDA) contributed to the nearly 30,000 excess cases of heart attacks and sudden cardiac deaths that resulted from the use of the drug between 1999 and 2003. While Merck sought to cover up the danger of its own drug to protect its bottom line, the US government aided the company by approving sale of the drug without conducting any serious investigation intopotential harmful consequences of its use."

Dr. Woodcock is among the agency's powerful administrative officers who tried to silence safety scientists--including David Graham, MD--who brought to light the lethal hazards of drugs such as Vioxx.

On November 18, 2004, Dr. David Graham, a senior FDA safety expert testified before the Senate Finance Committee, providing estimated excess deaths due to VIOXX and called the VIOXX case "a profound regulatory failure." Dr. Graham said flatly that the FDA was "'incapable of protecting America' from another dangerous drug" and cited five additional potentially dangerous drugs on the market: "the acne drug Accutane, the weight loss drug Meridia,the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent." And he was proven right on all counts!

References:

  1. Michael Johnsen. FDA official defends agency, warns drug pipeline could slow Drug Store News, Feb 14, 2005.
  2. Mathews AW and Martinez B. E-mails suggest Merck knew Vioxx's dangers at early stage. Wall Street Journal; November 1, 2004; available at http://www.wsj.com

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974


THE WALL STREET JOURNAL
FDA Scientists Ask Obama to Restructure Drug Agency
http://online.wsj.com/article/SB123142562104564381.html
By Alicia Mundy And Jared A. Favole

WASHINGTON -- A group of scientists at the U.S. Food and Drug Administration on Wednesday sent a letter to President-elect Barack Obama's transition team pleading with him to restructure the agency, saying managers have ordered, intimidated and coerced scientists to manipulate data in violation of the law.

The nine scientists, whose names have been provided to the transition team and to some members of Congress, say the FDA is a "fundamentally broken" agency and describe it as place where honest employees committed to integrity can't act without fear of reprisal.

"There is an atmosphere at FDA in which the honest employee fears the dishonest employee," according to the letter, addressed to John Podesta, head of Mr. Obama's transition team.

The letter will likely increase pressure on Tom Daschle, Mr. Obama's choice to head the Department of Health and Human Services, to make sweeping changes at the agency.

The scientists' main concerns are with the agency's scientific review process for medical devices, which they characterize as having been "corrupted and distorted by current FDA managers, thereby placing the American people at risk."

They sent a similar letter in October to the powerful House Energy and Commerce Committee, but the latest one provides more detailed allegations about problems at the agency, such as the threat of disciplinary action against scientists who dissent from management.

The FDA has been working "very closely" with Mr. Obama's transition team and will address any issues or concerns the team presents, said agency spokeswoman Judy Leon. She said the agency is "actively engaged in a process to explore the staff members' concerns and take appropriate action."

The group says they have taken their concerns to the head of the FDA,Commissioner Andrew von Eschenbach, and his assistant commissioner for accountability and integrity, attorney Bill McConagha. The scientists say no one has been held accountable, and say some of the problematic managers have been promoted and rewarded.

The Energy and Commerce Committee's Democratic and Republican leaders sent a letter to von Eschenbach in November, saying it had "received compelling evidence of serious wrongdoing" at the agency. The members wrote that they were told McConagha had found the FDA doctors' evidence compelling, and that their findings supported removal of certain managers in the device division.

The agency has been under fire from both parties in both Houses of Congress as being too close to industry. Several leading politicians, including Sen. Chuck Grassley have complained that FDA leaders often ignore or suppress their own scientists' opinions on safety issues involving drugs and devices.

Those concerns were also aired in a report by the National Academy of Sciences' Institute of Medicine in 2006. FDA leaders, including drug division chief Janet Woodcock, have said they are working to improve the culture at the FDA, and are listening to dissent from their experts and doctors.

In addition to Mr. Daschle, the letter was sent to the doctor leading the transition team's assessment of problems at the FDA, Joshua Sharfstein, and to nine members of Congress including Sen. Edward Kennedy who chairs the Health Committee.

Members of the transition team weren't available to discuss the letter or whether they intend to address it publicly.

The scientists appear to hope that their concerns will pressure Mr. Daschle to quickly change leadership at the FDA. Von Eschenbach has said he is planning to step down on Jan. 20, the date of Mr. Obama's inauguration.

Indeed, the group said Mr. Daschle has recognized in his book, Critical: What We Can Do About the Health-Care Crisis, that the 1998 approval of some mammography computer-aided detection devices is an example of the breakdown of the independent scientific review process at the FDA.

The group says the FDA approved such devices without clinical evidence showing they were effective in detecting breast cancer. Since 2006, FDA physicians and scientists have recommended five times that these devices not be approved without valid scientific and clinical evidence.

The group said there needs to be a complete restructuring of the evaluation and approval process, and that Mr. Obama needs to sign new legislation giving protection to government employees who speak out against corruption.

Write to Alicia Mundy at alicia.mundy@wsj.com and Jared A. Favole at jared.favole@dowjones.com


THE WALL STREET JOURNAL
January 8, 2009
FDA Outlays for Morale-Boosting Draw Fire From Lawmakers
http://online.wsj.com/article/SB123137470811862863.html
By Alicia Mundy

At a recent retreat for Food and Drug Administration employees, a slide show likened the agency's top drug regulator, Janet Woodcock, to "visionary leaders" such as Golda Meir and Gandhi. See the slide presentation. FDA slide http://s.wsj.net/public/resources/images/OB-CX588_fda_sl_D_20090107193024.jpg

Some lawmakers are fuming about a $1.5 million contract for morale-boosting that the FDA awarded the consultant that prepared the slideshow. The agency's problems, including questions about decisions on the safety of some popular medicines, are likely to come up in Senate confirmation hearings starting Thursday on Tom Daschle's nomination to be secretary of Health and Human Services.

The slide show was presented at a management conference last month for nearly 500 employees of the FDA's drug division, organized by the Center for Professional Development Inc., an Oakland, Calif., consulting firm. The meeting was part of a contract the division awarded to the consultant in late 2007 to "improve workplace leadership" and "empower staff" following a critical report by the Institute of Medicine, part of the National Academy of Sciences. The report faulted the division for sometimes ignoring FDA scientists' concerns about drug safety, including their complaints that the division tilts toward industry in decision-making.

Rep. John Shimkus (R., Ill.) called the contract and the conference a waste. "To remove managers for two days to discuss this morale problem, instead of putting food and drug safety first, is ridiculous," he said.

FDA officials defended the contract and the conference as appropriate responses to the IOM's 2006 report. John Jenkins, one of Dr. Woodcock's deputies at the Center for Drug Evaluation and Research, said the slide listing his boss alongside Margaret Thatcher, Steve Jobs and other "visionary leaders" was presented partly to inject humor into the proceedings. But Dr. Jenkins also said that "many people view" Dr. Woodcock "as being a visionary leader" in the context of her job. In a recent interview, Dr. Woodcock said she set up the current system for doctors to report possible side effects of drugs. She also says she has pushed efforts to give scientists a greater voice.

Republicans on the House Energy and Commerce Committee have opened an inquiry into the consultant contract, saying they are angry at how the FDA is spending money when it has cited a staff shortage in delaying decisions on new drugs.

Rep. Joe Barton, a Texas Republican, said of the slide presentation: "It's a cinch that if I spent a nickel of taxpayers' money to rank myself with [Sam] Houston and [Stephen F.] Austin, I'd have some explaining to do after the laughter died down."

Dr. Woodcock's critics say her division is at the center of problems cited by the IOM's report. It has been the focus of a series of drug-safety related crises in the past several years, prompting about a dozen hearings or investigations in the House and Senate. The division has come under fire for letting drugs such as the painkiller Vioxx and diabetes drug Avandia remain on the market after safety concerns were raised. Vioxx was pulled in 2004, while Avandia remains available with a strong warning about heart risk.

Mr. Shimkus complained that the agency shouldn't have given the contract to a firm that "lists numerous pharmaceutical companies as clients -- at a time when those same ties are being questioned within FDA." Ten major pharmaceutical companies are among the Center for Professional Development's current and former clients, including GlaxoSmithKline PLC, Bristol-Myers Squibb Co., Pfizer Inc., Merck & Co. and Novartis AG.

An official biography of the center's president, Charlotte Milliner, says she "worked with one of the leading pharmaceutical companies to build a partnership with the Food and Drug Administration that will allow them to bring drugs to market faster while maintaining safety."

Ms. Milliner said her experience with many drug makers is an assetfor the FDA. "I think any time that people have a sense of the environment in which people work, it's an advantage," she said.

Dr. Jenkins said there is no problem with hiring a consultant who also advises companies regulated by the FDA. "I think it's quite silly to bring that up as a point," he said.

Write to Alicia Mundy at alicia.mundy@wsj.com