Study: FDA Oversight Of Drug Tests Is Lax

Feds Inspected Just 1% Of Drug Trial Sites, Safety For Millions Of Patients At Risk, Report Says

(CBS/AP)  An inspector general's report of the Food and Drug Administration's oversight of clinical drug trials says such tests -- which involve millions of patients using experimental drugs and medical devices -- are inadequately monitored by the government for patient safety, according to a report released Friday.

Over a six-year period, the FDA inspected just one of every 100 trial sites, or one percent, raising questions about the agency's ability to ensure the safety of study participants, according to the report by Health and Human Services Department inspector general Daniel Levinson.

Even when clinical trials do get inspected, the report found that its often after they've been completed -- too late to help participants who might have been put at risk, reports CBS News correspondent Nancy Cordes.

Hampered by the lack of a comprehensive catalog of clinical trials, the FDA is unable to even identify all trials, the estimated 350,000 study sites, and the institutional review boards that oversee each study to ensure they meet scientific, ethical and legal obligations, the report says.

Those limitations hinder the FDA's ability to ensure participants are protected from unreasonable risks, Levinson said.

The FDA relies on just 200 inspectors to police human studies of drugs and devices. The inspections they perform focus more on ensuring the accuracy of trial data than on verifying the measures put in place to protect the study participants, the investigation found.

The report found that even when FDA inspectors did find serious violations, their superiors downgraded the infractions 68 percent of the time, reports Cordes.

“They feel the pressure to go easy on industry,” said Dr. Peter Lurie, deputy director of the Public Citizen’s Health Research Group. “So that's what you see when the senior people are overruling the people who have actually done the inspections.”

Between 2000 and 2005, the FDA found serious problems at test sites 348 times. But only 26 investigators were disqualified from conducting further clinical trials, and data were disqualified just twice, according to the report.

The findings come as no surprise to former FDA employee Dr. David Ross, reports Cordes. He says he was told to keep quiet concerning the behavior of the lead enroller in trials for the antibiotic Ketek.

“She made up patients who were enrolled in the trial, she enrolled patients every few minutes at times when the clinic was supposed to be closed, it just went on and on and on,” he said. “It was fraud. And she went to jail for it.”

Among the findings:

• The FDA does not maintain a clinical trial registry, so it cannot even identify all ongoing clinical trials and their associated trial sites.
  
• FDA relies on voluntary compliance to correct violations of regulatory significance.
  
• The majority of inspections conducted verify clinical trial data rather than human subject protections. Seventy-five percent of bioresearch monitoring inspections were of completed trials focusing on the verification of a clinical trial data's quality.

"The report makes clear without a tough cop on the beat to enforce the rules, unscrupulous researchers can take advantage of trial participants and potentially expose them to harm," said Rep. Edward Markey, D-Mass., co-author of a provision in an FDA bill signed into law this week that creates a mandatory clinical trial registry.

"Right now I think there is better protection, in some ways, afforded to animals that are involved in research than humans," University of Pennsylvania medical ethicist Dr. Arthur Caplan told CBS News.

The FDA told the inspector general that inspections make up only one part of its efforts to ensure human subject are protected. The agency sees its review of study protocols before they get under way as the most important step in protecting participants.

The FDA oversees the safety of companies' drug or medical device trials, while the Office for Human Research Protections does the same for federally financed tests.

There is no federal monitoring of privately financed, noncommercial trials.

The study was first reported in The New York Times' Friday editions.

The report made recommendations to the FDA, including developing comprehensive registries of drug trials and databases of inspections, and to seek the legal authority to provide oversight of all stakeholders in clinical trials.

[whispyseas]

'' ... i couldn''t give you less than free food and free medicine forever if i even wanted to ... nah, actually: to feed the world, i gotta tax everyone in the world and deny options to the begging ... soo laughing ... anyways: i''ve been wondering lately, if the average county is 577 square miles and 90,000 folk occupying 300 16 acre trail crossings and 300 folk in 300 weeks turn out 90,000 (little eco friendly non resource depleting) museums of medical you are here map song dance skit kit, and 90,000 folk turn out many billion museums of medical you are here map song dance skit kit in the same period, and for many many small small tips, and the average home is 340 squre feet with 2500 square feet of garden and costs anywhere from $2400 to $60,000; then, on a cosmic scale: what''s the average county skize? and how many trail trail crossings? of how many cubic light years? and how many naked folk dance get well feed world songs rallyd round the sick beds drifting the spore bloom weed dragon trail fickle first aid lunch farm cottage studio trail groups at each trail crossing? and how many (little eco friendly non resource depleting) museums of medical you are here map song dance skit kit does each collection of how many folk turn out in what amount of time? and how volume density surfacearea is the average homed sheltet and the average lawn? and what''s the average cost? ... ''

[getloud1]

If Americans don%u2019t wake up their will be nothing left, our Nation is broke and Wall Street is the only people making a profit. While the Hidden inflation tax continues to rise and the value of the dollar declines. Ron Paul is the only one who truely understands this, and honestly if he is not elected America should be prepared for a real economic depression like it has never seen before.

Unless you want a North American Union and a new currency the "Amero" split with Canada and Mexico. And lose all your rights and freedom. Vote For Ron Paul 2008!

So my advice is to bypass the media and spread the word to your family and friends about him. The power of the People is far greater than a campaign spending 10''s of million to buy an image. Because this man is a real American Hero. He has dedicated his life to this country and everyone in it, and now he is trying to save it from disaster.

Spread The Word! Go Ron Paul 2008!

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http://www.ronpaul2008.com

Join The ReVoLuTiOn:
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[larrs08]

How could this be? Bush put some of the food and drug industry''s top lobbyists in charge of the FDA. They should be running a very tight ship and protecting American consumers. I don''t believe this story. It can''t be true. Bush is awsome.

[drinuk]

tcoleman12. This is nothing to do with being Liberal, Right wing or even Left wing, the American people are being scammed across the whole political spectrum. Health Management in this country has been bought lock, stock and barrel by Big Pharma. The money they spend on gaining suspect approvals in Washington is equal if not greater than the gross national product of many third world countries. They have inflated the nations budget on health care beyond comprehension. They buy their favours from the very top in government to the lowest doctor around the block. They are evil, they are the real terrorists harming our nation and it''s people on a daily basis. If in doubt, get this! They are now spending millions lobbying to change the US law on Patents so that they may harvest and sell under patent the very plants from the Amazon they, along with the FDA have been trying to ban for the last two decades. Plants and Trees they have known to be successful against cancer. They are SCUM.

[drinuk]

Nice Try Denise and I''m sure the "Model" you write of is how it should be done but get real, in practice it just ''aint happening like that. Sure they will jump, guns out on the little guy selling B-17 but if your name is Merck or Glaxo or you just happen to be the ex CEO of Eli Lilley and now working in the White House you can get a ticket on any C R A P you wish. Sooner or later these crooked people will be exposed, only then will we see the true extent of this corruption.
What we now need following this report is a Whistle Blower, someone knowing how many people are dying because of these scams, an individual with new found honesty and integrity whose conscience is causing him or her concern, to blow the lid of the whole bunch. There must be a Christian out there who is prepared to hand a dossier to a honest politician like Ron Paul.

[tcoleman12]

And this is how you Libs want Health Care run??? This is the government at work right here, folks. Just one example after another.

[momofm3]

And who do you think is going to pay for the thousands of more staff members the FDA would need in order to clean up their act? Not the drug companies...

[ccra3]

Your report on how clinical trials are inadequately monitored by the government was misinformed and very misleading to the public. The FDA does oversee clinical trials consistently in this way:

Clinical trials are audited by privately employed (saving mil.in tax dollars) Clinical Trial Monitors (CRA''s) on a regular basis. Their primary purpose is subject safety as well as the efficacy of the drug involved. They are also highly trained to detect fraud at an investigative site. The investigative sites are required to follow specific laws set forward by the FDA. The FDA is made aware of any violations in these areas. Another oversite agency is the Institutional Review Board (IRB). The FDA requires all sites have an assigned IRB, independent of the site and the pharmaceutical company. The members must include appropriate professional competence to review the diverse types of protocols (studies) that are received. IRB''s report directly to the FDA any violations and subject safety issues. CRA%u2019s and IRB%u2019s are held to the highest ethical standards. Along with data results the FDA is fully informed on all audit findings.

Rest easy America - it''s not as bad as CBS News portends it to be. Without your help, we wouldn''t have many of the wonderful drugs that are on the market today. Don''t be afraid to be a part of a clinical trial that you have been fully informed through the consent process - Denise Galligar, San Diego, California, Clinical Research Consultant

[alphaa10-2009]

CBS comments, "The FDA relies on just 200 inspectors to police human studies of drugs and devices. The inspections they perform focus more on ensuring the accuracy of trial data than on verifying the measures put in place to protect the study participants, the investigation found."
---
In most proofs of value, we rely upon established authorities or independent replication of study results. Independent replication is the method scientists use to ground hypotheses and determine the promise of a research direction.

For FDA inspectors to "verify" trial data is not nearly the same as having independent replication of study results.

Put another way, the FDA cannot regulate if it has no scientific data which is reliable.

[drinuk]

I challenge the FDA to publish human trial results on Vitamin B-17. Tell the people of America, especially those suffering from Cancer, who carried out the study, who paid for the study and who is behind the draconian policing of that vitamin. Cut the ***, let us have the truth.

[alphaa10-2009]

Lars008 admits, "Just because Bush apointed a bunch of industry lobyists to run the FDA you think that everyone is on the take there."
---
I rest my case. Lars008 demonstrates the venal and corrupt in the GOP have reached the point of believing their own lies.

[drinuk]

This is of little surprise, the fact that Big Pharma has control over the FDA and key personnel means that the correct procedure''s and follow up are most definitely disregarded.

Lars! I''m no liberal, I am however Anti Elite Crooked Corporate America which corrupts every public office throughout the country. The FDA is rotten to the core, the incestuous relationship at the very top with the pharmaceuticals is not only costing the tax payer billions but killing them too. Aspartame is a major example of a total corruption which goes to the very top of our government and the White House in particular. This report is the tip of an iceberg endangering each and everyone of us.

[alphaa10-2009]

The problem at the FDA is an acute lack of mission. If boosting large pharmaceutical profits were its only objective, the FDA could not be better disposed to that task.

But what about us, the people in whose name these FDA staffers go to work every day? Our very safety depends on the now doubtful imprimatur the FDA provides. What does the FDA do for us?

On one hand, the FDA does little investigative or developmental work of its own-- a surprise to many Americans. The FDA does no independent verification of data provided by drug manufacturers. And as the HHS IG report indicates, "Over a six-year period, the FDA inspected just one of every 100 trial sites ... raising questions about the agency''s ability to ensure the safety of study participants..."

On the other hand, the FDA imposes steep fees on new drug proposals, ostensibly to fund the review process. This hefty pricetag excludes all but the biggest players (almost by design). It also stalls or even kills small, hopefully-funded drug development efforts. Many promising drug therapies are snared in the drug approval gauntlet as time runs out on limited investor funding, and the potential of new, untried approaches is lost to millions of Americans.

Despite their claims of billions invested in development, the majors invest the preponderant share of their investment dollars in promotion, fielding large sales teams to badger your doctor into buying their product.

[larrs08]

You libs make me sick! Demonicrats! Just because Bush apointed a bunch of industry lobyists to run the FDA you think that everyone is on the take there.

[Pecsnleather1]

I wish everybody would go to the FDA site and read the bio on just who is who in the FDA...Doctors,Doctors and drug salesmen