FDA Fails to Follow Up on Safety of Approved Drugs

November 30, 2009

Natural News

By Paul Louis

A new congressional report from the Government Accountability Office (GAO) reprimanded the FDA for failing to properly monitor drugs approved under the FDA’s 1992 accelerated approval process. The report focused on 90 drugs.

The accelerated approval process was ostensibly enacted to rush minimally tested cancer and AIDS drugs that were urgently needed to assist those with life threatening situations. In exchange for accelerated approval by the FDA, drug manufacturers agreed to provide the FDA with post-marketing reports to determine if the drug is safe and effective.

Yet most drug makers were not complying with post marketing follow-up reports. And the FDA has never removed a drug approved by the accelerated process from the market. Some of the drugs approved have gone 13 years without post marketing reports!

The GAO report states, “. . . the FDA has authority to expedite the withdrawal of a drug from the market if a sponsor does not complete a required confirmatory study with due diligence, or if a study fails to confirm a drug’s clinical benefit, [yet the FDA] has not specified the conditions that would prompt it to do so.”

This indicates that the FDA has never created a procedure to remove fast track drugs even if they are dangerous. This precludes quality control on drugs fast tracked for public consumption. Pre-market proposals based on theory and limited testing have been the only basis for continued use. Therefore the public becomes part of a medical experiment.

Some drugs that never reported were big money makers for over a decade. And the FDA never bothered to inquire about their follow up reports. The GAO report requested the FDA “clarify” under what circumstances it would voluntarily remove potentially dangerous or ineffective drugs from the market.

The FDA balked. They claimed there was no need for clarification.

FDA officials asserted that these fast track drugs are “. . . life-saving drugs for which there are no replacements.” Yet there is little or no documented proof of “life saving” efficacy or safety because post marketing reports have, for the most part, never been conducted.

It appears that the FDA’s requirements for post market reports from drug companies in exchange for accelerated approval were window dressing. The FDA’s lack of enforcement speaks for itself. Meanwhile many drug makers have made a lot of money dispensing often ineffective and sometimes dangerous drugs to desperate people.

Click here for the full report

Criminal Doctors and Researchers Still Allowed by FDA to Work on

November 19, 2009

Natural News

By E. Huff

(NaturalNews) The U.S. Government Accountability Office (GAO) recently released a report indicting the U.S. Food and Drug Administration (FDA) for allowing health professionals convicted of crimes to perform research for the agency and to supervise patients’ safety during clinical trials.

The FDA is required by law to disqualify from positions within its organization doctors that have been convicted of fraud or other crimes. Yet the GAO is publicizing that it takes an average of four years for criminals to be disbarred from their positions.

In one case, a doctor who was convicted of 53 counts of criminal offense was allowed to remain at the FDA for 11 years before action was taken. The doctor’s offenses included bribing an employee to cover up a patient suicide that occurred during a clinical trial and prescribing drugs without a license.

Another doctor was convicted of defrauding his employer of more than $10 million in clinical research funds. Rather than using the money to conduct the trial, he diverted it to entities owned or controlled by the clinical trial investigators.

One of the more notorious cases is the debarment of Anne Kirkman-Campbell, an Alabama physician who pled guilty to mail fraud in a clinical trial for Sanofi-Aventis SA’s antibiotic, Ketek. Though sentenced to more than four years in prison, it took the FDA nearly five years to actually debar the felon.

According to the report, three doctors who broke FDA regulatory rules or who have been convicted of crimes have yet to be debarred and continue to work for the agency. One of the doctors is involved in fraud that dates back to 2005; the doctor has yet to be debarred.

Falsified clinical trial data
In the majority of cases, doctors are convicted of falsifying clinical trial study data. Everything from submitting data for fictitious study participants to lying about study results has been tolerated by the FDA. The consequences of such deception are ultimately costing people their lives.

Other examples of common misconduct include failing to obtain informed consent from clinical trial participants, failure to properly maintain case histories and records, failure to comply with requirements to obtain initial and continuing approval from an institutional review board, and failure to follow the clinical trial’s research plan.

All such misconduct warrants debarment from the FDA, yet the GAO study has concluded that it takes the FDA an average of four years to remove criminal doctors from its ranks. While required to debar all doctors who violate federal guidelines as well as openly convicted criminals, the FDA habitually drags its feet in dealing with offenders.

One of the biggest problems with the FDA’s debarment policy is a loophole that allows convicted criminals to continue working in another area outside of the one in which they were convicted. For instance, a doctor convicted of drug trial fraud can still work in trials in other areas such as medical devices.

Another major problem is the fact that the FDA holds no actual authority to debar convicted criminals from engaging in medical-device industry activity, a growing segment of the health care industry. A doctor convicted of lying about the purported benefits of a new device to treat asthma, for instance, cannot be debarred under current FDA policy.

Proposed solutions to the problem
Representative Joe Barton of Texas has proposed a bill that would mandate removal of convicted criminals from the FDA within one year of either being found committing fraud or of being formally convicted of committing one.

One year is more than enough time to execute proper removal procedures. Yet the FDA’s track record of handling the crooks in its midst is far from satisfactory and many are demanding some type of reform within the agency.

The GAO has proposed that the FDA be given debarment authority over medical devices in order to curb the transfer from one area of research to another in cases of criminal activity. Regulatory revisions to eliminate any further participation by criminal offenders within the organization is necessary to maintain any sort of organizational integrity.

The foundational problem is that, even with guidelines, the FDA continues to break its own rules and perpetually fails to act in accordance with its mission statement. More rules would potentially do very little to remedy the corruption that continues to plague the agency.

Click here for the full report

Neocon Trying to Oust Ron Paul

October 28, 2009

InfoWars

By Kurt Nimmo

Tim Graney of Katy, Texas, has announced a bid to unseat Ron Paul in the 14th congressional district of Texas. According to FortBendNow, a news website in Houston, Graney is a small business owner and this is his first political campaign. Graney told FortBendNow the district needs a new voice in Congress, particularly in the area of foreign policy.
 
Ron Paul adamantly opposes the invasions and occupations of Iraq and Afghanistan. “I believe our founding fathers had it right when they argued for peace and commerce between nations, and against entangling political and military alliances. In other words, noninterventionism,” Paul wrote in 2007. He believes Congress needs to reassert its authority over foreign policy. The Constitution makes no distinction between domestic and foreign matters, Paul insists. “Policy is policy, and it must be made by the legislature and not the executive.”

“I am a fiscal conservative, but I do not support Ron Paul’s weak foreign policy views, nor do I support his do whatever you want ultra-Libertarian views that conflict with our American values,” Graney said.

In other words, Graney subscribes to the unitary executive doctrine of an imperial presidency. The Constitution makes a distinction between the power of the Congress and that of the president by stating that Congress shall “make all laws” and the president shall “take care that the laws be faithfully executed.”

Graney apparently believes invading small countries and killing large numbers of people — more than a million so far in Iraq — represents “American values.”

Ron Paul is not an “ultra-Libertarian” (ultra-libertarianism would be defined as anarchism). Paul is a mainstream Libertarian. Mainstream Libertarians support free market capitalism by advocating a right to private property, minimal government regulation of property, minimal taxation, and rejection of the welfare state, all within the context of the rule of law.

According to Graney, Paul’s mainstream Libertarianism is not consistent with the beliefs of residents in the district. Mr. Graney apparently believes the residents support undeclared and illegal wars, unchecked federal power over the states, federalized local police, and an astronomical federal debt that threatens to impoverish them and their children.

It is not clear if Mr. Graney’s campaign is supported by defenders of the Federal Reserve and the bankers. In February, Ron Paul introduced HR 1207, a bill to audit the Federal Reserve. If enacted, the bill would enable the Comptroller General of the GAO to audit the Federal Reserve system before the end of 2010. HR 1207 now has 307 sponsors. Committee hearings were held on September 25.

On October 12, the neocon Republican Lindsey Graham, a senator from South Carolina, told a town hall meeting he would not allow Paul to “hijack” the Republican Party. Graham supports a big government climate bill “because it could mean good business,” according to Politico. He told Politico he backs “combining an energy independence bill with one to control carbon dioxide emissions.”

“I am more resolute than ever to help steer our nation back onto the path of common-sense energy initiatives,” said Graney.

Ron Paul has signed the “No Climate Tax Pledge” sponsored by Americans for Prosperity. The pledge opposes “legislation relating to climate change that includes a net increase in government revenue” through taxation.

Click here for the full report.

GAO: FDA Can’t Estimate Its Own Budget Needs

July 20, 2009

Associated Press

by Matthew Perrone

The Food and Drug Administration — which has struggled to fulfill its mission of regulating food, drugs and other consumer goods that make up nearly a quarter of the U.S. economy — does not have the expertise to forecast its own budget needs, according to congressional investigators.

While many lawmakers and consumer advocates have long complained that the agency lacks the staff and equipment to accomplish its mission, the Government Accountability Office says the agency doesn’t even have “the data to develop a complete and reliable estimate of the resources it needs.”

The GAO places some of the blame on the FDA’s lopsided budget — which dedicates significant resources to approving new products, but far less to tracking their safety once they’ve reached the market.

FDA officials acknowledged the problems uncovered by the GAO, saying they are working to get a better picture of the agency’s spending and how much additional funding it needs.

“We have to be able to talk about the funds we need, and how we’re using the money, with more detail than FDA has in the past,” said Dr. Joshua Sharfstein, the agency’s deputy commissioner.

The GAO report, released Monday, is the latest in a series to document the problems facing the agency. The FDA has spent the last few years careening from one public health crisis to the next. They have included the recall of the painkiller Vioxx — which was linked to heart attacks, contaminated blood thinners imported from China, and an investigation into a salmonella outbreak that dragged on for weeks before peppers were identified as the culprit.

The agency’s product review program is largely funded by user fees from drug and medical device companies, while the company’s safety inspections are funded by taxpayer dollars. Over the last 10 years, funding from private companies increased nearly 270 percent, while funds from the U.S. government grew less than 70 percent.

Currently, the federal government pays for just over 30 percent of the FDA’s medical products budget. As a result, the FDA is approving more new products but is spending far less to make sure they are being used safely.

“The approval of new products has increasingly become the beneficiary of the agency’s budget,” according to the GAO report.

Between 2004 and 2008 the agency failed to inspect all U.S. drug manufacturing plants every two years, as required by law. In other areas, such as reviewing reports of negative drug side effects, the FDA could not even say how much money and manpower it spent.

Investigators recommended the FDA conduct a comprehensive assessment of its current workload and use that to develop future budget requests.

Sens. Ted Kennedy, D-Mass., and Charles Grassley, R-Iowa, and Rep. Henry Waxman, D-Calif., requested the GAO probe.

“This report makes it clear that the FDA has to get a handle on its own resource requirements and how to use resources more effectively,” Grassley said in a statement.

Under the Bush administration, FDA officials often insisted the agency had sufficient funding, even when its own advisers said it desperately needed more. In 2007, the agency’s independent group of science advisers said the FDA was in danger of failing in its mission due to a lack of expertise and resources.

“American lives are at risk,” the group concluded.

Sharfstein said President Barack Obama is aware of the agency’s funding woes and is working to boost its budget for safety and inspection activities. The administration’s fiscal year 2010 budget proposal would increase FDA’s federal funding by more than 14 percent, to $2.35 billion from $2.06 billion. The spending bill passed the House earlier this month and is moving through the Senate.

Obama tapped Sharfstein to fill the FDA’s No. 2 position in March. A pediatrician and former Baltimore Health Commissioner, he reports to FDA Commissioner Margaret Hamburg, who was confirmed by the Senate in May.

FDA officials already are working to keep better track of how the agency uses its funding.

“We’ve actually been working on this since we started here, but it’s a big agency and it’s going to take some work to get to the level of detail people want,” Sharfstein said.

Click here for the full report from the Associate Press.