Ketek Lawsuit & News Blog

Initiating Ketek Litigation

Wed, 21 May 2008 09:18:53 -0400

Anyone who performs even a modicum of Ketec research will discover that this antibiotic has brought about a number of lawsuits. These instances of Ketec litigation derive from various product liability lawsuits. This is an unfortunate occurrence as much of these problems could have been avoided. While it would not be completely accurate to say that the FDA could have averted the circumstances surrounding the Ketec litigation, it would be safe to say the FDA could have performed more due diligence.

This is because ,uch of the FDA's approval process was based on the performance of the drug overseas. This was an unfortunate decision because there have been a number of serious problems which have resulted from the inclusion of this drug on the US market. These serious problems have included liver damage, liver failure and even instances of death. Yes, there were a number of standard tests performed in the United States but these tests were horribly flawed. This is why there so many people dealing with serious Ketek side effects. Then again, this is why there are so many Ketek class action suits as well. Yes, the approval of Ketek was a true black eye on the reputation of the FDA.

Of course, while the FDA could have done a far better job this is no excuse to let the manufacturer off the Ketek litigation hook. Proper research into the safety of the drug would have averted many of the problems. This is why the manufacturer is now on the receiving end of a number of lawsuits instead of avoiding

FDA approved antibiotic drug - Telithromycin

Mon, 5 May 2008 14:56:30 -0400

Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Sanofi Aventis under the brand name Ketek. Telithromycin was U.S. approved in April 2004.

Telithromycin is indicated for the treatment of bacterial infections such as community-acquired pneumonia, acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis.

A report in the Annals of Internal Medicine explains that three patients had jaundice and abnormal liver function after taking telithromycin (Ketek). One patient recovered, one required a transplant, and one died. All three patients had previously been healthy.

At the time of market approval for telithromycin (ketek), the product label included a precautionary statement advising doctors that hepatic adverse event (hepatic dysfunction, increased liver enzymes and hepatitis, with or without jaundice) had been reported and that these events were generally reversible. This precaution was based upon the findings from the phase three clinical studies and post-marketing data from other countries.

Patients who have been prescribed telithromycin and who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers. Healthcare providers should monitor patients taking telithromycin for signs or symptoms of liver problems. Telithromycin should be stopped in patients who develop signs or symptoms of liver problems. As with all antibiotics, telithromycin should only be used for infections by a susceptible microorganism; telithromycin is not effective on viral infections, so a patient with a viral infection who took telithromycin would be taking a risk without any benefit.

Telithromycin is marketed and used extensively in many other countries, including Japan and European countries. The FDA is working with regulatory authorities in these other countries to obtain further information on reports of liver problems associated with the use of telithromycin.

While it is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

If you or a loved one is the victim of telithromycin liver damage, please contact us about a possible lawsuit. Find out what your legal options are.

The Bush administration has declined to comply with a congressional subpoena for documents related to Sanofi-Aventis' antibiotic Ketek.

Fri, 15 Feb 2008 10:36:03 -0400

An investigative subcommittee of the House Energy and Commerce Committee sought papers used to prepare Food and Drug Administration Commissioner Andrew von Eschenbach for testimony he gave at a hearing on the drug last March. The administration's response was released yesterday by the panel.

Suits Over Antibiotic Ketek Bolstered By House Inquiry Into Faulty Testing

Fri, 15 Feb 2008 06:14:05 -0400

New Jersey Law Journal reports that Plaintiffs in New Jersey and six other states who claim the antibiotic Ketek caused liver disease are getting a booster shot from a congressional inquiry into the clinical trials that led to FDA approval. On Tuesday, witnesses at a hearing before the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations testified that Ketek's trials were flawed and that the company had knowledge of flawed data even before FDA approval.

Ketek: Who can you trust?

Thu, 14 Jun 2007 11:41:01 -0400

Source: http://www.sptimes.com/2007/05/31/Opinion/Yet_more_suffer_as_FD.shtml

Dozens of people have suffered liver disease and five have died because the Food and Drug Administration (FDA) ignored serious fraud concerns to approve a new antibiotic for sinus infections called Ketek. The agency that is required by law to protect American consumers from dangerous medicines and tainted food has let us down again.

The FDA isn't the only culprit. The drug maker Sanofi-Aventis rushed the drug through the approval process, to the exclusion of serious doubts about the accuracy of its clinical trials.

Both the FDA and Sanofi-Aventis had early warnings that Dr. Anne Campbell of Alabama had faked patient data for the Ketek study. Even after an employee of the third party conducting the study for Sanofi-Aventis reported Campbell's suspicious data, the drug company did nothing. Concerned by similar findings, the FDA drug approval office notified its criminal division, but even then neither the FDA nor Sanofi-Aventis slowed the process.

When the FDA scheduled an audit of Campbell's files, the drug maker sent its experts to coach her in answering questions.

Ketek won FDA approval as a daily-use antibiotic. Soon thereafter, patients using the drug started suffering liver problems. The FDA has linked Ketek to 53 cases of liver failure, including five deaths and two people needing liver transplants. The drug's use is now limited to certain cases of pneumonia.

So far, the criminal investigation has resulted in only one charge, against Campbell, who is serving a prison term. Sanofi-Aventis has fared much better. U.S. sales of Ketek totaled nearly $400-million before the restriction was imposed, cutting revenues in half.

The failure of drug oversight begins with the dubious relationship between drug companies and their regulator. The FDA relies on drug maker fees to account for more than half of its drug approval budget. The entire process is designed for the pharmaceutical industry to get its products to market quickly.

Sinus Sufferers: Do Not Take Ketek

Fri, 1 Jun 2007 11:42:25 -0400

Source: http://www.nbc5.com/health/13361549/detail.html

Two North Carolina patients took Ketek for sinus infections. One died and the other needed a liver transplant. What's wrong with this picture?

Ketek is a relatively new antibiotic drug prescribed for sinus infections and bronchitis.

It's a scandal picture painted by the drug manufacturer in France to the U.S. Congress, where senators like Iowa's Charles Grassley were shocked at how the drug got FDA approval in the first place.
Grassley's sub-committee heard testimony that one of the doctors used in the drug's safety study had falsified results, and that FDA managers hid that fact from the FDA panel that recommended the drug. Then the FDA muddled the problem by using unscientific foreign reports of Ketek's side effects to claim it was safe.

When cases of death and injury began to appear, the testimony alleges the FDA did not issue an adequate new warning label for at least a year.

In the United States, Ketek is still on the market, but not for coughs and sniffles anymore -- only for a type of pneumonia.

A Sanofi-Aventis spokesperson said they are committed to patient safety and only learned of the fraudulent behavior of one of their investigators when the FDA discovered it. Meanwhile the FDA said it tossed out that study but approved Ketek based on foreign data on side effects and other smaller drug studies.

Prescription drug buyers beware; what does it take to get bad drugs recalled?

European Equivalent to FDA Says No to Ketek

Tue, 1 May 2007 10:47:25 -0400

http://www.medicalnewstoday.com/medicalnews.php?newsid=66667 - Well, at least Europe is paying attention and has the courage to just say no. The European Medicines Agency (EMEA) has recommended restrictions on the use of Ketek (telithromycin) in three of its four approved indications. For the treatment of bronchitis, sinusitis, and tonsillitis/pharyngitis, Ketek should only be used for infections caused by bacterial strains that are suspected or proven to be resistant to or cannot be treated with macrolide or beta-lactam antibiotics.

No such restrictions are recommended for the remaining indication, the treatment of community-acquired pneumonia.
The Agency's Committee for Medicinal Products for Human Use also recommended the contraindication of the use of Ketek in patients with myasthenia gravis and strengthened warnings on transient loss of consciousness and effects on vision.

The FDA and Ketek

Mon, 30 Apr 2007 10:44:36 -0400

Two of the allegations brought to the attention of the Senate Finance Committee relate to an FDA advisory committee meeting, specifically the Anti-Infective Drugs Advisory Committee (AIDAC or Advisory Committee) meeting held January 8, 2003. (According to the FDA, the value of an Advisory Committee is to provide independent expert advice, to lend credibility to the FDA's review process, and to allow for public discussion of controversial issues, among others.)

The two allegations are: 1-FDA management instructing FDA officials to present fraudulent data to the Advisory Committee because discussing issues regarding data integrity and the conduct of a safety study would not be productive; and, 2-the FDA actually presenting fraudulent study data to the Advisory Committee.

In 2001, the Advisory Committee requested that a phase III safety study of patients in a usual care setting to examine the potential toxicities of Ketek with regard to cardiac, hepatic (liver), visual, and vascular safety.

In response, the manufacturer submitted an amendment on July 24, 2002, containing the large safety study requested by the FDA to evaluate adverse events in the usual care setting.

Doctors were paid well for subjects to enroll which led to fake subjects, family members and staff, and people who did not suffer from the indications (community acquired pneumonia, bronchitis, and bacterial sinusitis). In one study site, an entire weight loss group was enrolled. Of the top 30 enrollers, eight enrolled 1 percent or more of the adult population of their city; plus there was failure to maintain completed informed consents and case report forms for study subjects and failure to sign the return shipment form for investigational product. Several doctors are now under criminal fraud investigation.

The FDA official charged with presenting Study 3014 at the Advisory Committee stated that he was not satisfied with what he knew about the integrity of Study 3014 and was against presenting it at all. When asked why he did indeed present a study he knew to have data integrity problems, the official replied that he was asked directly by the FDA Division Director to present Study 3014 during a team meeting. He said he viewed this as a verbal instruction.

Source: http://content.nejm.org/cgi/content/full/356/16/1601

How Did Ketek Ever Get Approved?

Wed, 25 Apr 2007 11:39:55 -0400

Ketek: How did Ketek get approved and into the marketplace even though its efficacy was questioned every step of the way by many experts and every study is plagued by fraud and negligence?

Modern America is a pill-taking society (as is Canada, Europe, and Asia). Most people are like sheep when it comes to taking pharmaceutical drugs. Perhaps you're faithful to the process because the doctor or healthcare professional prescribed it. We assume that our doctors know what works best. The drugs have been approved by the Food and Drug Administration (FDA). We assume that the FDA has had the drug manufacturers produce rigorous results through numerous clinical trials.

In a perfect world - yes - that would be true. But the FDA wais far from perfect when it came to Ketek.

It seems that everything that could go wrong with Ketek did. Yet, by large brush strokes of ineptitude and deceit, Ketek was approved and marketed for three indications - community-acquired pneumonia (CAP), acute exacerbation of chronic bronchitis [AECB], and acute maxillary sinusitis.

This article summarizes a 40+ page letter that was sent to the FDA by the U.S. Senate Committee on Finance reviewing the botched Ketek approval process.

The U.S. Senate Committee on Finance has exclusive jurisdiction over Medicare and Medicaid programs. The Committee has a responsibility to the more than 80 million Americans who receive healthcare coverage under Medicare and Medicaid to oversee the proper administration of these programs, including the payment for prescription drugs regulated by the Food and Drug Administration (FDA), and Department of Health and Human Services (HHS).

In spring 2006, the Committee on Finance began investigating extremely troubling allegations related to the approval and post-market surveillance of Ketek (telithromycin) by the FDA. As of December 2006, the FDA had failed to produce any of the documents and files for which they were subpoenaed.

Two of the allegations brought to the attention of the Committee relate to an FDA advisory committee meeting, specifically the Anti-Infective Drugs Advisory Committee (AIDAC or Advisory Committee) meeting held January 8, 2003. (According to the FDA, the value of an Advisory Committee is to provide independent expert advice, to lend credibility to the FDA's review process, and to allow for public discussion of controversial issues, among others.)

The two allegations are: 1-FDA management instructing FDA officials to present fraudulent data to the Advisory Committee because discussing issues regarding data
integrity and the conduct of a safety study would not be productive; and, 2-the FDA actually presenting fraudulent study data to the Advisory Committee.

In response, the manufacturer submitted an amendment on July 24, 2002, containing the large safety study requested by the FDA to evaluate adverse events in the usual care setting.

This phase III Ketek study became known as Study 3014.

About two months prior to the 2003 Advisory Committee meeting, the study site with the largest number of enrolled subjects (407) was under investigation by FDA's Office of Criminal Investigations. The FDA also inspected the second and third highest enrolling sites and found them to have similarly violated the protocol. In addition, 72 other sites raised red flags for FDA officials and investigators, including non adherence to the study protocol, which recommended between 4 and 50 study subjects per site. FDA officials also questioned how quickly more than 24,000 patients were enrolled in the study.

He said he proposed a closed session to discuss the agency's significant concerns with Study 3014 with the Advisory Committee members, but was told by his Division Director that FDA could not disclose information related to an ongoing FDA investigation. The official who presented Study 3014 later said the FDA should never have a role in deceiving the public.

Many FDA officials interviewed acknowledged that, at a minimum, data from the 407 subjects where the doctor was the first to be criminally investigated, should have been censored. Several officials acknowledged that, with hindsight, the Advisory Committee meeting should have been postponed or canceled.

The Advisory Committee members said they were not aware of the data integrity problems until receiving a letter dated July 7, 2006, from the FDA that included Senator Grassley's letter dated June 7, 2006, and subsequent materials from Senator Grassley's office dated October 27, 2006. Several Advisory Committee members also responded that knowledge of the data integrity problems might have affected their vote. An Advisory Committee member said that he/she would have recommended postponing the decision to approve Ketek until the extent and significance of the data integrity problems were better defined and would have sought more information about the nature and extent of the problems.

Most Advisory Committee members did not share the Office Director's opinion that it would not have been productive to spend time on issues regarding data integrity and
the conduct of Study 3014 and believed that all information of note or with significant ramifications should be made available to the Committee.

Aventis submitted Study 3014 to the FDA in July 2002. Its title page included a GCP (good clinical practices) statement: This study was conducted in accordance with standard operating procedures for clinical investigation and documentation. Aventis also provided verbal assurances to the FDA regarding the integrity of Study 3014 during a meeting held in late December 2002 to discuss the Advisory Committee meeting agenda, including the assurance, no more problems.

Aside from these written and verbal assurances to the FDA regarding the integrity of Study 3014, the vast majority of documents and information suggest that the FDA had sufficient information to determine that Study 3014 still had serious data integrity issues.

Despite the daily alarms as how the study was conducted, all concerns expressed by staff within the Review Division -- supervisory officials at the FDA continued to believe it was neither an option to disclose data integrity problems nor would it be productive.

The FDA did not ensure that the public received accurate, science-based information regarding Ketek. Advisory Committee members and the public who relied on the FDA's presentation of Study 3014 were misled because not all of the relevant findings and conclusions regarding Ketek were presented. If the FDA could not find a way to present only accurate, science-based information, the FDA should not have presented Study 3014 publicly or, alternatively, should have postponed or canceled the Advisory Committee meeting.

The FDA is broken.

Although the FDA seemed to ask the right questions and have the right doubts about the lack of study integrity - the buck stopped there. Why? Despite reaching the conclusion that data from the sites under criminal investigation should be censored, the FDA did not censor the suspect data before the Advisory Committee meeting.

This article and further investigation gives us pause. You have to wonder:

Were there no checks and balances of Sanofi-Aventis studies?
What happened to the FDA's compliances and reviews?
Obviously, Sanofi-Aventis cannot police itself but what about the FDA?
Are there not any whistleblowers at the FDA willing to call attention to the big unsafe gaping hole?
With this kind of reckless behavior, doesn't it appear that the FDA needs monitoring, investigating, and overseeing by a trusted source? By an independent bureau that does not receive funds from drug companies?
Who can you trust regarding prescription drugs?

If you have suffered liver damage or a loved one needs a liver implant or has died from taking Ketek - please consult a law firm specializing in unsafe drugs lawsuits.

It's Basic Black for Ketek

Fri, 20 Apr 2007 16:32:01 -0400

After months of public mud slinging and mountains of evidence, the FDA finally issued a black box warning on Ketek antibiotic.

You have to wonder exactly - whose side is the FDA on? Is the FDA really concerned about protecting public safety from harmful drugs or do they care more about the pharmaceutical companies who finance the FDA's paychecks and research?

Two of the three previously approved indications - acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis - are being removed from the label. According to the FDA, they determined that the balance of benefits and risks no longer supported approval of the drug for these indications. One has to wonder why and how they didn't make those determinations in the beginning when the drug was originally marketed.

Even Congress has gotten involved. It's hard to imagine that the pharmaceutically companies and their band of lobbyists have not lined the congressional parade's pockets but so far at least a few senators are speaking out with their concerns about Ketek. Stay turned as this topic won't go away soon.

http://pharmalot.com/2007/02/fda_puts_black_box_on_ketek.php