Jill E.
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Member # 9121
posted
I'm one of the people that was on the verge of going into complete liver failure from Ketek. Yet it also was very helpful in improving my Lyme symptoms, so I know it's powerful. I know many top Lyme doctors still recommend it, and several know of my case, so I would never say to not take it. I would just highly recommend having your liver enzymes checked even more frequently than usual.
My dad said there is a front page article in the Wall Street Journal claiming that much of the European research on Ketek turns out to be fraudulent - in terms of safety studies. So you might just want to check twice with your LLMD.
I was recently on Levaquin and it did not harm my liver - even though I will always be considered high risk for future liver problems. But I was only on it for a short time.
Jill
-------------------- If laughter is the best medicine, why hasn't stand-up comedy cured me? Posts: 1773 | From San Diego | Registered: Apr 2006
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Jill E.
Frequent Contributor (1K+ posts)
Member # 9121
posted
Hi again,
I was on liver support herbs and other supportive supplements during Ketek and the antibiotics I took before that. It still didn't help to protect me from Ketek in my case. But yes, do whatever you can to keep your liver in good shape on it.
Jill
-------------------- If laughter is the best medicine, why hasn't stand-up comedy cured me? Posts: 1773 | From San Diego | Registered: Apr 2006
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Dave6002
Frequent Contributor (1K+ posts)
Member # 9064
posted
Thanks Jill and Mo for sharing your experience and offering suggestions.
Jill, I remember that you mentioned you were taking Ketek with other herbs in another thread?
Ketek is a strong inhibitor of Cytochrome P450, which is needed for liver detoxification.
This means that Ketek will inhibit the liver detoxification of some toxins, which might result in high levels of these toxins accumulated in the liver, causing liver damage.
So I would be very carefull about what I eat or take while I am on Ketek.
On the other hand, we might be able to use this property of Ketek to prolong the half life of some Abx and thus enhance the killing efficacy.
Like probenecid prolongs the half life of amoxicillin.
Posts: 1078 | From Fairland | Registered: Apr 2006
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Dave6002
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posted
Thanks Jill for the suggestion.
Just curious: is it possible that the herbs and other supplements actually caused the problem?
quote: ...liver support herbs and other supportive supplements ...
Cause we haven't known all components in these stuffs.
The slowdown of the metabolism of some substances by Ketek might harm the liver.
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Jill E.
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Member # 9121
posted
Hi Dave,
I think it will always be one of those unanswered question about my liver damage while on Ketek. The biopsy was consistent with medication toxicity. However, the hepatologist cannot tell if it's just a medication or an interaction between a medication and something else.
I had been taking a fairly consistent list of supplements and herbs while on Doxy, then on Ketek, and only had this reaction on Ketek. And I didn't drink any alcohol or use any alcohol-based tinctures, so it's not that.
However, when I read the description of the biopsy results of one of the non-Lyme Ketek patients who needed a liver transplant, the biopsy report was identical to mine.
So now I'm off just about everything but antibiotics and vitamins, and have to add anything in one at a time, have my enzymes tested every two weeks, in case it ever happens again.
But you're right the Cytochrome P450 detoxification pathways are vital to removing toxins, and are greatly affected by many medications. I wasn't on any other antibiotic at the time, but again, it could have been some kind of unforseen dangerous interaction, or it could have been the Ketek alone. I wish there were a way to know for sure.
Jill
-------------------- If laughter is the best medicine, why hasn't stand-up comedy cured me? Posts: 1773 | From San Diego | Registered: Apr 2006
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posted
Well, lets see now. ketek can be dangerous all by itself, and levaquin can be dangerous all by itself, so I think that you could safely say that they could easily be a very dangerous combination. Of course these drugs affect everyone differently, and combos are the same way. It might kill one person while someone else can tolerate them just fine. Like Clint Eastwood says, "Do ya feel lucky, Well do ya Punk!"
I had some liver pain on Ketek for the first 3 days, then it was gone. All my bloodwork was normal for the 3 months that I took it. I took it in combo with 1000 mg Tinidazole bid.
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dontlikeliver
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posted
Jill,
Could you provide a link or reference to the article in which you refer to fraudulent research on Ketek?
DLL
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Mathias
Frequent Contributor (1K+ posts)
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posted
I was on Ketek and Factive (a floroquinlone) at the same time. My LLMD monitored me closely for liver problems. Fortunately, I had none.
Everybody is different and you should discuss the benefits and risks of a particular protocol with your LLMD prior to starting it.
-------------------- Mathias Posts: 1242 | From New Jersey | Registered: Feb 2004
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treepatrol
Honored Contributor (10K+ posts)
Member # 4117
posted
Drug Industry News Evidence Shows Liver Risks with Ketek Antibiotic
-May 1, 2006
Today, the Wall Street Journal published a report raising serious safety concerns over Sanofi-Aventis' antibiotic Ketek. The report also indicates that the primary study used to defend Ketek's safety is wrought with fraud, error, and other inconsistencies.
Ketek
Ketek is an antibiotic medication approved by the FDA in April 2004. Previously, the agency previously rejected the drug over safety concerns. Ketek is made by the third largest drug company in the world, Sanofi-Aventis, which raked in $34 billion in drug sales during 2005. Ketek was prescribed to over 3.3 million people in the US last year. The drug is used to treat respiratory infections and other illnesses.
Ketek and liver failure
Reports of Ketek and liver failure have begun to surface recently. The FDA has received at least 10 reports of serious liver failure in patients taking Ketek. According to the agency, this is just a preliminary estimate.
Was it a Ketek death?
Last February, 26-year-old Ramiro Pulquero was admitted to a North Carolina emergency room. He was diagnosed with liver failure after presenting with jaundice, a fever, and vomiting blood. Three days later he died. In light of autopsy findings, some of his doctor's believe that Ketek might have had something to do with the death of this young, and otherwise healthy, man.
He had taken Ketek a few weeks earlier for a nose sore.
Information about his death appears in the January issue of the Annals of Internal Medicine.
Ketek Clinical Trial Concern
Evidence suggests that the clinical trial, study 3014, used to defend the safety of Ketek, is enshrouded in controversy.
FRAUD: the doctor who treated most of the patients in the Ketek study is in prison for fraud. She fabricated the Ketek data sent to Aventis for inclusion in study 3014. The drug company did not tell the FDA of their initial concerns about Dr. Campbell.
MALPRACTICE: another doctor who treated patients in study 3014 was on probation with the state medical board for medical malpractice. The police were called to his house for domestic violence when they found a bag of cocaine and a loaded semiautomatic weapon. He lost his license.
CONFLICT OF INTEREST: a recent New England Journal of Medicine article sited study 3014 when suggesting that Ketek was as safe and effective as other antibiotics. Five of the six authors who wrote this article received funding from Sanofi-Aventis. The sixth author was a Sanofi-Aventis employee.
Previous clinical trials
Earlier clinical trials prompted the FDA to reject Ketek in 2001, over concerns of liver damage, vision problems, and other side effects associated with Ketek.
Growing concern
It is no longer clear to many that Ketek is safe and effective.
Federal legislators are examining the issues raised by the Ketek ordeal. Others are looking at the history of Ketek.
What to do if you've been harmed by Ketek
While the exact risks posed by Ketek remain unclear, this drug is known to cause serious side effects. If you or a loved one has suffered serious injury while taking Ketek, you should speak with your doctor further.
Those who have suffered Ketek side effects may be eligible to seek compensation for their losses with the help of a qualified attorney. Please contact us to speak with an attorney who can answer your questions and determine your legal rights and options.
::::::::::::::::::::::::::::
:::::::::::::::::::::::::::::::::::::: Drug Industry News Ketek Antibiotic Risks: FDA warns
-January 24, 2006
According to the FDA, three people have suffered severe liver damage as a result of taking the antibiotic Ketek {telithromycin} .
This antibiotic medication is commonly used to treat pneumonia, bronchitis, and sinus infections. The FDA states they are currently evaluating Ketek's safety to determine the frequency of liver problems associated with the drug, manufactured by Sanofi-Aventis.
Researchers have published a detailed report of the three cases of serious Ketek liver problems in the Annals of Internal Medicine .
All three of these seriously injured patients developed jaundice-yellowing of the skin and eyes-and abnormal blood tests indicated diminished liver function. Of these three Ketek liver damage patients, one recovered, one required a liver transplant, and other third died.
Alcohol use was a factor in the two latter cases, which indicates a potentially increased risk of liver damage when alcohol and Ketek is used in combination.
All three Ketek liver damage patients had been in good health and were not taking any other medications when they began using Ketek.
While the FDA continues to investigate the risk of Ketek liver problems, the agency recommends that patients taking Ketek should seek immediate medical attention at the first sign of liver damage, such as blurry vision, jaundice and/or abnormal kidney function as indicated by a blood test. Patients currently using Ketek may wish to speak with their health care professional about the drug side effects associated with this medication.
For more information on Ketek and safety problems, please contact us to confer with an attorney.
-------------------- Do unto others as you would have them do unto you. Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.
treepatrol
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posted
newdurham77 Frequent Contributor Member # 7815
posted 04 May, 2006 07:58 AM -------------------------------------------------------------------------------- Infected Data: Fraud, Errors Taint Key Study Of Widely Used Sanofi Drug --- Despite Some Faked Results, FDA Approves Antibiotic; One Doctor's Cocaine Use --- Company Defends Safety By Anna Wilde Mathews 3388 words 1 May 2006 The Wall Street Journal A1 English (Copyright (c) 2006, Dow Jones & Company, Inc.)
On Feb. 3, 2005, a 26-year-old construction worker named Ramiro Obrajero Pulquero walked into the emergency room at Carolinas Medical Center in Charlotte, N.C. Yellow from jaundice, he was running a fever and vomiting blood. Doctors quickly diagnosed liver failure, but a battery of tests couldn't explain its cause. He died three days later.
After seeing an autopsy report, physician Kimberly Clay and her colleagues concluded the answer might lie in a prescription bottle that Mr. Obrajero's wife brought with her to the hospital. It had contained the antibiotic Ketek, which her husband had taken a few weeks earlier after getting a sore in his nose. "When everything came back negative, the only thing we had was the Ketek," said Dr. Clay. An account of the death appeared in the Annals of Internal Medicine online in January.
Mr. Obrajero's widow, Ana Patricia Juarez, returned with the couple's two small daughters to La Concepcion, his native village in central Mexico. "He was a healthy man, strong, and then suddenly we were watching him slip away," she recalls in an interview. "But we never knew why or how it could happen."
Ketek (pronounced KEY-tech) was approved by the Food and Drug Administration in April 2004. Its maker at the time was Aventis, a French-German company that after a merger is now called Sanofi-Aventis SA and based in Paris. Sanofi-Aventis, the world's third-largest drug company with 2005 revenue of $34 billion, says Ketek is an important weapon against respiratory infections. Last year the pills were prescribed 3.35 million times in the U.S. and brought in $193 million, according to IMS Health.
However, reports of severe liver damage among people taking Ketek have surfaced. An internal FDA analysis cited 10 reports of people suffering liver failure after taking Ketek, though it wasn't clear how many cases were caused by the drug. Agency officials say this is a preliminary estimate.
Now documents including internal Aventis emails reviewed by The Wall Street Journal are raising questions about a key clinical trial -- called study 3014 -- of more than 24,000 people that the company submitted to the FDA seeking approval for the drug.
The doctor who treated the most patients in the study, Maria "Anne" Kirkman Campbell, is in federal prison after pleading guilty to defrauding Aventis and others. An indictment says Dr. Campbell fabricated data she sent to the company. The documents show that Aventis was worried about Dr. Campbell early in study 3014 but didn't tell the FDA until the agency's own inspectors discovered the problem independently.
A doctor in California who treated the third-most patients in the study was on probation at the time with the state medical board for gross negligence and failure to keep adequate records. Shortly after his involvement in the study ended, police responding to a domestic-violence call found the doctor at home hiding a bag of cocaine in his underwear and holding a loaded semiautomatic handgun, according to a later complaint by the California medical board. The doctor lost his license.
The full extent of the study's problems has never been made public. Its results were cited last month in an article in the New England Journal of Medicine that suggested Ketek is as safe as other antibiotics. Five of the six authors of that article disclosed that they received consulting fees from Sanofi-Aventis, and the sixth was an Aventis employee at the time of the study.
Aventis originally undertook study 3014 in 2001 at the request of the FDA, which was worried about liver damage, blurry vision and other possible side effects from Ketek after reviewing the company's earlier trials. The agency said at the time that it couldn't approve Ketek without further research. It later concluded study 3014 was so rife with flaws that its data couldn't be relied upon.
An FDA official, Janice Soreth, says the agency nonetheless approved Ketek because of a key piece of information it didn't have in 2001: the drug's record in Europe and other countries. It was approved for use in Europe in July 2001. Dr. Soreth says Ketek was used about four million times overseas and reports of safety problems were minimal. The FDA typically prefers clinical trials to spontaneous reports of side effects partly because not all incidents get reported.
In a written statement to The Wall Street Journal, Sanofi-Aventis defends study 3014. "Although deviations were identified at several sites in the study, the data nevertheless provide important insight into the safety profile of Ketek," the statement says. Overall results from the study showed that Ketek was generally safe and didn't cause any cases of liver failure or death.
Sanofi-Aventis denies withholding any information that it was supposed to disclose to the FDA. It says it has reported "infrequent" liver events to the FDA but after a review the company "concluded that these events do not alter the overall benefit/risk profile of Ketek." The drug's label already mentions potential liver concerns, though not prominently.
Asked detailed questions about the emails and documents viewed by The Wall Street Journal, Sanofi-Aventis confirmed the gist of some but didn't comment on specifics.
The Senate Finance Committee is now examining issues raised by Ketek. "The Ketek allegations appear to be as serious as anything I've seen so far," said Sen. Charles Grassley, an Iowa Republican who is chairman of the Finance Committee, in a statement.
In the House, the offices of Democratic Reps. Edward Markey of Massachusetts and Henry Waxman of California are looking at the drug's history. Reps. Markey and Waxman also expressed their concerns in statements. Mr. Waxman said he is "deeply disturbed" by the approval of Ketek. He said Aventis "failed to disclose to FDA grave flaws in a key safety study."
The Ketek case reflects the constant tension at the FDA between the push for new treatments and safety issues. As drug-resistant bacteria spread, the agency has faced pressure to approve new antibiotics. Even for antibiotics that raise safety issues, the chance that any individual will suffer serious damage is extremely low. The antibiotic Trovan was used by 2.5 million people as of 1999, and the FDA received 14 reports of liver failure. That was enough for the agency to severely restrict use of the drug.
John Jenkins, who heads the FDA's office of new drugs, says the agency and outside experts are assessing the recent reports of liver damage but the FDA still believes Ketek is "safe and effective when used according to the labeling." Dr. Jenkins says the rate of liver-related problems looks "not all that different than we would see for other antibiotics" for similar infections.
Aventis first sought permission to sell Ketek in the U.S. in March 2000. Fifteen months later the FDA refused to approve it. Eager to save a drug then seen as a potential big seller, Aventis hired a contractor called Pharmaceutical Product Development Inc., which specializes in coordinating clinical trials.
Starting in October 2001, the study enrolled patients with respiratory infections. They were given either Ketek or Augmentin, a widely used antibiotic. Aventis and its contractor, PPD, offered doctors $100 for each patient they signed up, another $150 when they submitted results and a final $150 after all questions were resolved, according to a contract with Dr. Campbell, the doctor who is now in prison. The contract became public during her court case.
Sanofi-Aventis says in its statement that it chose many primary-care doctors to conduct the study in order to mimic the real-world conditions in which Ketek would be used. It says most of the 1,824 doctors involved in the study had research experience.
Dr. Campbell oversaw a busy practice in Gadsden, Ala., that attracted patients by advertising weight-control treatments. By the middle of January 2002, she had signed up 287 patients and was receiving enough of the drugs to enroll 30 new people a day, according to emails sent by a PPD employee on Jan. 15 and 17.
The employee wrote that Nadine Grethe, an Aventis manager overseeing the study, had "put a cap" on shipments of the drugs to Dr. Campbell. Minutes from a study management meeting a week later showed that someone was a "little uncomfortable" with Dr. Campbell's site and the site required "additional monitoring." Ms. Grethe, who no longer works for Aventis, couldn't be reached for comment.
On Feb. 27, Ms. Grethe got an email from PPD warning that there were potential problems at the Campbell site including the lack of "proper diagnosis of an appropriate medical condition," medical charts described as "very limited," and laboratory test results that were "suspiciously similar" for multiple patients. PPD staffers also found that many patients signed on for the study during a lunch period when the office was supposed to be closed.
To check for possible fraud, Aventis directed a company statistician to analyze Dr. Campbell's lab information and other data, documents show and the company confirms. On March 14, 2002, the statistician wrote to Ms. Grethe and others that lab results for Dr. Campbell's site were "consistent" with those of two other top enrollers and a "systematic pattern is unlikely," apparently referring to a pattern indicating fraud. By then, however, Dr. Campbell was "refusing to address any issues via phone" or respond to faxes or FedEx deliveries, according to a March 15 email by a PPD staffer.
Sanofi-Aventis says in its statement to The Wall Street Journal that Dr. Campbell later did address questions raised by the monitoring, according to information the drug maker received from PPD. The company says it took several steps to deal with concerns about Dr. Campbell, including follow-up visits and training for her.
In a statement to The Wall Street Journal, PPD declined to discuss specifics but said it complied with FDA regulations and its contract with Aventis in monitoring the trial. It said it reported all issues including those involving Dr. Campbell to Aventis.
Emails from PPD staffers to Aventis officials indicate that PPD employees raised red flags about other doctors as well. A doctor in Indiana with more than 150 patients in the study had over 20 violations of the study instructions in an inspection, according to a PPD employee's email. The doctor, William Terpstra, says in an interview that there was no fraud but some "minor" violations of the instructions.
When Aventis turned in the results of study 3014 to the FDA on July 24, 2002, they included 407 patients from Dr. Campbell. At that point, Aventis "did not alert the Agency to any problems" with Dr. Campbell, according to a nine-page review of Ketek's history, safety and efficacy written later by an FDA official, David Ross. The review is posted on the agency's Web site.
The FDA's Rachel Behrman, deputy director in the office of medical policy, says in a statement that in general, if a drug company suspects fraud during a trial, "it is critical that . . . we be informed promptly, and we are considering new options to address this very issue." She says the FDA is planning a broad new effort to "modernize" how it monitors research.
An FDA inspector examined Dr. Campbell's office in the fall of 2002, selecting her simply because she had enrolled so many patients, according to Dr. Soreth, the director of the FDA division that oversees antibiotics. The inspector found serious problems. Some of Dr. Campbell's patients said they hadn't gotten any medication, even though records said they had, according to the review by the FDA's Dr. Ross. Others were allegedly being treated for weight loss and not respiratory infections, and some study patients were family members and friends of Dr. Campbell.
The FDA scrutinized the next-largest site, that of Carl Lange in Buffalo Grove, Ill., where 251 patients had been treated. That inspection, according to a public agency database of inspections, found Dr. Lange failed to follow the study plan and report adverse drug reactions. Dr. Lange says in an interview that he had never worked on a study before. He acknowledges he made some paperwork errors and didn't report an infection he thought was irrelevant, but he says "there was no question at all regarding the accuracy of the data."
The FDA also inspected the site of Egisto Salerno, a doctor in San Diego whose 214 patients made him the third-biggest enroller. Dr. Salerno's medical license was on probation during the study. The agency found deficiencies including use of white-out on some study records, according to the database and Dr. Ross's review.
In April 2002, police found Dr. Salerno with cocaine in his underwear and a loaded handgun, according to the state medical board's complaint that led to him surrendering his license. This happened seven weeks after Dr. Salerno saw his last patient in the study, according to Dr. Ross's review.
The complaint says Dr. Salerno was threatening to kill his wife and admitted using cocaine. Marijuana was also found in his home, it says. He pleaded guilty to a misdemeanor, which was expunged from his record after he did community service and completed drug counseling, says his lawyer, Gayle Askren. Dr. Salerno will soon receive his medical license back, says Mr. Askren.
Aventis told the FDA in December 2002 that it didn't know Dr. Salerno was on probation, according to minutes of the meeting.
As for Dr. Campbell, Sanofi-Aventis says in its statement that it had no "substantiated basis" to suspect fraud or serious problems with her work before the FDA's inspection of her site. As a result, the company says, "the conditions for reporting" Dr. Campbell as a potential problem to the FDA "were not met." Sanofi-Aventis says it was only after the government investigation that it discovered Dr. Campbell was fabricating data. The company notes it is named as a victim of her fraud by the court that ruled on her sentence.
The indictment against Dr. Campbell accuses her of cheating Aventis by sending the company false information through the mails. She pleaded guilty to one count of mail fraud in March 2004 and was sentenced to four years and nine months in federal prison. Through prison officials, Dr. Campbell declined requests for an interview.
When a committee of outside advisers to the FDA met early in 2003 to weigh a recommendation on Ketek, agency officials didn't mention the problems turned up by its inspections. The FDA's Dr. Soreth and Dr. Jenkins say revealing the suspicions might have biased the decision and impaired the investigation. The committee voted to recommend Ketek's approval. Two weeks later the FDA rejected the recommendation. It asked Aventis for more documents on study 3014 and potential side effects overseas.
Aventis complied. But the FDA ultimately decided the study was so flawed that the data couldn't be trusted. A March 25, 2004, FDA memorandum from the Division of Scientific Investigations says Aventis's monitoring program "uniformly failed to detect data integrity problems when they clearly existed." The report cited "noncompliance with FDA regulations and multiple instances of fraud" at four of the eight high-enrolling sites that inspectors visited. Dr. Campbell's site was one of the four.
One doctor who participated in the study, Jeffrey McLeod of Midlothian, Va., last year agreed with the FDA to stop doing research after an agency inspector accused him of backdating consent forms in study 3014 and failing to properly record which drugs his patients were taking. Dr. McLeod calls the accusations "nonsense" and says there was no fraud, although he acknowledges that perhaps "all the i's weren't dotted and the t's weren't crossed."
Sanofi-Aventis says that despite the FDA's criticism, the study still provided "useful information regarding adverse events" that was consistent with other data about Ketek's safety. It says PPD visited more than half of the study sites and took corrective action when problems were found.
Once the FDA found fault with study 3014, it still had to decide whether to approve Ketek. It had the same data Aventis had submitted back in 2000 -- which the agency had then found inadequate to demonstrate the drug's safety -- and overseas data on adverse reactions to the drug as well as some smaller new studies mostly on Ketek's efficacy against certain infections.
One document gives a hint of debate within the FDA about what to do. This is a version of Dr. Ross's review in which he calls approval of Ketek to treat sinusitis and bronchitis "doubtful," in part because of the drug's "risk profile." When he posted this version on an internal FDA document-sharing system, Dr. Ross appended a note saying his boss, Dr. Soreth, directed him to change that paragraph. The public version of the paragraph says neutrally that approval for those conditions "would depend" on further information.
Dr. Soreth denies ordering a change. "If he felt strongly, he was free to keep it," she says, adding that the review didn't reflect Aventis's final submission to the agency. In both versions, Dr. Ross's examination says Ketek could be approved for a third condition, pneumonia. Dr. Soreth says the Ketek application generated "discussion and the normal repartee about the merits of the data, no more and no less."
The FDA formally approved Ketek on April 1, 2004, for use in sinusitis, bronchitis and pneumonia acquired outside a hospital. Despite all the problems at the study-3014 sites, FDA officials say they believed the original Aventis data submitted in 2000, plus the data from the smaller studies and the drug's safety record overseas, justified approval.
Currently Sanofi-Aventis is studying the drug in children with ear infections and tonsillitis. The FDA rejected its application to sell the drug to adults with tonsillitis.
Meantime, study 3014 is still cited to back Ketek's safety. When the Annals of Internal Medicine published its article about potential Ketek liver damage, it also published an editorial that referred to study 3014 as a reassuring sign of the drug's safety.
The same day the Annals report came out online, the FDA said in a notice that based on data reviewed by the agency before approval, Ketek appeared no more dangerous to the liver than other antibiotics. The agency also cited study 3014. The FDA's Dr. Jenkins says he regrets that. "In retrospect, it probably would have been better not to reference it," he says.
In La Concepcion, the revelation that Mr. Obrajero's death might have had a connection to a medicine he took has dredged up painful memories for his widow, Ms. Juarez. "After he died, I returned to Mexico and said to myself that I wouldn't leave again," she says. "The only reason I would ever go back to Charlotte is if I could find out what happened to my husband."
---
John Lyons and Ricardo Millan in Mexico City and Henry van Wagenberg in Charlotte, N.C., contributed to this article.
---
Safety Questions
History of the antibiotic Ketek
-- March 2000: Aventis submits first application to sell Ketek in the U.S.
-- June 2001: FDA declines to approve the drug, wants more information about safety.
-- July 2001: Ketek approved in Europe.
-- October 2001: Aventis begins enrolling patients for study 3014, which will test safety of Ketek.
-- January 2003: FDA declines to approve the drug, wants more information about study 3014 and reports of safety where drug is sold overseas.
-- April 2004: FDA approves Ketek despite not relying on study 3014, depending on the overseas reports and smaller clinical trials.
-- Feb. 6, 2005: Man dies of liver failure in North Carolina after taking Ketek.
-- January 2006: Annals of Internal Medicine publishes online a report of three cases of liver damage in people who had taken Ketek, including the North Carolina death.
Source: FDA
-------------------- Do unto others as you would have them do unto you. Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.
treepatrol
Honored Contributor (10K+ posts)
Member # 4117
posted
US lawmakers question FDA OK of Sanofi antibiotic Tue May 2, 2006 12:35 AM BST Printer Friendly | Email Article | RSS
By Susan Heavey
WASHINGTON (Reuters) - Several U.S. lawmakers on Monday questioned the U.S. Food and Drug Administration's 2004 approval of Sanofi-Aventis SA's antibiotic Ketek, raising concerns about faulty data and asking for internal agency documents.
At issue is whether the FDA dismissed problems with a major trial after several physicians were cited by agency investigators for falsifying data or improper record-keeping, said the lawmakers, two Democrats and a Republican.
Ketek, approved to treat respiratory infections, drew renewed scrutiny in January when researchers reported that three patients using the drug developed severe liver damage and one died.
Senate Finance Committee Chairman Charles Grassley said he was troubled that the FDA approved Ketek despite unresolved questions about the drug's safety and effectiveness.
In an April 27 letter to the agency, released on Monday, the Iowa Republican said some information supporting its approval was "beset by systemic data integrity problems."
Democratic Reps. Edward Markey of Massachusetts and Henry Waxman of California, in a letter sent Monday, also questioned the Ketek approval process.
The FDA had rejected the drug in 2001 and 2003, asking for more safety information. After the first rejection, the company began the trial in question, known as 3014.
Officials for the private contractor that oversaw the trial notified the Paris-based drugmaker about the 3014 data problems, according to a report in Monday's Wall Street Journal.
FDA investigators later discovered discrepancies, the newspaper said. In one case, an Alabama doctor pleaded guilty fraud and was sentenced to jail.
Sanofi's Vice President of U.S. Medical Affairs Bruce Lavin said his company lacked the FDA's power to investigate. "On the basis of the information we had at that time, we had nothing to suggest fraud," he told Reuters.
In 2003, an FDA advisory committee recommended Ketek's approval but was not told about the flawed data. The FDA later declined approval, asking for more safety information before clearing it in 2004.
FDA spokeswoman Susan Bro said the approval was based on other data. The company also provided a new analysis of the 3014 study without the questionable data.
"It was very important to the agency ... not to bias the (advisory) committee," she said.
But Waxman and Markey said the Ketek case points to larger problems at the agency.
Last week, a government report found no clear FDA process to monitor problems with drugs after approval. The findings followed criticism of the FDA's oversight of suicidal behavior among youth taking antidepressants and heart risks with Merck & Co. Inc's withdrawn arthritis pill Vioxx.
"The Ketek case demonstrates the urgent need for reform at the FDA and in the pharmaceutical industry," Waxman said in a statement. "FDA approved the drug on flimsy data without resolving the safety issues, and it failed to penalize Aventis."
-------------------- Do unto others as you would have them do unto you. Remember Iam not a Doctor Just someone struggling like you with Tick Borne Diseases.
posted
Just a comment on Levaquin, I know some people use it fairly commonly, but a friend almost died from the side effects, it virtually destroyed her digestive tract. Doctors wouldn't not admit it was an adverse drug reaction, they told her she had "crohn's", like out of the blue. She's mostly recovered, three years later, but there are still things that she cannot eat. Nasty stuff....at least be aware of the side effects, do some googling and check out some of the groups of people who've had bad reactions.
Posts: 18 | From NH | Registered: Apr 2006
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Dave6002
Frequent Contributor (1K+ posts)
Member # 9064
posted
Thanks guys for your inputs.
I just did blood tests today and we'll see the results tomorrow.
Good health for everyone.
Posts: 1078 | From Fairland | Registered: Apr 2006
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NJ08534USA http://www.lymenet.org/
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