Ketek

ALSO NOTED: Lentigen moves to Gaithersburg; Acorda prices shares; Cytheris releases data; and much more...

Wed, 13 Feb 2008 06:59:50 -0500

> Lentigen Corporation today announced the company is moving its corporate headquarters and manufacturing facilities from the University of Maryland Baltimore County TechCenter to a new 26,000 square-foot facility in Gaithersburg. Release

> Acorda Therapeutics has priced a share offering at $21.50. Report

> Cytheris released new data from a Phase I/II study designed to investigate the safety of Interleukin-7 therapy in chronically HIV-1 infected patients. Release

> Combimatrix won a $31.4 million judgment in its lawsuit against an insurer. Release

> Watson Pharmaceuticals says its NDA for the enlarged prostate drug silodosin has been accepted for filing by the FDA. Report

> The Ketek saga has opened a new chapter, with subpoenas and accusations and even threats. Report

> Want a preview of some "sobering" and "possibly a little alarming" market data? IMS Health gave preliminary figures on the state of the pharma industry to the Health Industry Group Purchasing Organization. Brace yourself: U.S. market growth for drugs grew by only 3.8 percent in 2007--the worst growth rate since 1961. Report

> Will a new Avastin-in-breast-cancer study persuade the FDA? Genentech hopes so. Report

> It's a new blow for the controversial painkiller fentanyl. Johnson & Johnson and Sandoz are recalling defective fentanyl patches that could cause patients or caregivers to overdose. Report

> A protein may hold the key to a new vaccine that could effectively target pneumonia, according to Children's Hospital of Pittsburgh of UPMC. Report

> In a first, Geron made headlines at the BIO CEO conference in New York with its announcement that it could begin its first human trials using embryonic stem cells to treat spinal cord injuries as early as this spring. Report

And Finally... Long after Sept. 11, 2001, Americans' terrorism-related thoughts and fears are associated with increased depression, anxiety, hostility, post-traumatic stress and drinking, University of Illinois at Chicago researchers have found. Release

FDA criticizes Aventis for Ketek study failures

Thu, 25 Oct 2007 06:59:57 -0400

Aventis allowed a clinical trial of Ketek to proceed uncorrected despite its own audits that revealed "serious protocol violations and regulatory noncompliance by multiple clinical investigators." In a letter to Sanofi-Aventis, regulators severely criticized Aventis for not throwing doctors out of the study or informing the FDA. The FDA approved Ketek back in 2004. Ketek has since been linked to an increased risk of liver damage, and the questionable study was designed to investigate the drug's potential side effects, including liver damage. One doctor responsible for one site involved in the study was subsequently convicted of fraud. Sanofi-Aventis says the company acted in good faith and plans a detailed response, but that's hardly likely to mollify the company's critics.

- see the FDA release
- here's the article from The Wall Street Journal

Related Articles:
Sanofi underscores pipeline advances, setbacks. Report
FDA panel votes to restrict Ketek. Report
Senator makes dramatic demand in Ketek probe. Report
Sanofi's Ketek could cause liver problems. Report

SPOTLIGHT: FDA panel votes to restrict Ketek

Sun, 17 Dec 2006 19:01:33 -0500

An FDA advisory panel has voted to restrict the use of Sanofi-Aventis' controversial antibiotic Ketek. Panel members said that the risks outweighed the benefits of using Ketek against acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis. Report

ALSO NOTED: FDA staffers back Ketek; Abbott gains a majority of Kos shares; and much more...

Tue, 12 Dec 2006 19:01:30 -0500

> In advance of an FDA advisory committee meeting on the controversial antibiotic Ketek, agency staffers have concluded that the data on the Sanofi-Aventis therapy demonstrates that it is safe and effective. Report

> Abbott's cash tender offer has won a majority of Kos Pharmaceuticals' shares. Report

> Amgen plans to repurchase up to $5 billion of its stock. Release

> Biomira has arranged $13 million in financing. Release

> Athenagen has begun a Phase II clinical study of the company's lead compound, GTS-21, in patients with Alzheimer's disease. Release

> OncoMethylome Sciences has licensed its prostate cancer test to a subsidiary of Johnson & Johnson. Report

> Eden Bioscience has received a delisting notification from Nasdaq. Report

And Finally… A new study says that a sleep apnea therapy also improves memory. Release

Senate confirms von Eschenbach as chief of FDA

Thu, 07 Dec 2006 19:01:37 -0500

Andrew von Eschenbach gained the overwhelming support of the Senate in his long-delayed bid to become chief of the FDA. Senators supported his nomination by a vote of 80 to 11. Among the small band of opponents were several Republicans, including Senator Charles Grassley, who has been steaming over what he sees as a lack of cooperation at the agency in his investigation of the controversial antibiotic Ketek. Von Eschenbach has been acting head of the FDA for slightly more than a year now. During that time he erased a major obstacle to his confirmation by allowing access to Plan B, the morning after pill, without a prescription.

Von Eschenbach's confirmation as head of the FDA will likely trigger a collective sigh of relief in the drug development world. Over the past six years of the Bush administration, the agency has had an official chief for only 18 months. The previous head of the FDA resigned shortly after gaining confirmation to the office and was recently charged with a conflict of interest. Drug developers are looking to the FDA to deliver on the Critical Path Initiative and other projects aimed at streamlining the drug approval process. They're also wary of just how much new research work they'll be required to do on newly approved drugs as the FDA works to reassure a skeptical public that the drugs it approves are indeed safe. Von Eschenbach will play a major role in all of those decisions.

- here's the Washington Post's report on the vote
- read BIO's statement on von Eschenbach's confirmation

Related Articles:
Two Senators block von Eschenbach. Report
FDA clears way for Plan B to go OTC. Report
Investors anxious to see Eschenbach confirmed. Report

FDA's showdown with Grassley to delay nomination

Thu, 30 Nov 2006 19:01:35 -0500

Acting FDA commissioner Andrew von Eschenbach is refusing to turn over information on the antibiotic Ketek to Senator Charles Grassley. According to von Eschenbach, giving the senator everything he asked for would make it difficult for the agency to conduct independent investigations. From Grassley's perspective, the FDA is not being compliant with a subpoena. It all adds up to a further delay for von Eschenbach's nomination, which is now being blocked by Grassley, a powerful Republican senator who has often been harshly critical of drug companies as well as the FDA.

- read the Washington Post report on the showdown

Related Articles:
Senator makes dramatic demand in Ketek probe. Report
Two Senators block von Eschenbach. Report
FDA safety official called for halt to Ketek trial. Report

FDA whistle-blower attacks safety of Arcoxia

Tue, 12 Sep 2006 20:01:37 -0400

FDA whistle-blower David Graham has blasted Merck's Arcoxia, a new painkiller designed to replace Vioxx, as unsafe. "The FDA, academia, and the medical research enterprise are once again faced with the opportunity to forsake common sense by willfully accepting misdirection and disinformation presented in the guise of science," Graham writes in the Journal of the American Medical Association. Merck researchers have compared the risk profile of Arcoxia, which has been submitted for FDA approval, to diclofenac, an older generation painkiller. But, as the link below illustrates, there's new data to show that diclofenac is unsafe. Graham, a drug safety expert, achieved prominence when he told a congressional committee that the FDA was ill-equipped to prevent a harmful drug like Vioxx from hitting the market.

- here's the article on Arcoxia from USA Today

Related Article
David Graham was also vocal in his criticism of Ketek, Sanofi-Aventis' controversial antibiotic. Report

PLUS: Researchers have concluded that the data from 23 clinical trials demonstrates that the drug diclofenac, which sold as Cataflam or Voltaren, has the same risk profile as low-dose Vioxx. The pain drug, they conclude, increases the risk of heart attacks by 40 percent. Report

New warnings added to controversial antibiotic

Thu, 29 Jun 2006 20:01:35 -0400

Sanofi-Aventis has added new warnings to its antibiotic Ketek after talks with the FDA. The drug company says the warnings are intended to update doctors and patients on potential adverse events. But the warning is unlikely to quell the controversy around the drug, which has been linked to 12 cases of liver damage. Sanofi-Aventis says the rewards still outweigh any risks associated with Ketek.

- read the AFX report on Ketek

FDA reviews new rules for clinical trials

Tue, 20 Jun 2006 20:01:39 -0400

Following close on the heels of the scandal surrounding the antibiotic Ketek, the FDA is looking at toughening rules to govern when and how fraud in a clinical trial is reported to the feds. Currently, drug developers are barred from knowingly using fraudulently obtained data but don't necessarily have to report the fraud itself. That may soon change, along with the standardization of paperwork, new rules governing patients' access to medications and a clarification on which adverse events must be reported to a monitoring committee. Several congressional leaders have been vehemently critical of the agency's handling of Ketek, an antibiotic that was approved despite the fraud surrounding a late-stage trial. The agency is likely to paint this as a continuation of their ongoing review of clinical trials, which it is. But the timing related to fraud won't go unnoticed.

- here's the report from The Wall Street Journal for more (sub. req.)

PLUS: Two influential senators are planning to introduce legislation that would force developers to disclose data and set up a risk management program. Article

Senator makes dramatic demand in Ketek probe

Wed, 14 Jun 2006 20:01:37 -0400

Senator Chuck Grassley (R-IA) says he suspects the FDA is involved in a cover-up of its activities involving the controversial antibiotic Ketek, citing the agency's refusal to make one of its investigators available for questioning. Grassley showed up at the Department of Health and Human Services to make his demands known and quickly filled in reporters after he left with nothing. HHS says that they aren't involved in a cover-up, claiming that they've already turned over more than 400 boxes of information on Ketek and wouldn't offer up the investigator in the middle of an agency inquiry. One point of contention is the use of data from a clinical trial for Ketek that was riddled with fraud. Safety data from that trial was presented to an FDA committee, which wasn't told about the problems that surrounded the study.

- read the article from The Washington Post on Ketek

ALSO NOTED: DrugAbuse Science to raise $25.2M in an IPO; Covance inks a $187M contract; and much more...

Tue, 13 Jun 2006 20:00:50 -0400

> France's DrugAbuse Science plans to raise $25.2 million in an IPO. Much of that money will be used to mount late-stage trials of Naltrexone Depot. The market for drug and alcohol abuse therapies has been growing steadily. Report

> Powerful U.S. Senator Chuck Grassley (R-IA) says he plans to confront the Department of Health and Human Services over information about the controversial antibiotic Ketek that he says was never disclosed by the FDA. Report (WSJ sub. req.)

> Akzo Nobel's Nobilon International business, active in the field of human vaccines, is to work together with the Dutch Erasmus Medical Center's spin-off CoroNovative BV to expand and accelerate CoroNovative's virus discovery program. Release

> Shares of Covance were on the rise after it announced a $187 million contract. Report

> First Horizon Pharmaceutical has gained orphan status for an experimental therapy that prevents drooling in children with neurological conditions. Report

> Advanced Magnetics stock surged on the news that an independent committee found no safety concerns involved in a late-stage study of a new product--ferumoxytol iron replacement therapy. Report

And Finally... An advocacy group has sued Kentucky Fried Chicken in an effort to force the company to stop using partially hydrogenated oils in the Colonel's secret recipe. Article

Editor's Corner

Sun, 11 Jun 2006 20:01:40 -0400

Just when you think the FDA is getting the message about drug safety, it stumbles its way through another PR disaster. This time the drug in question is Ketek, and the disaster was last week's revelations that an FDA official had issued a searing memo questioning why children's lives were being put at risk so that Sanofi-Aventis could determine if the controversial antibiotic could work as a therapy for ear aches and tonsillitis.

In recent months we've been treated to a series of reports raising questions about the agency's approach to approving the drug, which has been linked to multiple cases of liver failure. A late-stage trial was riddled with reported fraud. And the real-world results the agency relied on from Europe seem a far-from-exact approach to establishing safety. The agency needs to have the ability to respond swiftly and effectively when these cases come up. Anything less will simply underscore a growing sense in the public that the bureaucracy at the FDA is not effective when it comes to protecting them from dangerous side effects. - John Carroll

Sanofi halts Ketek trial amid blistering warnings

Thu, 08 Jun 2006 20:01:38 -0400

Sanofi-Aventis halted enrollment in a trial of the antibiotic Ketek yesterday but denied that it had anything to do with the same-day news reports of the dire safety warnings issued by a senior FDA official. Sanofi said the company merely wanted to make sure that it was conducting the trial in accordance with FDA requirements. That explanation was likely to quickly elicit scoffs from drug experts who have poured criticism on Ketek, an antibiotic which has been linked to liver failure in adults.

Sanofi researchers are exploring the use of Ketek as a therapy for ear infections and tonsillitis for children, which provoked one agency expert to call for a halt to the trials, saying they presented an unnecessary and severe risk to the thousands of children that were to be enrolled for the clinical study. A late-stage trial of Ketek was marred by fraud. The FDA said they ignored the data from that report, relying instead on the results tracked in Europe following the approval of Ketek.

- read the New York Times article on Ketek

FDA safety official called for halt to Ketek trial

Wed, 07 Jun 2006 20:01:38 -0400

A senior-level FDA safety official recently called for a halt to a clinical trial of the antibiotic Ketek in children, citing indications of the drug's unusual toxicity. Sanofi-Aventis has been testing Ketek as a therapy to fight ear infections and tonsillitis in children. But Dr. Rosemary Johann-Liang made it clear in a memo that the trial was taking unnecessary risks with their lives. "How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" she wrote in a memo obtained by The New York Times. Sanofi-Aventis says that they are in discussions with the FDA about the drug, which has been linked to a variety of cases of liver failure, blurred vision and loss of consciousness.

The FDA ignored early trial data on Ketek after it was revealed that the trial had been conducted fraudulently. Instead, it relied on actual experience with the drug in Europe. That decision has proved highly controversial. Safety officials at the agency have suggested that the FDA force the drug off the market or add warnings about the potentially fatal side effects presented by the therapy.

- read the New York Times article on Ketek

SPOTLIGHT: FDA calls for Ketek warning

Thu, 18 May 2006 20:01:33 -0400

The FDA wants Sanofi-Aventis to put a warning label on the antibiotic Ketek that spells out concerns that the drug may be linked to liver failure. Sanofi insists the drug is safe and effective. Report

Ketek report spurs call for FDA reform

Mon, 01 May 2006 20:01:37 -0400

Following yesterday's troubling review of Sanofi-Aventis' antibiotic Ketek in The Wall Street Journal, a number of Congressmen have launched calls for an investigation into its approval. Some, like Representative Henry A. Waxman, say the FDA's action highlights the need for reform at the agency. The Journal reported that a number of patients taking the drug have died and raised a number of questions about Aventis' last drug trial.

"Recently the GAO found that the FDA does not have a good enough system in place to protect the public from drugs once they are on the market," said Rep. Edward Markey. "However, the Ketek case shows that the FDA may also not be doing a good enough job deciding which drugs should or should not be approved in the first place."

- read this release for Washington's reaction

Ketek safety data, liver problems draw scrutiny

Sun, 30 Apr 2006 20:01:37 -0400

The Wall Street Journal investigates study 3014, a clinical trial of Sanofi-Aventis' antibiotic Ketek. The principal investigator for the trial is in jail for fabricating data and another trial investigator was on probation during the trial and later lost his medical license after being arrested for hiding cocaine in his underwear. The FDA had asked for the study to look at potential liver damage. While the agency later discounted the trial results, it did approve Ketek in 2004 based on its approval and track record in Europe. Now, though, instances of liver failure have been documented among patients taking Ketek, and Sanofi-Aventis denies that it has hid evidence linking the drug to potentially deadly side effects.

- read the article from The Wall Street Journal (sub. req.)

Sanofi's Ketek could cause liver problems

Thu, 19 Jan 2006 19:01:36 -0500

A report from the Annals of Internal Medicine warns that Sanofi-Aventis' antibiotic telithromycin Ketek could be linked to liver problems. Doctors at Carolinas Medical Center in Charlotte, NC, said that one patient died as a result of liver failure and another needed a liver transplant. A third patient developed Hepatitis C but later recovered. All three patients were taking the antibiotic Ketek, which was approved by the FDA in 2004. Though the FDA won't make any immediate changes to the drug's warning label, it will continue to monitor adverse events related to the drug.

- read this Wall Street Journal article (sub. req.)