Drug Injury Watch

Drug Industry Document Archive (DIDA) Adds 15 More Pharma-Related Documents To Collection In November 2009

2009-11-20T16:36:00-05:00

This Archive Contains Some "Secret" Documents Only Made Public In The Course Of Lawsuits Filed Against Pharmaceutical Companies

(Posted by Tom Lamb at DrugInjuryWatch.com)

Created and maintained by the University of California at San Francisco (UCSF), the Drug Industry Document Archive (DIDA) contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against drug companies.

In September 2009 Kim Klausner, who is the Tobacco Digital Library Manager at UCSF, kindly sent us an email notification about the addition of some Wyeth ghostwriting documents to the DIDA collection.

Now, a couple of months later, Kim Klausner has let us know about 15 new rather "revealing" pharma-related documents that have been added to this DIDA collection. From her recent email:

I’m pleased to announce that we’ve added 15 new documents to the Drug Industry Document Archive (DIDA). You can find them by typing in “ddu:20091112” without the quotation marks in the query box at http://dida.library.ucsf.edu. (A few of the documents in this batch replace damaged ones so are not strictly “new.”)

The documents include:

-- Depositions from Karen Mittleman, the DesignWrite staffer who worked on Wyeth’s publication plan for Premarin products. She responds to questions about how academic authors, her medical communications company and the drug manufacturer implemented its plan. (Parts of these documents appear redacted because the version we received had highlighting which doesn’t OCR well.)

-- A letter from Thomas Sullivan, President of Rockpointe, a medical communications firm, spells out the terms under which his company does business with numerous drug company clients and clarifies his relationship with ACRE, the Association of Clinical Researchers and Educators. He also provides a list of payments from drug and medical device companies for Rockpointe services from 2006 to June 2009.

-- The 1999 Tactical Plan for Paxil which includes participation in ISAAC (Initiative for Social Anxiety Assessment and Care), a disease-based registry of potential patients/customers, for which physicians will be paid $100 for each person recruited.

-- The 2004 Lexapro Marketing Plan which includes this gem: Bylined articles will allow us to fold Lexapro messages into articles on depression, anxiety and comorbidity developed by (or ghostwritten for) thought leaders (page 23).

Feel free to forward this announcement to anyone who might be interested. And please click on the Contact Us link at the bottom of DIDA’s pages if you want help searching.

Once again, we are grateful that Kim took the time to let us know about these additions to the DIDA collection, and we thank all the good folks at UCSF who are involved with the creation and growth of this project.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Consumers Union’s Safe Patient Project Forum Webcast: “To Err Is Human, To Delay Is Deadly”

2009-11-17T08:33:45-05:00

Marks 10th Anniversary Of IOM Study On Medical Errors And Raises Concerns About Lack Of Progress

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Consumers Union’s Safe Patient Project (formerly Stop Hospital Infections) is holding a forum, “To Err Is Human, To Delay Is Deadly,” in Washington, DC, today, Tuesday, November 17, 2009, from 10 a.m. to 3:30 p.m. EST.

There is a free live webcast on this “To Err Is Human, To Delay Is Deadly” forum on the day of the event. If you cannot tune in then, a recording of this forum webcast will be available up to a year after this date.

The forum marks the 10th anniversary of the IOM study on medical errors and raises concerns about the lack of progress over the past decade in preventing medical harm. Speakers at this forum include:

Arthur Levin, Center for Medical Consumers, member of the original IOM committee and long-time consumer advocate for patient safety;

Dr. Richard Shannon, University of Pennsylvania Health System, successful advocate for patient safety from within the walls of the hospital, challenging those in the medical community who say it is too difficult to stop hospital-acquired infections;

Merrill Goozner, independent author, writer and active blogger on health issues, former director of the Integrity in Science project at the Center for Science in the Public Interest, who will speak about conflicts of interest and the influence of the medical industry on creating a safer and more patient oriented health care system; and,

U.S. Representative Bruce Braley of Iowa, a strong advocate for eliminating medical harm to save patients’ lives and to reduce costs to the health care system.

The Safe Patient Project campaign released a report earlier this year on the subject, which describes how this campaign covers the following issues:

hospital-acquired infections
medical errors and other medical harm
physician accountability
drug safety

We encourage those who are interested in medication mistakes and medical errors to take the time to view this “To Err Is Human, To Delay Is Deadly” forum webcast either live, today, or at your convenience in the weeks or months to come. Of course, you should feel free to share this forum webcast information with others, also.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Anemia Drugs Procrit And Aranesp May Increase Twofold The Risk Of Potentially Fatal Blood Clots

2009-11-11T16:45:00-05:00

Results From Large Long-Term Study Show Association Between These Erythropoiesis-Stimulating Agents And Venous Thromboembolism

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late October 2009 we learned that the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT) indicated that the anemia drug Aranesp might cause an increased risk for stroke in patients with diabetes and chronic kidney disease.

Just a couple of weeks later we have been presented with a possible explanation as to why this might be so.

From a November 10, 2009 article by HealthDay reporter Steven Reinberg, "Anemia Drugs May Cause Deadly Blood Clots", we get this new information about erythropoiesis-stimulating agents (ESAs) such as Procrit (epoetin alfa) and Aranesp (darbepoetin alfa):

"These drugs hit the market in the mid-1990s, and by 2002, 50 percent of patients on chemotherapy were receiving them," said lead researcher Dr. Dawn Hershman, co-director of the breast program at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital/Columbia University Medical Center in New York City.

Initial testing of these drugs was done on only 12 weeks of use, she noted. "Right from the beginning, there was concern that these drugs would cause some side effects, but the initial studies did not find any risk of thrombosis."

Her longer study was more informative. "We confirmed that these agents can increase the risk of thrombosis by twofold," Hershman added.... [emphasis added]

Hershman thinks the findings raise questions about the drug's approval process and whether adequate post-marketing research was undertaken to ensure their long-term safety.

These drugs do have a place, she said. "But we have to figure out what the best indication is and use every agent with caution. We should think about the drugs that we give."

The underlying study, "Patterns of Use and Risks Associated With Erythropoiesis-Stimulating Agents Among Medicare Patients With Cancer", was published in the November 10, 2009 online edition of the Journal of the National Cancer Institute in advance of its print publication in the December 2 edition of this medical journal.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Aranesp Associated With Increased Risk For Stroke In Patients With Diabetes And Chronic Kidney Disease

2009-11-06T16:35:00-05:00

TREAT Study Revealed, Also, That This Amgen Anemia Drug Was No Better Than Placebo In Reducing Deaths Or Cardiovascular Problems

(Posted by Tom Lamb at DrugInjuryWatch.com)

The anemia drug Aranesp (darbepoetin alfa) might cause an increased risk for stroke in patients with diabetes and chronic kidney disease, according to the results from the Trial to Reduce Cardiovascular Events with Aransep Treatment (TREAT), a new study that was published in the October 30, 2009 edition of the New England Journal of Medicine (NEJM) and presented recently at the annual meeting of the American Society of Nephrology.

As background, patients with type 2 diabetes and kidney disease often become anemic. In turn, heart and kidney problems can be accelerated by anemia. Accordingly, doctors have long prescribed Aranesp and other erythropoiesis-stimulating agent (ESA) drugs based on the belief that treating the anemia would improve patient’s prognosis.

In an October 31, 2009 Boston Globe article, "Researchers question anemia drug benefits", reporter Elizabeth Cooney provides a good summary of the unexpected results from this TREAT study and the implications of those results:

The study, led by Boston researchers, is the first trial to compare this class of anemia drugs with a placebo in the ability to prevent death and serious complications - even though the drugs have been in use for decades.

"The risks of the therapy were bigger than we thought, namely stroke, and the benefits were less than we thought, in quality of life," said Dr. Marc Pfeffer, a cardiologist at Brigham and Women’s Hospital who led an international group studying Aranesp, which raises red blood cell levels....

The study confirmed that patients taking Aranesp required fewer blood transfusions and suffered less fatigue, but other hoped-for outcomes were not seen.

Dr. Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice said the findings reinforce a crucial message in medicine.

"This current study is an important reminder of how important it is not to assume the treatments work, but to prove them," said Woloshin, who was not involved in the study. Aranesp, made by California-based Amgen, was approved by the Food and Drug Administration in 2001 for use in kidney patients, but a similar drug also made by Amgen has been prescribed for 20 years.

The NEJM article about this TREAT study concerning Aranesp, "A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease", was accompanied by an editorial, "Treatment of Anemia in Chronic Kidney Disease — Strategies Based on Evidence", from Philip A. Marsden, M.D.

Amgen, the drug company that makes Aranesp, issued a press release about the TREAT study results, "Large Study of Anemia Treatment in Chronic Kidney Disease Patients Not on Dialysis Published in the New England Journal of Medicine Failed to Meet Primary Efficacy Endpoints", which includes this statement:

Amgen has shared this information with global regulatory authorities and anticipates that the TREAT results will be included in labeling once discussions are complete.

We will be watching for this revised package insert, or label, for Aranesp which may or may not be announced by means of a so-called "Dear Doctor" letter.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Diabetes Drug Byetta Linked To Kidney Problems And Cases Of Renal Failure

2009-11-03T17:35:00-05:00

October 2009 Byetta Label Change Follows Earlier Alert From U.K. About Kidney-Related Side Effects

(Posted by Tom Lamb at DrugInjuryWatch.com)

In March 2009 the Drug Safety Update Newsletter alerted us about reports of kidney-related side effects associated with the use of the diabetes drug Byetta (exenatide) from the U.K.

About eight months later, in early November 2009, the FDA informed doctors and other healthcare providers in the U.S. that it had approved revisions to the Byetta package insert, or label, so that it will now include information about numerous post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

This move seemingly was prompted by reports of 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency) in patients using Byetta that were received by the FDA from April 2005 through October 2008.

From the Information for Healthcare Professionals: Reports of Altered Kidney Function in patients using Exenatide (Marketed as Byetta) issued by the FDA on November 2, 2009, and the Data Summary part of that document in particular, we get these details:

FDA has completed a review of 78 cases of altered kidney function reported in patients with diabetes using Byetta. The cases were reported to FDA’s Adverse Event Reporting System (AERS) between April 28, 2005 and October 29, 2008. Sixty-two of the cases were classified as acute renal failure and 16 cases were classified as renal insufficiency. Cases of acute renal failure or insufficiency occurred as soon as 3 days and up to 2 years after initiation of Byetta. The patient ages ranged from 23 to 83 years, with an average age of 60 years.

The majority of patients, 74/78 (95%), had at least one contributory risk factor for altered kidney function, such as cardiac insufficiency, hypertension, pancreatitis, rhabdomyolysis, and urinary tract infection, as well as concomitant medications such as antiretrovirals, antihypertensives, diuretics, and non-steroidal anti-inflammatory drugs (NSAIDs)....

Hospitalization was required in 71 of 78 (91%) patients and there were 4 deaths reported in the cases reviewed. Eighteen patients required dialysis and two patients required kidney transplantation after initiation of Byetta. Of those patients who required dialysis, six had no prior history of altered kidney function, two had a prior history of altered kidney function, and the remaining 10 patients reported no information regarding prior renal history.

Byetta was discontinued in 63 of 78 (80%) patients, with 39 (50%) patients reporting improved signs and symptoms after discontinuation of the drug. One patient experienced recurrent altered kidney function after re-initiation of Byetta....

Due to the serious potential consequences of altered kidney function and temporal relationship between the development of renal effects and initiation of Byetta, FDA has approved revisions to the drug label for Byetta to describe this risk.

For the drug-company perspective concerning this Byetta label change about kidney-related side effects, we direct you to the October 2009 "Dear Doctor" letter from Amylin Pharmaceuticals Inc. and Eli Lilly and Co. which includes, as an enclosure, the "BYETTA® (exenatide) injection Full Prescribing Information (October 2009)".

We will continue to monitor and report about this emerging drug safety issue involving the diabetes medication Byetta.

P.S. On November 2, 2009 Amylin Pharmaceuticals, Inc., and Eli Lilly and Company issued their joint statement in response to the FDA on BYETTA® (exenatide) injection. (11/4/09)

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

FDA Should Make Drug Efficacy And Safety Information More Accessible To Patients

2009-10-27T16:40:00-04:00

Package Inserts Prepared By Drug Companies Which Exagerrate Benefits And Downplay Risks Need To Be Addressed

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the October 21, 2009 edition of The New England Journal of Medicine (NEJM) there is a Perspective piece, “Lost in Transmission — FDA Drug Information That Never Reaches Clinicians”, by Lisa M. Schwartz, M.D., and Steven Woloshin, M.D., that will ring true with most patients who have used prescription drugs.

From that NEJM editorial, two of the primary points raised by the authors are:

“Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”

[A]lthough the US “federal stimulus package included $1.1 billion to support comparative-effectiveness research” no money has been allocated to “disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs.”

Reporter Matthew Perrone does a good job of breaking down this NEJM editorial piece for us in his October 21 AP news article, "Drug safety experts urge FDA to make drug safety info more accessible to patients", published by the Chicago Tribune. He starts by sharing part of his discussion with Dr. Lisa Schwartz:

"The take home point is that just because a drug is approved doesn't mean it works very well," said Schwartz, in an interview with the Associated Press. "You really need to know more to see whether it's worth the cost."

He then focuses on the the fact the FDA-approved label for a prescription medication often comes up short as regards the drug's efficacy, or benefits:

In the case of Sepracor Inc.'s blockbuster sleeping pill Lunesta, it's virtually impossible to tell how well the drug works based on the labeling, which only indicates that it worked better than placebo, or a dummy pill.

Only by wading through the FDA's 403-page internal review of Lunesta do the details emerge: patients fell asleep 15 minutes faster and slept 37 minutes longer, on average.

"Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness," the authors state.

Despite that lackluster finding, the drug has grown into a $600 million-a-year drug for Sepracor, helped by the company's advertisements featuring a green Lunesta moth.

Next, Perrone's October 21 AP article shows how important safety information may not only be missing from a drug's package insert but, furthermore, how the FDA makes this critical information hard to find and hard to understand:

The authors [Schwartz and Woloshin] point to the example of Novartis' Zometa, which was approved in 2001 to prevent skeletal fractures in cancer patients with brittle bones. The drug was approved in both 4-mg and 8-mg doses, despite FDA findings of increased kidney damage and death with the higher dose.

FDA went back and added language about kidney toxicity in 2008, but the information about death rates is still missing from the label.

While FDA reviews are posted online, they are often hundreds of pages long and written in extremely dense medical language.

In closing, Perrone reports that a spokesman for the FDA declined his invitation to comment or be interviewed for his article about the points raised by Dr. Schwartz and Dr. Woloshin in their October 2009 NEJM editorial piece.

Here, we welcome your Comments about the adequacy of drug labels as concerns the disclosure of balanced and comprehensive information about the benefits versus risks of prescription medications.

P.S. Here is a clarification issued by the AP regarding the October 21, 2009 Matthew Perrone article referenced in this post:

Correction: FDA drug label story

October 27, 2009

WASHINGTON (AP) — In an Oct. 21 story about drug labels, The Associated Press erroneously described the Novartis drug Zometa. Zometa was approved in 2001 to treat excessive calcium levels, not to treat a form of osteoporosis in cancer patients. Also, the drug was approved only in a 4 milligram dose, not in both 4 milligram and 8 milligram doses. A corrected version of the story appears below.

(10/28/09)

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Yasmin And Yaz Birth Control Pills Are Under Scrutiny By Drug Regulators In Europe

2009-10-22T17:26:07-04:00

Bayer Confirms To German Newspaper There Are 129 Yasmin / Yaz Lawsuits In U.S. As Of Mid-October 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

From an October 21, 2009 article, "Bayer under pressure as birth control pills linked to blood clots", published by the German newspaper Deutsche Welle, we learn that the popular birth control pills Yasmin and Yaz have come under scrutiny in Europe as well as in the United States.

As reported here previously, Swissmedic is analyzing the safety of Yaz and other drospirenone-containing contraceptives following the death of 21-year old woman in Switzerland who died while using Yaz.

The October 21 Deutsche Welle article starts by pointing to two recent studies published in the BMJ medical journal which found birth control pills containing drospirenone and has almost twice as likely to cause blood clots when compared to older oral contraceptives containing the progestin levonorgestrel.

From there, this German newspaper article about Yasmin and Yaz goes on to focus on what is going on in Germany as regards these Bayer birth control pills:

In Germany, 25-year old Felicitas Rohrer collapsed in July with three thromboses in her lung. Since 2001, seven women in Germany have died while taking a contraceptive from the Yasmin family.

In total, 130 cases of adverse drug reaction have been reported to Germany's Federal Institute for Drugs and Medical Devices. However, not all of them are related to thrombosis, Ulrich Hagemann, head of the institute's department of drug safety, told Deutsche Welle....

Bayer said that it is known that the risk for venous thromboembolism, or blood clots in the veins, can be increased when starting the pill. Earlier studies funded by Bayer concluded that the drospirenone-containing pills held no higher risk than older, so-called second-generation pills.

But "arznei telegram," an independent publication for doctors and pharmacists, said the studies were not valid due to "massive method-related deficiencies."

Next, this October 21 Deutche Welle article focused on what the German drug oversight agency has to say about Yasmin and Yaz:

Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices said 20 out of 100,000 women who take an oral contraceptive from the second-generation, which were developed in the 1970s, develop thromoembolic symptoms. For the newer, third-generation pills - and also for contraceptives containing the hormone drospirenone, like Yasmin - women face a risk twice as high, with 35 to 40 women out of 100,000 experiencing thromboembolic effects each year....

"There is a need from my point of view to change the text" in the product information that accompanies the pills, said Hagemann.

Also of interest is what a Bayer spokesperson had to say to this German paper about the Yasmin and Yaz lawsuits filed in the United States:

Bayer, who earns 1.2 billion euros ($1.8 billion) from the worldwide sales of the Yasmin line, confirmed to Deutsche Welle that it currently faces 129 lawsuits in the United States, brought by women who say they've developed health problems after taking Yaz or Yasmin.

"Bayer is still in the process of gathering information on these cases, and the complaints we have received so far pertained to side effects that are warned about in our approved labeling and the labeling for other oral contraceptives," said spokesperson Friederike Lorenzen. "Bayer will defend itself vigorously against these lawsuits."

Going back to Switzerland, it is expected that the results of the safety analysis concerning Yasmin and Yaz side effects reports will become available sometime later this month.

As they say, stay tuned for more about this emerging drug safety issue.

For a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella, see our Focus Page on YAZ / Yasmin / Ocella.

P.S. According to an October 22, 2009 Swiss news article about the Swissmedic analysis, the agency's (rather ambivalent) conclusion is: "Birth control pills containing the active ingredient drospirenone carry the same health risks as similar contraceptives on the market."

You can translate and read the Swissmedic Announcement, "Venöse Thromboembolien unter Antibabypillen: Swissmedic informiert über Abklärungen und erinnert an die Vorsichtsmassnahmen", to see if you think this Swiss news article accurately characterizes the agency's conclusion. (10/23/09)

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

First Zometa-ONJ Personal Injury Lawsuit Against Novartis Goes To Jury This Week

2009-10-20T11:26:42-04:00

Montana Woman's Case Is First To Trial; More Than 500 Other Jaw Side Effect Cases Filed In Federal MDL And New Jersey Courts

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Missoula woman awarded $3.2M in lawsuit against maker of bone-strengthening drug Zometa" (10/22/09)

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Let us set the stage, medically, by starting with an article, "Osteoporosis treatments and adverse events", which was published in the April 30, 2009 edition of Current Opinion in Rheumatology. It concerns the class of drugs known as bisphosphonates, with Fosamax, Boniva, and Actonel being the more popular brand names for the pills that are prescribed for the prevention and treatment of osteoporosis. In relevant part:

... relatively little is known about their long-term safety. Recent case reports cite a range of potential adverse events. We review data regarding atrial fibrillation, bone pain, osteonecrosis of the jaw (ONJ), atypical fractures, and osteosarcoma....

Zometa is in the bisphosphonate class of drugs, also, but it is primarily used by patients with cancer and it is administered intravenously. Despite those differences, Zometa has been associated with the same set of serious side effects listed above.

Peggy L. Stevens is a Montana woman who allegedly developed osteonecrosis of the jaw (ONJ) due to her use of Zometa and, in turn, sued the drug's maker, Novartis Pharmaceuticals Corp., for failure to warn adequately about that particular side effect. This Zometa lawsuit, according to an October 19, 2009 article published by the Missoulian newspaper, "went to trial on Oct. 13 in Missoula District Court and closing arguments will likely begin on [October 20, 2009]."

In more detail, from this October 19 article, "Verdict in Missoula woman's lawsuit against drugmaker could have national significance", by Missoulian reporter Tristan Scott:

Stevens, who has lymphoma, developed severe dental and jaw-related problems after taking Zometa, a bone-strengthening medication manufactured by Novartis. Her attorneys say the company knew patients taking Zometa were vulnerable to a degenerative jaw disorder called osteonecrosis, particularly those patients who undergo invasive dental procedures, like root canals or tooth extractions.

Doctors in Missoula administered Zometa to Stevens intravenously for about three years before she had a tooth pulled and developed the disease. Its symptoms include pain, loosening of teeth, exposed bone and infection.

"Instead of disclosing concerns about this relationship [between dental work and the jaw disorder] in a timely fashion, Novartis focused on obscuring the causal relationship, delaying disclosure and controlling the public relations fallout that would occur from the disclosure," attorneys wrote in a pre-trial brief....

On a national level, Novartis faces lawsuits from approximately 550 plaintiffs whose cases have been consolidated in a Tennessee federal court and a New Jersey state court. The first of those cases is slated for trial in March 2010.

We will be watching the Missoulian for their continuing coverage of this first Zometa trial, and will report the result of this Montana Zometa case as well as future significant developments concerning the Zometa litigation.

As some of you may have heard, the first Fosamax trial in the federal court Fosamax MDL involved Shirley Boles, a woman who used Fosamax from 1997 to 2006 and eventually developed osteonecrosis of the jaw (ONJ). The trial of her lawsuit concluded with the judge essentially declaring a "draw" after determining that the jury was unable to reach a verdict, as explained in September 11, 2009 Reuters article, "Merck lawsuit over Fosamax ends in mistrial".

The next Fosamax MDL trial is scheduled to start on January 5, 2010, followed by another case which will go to trial on April 19, 2010. Sometime after those trials, it is expected that the Boles Fosamax case will be scheduled for a second trial in an attempt to get a jury verdict.

Of course, we will continue to monitor the Fosamax litigation, also.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

FDA’s Sentinel Initiative Project: An Overview, Progress To Date, And Next Steps

2009-10-15T16:50:28-04:00

Presentation Made At September 17, 2009 FDA Drug Safety Oversight Board Meeting

(Posted by Tom Lamb at DrugInjuryWatch.com)

At the September 17, 2009 meeting of the FDA Drug Safety Oversight Board (DSB), members heard presentations and discussed four topics:

An update on the Sentinel Initiative;
The DSB path forward in 2009 and beyond;
The CDER Center Director’s conversation with the DSB; and,
A one-year follow-up on issues presented to the DSB.

We were most interested in the update on the FDA's Sentinel Initiative project for monitoring medical product safety, which we last reported on in March 2009.

From the Public Summary for the September 17, 2009 DSB meeting we get the following information about the Sentinel Initiative update:

The Scientific Lead on FDA’s Sentinel Initiative presented an overview, progress to date, and next steps in FDA’s Sentinel Initiative. The goal of the Sentinel Initiative is to develop an active electronic safety monitoring system to strengthen FDA's ability to monitor the postmarket performance of medical products. The Sentinel Initiative’s intent is to augment, not replace, existing safety monitoring systems, and to enable FDA to access existing automated healthcare data by partnering with healthcare insurance providers, academic institutions, federal and state government agencies, healthcare providers, and other owners of various electronic health records.

The Board discussed the following advantages of the Sentinel Initiative:

1. Identifying and evaluating safety issues in near real time

2. Expanding FDA’s capacity for evaluating safety issues

3. Improving access to information on subgroups and special patient populations

4. Improving precision of risk estimates because of expanded numbers of patient available for study

5. Actively surveying and identifying an increased risk of common medical product-related adverse events that health care providers may not suspect are related to medical products

As for the make up of the Drug Safety Oversight Board, at the present time it consists of representative from three FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health) and six Federal Partners (the Agency for Health Care Research and Quality, Centers for Disease Control and Prevention, Department of Defense, Indian Health Service, National Institutes of Health, and Department of Veterans Affairs).

We will continue to monitor developments related this FDA Sentinel Initiative project.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

A Review Of Recent Research On Issue Of Whether Januvia Can Cause Pancreatitis

2009-10-12T17:07:00-04:00

Is Pancreatitis A Januvia Side Effect Or Is There An Increased Risk Of This Medical Condition Among Type 2 Diabetics Across All Treatments

(Posted by Tom Lamb at DrugInjuryWatch.com)

A few weeks back we reported that the FDA wants Merck to change the package insert, or label, for the diabetes drug Januvia (sitagliptin) so as to show an increased warning about the risk of developing pancreatitis.

Since then we have found some reports about relatively recent research about this issue of whether or not there is, in fact, any link between Januvia and pancreatitis.

We start with the early online publication of "Beneficial Endocrine but adverse Exocrine effects of Sitagliptin in the HIP rat model of Type 2 Diabetes, interactions with Metformin" in the medical journal Diabetes back in late April 2009.

From a press release which was issued by UCLA in connection that online publication, "Popular diabetes treatment could trigger pancreatitis, pancreatic cancer", we get these points:

[R]esearchers from the Larry L. Hillblom Islet Research Center at UCLA found that sitagliptin, sold in pill form as Januvia, caused abnormalities in the pancreas that are recognized as risk factors for pancreatitis and, with time, pancreatic cancer in humans.

Sitagliptin [i.e., Januvia] is a member of a new class of drugs that enhance the actions of the gut hormone known as glucagon-like peptide 1 (GLP-1), which has been shown to be effective in lowering blood sugar in people with Type 2 diabetes.

The UCLA study suggests that there may indeed be a link between drugs that enhance the actions of GLP-1 and pancreatitis — by increasing the rate of formation of cells that line the pancreatic ducts.

Moving on, we turn next to an October 1, 2009 article, "EASD: No Extra Risk of Acute Pancreatitis Seen with Exenatide", published online by MedPage Today. While this article is principally about a presentation on a large study concerning the diabetes drug Byetta (exenatide), it contains some discussion that is relevant to the Januvia - pancreatitis issue.

To start, the underlying study is "Incidence of acute pancreatitis in exenatide initiators compared to other antidiabetic drug initiators: a retrospective, cohort study", by Gary Bloomgren, of Amylin Pharmaceuticals, et al, which can be found in the medical journal Diabetologia (2009; 52: S9).

From the October 1 MedPage Today article we set these items for thought:

Two years ago, after reports of 30 cases of acute pancreatitis in patients taking exenatide, the FDA forced Amylin and its marketing partner, Eli Lilly, to add a caution to the drug's prescribing information. [See: "FDA Alerts Doctors About Diabetes Drug Byetta And Acute Pancreatitis Reports"]

The issue of acute pancreatitis and drugs acting on the glucagon-like peptide-1 pathway gained new prominence last week when the FDA requested a caution on the drug sitagliptin (Januvia), after 88 cases were reported to the agency.

However, the agency never determined that [Byetta] actually caused these effects, or that the incidence was any greater than might be expected in a diabetic population.

Bloomgren cited one recent study that found the risk of acute pancreatitis among type 2 diabetics is about three times that of nondiabetic individuals, across all treatments.

Exenatide [i.e., Byetta] is a synthetic GLP-1 mimic, while sitagliptin [i.e., Januvia] inhibits the dipeptidyl dipeptidase-4 (DPP-4) enzyme that degrades GLP-1, thereby making the peptide more available.

Another DPP-4 inhibitor was reported here to have no association with acute pancreatitis in a review of controlled clinical trial data involving nearly 12,000 patients.

The drug was vildagliptin, marketed in Europe as Galvus but not available in the U.S.

As you can see, the findings from these two recent medical studies about the diabetes drugs Januvia and Byetta are mixed as regards the issue of whether Januvia causes an increased risk of pancreatitis.

We welcome any and all feedback or guidance as regards this emerging drug safety issue concerning Januvia. Please participate in the conversation by submitting a Comment, below.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects