Diabetes Drugs Pancreatic Cancer Risk Not Backed By Existing Evidence: FDA
In yet another boost to several large drugmakers, the FDA has decided that there is no evidence that to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer, an FDA spokeswoman says. The decision comes several days after the European Medicines Agency reached the same conclusion (here is the EMA statement). “The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency believes that the current labeling for approved GLP-1 based therapies reflects the exten...
Source: Pharmalot - July 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

EMA Decides No Risk Of Pancreatic Cancer With Diabetes Drugs
In a decision that is a big boost to several drugmakers, the European Medicines Agency has concluded that there is no evidence to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer. The review took place in response to a ruckus caused by a study published in Diabetes four months ago that found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. The researchers examined the pancreas of 20 deceased human organ donors with type 2 diabetes (here is the abstract). However...
Source: Pharmalot - July 26, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Zero tolerance for hypoglycemia
Wheat elimination starts you powerfully on the path to reversing diabetes. We’ve seen it many times and it continues to develop in people who kiss their bagels, pretzels, and processed foods booby-trapped with wheat goodbye. But, as diabetics become less diabetic–a process that can occur VERY quickly, often within days of removing all wheat products from their diet–but they are taking insulin or certain diabetes drugs, there is potential for hypoglycemia or low blood sugar. Low blood sugar from diabetes drugs can be dangerous and should be avoided at all costs. (Imagine if a non-diabetic started administ...
Source: Wheat Belly Blog - July 20, 2013 Category: Cardiology Authors: Dr. Davis Tags: Diabetes Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning, everyone. Another busy day is unfolding here on the Pharmalot corporate campus, where the humidity is rising and the short people are preparing for the coming summer by snoozing. We, however, are doing nothing of the sort. As always, we are busy hunting and gathering, and fortifying ourselves with our favorite form of neuron stimulation. Please join us if you so wish. Meanwhile, here are some tidbits. Have a grand day and stay in touch... Hormone Drugs Do Not Impede Cognition in Post-Menopausal Women (Bloomberg News) Hepatitis C Testing Now Recommended For All Baby Boomers (The New York Times) Nearly 70 Perce...
Source: Pharmalot - June 25, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

A Bristol-Myers And AstraZeneca Diabetes Trial Is A 'Dud'
In a setback to an important joint venture between Bristol-Myers Squibb (BMY) and AstraZeneca (AZN), the top-line results of a large, late-stage study of their Onglyza diabetes drug failed to show superiority in reducing cardiovascular deaths, heart attacks and strokes compared to a placebo in Type 2 diabetes patients with cardiovascular risk factors (read this). At the same time, the findings of the so-called SAVOR study, which examined more than 16,000 patients, also indicated that Onglyza did not cause cardiovascular harm, which is a key FDA litmus test for diabetes pills since heart risks are a common concern for diabe...
Source: Pharmalot - June 19, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

READER POLL: Should Diabetes Drugmakers Provide Patient-Level Data?
Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. The outcome was inconclusive, but the FDA may want further studies. The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia (MRK); Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also sold by Bristol-Myers; the Tradjenta med sold by Eli Lilly (LLY) and Boehr...
Source: Pharmalot - June 17, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

New Merck R&D Chief Overhauls Operations & Cuts Are Coming
Two months after arriving at Merck as the new head of R&D, Roger Perlmutter is moving quickly to overhaul the operation, which is known as Merck Research Laboratories (back story). As part of the changes, various senior management roles have been eliminated, including franchise heads and site head, and the licensing unit will now report directly to Perlmutter, who is searching for a new head. "These changes are part of Merck’s existing strategy and ongoing commitment to streamline our operating model and aggressively manage our cost structure," a spokesman writes us. "By doing so, we will ensure that we are able to ...
Source: Pharmalot - June 14, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

The ADA's "Investigation" of Incretin Drugs is a Gift to the Drug Companies
You may have heard that the American Diabetes Association (ADA) had called for a review of the incretin drugs--Januvia, Onglyza, Byetta, Victoza, etc.--in response to the recent discovery, which I described HERE, that they cause abnormal patterns of growth within the pancreas of a kind that lead to both pancreatitis and cancer. The call for review can be read HERE.Sadly, this call for review has nothing to do with protecting people with diabetes, a group for whom the ADA has never had much concern, save as a source of contributions to pay the inflated salaries of its top executives.The ADA is heavily funded by drug manufac...
Source: Diabetes Update - June 14, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

Diabetes Drugs Under Scrutiny As FDA Considers Another Study
As a two-day NIH workshop gets underway to examine the safety of several widely used diabetes drugs, the FDA is considering whether to run a study to determine whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that have generated considerable controversy. “A review of FDA-required epidemiological studies submitted to (the FDA) have provided conflicting results and do not provide reliable evidence to refute or support a causal link between GLP-1 based therapies and risk of acute pancreatitis,” wrote Solomon Iyasu, who heads one of the FDA e...
Source: Pharmalot - June 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? - BMJ
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3680 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3680Article Related content Article metrics Deborah Cohen, investigations editor Author Affiliations dcohen@bmj.com Incretin mimetics have been called “the darlings of diabetes treatment” and they may soon also be licensed for treating obesity. But a BMJ investigation has found growing safety concerns linked to the drugs’ mechanism of action. Deborah Cohenasks why patients and doctors have not been told. They’ve been touted as th...
Source: PharmaGossip - June 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

A Lone Voice Raises Alarms on Lucrative Diabetes Drugs - NYT
LOS ANGELES — Dr. Peter C. Butler initially declined a request by the drug maker Merck to test whether its new diabetes drug, Januvia, could help stave off the disease in rats.“I said, I’m not interested in your money, go away,” Dr. Butler recalled.Merck no doubt now wishes it had. When Dr. Butler finally agreed to do the study, he found worrisome changes in the pancreases of the rats that could lead to pancreatic cancer. The discovery, in early 2008, turned Dr. Butler into a crusader whose follow-up studies now threaten the future of not only Januvia but all the drugs in its class, which have sales of more than $9...
Source: PharmaGossip - May 31, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Januvia and the pancreas
Merck's juggernaut diabetes drug Januvia now faces renewed scrutiny five years after an endocrinologist found that lab rats given the medicine were more susceptible to pancreatic cancer, according to a report in The New York Times. After followup studies by the same doctor, Peter Butler, the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on Whitehouse Station-based Merck's Januvia and other drugs in its class, according to The Times report. In March, the FDA also said it was reviewing unpublished findings by a group of academic researchers tha...
Source: PharmaGossip - May 30, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

What Patient Harm? FDA Slams Shionogi For Not Preparing Studies
File this under ‘what chutzpah!” Last September, the FDA informed Shionogi that two clinical trials would be required after a serious risk of an irregular heartbeat was associated with its Rybix painkiller. The agency informed the drugmaker that a draft protocol was due this past February and a final report was expected by September 2014. But last November, Shionogi told the FDA to forget about it. Why? The drugmaker wrote the agency that “the costs of participating in the PMR (post-marketing requirement)… were not commercially justified based on the sales potential for Rybix.” Never mind that patients may have b...
Source: Pharmalot - May 28, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

We The People vs. The Pharmaceutical Industry - Bernard Munos
The pharma industry is in a pickle. It is losing all its friends and handing over sticks to its enemies. In the last few weeks: Novartis lost a major patent dispute in India Merck was denied an injunction against a generic Januvia South Africa announced plans to tighten its patenting requirements to deny IP protection to incremental innovations, often used by drug companies to “evergreen” their patents Germany extended the application of its much-hated pricing formula to the country’s most popular drugs 100 leading oncologists have risen against drug prices, accusing the industry of having lost its moral compa...
Source: PharmaGossip - April 29, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Disturbing Study: Both Families of Incretin Drugs Appear to Cause Potentially Cancerous Changes in the Pancreas
Researchers just published a study in the journal Diabetes in which they autopsied the pancreases of 20 people with diabetes, 12 of whom were taking incretin drugs as well as those of 14 people without diabetes. Most had died of stroke or head injuries, leaving their pancreases in excellent condition. The researchers wanted to see if, in fact, as claimed, the incretin drugs--the drugs that raise the concentration of GLP-1 or mimic GLP-1--cause an increase in the beta cell mass. These drugs have been promoted with the promise that they do, that they regenerate the pancreas. This is one major reason doctors prescribe them ev...
Source: Diabetes Update - March 25, 2013 Category: Diabetes Authors: Jenny Source Type: blogs