Diabetes Drugs Evaluated by FDA on Pancreatic Cancer Risk

Diabetes drugs including Merck & Co. (MRK)’s Januvia, Bristol-Myers Squibb Co. (BMY)’s Byetta and Novo Nordisk A/S (NOVOB)’s Victoza are being scrutinized by U.S. regulators for a potential link to pancreatic cancer.

The Food and Drug Administration is reviewing unpublished findings by a group of academic researchers that suggest pre- cancerous cellular changes may be associated with Type 2 diabetes drugs called incretin mimetics, according to a statement today from the agency. The findings suggest the class of medicines may be linked to the risk of developing an inflammation of the pancreas tied to cancer and kidney failure that was previously reported in some of the medicines.

Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis.

The drugs in the class include exenatide, liraglutide, sitagliptin, saxagliptin, alogliptin and linagliptin. They mimic incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal, the FDA said.

No Conclusions

The FDA said it hasn’t reached any new conclusions about the safety risks associated with the drugs and hasn’t determined whether they may cause or contribute to pancreatic cancer. The agency suggested patients continue taking the drugs and talk with their doctors.

Merck, the second-largest U.S. drugmaker, is confident in the safety of sitagliptin, which is found in Januvia as well as the company’s Janumet and Juvisync, Pamela Eisele, a spokeswoman, said in an e-mail. The Whitehouse Station, New Jersey-based company reviewed all the safety data available to them on sitagliptin and “find no compelling evidence establishing a causal relationship between the use of sitagliptin and pancreatitis or pancreatic cancer,” Eisele said.

Merck will continue to monitor the safety of the drug with regulatory agencies and scientific experts, she said.

Merck reported $4 billion in sales, or about 9 percent of total revenue, from Januvia last year. The daily pill blocks an enzyme that breaks down GLP-1. Janumet, which combines Januvia with the older diabetes drug metformin, generated $1.7 billion in sales last year.

Bristol-Myers, based in New York, acquired Byetta last year when it bought Amylin Pharmaceuticals. Byetta, which mimics GLP-1, had sales of $148 million for Bristol-Myers last year, and $159 million for Indianapolis-based Eli Lilly & Co. (LLY), which ended its marketing partnership with Amylin in 2011. Novo Nordisk’s Victoza generated about $1.6 billion in sales, according to data compiled by Bloomberg.


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Source: BloomBerg (Edney, 3/14)

Importance of a Drug's "Risk-Benefit" Profile Eludes Former FDA Commissioner

One would think that having a full understanding of a drug’s profile would be crucial to have before unleashing such a compound to patients around the world. Surprisingly, however, some are espousing the view that the U.S economy is being shackled by overregulation and that the Obama administration could stimulate economic growth by “lowering unnecessary barriers facing innovative U.S companies that are trying to bring new products to market.” For potential new drugs, the overregulation in question is the requirement to conduct late stage clinical trials to show the risk-benefit profile of the new medicine.

Critics of the pharmaceutical industry would deem such a proposal as another example of this industry’s attempt to exploit patients for profits. Ironically, it is not the pharmaceutical industry pushing this view. It is being brought forth by Dr. Andrew von Eschenbach, a former commissioner of the FDA and Dr. Tomas Philipson of the University of Chicago.

Von Eschenbach and Philipson have recently proposed a system in which a “drug could come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required”. In other words, if a drug works in 500 – 1000 patients, the FDA should allow this compound to be marketed to the patients who could benefit from it – which could be anywhere from 10,000 to millions of people. The company would then run surveillance studies to be certain that no unusual side effects arise during its use.

What are the benefits of this newly proposed system? This would eliminate the costly late stage studies (phase 3) that are now required by the FDA. These studies make up at least 25% of the overall R&D spending for innovative companies. Furthermore, drugs would be approved at least 3 – 4 years sooner, thus extending the amount of time a drug can be marketed on its existing patent. Presumably, these saving and added profits would be ploughed back into funding new R&D programs, thereby generating greater medical innovation.

This all sounds great, but what about unforeseen side effects? The authors handle this in the following way.

“Companies would still be liable for unforeseen side effects, but patients and doctors would be warned – through the drug’s labeling – that the product had been approved based on promising but provisional research.”

This is not the first time that von Eschenbach has made this proposal. He first discussed this in a Wall Street Journal op-ed last year . He based his arguments back then on the need for the U.S. to remain a leader in medical innovation and that the FDA’s clinical trial requirements were restricting this potential. Philipson and von Eschenbach frame their arguments this time on the belief that their proposal would help to stimulate the U.S. economy via the biopharmaceutical industry’s enhanced success.

This proposal was flawed last year and it is even more flawed today. I have no doubt that their system will result in reducing the money spent in getting new drugs to market. But phase 3 trials are crucially important for a number of reasons.

1) Phase 3 is a not a glorified efficacy trial. Rather, it exists to help to define the risk and benefits of a drug. You really can’t do such an evaluation solely on the results of a small subpopulation of patients.

2) Only with a full risk-benefit profile can the FDA judge whether a drug merits approval. A significant side effect for an obesity drug, which potentially would be taken by millions, would likely make its use untenable, whereas this same side effect for a new pancreatic cancer treatment may be perfectly acceptable given the life saving nature of the latter medicine.

3) Phase 3 studies are also needed to compare the efficacy of a new drug with existing therapies. How are doctors and patients to know whether a new drug should be used without knowing this?

The von Eschenbach/Philipson proposal, if adopted, would likely result in more drug recalls and more liability costs, resulting in a decrease of confidence in the work of pharmaceutical companies on the part of physicians and patients. Critics of the industry already challenge (wrongly, in my view) that new medicines offer little advantage to older products and may even be less safe. Eliminating phase 3 studies would erode the attempts that the industry is making to restore its image.

I, for one, feel that the FDA does a good job in evaluating the risks and benefits for new drugs under the current paradigm and I don’t believe that they are being restrictive. Hopefully, they will not pay heed to the advice of their former colleague. I also think that the pharmaceutical industry would benefit by disassociating itself from this proposal. Silence on this issue may cause people to assume pharma support.

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Source: Forbes (LaMattina, 3/5)

Sedona Labs recalls iFlora children's supplements

Sedona Labs, a unit of Canada's Atrium Innovations Inc, is recalling two children's dietary supplements because they may be tainted with salmonella, the company said.

Sedona is pulling some lots of its iFlora Kids Multi-Probiotic and iFlora 4-Kids Powder because the company's supplier of galactooligosaccharide has recalled the ingredient because of possible salmonella contamination, Sedona said in a statement on the Food and Drug Administration website.

No illnesses have been reported from the supplements.

The supplements were distributed between March 16 and May 3. They carry lot numbers 1074711, 1479611, 1640811 and 1734411, the company said in a statement Tuesday.

Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

iFlora Kids Multi-Probiotic was sold throughout the United States to health food stores and Internet retailers. iFlora 4-Kids Powder was sold via healthcare professionals.

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source: Reuters (Simpson, 7/10)

GlaxoSmithKline to pay $3 billion to settle bribery, fraud allegations with US

The announcement by the Justice Department of a settlement with drugmaker GlaxoSmithKline of bribery allegations generated heavy media coverage last night and this morning, including more than seven minutes of coverage on network newscasts.

The CBS Evening News (7/2, story 6, 2:50, Pelley) reported, "The US government is calling it the biggest case of healthcare fraud in American history. The British drug maker GlaxoSmithKline is accused of withholding important safety information about the diabetes drug Avandia [rosiglitazone] and illegally promoting two other drugs for unapproved uses. GSK agreed to pay $3 billion in fines."

NBC Nightly News (7/2, story 4, 2:00, Williams) reported, "At the launch of asthma drug Advair prosecutors say global drug giant GlaxoSmithKline pushed the sales force to push hard even for uses not Federally approved. Today the company admitted its sales force bribed doctors to prescribe its drugs by offering such incentives as Hawaiian vacations and tickets to Madonna concerts."

ABC World News (7/2, story 4, 2:15, Muir) reported, "The goal to rev up sales as part of what prosecutors say was a culture of greed where patient safety took a back seat to profit. The government claims GSK engaged in an illegal marketing campaign where drugs were promoted for disorders where there was no medical evidence they would help. Allegations of promoting the drug Paxil for treating depression in patients under age 18 even though the FDA's has never approved it for kids."

The Los Angeles Times (7/3, Hsu) reports, "The agreement is the largest healthcare fraud settlement in history, spanning nearly every state, according to the Justice Department. It's also the largest payment ever by a drug company. The settlement is 'unprecedented in both size and scope,'" Deputy Attorney General James Cole said in a statement.

USA Today (7/2) reports, "Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400. The company also will pay $2 billion to resolve civil claims under the federal government's False Claims Act. Glaxo is pleading guilty to these violations of FDA regulations, which are misdemeanors. It has set aside $3.5 billion to cover the cost of the fines and other penalties related to the government's seven-year probe of the company's marketing practices for Paxil [paroxetin], Wellbutrin [bupropion] and Avandia, three of its blockbuster drugs."

In a front-page story, the New York Times (7/3, A1, Thomas, Schmidt, Subscription Publication) reports, "The fine against GlaxoSmithKline over Paxil, Wellbutrin and Avandia makes this year a record for money recovered by the federal government under its so-called whistle-blower law. In May, Abbott Laboratories settled for $1.6 billion over its marketing of the antipsychotic drug Depakote. And an agreement with Johnson & Johnson that could result in a fine of as much as $2 billion is said to be imminent over its off-label promotion of another antipsychotic drug Risperdal."

[Contact a Texas Personal Injury Attorney if you've suffered from prescription errors]

F.D.A. Orders Surgical Mesh Makers to Study Risks

The Food and Drug Administration issued an order on Wednesday requiring makers of implantable surgical mesh used to treat urinary incontinence in women to study its risks.

The move comes after years of reports of serious injuries linked to the devices, including infections, pain and other complications. It follows a recommendation in September by an F.D.A. advisory panel that the agency require such studies.

The move Wednesday by the agency is similar to one it took last year when it ordered producers of all-metal artificial hips to undertake patient studies. The mesh products and the hips belong to a class of implantable devices that manufacturers do not have to study in patients before they are marketed or closely follow in patients afterward.

Female incontinence is often caused by two conditions. One is called pelvic organ prolapse, in which muscles that support organs like the bladder weaken, allowing them to descend and press against the vaginal wall. The other, stress urinary incontinence, is also caused by muscle weakening.

In 2008, the F.D.A. issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse, said Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices.

Dr. Maisel emphasized that the order Wednesday did not cover all uses of surgical mesh to treat incontinence. He added that the safety of such devices when surgically implanted through the abdomen was “well established.”

The top producers of vaginal mesh include Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates.

In 2010, about 185,000 women underwent procedures in which mesh was implanted vaginally to treat urinary incontinence.

That same year, researchers reported in a medical journal that about 15 percent of the women treated with vaginal mesh experienced potential complications. The study, which appeared in the journal Obstetrics and Gynecology, also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.

Dr. Maisel said he expects that mesh manufacturers, once studies are started, will follow patients for about three years to determine the frequency and severity of complications.

Over the last year, the F.D.A. has increasingly used its authority to order manufacturers to conduct emergency studies. But the effectiveness of that procedure in preventing patient injuries is questionable because by the time the agency acts, a device has been on the market for years and been implanted in hundreds of thousands of patients.

Also, while the F.D.A. in May ordered makers of all-metal hips to conduct postmarket studies of their risks, the agency and company officials are still discussing study designs, Dr. Maisel said.

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source: New York Times (Meier, 1/4)


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Novartis Confirms Patient Died After Starting Gilenya (fingolimod)

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Tim Anderson, an analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

“In the case of MS drugs, there is often significant safety baggage of different sorts,” Anderson wrote. He rates Novartis’s shares “outperform” and estimates that by 2015 Gilenya sales will reach $1.4 billion, about 2 percent of the Swiss company’s revenue.

The exact cause of the death hasn’t been established, Novartis said. Sudden death “smacks of being cardiovascular in nature,” Anderson wrote, adding that the possibility of a temporary slowdown in heart rate after patients start treatment with Gilenya is part of the reason for a recommendation for monitoring in a doctor’s office after treatment begins.

The patient who died had begun treatment on Nov. 22 and had been monitored “without incident” for six hours after taking the first dose, Althoff said.

Novartis said it has sent details of the case to the U.S. Food and Drug Administration and other regulatory authorities.

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source: Bloomberg.com (Kresge, 12/13)



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Family Files Suit Against Cantaloupe Producer

HOUSTON - An Angleton family has filed a lawsuit against a cantaloupe producer, alleging their fruit is tainted with harmful bacteria.

A law firm states Juanita Gomez contracted Listeria after eating a cantaloupe from Colorado-based Jensen Farms Rocky Ford.

Gomez had purchased the fruit in early August, according to the lawsuit. She became ill and developed a fever by Aug. 20.

Hospital doctors noted Gomez’s temperature was 105.6 degrees Fahrenheit. She had glassy eyes and was unable to respond to simple questions.

Tests confirmed Gomez was infected with the same train of bacteria linked to the illness of 35 people nationwide and the death of four others.

Gomez has since been released from the hospital and is recovering at home.

Listeriosis, caused by consuming Listeria, primarily affects older adults, pregnant women, newborns, and adults with weakened immune systems.

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source: www.myfoxhouston.com (Perera, 9/21)

Pfizer accused of under-reporting side effects of smoking-cessation drug

(WASHINGTON) -- Everyone knows smoking cigarettes can kill you, but so might drugs that are supposed to help you kick the habit.

While severe side effects from the smoking-cessation drug Chantix have been documented for years, it turns out that suicides resulting from using the product made by Pfizer Inc. were actually more than twice in number than the pharmaceutical company admitted.

It's all there in a new analysis by the Institute for Safe Medication Practices (ISMP), which says that there were 150 instances of Chantix users taking their lives out of the nearly 600 delayed reports of severe issues noted in the study.

The Food and Drug Administration contends that Pfizer covered up the actual number of suicides by submitting information through "improper channels." As a result, the FDA wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts.

One ISMP scientist said of the data, "It’s really chilling. This seems to unleash something in people. It can be violence to anything around. We’ve had a major breakdown in safety surveillance."

While Pfizer says it will comply with the FDA request, the company contends there's no concrete evidence Chantix causes suicides.

Last year, the drug was prescribed 3.2 million times worldwide.

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source: www.abcnewsradioonline.com
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