Addendum...Of Interest this Week.

Addendum...of Interest this Week

New interesting articles and legal updates:

Product Liability Blog - FDA to Crack Down on Dietary Supplements, - Antibacterial Soap Can Hurt You, - Drop-Side Cribs Finally Banned.

Food & Drug Safety Blog - Dannon to Settle Complaint over Yogurt Ad, - Minnesota Man Awarded 1.7 Million in Levaquin Trial

 

FDA Looks At New Orexigen Weight Loss Pill

Article by Crystal Yagoobian

The Food and Drug Administration says a pill to treat obesity from Orexigen Therapeutics Inc. helped patients lose weight, though it didn’t meet all the criteria set forth by the agency.

Orexigen’s pill Contrave is the third weight loss pill to be reviewed by the FDA this year. FDA officials have acknowledged the need for new weight-loss drugs amid an epidemic of U.S. obesity, though the agency rejected the other two medications due to safety concerns.

Contrave did meet a second measure of effectiveness involving the number of patients who lost at least 5 percent or more of their weight. FDA guidelines published in 2007 state that a drug can be considered effective if it meets this requirement.

In documents posted online Friday, the FDA said studies by Orexigen showed patients taking its drug lost, on average, 4.2 percent more weight than patients taking a placebo. However, these results did not meet an FDA guideline that there should be at least a 5 percent difference in weight loss between the groups.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential.

But the search for a drug that helps patients safely shed pounds has been largely unsuccessful. Earlier this year Abbott Laboratories’ Meridia weight-loss pill was pulled from the market after regulators said it increased the risk of heart attack and stroke.

The FDA will ask a panel of experts to vote on the drug’s efficacy and safety tomorrow, December 7. Orexigen’s briefing documents for the December 7 panel hearing can be found here.

Darvon and Darvocet Pulled from the Market

Prescription painkillers Darvon and Darvocet were pulled from the market Friday by their manufacturer, Xanodyne Pharmaceuticals, Inc. According to a report from CNN, Xanodyne reportedly pulled the drugs at the request of the Food and Drug Administration. Darvon is the brand name for the drug propoxyphene, and Darvocet is a brand name for propoxyphene mixed with acetaminophen.  Darvon and Darvocet have been approved for use since 1957, but officials at the FDA now believe the risks of using the drugs outweigh the benefits. The medications, which have been prescribed for 10 million people since 2009, can cause serious heart rhythm abnormalities that could potentially be fatal. Generic forms of the drugs are still available, but the FDA has asked manufacturers to stop selling them and recommended that physicians stop prescribing them.  

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Controversy has surrounded propoxyphene for some time. According to an article in the Washington Post, Britain pulled the drug off the market six years ago, and Europe pulled it more than a year ago. Public Citizen’s Health Research Group has been calling for the U.S. to remove the drug for some time. In a statement issued on Friday, the group said that 1,000 to 2,000 people in the United States have died because of the drug since the United Kingdom banned it.

Patients have been advised not to stop taking it, but instead contact their doctors. Some have pointed out that stopping abruptly can cause withdrawal symptoms. For those that need to take painkillers, there are still plenty of other options out there. Consult your doctor on which one is right for you.

FDA Issues Warning Letter Over Alcohol Dependency Drug

 

For anyone whose life has been ruined by alcoholism, the chance to turn everything around with a shot in the arm must be appealing. Get an injection from your doctor and instantly repair every personal relationship that was destroyed by the disease. The appeal of such easy redemption is obvious, but it is also obviously a fantasy. The FDA has told one drug company that it cannot advertise that fantasy. Earlier this month, the Food and Drug Administration sent a warning letter to Alkermes, Inc., the makers of the alcohol-dependency drug Vivitrol. The drug is designed to decrease cravings for alcohol, but Alkermes has been advertising that it can do much more. The letter advised Alkermes that it had to stop distributing a DVD shown to potential Vivitrol users and a patient brochure because of exaggerated claims of efficacy. The DVD featured testimonials in which Vivitrol users said things such as this, from “Tina S.”:

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“The money was going towards alcohol and not the kids. . . .  With the drinking, DSS got involved. . . . Julie at the clinic, she suggested Vivitrol. . . .  Since I’ve been on the shot. . . .  I feel better about myself now that I’m sober.  I’ve got a little bit more respect from the kids and that I feel like a mother now. Physically I’m in better shape than I was. . . . Couldn’t even crawl out of bed and now I’m back to work. . . .  My life has changed so much in the past year.  I’ve gotten remarried.  We’re working on the house and everything’s going pretty good.”

The patient brochure featured similar statements, and a list of ten reasons to quit, including:

2. You will have a better relationship with your family.

3. You will have a better relationship with your friends.

7. You will accomplish more of the things you want to get done.

10. You will experience personal and spiritual growth.

The FDA said all of this went too far. “These claims misleadingly overstate the efficacy of Vivitrol by implying that the usual outcome of treatment with Vivitrol is a positive effect on a patient’s interpersonal relationships, emotional functioning, work productivity, productivity in general, and overall quality of life. FDA is not aware of substantial evidence or substantial clinical experience to support such effects of Vivitrol treatment.” It also faulted Alkermes for burying warnings about risks after the testimonials where they were not likely to attract any attention from viewers.

Some have suggested that Alkermes executives need to find a better way to present accurate information to vulnerable clients. It certainly seems like a cheap way to sell a drug, exploiting the desperation of people who have hit rock bottom. The drug may very well help people stay sober, and that is undoubtedly an important step in putting a life back together. But anyone considering taking Vivitrol should keep in mind that the drug is only designed to help them fight the urge to drink. The rest they have to figure out on their own.

 

Fosamax Trial Highlights Problems with Bone Medications

The latest trial dealing with the drug Fosamax is highlighting some of the risks of medications designed to treat osteoporosis. The New York Times reported on November 10, that the latest trial involving a plaintiff allegedly injured by the pharmaceutical drug Fosamax is underway in New York City. The plaintiff in the latest case is Judith Graves, a 67-year-old retired investigator for the United States Army. After taking Fosamax, Graves suffered jawbone death, a condition that involves debilitating jawbone deterioration. She had to have five operations, eventually having her jaw replaced with bone from her left arm.

Graves says Fosamax is to blame for her jaw troubles. Fosamax is an oral bisphosphonate manufactured by Merck. The drug is designed to prevent bone mass deterioration caused by aging. Graves’s case is one of several test cases against Merck that is being tried. There are roughly 1,400 other cases against Merck alleging injuries caused by Fosamax. Two test cases have already been tried, with Merck winning one and the plaintiff winning a multimillion dollar judgment in the other. We have filed cases on behalf of people injured by the drug. 

It is unclear how the Graves case will turn out, but as the New York Times reports, the case is serving as a backdrop for a larger debate about the proper use of oral bisphosphonates. Although the drugs have been shown to be effective in reducing bone fractures in postmenopausal women with osteoporosis, many doctors are concerned about the risks of prescribing them for too long. The Food and Drug Administration now requires the labels on Fosamax, Actonel, Boniva, Reclast, Atelvia, and generic versions, to state that the optimal period of use of these drugs is unknown. The fear is that long-term use of the drugs could cause not only jawbone deterioration but also thigh fractures. And for many these risks outweigh the benefits of prescribing the drug to women who have not yet developed osteoporosis. Others have commented on the dilemma this poses for doctors.

This trial underscores how important it is for patients on oral bisphosphonates to discuss the risks of these drugs with their doctors. Although they have saved people from the aggravation of broken bones, they carry considerable risks as well.

Addendum...Of Interest this Week

FDA Failing to Monitor Safety of Medical Devices - The U.S. Food and Drug Administration (FDA) is not doing its job of properly monitoring the safety of medical devices, the authors of a new report charges. HealthDay News, Nov.2nd.

Genentech Offers Secret Rebates to Promote Lucentis - Genentech has begun offering secret rebates to eye doctors as an apparent inducement to get them to use more of the company’s expensive drug Lucentis rather than a less costly alternative. - New York Times, Nov 3rd.

Watchdog Says FDA Risked Integrity - Congress's watchdog arm has criticized the Food and Drug Administration for creating the appearance of favoritism toward a Boston company that won lucrative first rights to sell a generic drug after providing free consulting work to the agency. Wall Street Journal, Nov. 8th.

Stage Set for Showdown on Online Privacy - Privacy advocates are pushing for a “do not track” feature that would let Internet users tell Web sites to stop surreptitiously tracking their online habits and collecting clues about age, salary, health, location and leisure activities. New York Times, Nov. 9th.

Club Car Recalls Golf Cars and Hospitality, Utility and Transport Vehicles - The brake pedal can crack and separate, resulting in a loss of braking ability. Kansas City Info Zine, Nov. 9th.

J&J in Talks to Resolve US Probe of Risperdal Marketing - Johnson & Johnson said it's in discussions with the government to resolve a long-running investigation of whether it improperly marketed the antipsychotic Risperdal. Fox Business News, Nov.10th

Caffeine: Is it Possible to Have Too Much of a Good Thing?

Caffeine PillsMost of us could not get through the day without our favorite caffeine-laden drink. The long history and widespread use of caffeine make us trust both its safety and effectiveness. For one British man, however, an overdose of pure caffeine was fatal. Pure caffeine, available in a wide range of forms, is widely available online and lightly regulated. The most common use of pure caffeine is as a beverage additive. Energy drinks have been found to contain up to 141mg of caffeine per serving, although the naturally occurring caffeine in a large coffee can be more than double that.  Sodas fall in the range of 20-55mg of caffeine. None of these products warn of the possible side effects of consuming excessive amounts of caffeine. This is not much of a problem for products with relatively low doses of caffeine, such as soft drinks, but the lack of warnings on containers of pure caffeine is disturbing.

               The FDA has classified caffeine as both a food and a drug, depending upon the marketed use, with the regulation of caffeine as a food additive being lax due to its GRAS classification—“generally regarded as safe”—which includes salt, vinegar, and common spices. The FDA has warned about certain possible health problems associated with long-term use, although there has been little attention until recently about the short-term dangers. Currently, the FDA is focusing on the dangers of caffeine added to alcoholic drinks.

Just a week ago, a British man died after ingesting 5,600mg (equivalent to 70 cans of Red Bull) of pure powdered caffeine. Doctors worry about the easy availability online and poor labeling of pure caffeine. The British man had taken two spoonfuls of the caffeine and chased it with an energy drink, although the label indicated that the caffeine should only be taken in doses of one-sixteenth of a teaspoon. Pure caffeine in powdered form is readily available from US-based sellers, although most sellers incorporate the caffeine into some other product (e.g. http://www.thinkgeek.com/caffeine/). None of these products contain warnings about the possibility of an overdose. Caffeine intoxication can occur after consuming as little as 250mg of caffeine with death occurring after consuming around 5,000mg.

Due to the publicity that these cases have received, increased regulation of pure caffeine should follow. The public should be aware of both the possible short- and long-term dangers of caffeine consumption. Moreover, the manufacturers of pure caffeine should prevent its easy purchase online and should add much more noticeable warnings on its products about how only two spoonfuls of its product can kill a grown man.

Avanir Makes Laughing and Crying a Thing of the Past

Ever wonder how to get rid of that pesky crying and laughing that was wearing out your facial muscles? Well you don’t need to wonder anymore, Avanir Pharmaceuticals has  developed a drug that was approved by the FDA on October 29, 2010 that will treat that condition.   Hopefully the sarcasm is obvious.

The drug is called Nuedexta and it will be used to treat patients who develop symptoms known as the pseudobulbar effect, which can usually be found in patients with neurological disorders and brain injuries.  The pseudobulbar effect has been called emotional incontinence where one has no control over laughter or tears. Sounds like a fake problem , well Avanir thought so and they unsuccessfully tried to change the name of the condition to involuntary emotional expression disorder.  

Not to take anything away from patients who suffer from something like this but when did it become the norm to treat “conditions” that are essentially harmless and out of one’s control. I mean, this drug is going to be marketed to people with serious underlying medical conditions to treat an uncontrollable action that poses no serious health risks.  Besides being driven by the profits that could be made from targeting this population, what other incentive would the pharmaceutical company have? I understand that uncontrollable crying or laughter may have an impact on ones social life or lead to embarrassment but is that outweighed by the known cardiac and hepatitis risks associated with taking the drug?

I previously wrote about the “condition”  that women go through and how pharmaceutical companies have found a way to help cure us. This too reminds me of how big pharma will find a way to help us deal with all of the “conditions” we may go through or “suffer” from in life. Is uncontrollable laughing a serious health risk, not really, but how about if there is a medication out there to treat it? Then people start looking at it as more than just an inconvenience, and now it is a condition that can be treated.  Perhaps one day prescriptions will only be used to treat serious ailments or at least provide measurable health benefits to the users……but I wouldn’t hold my breath.

FDA Sends Warning Letter to AMAG Pharmaceuticals, Inc.

The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed AMAG Pharmaceuticals, Inc.'s websites marketing its drug products, GastroMARK (an oral gastrointestinal imaging agent for delineation of the bowel) and Feraheme (an iron replacement therapy for individuals with kidney disease). 

The DDMAC found the websites for both drug products misleading and in violation of FDA rules.  Pursuant to a warning letter issued on October 18, 2010, it criticized AMAG for omitting the risks associated with the use of its two drug products, suggesting unapproved new uses for the products, and omitting important information about the approved indication for GastroMARK. 

FDA Concerns

  • Both websites present numerous efficacy claims for GastroMARK and Feraheme but fail to communicate any of the risks associated with the drugs, e.g., the GastroMARK web page omits the drug's contraindication in patients with known or suspected intestinal perforation or obstruction;
  • The GastroMARK website fails to present the complete indication for the drug, including material limitations to the indication, e.g., the GastroMARK web page fails to include that the drug is indicated only in adult patients, and that its usefulness in the lower gastrointestinal tract and retro-peritoneal region is limited by the transit time and dilution; and
  • Both websites present both approved and unapproved product information for the products together, which implies that the drugs are effective for unapproved uses. 

According to the FDA, "[t]hese violations are concerning from a public health perspective because they suggest that GastroMARK is useful in a broader range of patients and conditions than has been demonstrated by substantial clinical experience, and that GastroMARK and Feraheme are safer than has been demonstrated by substantial evidence or substantial clinical experience."

As such, the DDMAC requested that AMAG immediately cease the dissemination of its promotional materials for both drugs and submit a written response to its warning letter no later than November 1, 2010.    

 

 

 

 

   

Manufacturers Beware: FDA Launches Its Own "Front of Package" Labeling Investigation

While the CDC is using quantitative data to examine the advantages and disadvantages of "front of package" ("FOP") labeling, the FDA recently put manufacturers on notice of its own plan to launch a more qualitative investigation into certain FOP labels. The FDA's approach involves comparing the nutritional criteria used to support these labels against FDA regulatory requirements, and focuses specifically on foods that make "smart choice" or "heart healthy" type claims. While certain nutritional labeling is mandated, this type of FOP labeling is voluntary, but is nonetheless subject to the requirements of the Food, Drug and Cosmetic Act.

The FDA's investigation comes on the heels of research which reflects that when provided with FOP labeling, consumers are less likely to check the nutritional facts on foods, instead relying on the often bold and readily visible FOP claims. In its notice to manufacturers regarding the investigation it noted that they must take care to ensure that the FOP information presented to consumers is "nutritionally sound and well-designed to help consumers make informed and healthy choices and not be false or misleading." In other words, the labeling must be wholly supported by the nutritional content of the product and be presented in a way that does not distract consumers from analyzing the  product's overall nutritional value, or lack thereof.

The recent CDC studies and the investigation being launched by the FDA make it clear that the federal government has seen a recent need to provide more oversight of FOP claims, ostensibly because it has identified areas of concern. Those manufacturers whose claims are now under the microscope should be prepared for a potential backlash, both in the marketplace and in the courtroom, if their claims are determined to be unsupported and misleading. 

FDA Shuts Down Estrella Family Creamery Following Investigation

In a surprising move, the Food and Drug Administration forced the state of Washington's most well-known artisan cheesemakers to shut down, saying the product could be contaminated with bacteria that can cause serious illness.  Following Estrella's refusal to issue a recall, on Oct 21, the FDA took action by seizing all cheeses, including in-process and finished products (labeled and unlabeled), held on the premises of the Estrella Family Creamery, pursuant to a warrant issued by Judge Benjamin H. Settle of the Western District of Washington. Judge Settle issued this warrant at the request of the United States Attorney’s Office, which filed a complaint in the District Court alleging that cheese and other articles of food held at Estrella Family Creamery are "adulterated under the Federal Food, Drug, and Cosmetic Act because they have been held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health."

Problems at Estrella began in February when an inspection by the Washington State Department of Agriculture (WSDA) turned up Listeria monocytogenes, a bacteria found in animal feces, in the creamery's production areas and in its finished cheese, according to court records. In March, the WSDA again found bacteria at the facility.  The problems centered on a particular cave where soft cheeses are aged, according to co-owner Kelli Estrella, adding that soft cheeses are more susceptible to bacteria growth. The company voluntarily recalled several cheeses, destroyed the cheese in that cave and temporarily shut down production while it improved the facility. On Aug. 2, the FDA conducted an unannounced inspection, taking scores of swabs throughout the operation. Several swabs turned up listeria, although no cheese tested positive at that time. No illnesses have been linked with the cheeses, the state Department of Health said.

Estrella's raw-milk cheeses, made in Montesano, Grays Harbor County, Washington are sold at farmers markets, high-end restaurants and retail stores in several states.  It remains unclear  if and when the company will resume operations.  In the meantime, the FDA has advised consumers to throw away any Estrella cheeses they have in their households.

Three States Settle With Bayer Over Misleading Vitamin Claims

On October 26, 2010, Reuters reported that Attorneys General in Illinois, Oregon and California agreed to a $3.3 million settlement over misleading claims that Bayer vitamins reduce the risk of prostate cancer. Bayer had made claims in its packaging and promotional materials that selenium in its men’s vitamins reduced the risk of certain cancers. In June 2010, the FDA concluded that there was very limited credible evidence for qualified health claims for selenium dietary supplements and prostate cancer. In addition to the monetary payments, Bayer was revising its packaging and promotional materials.

Significantly, the FDA made findings about selenium dietary supplements as it relates to other site-specific cancers. The FDA concluded that there is no credible evidence to support qualified health claims for selenium dietary supplements and a reduced risk of urinary tract cancers other than bladder cancer, lung and other respiratory tract cancers, colon and other digestive tract cancers, brain cancer, liver cancer, or breast cancer. However, FDA concluded that there is very limited credible evidence for qualified health claims for selenium dietary supplements and bladder cancer,  prostate cancer, and thyroid cancer, provided that the qualified claims are appropriately worded so as not to mislead consumers. 

This settlement and the FDA findings should remind all dietary product manufacturers to use caution when making health benefit claims about their products and to appropriately limit claims so as not to mislead consumers.

Botox Approved For Severe Migraines

The wrinkle smoothing injection, Botox (botulinum toxin), has been approved by the Food and Drug Administration to treat severe migraine headaches in adults. Individuals who experience 15 or more days of migraine headaches per month can now rely on the injections to alleviate their pain. Doctors are directed to inject patients with 31 Botox injections into seven specific head and neck sites at intervals of 12 weeks at a time to dull future headaches.

The approval comes just over a month after Allergan, the manufacturer of the drug, agreed to pay $600 million to settle a federal probe into its marketing practices for Botox. The company was accused of marketing the drug for medical uses for which it had not been approved.

Botox has become one of Allegran’s top selling drugs since being introduced in 1989. Last year, Botox alone accounted for more than $1.3 billion of the company’s $4.4 billion sales. Profits are expected to increase tremendously given this new use approval and the ability for qualifying patients to have the insurance companies pick up the tab.

Botox is most famous for its ability to smooth wrinkles on aging faces. It is also approved to treat eye muscle disorders, neck spasms and excessive underarm sweating. Although the FDA has approved the drug for chronic migraines, studies have failed to show that it works for occasional headaches or occasional migraines.  

Diabetes Drug Avandia Still Causing Debate

Coverage on the popular GlaxoSmithKline medicine, Avandia, has recently sparked due to a new Senate report.  Although hundreds of individuals suffer each month from the dangerous side affects associated with the drug, the drug still remains on the market.  A better look at these latest developments can be read in this NY Times article - "Research Ties Diabetes Drug to Heart Woes"

Shawn Khorrami and James Kenna of KPA have been appointed to the JCCP Steering Committee for Avandia, and will continue to fight on behalf of those injured individuals. 

Medical Device and Safety Act of 2009

After the Supreme Court’s decision in Riegel v. Medtronic, which, in a nutshell, took away a consumer’s right to sue a medical device manufacturer for injuries and/or death caused by their faulty devices if the device had received FDA approval, Congress introduced the Medical Device and Safety Act which will restore a consumer’s right to state tort remedies.    

Is there really a doubt that this needs to pass? For 30 years state law and FDA regulations worked together to ensure the safety of medical devices both pre and post approval and then with one flawed decision, injured consumers were stripped of their ability to hold medical devices liable. Now, so long as they receive FDA approval, they are immune. That’s an interesting concept, seeing that the manufactures are the ones that conduct their own studies, and then submit their findings to the FDA for approval. Basically, the manufacturers are the ones approving their own products and then they are in the clear.  There was already a concern about the “findings” from their studies that they used to get the approval but now there is the added concern that the medical device manufacturers have absolutely no incentive to conduct post-approval safety studies of their products? 

Currently, if a patient is implanted with a faulty medical device and endures injuries and hospitalizations, the medical bills are the responsibility of the patient and in some cases the taxpayers. So, in short, a medical device manufacturer can conduct its own studies, submits its results for FDA approval and then once approved sit back and let the profits come in while the general public is left footing the bill for any problems with their products.  

Any argument made against the passing of this bill does not compare to the necessity of this bill for public safety reasons.    Here is an idea for the manufacturers who are against the passage of this bill, conduct proper pre-market studies, warn about any safety problems learned of post –market and recall devices that have problems. It may be a stretch but I am confident that if those few simple steps are followed the manufacturers wouldn’t be affected by the passage of this bill.