Skippy Peanut Butter has been recalled because of salmonella risk. Image: Flickr / consumerist / CC-BY

Every month, the Food and Drug administration heads up hundreds of small recalls. Many recalls go unnoticed, but the most recent peanut butter recall — 2011′s Skippy recall — is calling attention to another problem with the federal budget. Despite many safety recalls, the FDA and USDA are facing serious funding cuts.

First peanut butter recall for 2011

In a move expected to cost about $50 million or more, Skippy has recalled peanut butter in 16 states. The Skippy Reduced Fat Creamy Peanut Butter Spread and Skippy Reduced Fat Super Chunk Peanut Butter Spread have both been possibly contaminated with salmonella bacteria. The 16.3-ounce plastic jars with UPC numbers 048001006812 and 048001006782 are included in the recall. The FDA is working in cooperation with Unilever, the company that manufactures Skippy, to pull the possibly tainted product off the shelves.

Finding funding for food safety

In a new bill signed into law last year, the Food and Drug administration got an update. Rather than requiring the agency to work with companies offering tainted products, the FDA will soon have the right to require a recall. The FDA’s budget also included funding to hire new inspectors and generally keep a closer eye on food safety. The funding for these changes, however, appears to be at risk. Part of the funding is appearing from cuts to the USDA, which is responsible for the safety of the meat supply. Congress is also calling for additional cuts to the budget of the FDA, which may leave new food safety initiatives un-enforceable. With more than 3,000 deaths each year attributed to tainted food, the consequences of the lack of funding are immediate and serious.

The essential problem with food safety

Funding the food safety system in the United States is a difficult regulatory challenge. The FDA is responsible for both food and drug safety in the United States, both of which are huge challenges with thousands of moving parts. Food safety is also, alternately, handled by the United States Department of Agriculture or 14 other federal agencies. State and local governments take on another level of oversight. Though heavier regulations and more funding could improve food safety, heavier regulation comes with its own challenges. Small farms, farmer’s markets, and other local food producers have already expressed concern that increased regulation costs them a significant percentage of their sales. Each food-safety recall pulls millions of dollars out of the safety budget and the economy in general, but reforming the system will take political, social and economic changes that could prove overwhelming.

Sources

Slate
MSNBC
Food Safety News
Government Accountability Office (PDF)

Contrave is the latest diet drug to be recommended for FDA approval. Image: Flickr / tacitrequiem / CC-BY

This morning, a Food and Drug Administration review panel recommended that Contrave be approved. Contrave is a weight-loss drug that has shown “modest effectiveness” in helping people lose weight. The FDA panel also voted for additional study of the safety and effects of Contrave.

The effectiveness of Contrave

Contrave is a drug developed by Orexigen Therapeutics out of San Diego. The drug, in studies, had “modest” effectiveness helping overweight individuals drop the weight. Contrave is a combination of two weight loss drugs that have previously been approved, bupropion and naltrexone. By blocking opioid and dopamine receptors, the drugs help limit the pleasure taken out of eating. The drug has been in trials since 2006 and shows about 7 percent better weight loss than diet and exercise programs alone.

The danger of Contrave

Though the panel did vote for the approval of Contrave, the FDA panel also voted 11 to 8 that a larger-scope study should be conducted. The FDA believes that this study can be conducted after the drug is approved and on the market, however. Contrave has shown to increase both blood pressure and pulse rate. These effects could raise the risk of heart attack and stroke in a population already predisposed to those conditions. Orexigen has already conducted some studies, but none were extensive enough to determine heart attack and stroke risk.

Too high a bar for obesity drugs?

The vote to recommend approval of Contrave happened at a complicated time for obesity drugs at the FDA. The same advisory committee suggested that both Qnexa and Lorcaserin, two other wight loss drugs, be denied approval. At the meeting where the advisory panel voted for Contrave, members discussed whether obesity drugs are being held to an unrealistic standard for safety. Given the recalls of multiple drugs recently, the other possibility is that too many drugs are not being held to a high enough standard. What do you think?

Sources

New York Times
Wikipedia

Electronic cigarettes have been ruled a "tobacco product," not a drug. Image: Wikimedia Commons

Electronic cigarettes are a product that have been on the market for more than a year. The FDA has been trying to ban electronic cigarettes as “unapproved drug delivery devices.” Today, however, the U.S. Court of Appeals ruled that the FDA does not have authority to regulate them as anything other than tobacco.

The basics of electronic cigarettes

Electronic cigarettes or “e-cigs” are basically a small, tube-shaped vaporizer. They vaporize a liquid solution to make it inhale-able. Electronic cigarettes are usually packaged with a nicotine solution intended for inhalation. Usually, electronic cigarettes are marketed as “safer” than traditional cigarettes.

The FDA argument against electronic cigarettes

The FDA tried to ban electronic cigarettes earlier this year. It wanted to label electronic cigarettes as “unapproved drug delivery devices.” The FDA banned the importing of electronic cigarettes, alerting customs officials to not accept any shipments of the products. The FDA currently regulates nicotine gums and patches as drugs and certifies their safety and efficacy. The FDA argued that electronic cigarettes should be studied for the same standards of safety and efficacy.

Ruling shields electronic cigarettes from FDA

After the FDA tried to ban electronic cigarettes, two companies filed for an injunction. NJOY and Smoking Anywhere, two companies that develop and market electronic cigarettes, argued that electronic cigarettes should not be subject to FDA review. A lower court and now the U.S. Court of Appeals have ruled that electronic cigarettes are subject to regulation through the 2000 tobacco control act. In 1996, the FDA tried to regulate all tobacco products, but the Supreme Court ruled against the move, 5-4. The Campaign for Tobacco-Free Kids, a supporter of the FDA when it comes to electronic cigarettes, responded to the ruling by stating “This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health.”

Sources

Business Week
New York Times

The Food Safety Enhancement Act gives the FDA resources to increase inspections and issue mandatory recalls. Image: CC THINSPO/Picasa Web Albums

A food safety bill passed a Senate vote Tuesday after being delayed by politics for more than a year. A recent flurry of salmonella and E. coli outbreaks has underscored that the Food and Drug Administration lacks the resources to adequately protect the population from tainted food. The food safety bill, coming with a price tag of of $1.4 billion, authorizes the federal government to increase inspections and initiate recalls of tainted food.

Food safety bill survives lame-duck session

The food safety bill that passed the Senate by a vote of 73-25 is one of the few items of legislation that Congress was expected to deal with in its lame-duck session at the end of the year. The Food Safety Enhancement Act requires FDA inspections of food processing plants and farms with a high risk of contamination once every three years. Until now, the FDA, when it has conducted inspections at all, has done so about once a decade. The food safety bill also gives the FDA authority to order mandatory recalls, instead of the current practice of waiting for corporations to do so voluntarily. Imported foods, of which the FDA currently inspects about 1 percent, will also be subject to stricter standards.

Food safety tainted by politics

The food safety bill is supported by both big agribusiness and consumer advocate groups. But despite being passed by the House in July 2009, the Senate played politics with the legislation for a year and a half. Sen. Tom Coburn, R-Okla., blocked the food safety bill last fall. Tea Party activists cried overreaching government. Glenn Beck called the food safety bill a government plot to inflate meat prices and force consumers to become vegetarians. As the bill languished in the Senate, there were 85 recalls of FDA-regulated foods associated with 1,850 food-borne illnesses.

Food industry stands behind bill

The food safety bill passed despite conflicts between agribusiness and small farms. Small farmers refused to be held to the same standards as major corporations. Agribusiness said no one should be exempt. After Sen. John Tester, D-Mont., added an amendment exempting small farmers, some large agricultural groups withdrew their support. However, even major corporations involved in recent recalls have said they will benefit from a food safety bill that provides clear regulation and levels the playing field in the food industry.

Sources

Washington Post

USA Today

Des Moines Register

The FDA has warned makers of Four Loko and similar drinks that their products are unsafe. Image from Wikimedia Commons.

Four Loko, a caffeinated alcoholic beverage, and similar products, have been labeled “unsafe” by federal authorities. The makers of Four Loko and similar caffeinated alcoholic beverages are being told to change their product or face consequences by federal agencies. Caffeinated alcoholic drinks have been under FDA investigation for months.

Four Loko already under investigation

Caffeinated alcoholic drinks, such as Four Loko, have been under federal investigation since November of 2009, according to the Washington Post. The investigation of products from at least 30 companies was spurred by requests for investigation from several state attorneys general. However, a string of recent incidents caused federal officials to take action. Letters were issued by the Food and Drug Administration to four companies that make seven similar products — including Phusion Projects Inc., which makes Four Loko — that mixing caffeine and alcohol is not approved by the FDA and was classified as unsafe. The companies that were notified of the FDA’s decision have 15 days to removed caffeine from their products or face legal action.

The Wildcats that broke the camel’s back

A couple of months ago, several students from Central Washington University were admitted to a hospital after consuming Four Loko along with other beverages, and Four Loko was subsequently banned in Washington state, effective Friday. However, Four Loko has also been implicated in other incidents, according to the New York Times. An 18-year-old died in Florida after taking diet pills and drinking Four Loko, and a 20-year-old in Tennessee drank Four Loko and committed suicide by gunshot later that night. Though it isn’t known whether Four Loko or similar beverages are clear culprits in any of these incidents, or were complicating factors, calls for having Four Loko banned are increasing. Phusion announced recently that it will discontinue the addition of caffeine to its drinks.

Bans implemented

Michigan and Washington State have banned Four Loko and similar products and New York state is right behind because there is some evidence that mixing caffeine and alcohol is not a safe combination.

Sources

Washington Post

New York Times

Benlysta gives hope to people with Lupus, such as Lada Gaga, but Wall Street isn't so impressed with the drug's profit potential. Image: Wikimedia Commons

Human Genome Sciences has been developing a drug called Benlysta for the treatment of Lupus, a painful, deadly disease. Benlysta has been in trials conducted by the Food and Drug Administration to determine whether the drug is safe and effective. Benlysta has given people with Lupus hope, and the FDA appears to be on the verge of approving the drug. However, Wall Street downgraded Human Genome Sciences’ stock because people with Lupus won’t be charged as much for Benlysta treatment as investors had hoped.

Human Genome Sciences and Benlysta

Human Genome Sciences stock was downgraded Wednesday because sales revenue for Benlysta may not be as lucrative as they had once assumed. MarketWatch reports that analysts at Citigroup and Bank of America cut their stock-price targets for Human Genome Sciences before trading commenced. While Lupus sufferers wait in anticipation for potential life-saving relief, fearful investors worry about how much money they can make. Bank of America Analyst Rachel McMinn told MarketWatch that information provided by an FDA panel Tuesday “underscored concerns that Benlysta will have a smaller than expected role in lupus treatment.”

Good news for Lada Gaga

Human Genome Sciences’ Benlysta will be the first new treatment for lupus in 50 years. About 1.5 million Americans have Lupus. Lada Gaga may be the most prominent of them. Lupus tricks the body into attacking itself. Symptoms include skin rashes, aching joints and inflammation of vital organs. Current Lupus treatments come with serious side effects. Patients often have to choose between suffering from either Lupus or the side effects from treatment. There is no cure.

Bad news for Wall Street

In a one-year FDA study people with Lupus given Benlysta had greater improvement than people given standard treatment. However, the drug loses some of its effectiveness after the first year. This result has led McMinn to lower her estimate of Benlysta treatment from $40,000 per patient to $35,000. She downgraded Human Genome Sciences to “underperform” from “buy” and cut the price target from $33 a share to $24. A Citigroup analyst told MarketWatch that global sales for Benlysta, which investors had hoped would reach $2.6 billion by 2015, are now only expected to reach $1.6 billion.

Sources

MarketWatch

WebMD

CBS News

The FDA is heading in the direction of European countries with new cigarette warning labels that bluntly depict the effects of smoking. Image: CC andybullock77/Flickr

Cigarette warning labels have been printed on packs of smokes for 25 years — and smokers generally ignore them. The Food and Drug Administration is proposing new, larger cigarette warning labels that use graphic shock tactics to discourage people from smoking. The new cigarette warning labels are a result of congressional legislation that granted the FDA authority to regulate tobacco as a drug.

New cigarette labels shock and awe

New cigarette warning labels that graphically depict the consequences of smoking have been submitted by the FDA for public comment at fda.gov. The FDA’s proposed cigarette warning labels cover half the surface area of the pack. Some of the labels use pictures illustrating the effects of smoking which include a man smoking from a tracheotomy tube in his throat, a woman smoking with a baby in her lap, a body lying in a morgue and a man wearing a t-shirt with the words “I quit.” More than 30 countries already require large graphic cigarette warning labels that include images of blackened teeth and cancerous mouths and organs.

FDA seeks public comment on cigarette warnings

The Food and Drug Administration, is gathering public comment on 36 proposed cigarette warning labels until Jan. 9. Nine cigarette warnings will be chosen by June 22. Cigarette companies won’t be allowed to sell smokes without the new warning labels after Oct. 22, 2012. In a statement, Philip Morris USA, the nation’s largest cigarette manufacturer said it supported the the new warnings. However, Dr. Richard Hurt, director of the Nicotine Dependence Center at the Mayo Clinic, told the New York Times that cigarette makers can be expected to try diluting the message with creative packaging schemes.

Tobacco use statistics

Tobacco use causes 443,000 deaths in the U.S. every year and costs $96 billion, according to the federal government. More than 46 million adults and nearly 3.5 million teenagers smoke. Each day about 1,000 teenagers and children become regular smokers and 4,000 more try smoking for the first time.

Sources

New York Times

Washington Post

CNN

Teething hurts. So does belladonna poisoning. (Photo: CC BY-SA/Daniel Schwen/Wikipedia)

Parents know that teething is a painful time for both their kids and themselves. Tablets that help soothe the gums can sometimes be the only thing that permits a good night’s sleep, making them a mainstay for well-prepared moms and dads. This is why the U.S. Food and Drug Administration’s recent announcement that Hyland’s Teething Tablets have been voluntarily recalled because of potential toxicity is particularly disturbing. The popular organic, homeopathic teething relief contains a small amount of medicinal belladonna, an alkaloidal extract taken from the poisonous belladonna plant that can be lethal in large doses.

Hyland’s Teething Tablets should be discarded immediately, company says

According to Hyland, any teething tablets should be thrown away immediately. For safe replacements, parents are advised to contact the company at hylandsteething.com/recall or 877-496-5044. The customer service call center is open Monday through Friday, 8 a.m. to 10 p.m. Eastern Standard Time and Saturday and Sunday, 9 a.m. to 5 p.m.

Belladonna must be ‘carefully controlled’

The FDA reports that while belladonna does have a history of being used as an anesthetic, its use must be carefully controlled. This is particularly true when young children are involved. Laboratory analysis has found “inconsistent amounts of belladonna,” yet parents are advised to err on the side of caution. This is in part because the FDA has gotten reports of children suffering adverse effects consistent with belladonna toxicity (dilated pupils, blurred vision, light sensitivity, confusion, rash, constipation, etc.). Considering that Hyland’s Teething Tablets packages are not manufactured with child resistant caps, the danger is obvious.

Hylands Teething Tablets included in the recall

Hyland’s Teething Tablets, 125 tablets, UPC #3 54973 75041

Hyland’s Teething Tablets, 250 tablets, UPC #3 54973 75042

Hyland’s Teething Tablets, 125 tablets, UPC #3 54973 75066

Hyland’s Teething Tablets, 50 tablets, UPC #3 54973 75044

Hyland’s Teething Tablets, 145 tablets, UPC #3 54973 75121

Hyland’s Teething Tablets, Clip Strip 6×125 tablets, UPC #3 54973 35109

Sources

Babble.com

U.S. Food and Drug Administration

Wikipedia

What moms want to know, from a mom

The FDA won't pull Avastin completely, but might say it can't be sold for certain purposes. Image from Wikimedia Commons.

A committee of the Food and Drug Administration has recommended that the approval for Avastin to be marketed as a breast cancer drug be pulled. A new round of clinical testing revealed the drug had little or no effect on breast cancers, after the first round of clinical trials for the drug showed positive results. The FDA has not ruled on whether the drug’s approval for marketing purposes is being canceled. Should the marketing approval be pulled by the FDA, the manufacturer of the drug, Roche, stands to lose a lot.

Avastin is the best selling cancer drug ever

Avastin is the trade name of Bevacizumab, a cancer medication. It’s called an angiogenesis inhibitor, which means it prohibits the growth of new blood vessels. It works by stopping a hormone called vascular endothelial growth factor, which stimulates blood vessel growth. According to the Los Angeles Times, the FDA fast tracked the drug for approval in 2008, conditioned on follow up studies to prove the drug really works. Roche and its subsidiary Genentech, which makes the drug, have failed to prove in a second round of trials that Avastin is definitely effective in eliminating or stopping breast cancer. The drug sells about $6 billion worth annually, and up to $1 billion of that is for breast cancer patients.

Roche feels side effects

The company that owns Genentech, Roche Holding Inc., dropped 4.1 percent in market shares after the FDA panel recommended pulling the approval to market the drug as a breast cancer treatment, according to Market Watch. The drop in share value comes on the heels of a series of lawsuits concerning Accutane, an anti-acne medication the company produces. Regardless of whether the drug won’t be used to treat breast cancer patients, it has proven very promising for treating other cancers.

Not the end of the drug

It takes a long time to develop effective medications, especially for diseases like cancer. There may well one day be a cure for cancer, but it will take a long time. If the FDA does pull its approval of Avastin being marketed for breast cancer treatments, it may lead to selling fewer pills, but that’s about it.

Further Reading

Los Angeles Times

Market Watch

Bevacizumab

The new diet drug Lorcaserin is currently being reviewed by the FDA. (Photo: CC by alancleaver_2000/Flickr)

Developed by Arena Pharmaceuticals, the new diet drug Lorcaserin has been submitted to the FDA for approval. A two-year study of the drug has recently been completed, and researchers say the weight loss drug is both safe and effective. The long-term safety of the drug has not yet been established, but within the race for the newest weight-loss drug, Lorcaserin may be the next one to make millions on the market, safe or not.

The effects of Lorcaserin

Hunger impulses come from serotonin, which is blocked by Lorcaserin. The drug mimics the same hormone in the brain the “fen” half of fen-phen targeted. Blocking this hormone blocks hunger impulses. These same chemical interactions are used to create anti-depressants and anti-convulsants.

Lorcaserin’s weight loss

Just recently released, the latest study on the safety and effectiveness on Lorcaserin seems promising. The study shows that about half of the people taking Lorcaserin lost 5 percent or more of their body weight. Twenty percent of participants lost a full 10 percent or more of their body weight using the drug.

The safety profile of Lorcaserin

Lorcaserin is being very carefully watched for safety because it works in ways comparable to fen-phen. In 1997, fen-phen was taken off the market because it considerably weakened heart valves. In studies, Lorcaserin hasn’t been shown to weaken heart valves the exact same way. Lorcaserin targets hormones that regulate not only appetite, but endocrine system secretions and mood.

Will Lorcaserin be approved?

The FDA has received a New Drug Application for Lorcaserin. The FDA will complete its review of Lorcaserin by Oct. 22, 2010. The FDA might approve the drug for sale, request additional studies or simply deny certificiation. The documents from Arena estimate that Lorcaserin will sell more than $3 billion worth of products by 2015.

Though you will find dozens of weight loss drugs on the market and in development, the reality is that almost none of these drugs are shown to be more effective than watching your diet and exercising regularly.

Is this going to wind up on Tylenol labels? Image from Wikimedia Commons

Drug maker Johnson & Johnson has encountered yet another setback. The Food and Drug Administration has temporarily shut down a medicinal manufacturing plant in Lancaster, Penn.  The plant failed an inspection and will remain closed until the plant is restored to satisfactory condition.  Johnson & Johnson has already suffered some high profile setbacks over the past several months, on the heels of a large recall of children’s Motrin and Tylenol products.

Lancaster PA plant closes its doors

A plant run by a Johnson & Johnson-Merck Consumer Pharmaceuticals joint venture was ordered to halt production by the Food and Drug Administration, according to CNN Money. The Lancaster, Penn., plant was given a Form 483, which is an FDA notice of non-compliance with FDA guidelines. It is the second plant in the last few months for Johnson & Johnson to get hit with sanctions, and a setback for the Johnson & Johnson-Merck joint venture. The plant manufactured Mylanta, Immodium and Pepcid.

Newest plant closure for J & J

In May, Johnson & Johnson was ordered by the FDA to close a Fort Washington, Penn., plant for non-compliance with codes. That plant manufactured children’s Motrin and Tylenol. The plant in Fort Washington was run by a Johnson & Johnson subsidiary, McNeil Consumer Healthcare, which just announced a layoff of 300 of the 400 employees at the plant. The Fort Washington plant was implicated in contaminating numerous shipments of children’s Motrin and Tylenol which were recalled in 2009. Another Tylenol recall was initiated recently where 130 million bottles of children’s Motrin and Tylenol were recalled on May 6 of this year.

McNeil execs might need some of their own drugs

McNeil Consumer Healthcare has been lambasted by the FDA on an almost quarterly basis for years. McNeil and the Fort Washington plant have been constantly under investigation since 2003, and McNeil has issued five recalls of products in the last 8 months. One wonders if consumers can actually find medicine that won’t kill them.

Sources

Lancaster PA plant

Fort Washington plant closing

Red and green romaine lettuce is a favorite in salads. Image from Flickr.

Freshway Foods, based in Ohio, has instituted a romaine lettuce recall 2010. In all, 19 cases of E Coli have been confirmed in connection to the romaine lettuce recall. If you have possibly been sickened by the Freshway Foods lettuce recall, you may need money now to go see a doctor – though most cases are not severe.

Romaine lettuce recall 2010 affects shredded romaine

The romaine lettuce recall 2010 announced yesterday evening includes only shredded romaine lettuce. Any Freshway Foods shredded romaine with a “use by” date after May 12 should be thrown out. Additionally, grab-and-go salads from in-store salad bars at Kroger, Giant Eagle, Ingles Markets and Marsh stores should not be eaten. Other suppliers of romaine lettuce and other fresh greens are not included in the lettuce recall. It appears the recalled lettuce was grown in Arizona and shipped to wholesalers across the country.

Calls for stronger food safety after romaine lettuce recall 2010

The romaine lettuce recall 2010 has once again raised calls for stronger food-safety regulation. Last year, the House passed a bill that gave the FDA stronger food-regulation powers, but the Senate has yet to vote on the bill. E. Coli infections are usually found in undercooked meat, but because lettuce and other greens are not usually cooked, there is no way for the infection to be killed. Thorough washing and proper storage help minimize the risk.

Why stronger regulations may hurt, even with lettuce recall

The lettuce recall, like spinach and fresh greens recalls before it, has raised questions of food safety. Though many often call for “stronger regulation” to “protect food safety” after lettuce recalls, there is an argument against this stronger regulation. This lettuce recall originated with a large grower who grows hundreds of thousands of acres of lettuce and ships it across the country. Stronger regulation on food tends to favor mega-food companies who can afford the new inspections, equipment or processes required. Small growers, who are not usually at fault for issues like the lettuce recall, are usually pushed out of business. Stronger across-the-board regulation, unless written carefully, tends to make the problem worse by pushing out small growers.

What to do about the romaine lettuce recall 2010

If you think the lettuce recall affects you, then contact your local health department. Do not eat the products implicated in the lettuce recall. Thoroughly wash and properly store all greens. The good news is that the lettuce recall affects a relatively small percentage of the lettuce available in the United States – and no other greens or growers have been shown to be unsafe in this lettuce recall. If you are concerned about possibly eating romaine lettuce recall 2010 lettuce, give mescalun greens a try — or iceburg, or spinach, or raddicio or even rocket lettuce.

Sources:

The Associated Press
FDA.gov

InterMune has been given a bitter pill to swallow. Image from Wikimedia Commons

The FDA has been having a busy week, after approving Provenge for use and taking Tylenol to task, it has given InterMune a cold shot. InterMune had previously submitted a drug to treat pulmonary fibrosis for approval, and the FDA has turned InterMune down.  The drug, called pirfenidone, was denied by the Food and Drug Administration because apparently it had failed to live up to expectations in a second clinical trial.  It sent InterMune stock plummeting, and investors may be sent scrambling for unsecured loans to get back to drawing board.

InterMune wonder drug deflated by FDA

The InterMune corporation had previously had soaring stock prices.  However, the FDA did not see sufficient evidence of efficacy in a second clinical trial, and this announcement and subsequent rejection sent prices plummeting.  For the last few months, the company stock had been on a high, and earlier this week had been trading at $45.44 a share, according the New York Times.  After the word from the FDA, InterMune stock, designated ITMN, was sent plummeting to the bottom, losing 80 percent of its value or $36 per share.

Wonder drug to treat Pulmonary Fibrosis

The drug in question, pirfenidone, would have treated symptoms of pulmonary fibrosis, especially idiopathic pulmonary fibrosis.  Pulmonary fibrosis is a disease which causes scarring and hardening of lung tissue.  (Idiopathic means no known cause.) The disease is often fatal, and sufferers generally live only a few years after diagnosis.  The drug would have been sold under the trade name Esbriet.  The Times article indicated that the drug merely postponed death for a short period, without slowing any symptoms.  Therefore, there would be dubious benefit.

Back to the drawing board

Some feel the FDA should have been more lenient, considering the vicious nature of the disease. This isn’t entirely bad news, as it means that InterMune will likely return to work on the drug. In turn, this may lead to a more effective treatment than pirfenidone, which had only undergone the second round of clinical trials. Even in the first, it did not reverse the disease or damage caused by it.

Dendreon Provenge treatments are a little more complex than a shot. From Wikimedia Commons

The Food and Drug Administration has approved Provenge, a anti-cancer vaccine made by Dendreon, for use in treating prostate cancer.  The drug is the first anti-cancer vaccine to get FDA approval.  The drug was found to extend the life of cancer patients by a median of four months.  That said, the process behind the vaccine is in its infancy, and treatment would require a lot of cash now to get.  The drug is so far a success story, and a potential precursor to better ways of treating one of the world’s worst diseases.

Dendreon Provenge study results

According to WebMD, the results of the Dendreon Provenge study, done by researchers unaffiliated with the company, found that patients suffering from prostate cancer lived a median of 4.1 months longer than those who received the placebo. Follow up studies indicated that 32 percent of Provenge treated subjects remained alive three years after treatment, compared with just 23 percent of subjects that received the placebo.

Not just a simple shot

Provenge isn’t just a simple shot, it’s a process.  Immune cells are harvested, and then transported to Dendreon laboratories.  There they are treated with Provenge, a proprietary hormone treatment process, and once confirmed as being sufficiently modified, are re-introduced into the patient’s system in a three dose series.  It works by altering immune system responses, so that any cancer cells that would be mistaken for ordinary cells are recognized as a danger. So far, it is not expected to be cheap, at all. The costs of a course of treatment are expected to run between $40,000 and $100,000.

Kind of a breakthrough

The Dendreon Prevenge treatment will not prevent cancer, it’s only a treatment.  There are no dyed-in-the-wool cures for cancer as yet, but this is at least a positive step in that direction.  The only vaccines against cancer are actually vaccines against certain strains of the human papillomavirus, which can cause cervical cancer.  This may be the dawn of further breakthroughs, as strides against cancer are being made all the time.  Perhaps a cure will be found in the next generations.

FDA Sodium study could take years

Trials by the FDA take a long time to determine the positive or negative impact of a particular substance.  Sodium, though it is a vital part of the diet, is good for the body up to a certain point, after which it becomes a detriment.  The US Institute of Medicine, part of the National Academy of Sciences, is spearheading the call for the FDA to regulate sodium in food.  A recently published Institute of Medicine report states that Americans have too much sodium in their diets.  The study was initiated by a Congressional request in 2008.

Sodium is vital in proper proportion

Sodium does play a vital part in the body, and according to this Health Canada page concerning sodium intake, it’s directly involved in maintaining and balancing fluids.  However, too much sodium results in higher blood pressure, which leads to hypertension and heart disease, the number one killer among U.S. adults.  According to the IOM brief, the main source of sodium in the American diet is through added salt.

Key ingredient in foods not exactly Weight Watchers approved

Many high fat foods, such as french fries, pizza and a lot of preserved and processed foods, a maligned mainstay of the American diet, use more salt than the IOM or American Medical Association would like. The American Medical Association has asserted, according to USA Today, that if restaurants and other food companies were to reduce sodium content by half over the next 10 years, about 150,000 fewer people would die as a result.  The IOM states that normal intake is 3,400 milligrams daily, over twice the recommended 1,500 milligrams.

Number one cause of death for U.S. Adults is heart disease

The number one killer of Americans is known to be heart disease. It has long been suspected that it is tied to our diet.  Sodium intake that’s too high is known to lead to higher blood pressure, a common cause of heart disease, and a heart transplant even on the insurance of Croesus costs more than no fax loans can possibly cover.  If there is possibly merit to limiting sodium levels, perhaps it’s worth looking into.

(Photo Credit: http://www.flickr.com/photos/toofarnorth/ / CC BY 2.0)

If your child has had the Rotarix vaccine, there is no danger to their health. Image from Picasa.

Yesterday afternoon, FDA drug regulators sent a notice to pediatricians, recommending that they stop using the Rotarix rotavirus vaccine from GlaxoSmithKline. The European Medicines Agency and Swissmedic have also issued this advisory to doctors in Switzerland and most of Europe. There does not appear to be any danger to humans, and the vaccine is not being recalled – yet. British drug maker GlaxoSmithKline manufactures the drug, and spent several million dollars – some of it from a loan company – on Roatrix’s development.

Rotarix is intended to vaccinate against diarrhea

Originally approved by the FDA for use in 2008, Rotarix is a vaccine intended for children. It vaccinates against the rotavirus, an intestinal infection that can cause severe dehydration. The virus is responsible for more than 600,000 children’s deaths each year worldwide. Rotarix is not the only vaccine on the market intended for this use – Merck’s RotaTeq was approved in 2006. Rotarix is a two-dose vaccine, while RotaTeq is a three-dose vaccine. The FDA estimates that Rotarix has been used to vaccinate approximately 1 million children.

PCV1 found in GSK’s Rotarix

The recommendation that doctors pause the use of Rotarix came after independent researchers found porcine circovirus 1 (PCV1) in the Rotarix vaccine. The PCV1 virus is not known to cause illness in humans or animals, and every health agency has stressed that there is no risk to anyone who has had the Rotarix vaccine. The reason they have asked doctors to stop the use of Rotarix is based, instead, on the fact that vaccines are supposed to be sterile and the virus is unexpected in the Rotarix drug.

What will happen to Rotarix

The FDA has announced that it intends to convene an expert advisory committee within the next few weeks to make recommendations on the use of rotavirus vaccines. GlaxoSmithKline has also issued a statement on the contamination of Rotarix, stating that they will continue producing the vaccine with the extraneous virus that originated in pigs until they could find an “acceptable substitute.” It is without question, though, that GSK will most likely have to do more toward its reputation credit repair in the future.

What to do if your child has taken the Rotarix vaccine

If your children have been given the Rotarix vaccine, there is no risk to to their health. PCV1 is regularly found in both the food supply and the environment, and is not considered dangerous. Both Rotarix and RotaTeq are multiple-dose vaccinations. If your children have had one dose of Rotarix, they will be fully protected if they are given two additional doses of RotaTeq. As with all vaccines and medications, keep a close eye on your children and talk to their pediatrician if you have any concerns.

Sources:

Reuters News Service
U.S. News and World Report
The New York Times

ITMN's drugs are currently under FDA review. Image from Flickr.

This morning, IterMune stocks (on the New York Stock Exchange as ITMN) rose over 60%. This was a result of the FDA annoucing it would be reviewing ITMN’s drug application for their new drug Esbriet (pirfenidone). The FDA has expressed concerns over this particular drug, however, so I wouldn’t yet recommend taking out personal installment loans just to buy this stock – at least, not yet.

ITMN drug treats lung problems

The new drug from ITMN that the FDA will be reviewing is intended to treat idiopathic pulmonary fibrosis. This is a condition where a person’s lungs (pulmonary system) develops thick, heavy scarring (fibrosis). Idiopathic cases are simply cases that have no known cause. Learn more about the disease ITMN’s new drug is intended to treat on the Mayo Clinic website or on Google Health. If the drug ITMN developed is approved, it would be the first and only treatment intended for this deadly disease.

ITMN dodges a bullet of criticism – so far

When the FDA announced that InterMune’s drug would be take up for review, the outlook was not entirely rosy. While the commentary was rather critical, it was still better than industry watchers and ITMN officials had expected – which is why ITMN stocks jumped so quickly this morning. A large part of the criticism, as pointed out by Bloomburg News was based on the fact that the drug actually failed in one of the two studies intended to test the ITMN drug’s effectiveness.

The future of ITMN looks good

While ITMN has a very long and stressful week ahead of it, the outlook for this company is fairly good. Currently, ITMN has only one approved drug – Actimmune – which treats rare congenital disorders. However, on ITMN’s website they list several more drugs in development, including second-generation HIV treatments. Business Week also points out that the drug ITMN is hoping to get approved by the FDA was approved for use in Japan in October of 2008. Their stock has had some fairly severe ups and downs, though if they can successfully use this drug to make progress on their debt repair, they will be in a good financial position for future earnings.

Still from the unmade classic "Salmonella and You!" (Photo: Nasa.gov)

According to Wikipedia, salmonella is a form of bacteria that can cause serious illness in those with suppressed immune systems. Symptoms of infection include diarrhea and typhoid fever, and resulting dehydration can lead to death if left untreated. Thankfully, only 30 Americans die due to salmonella infection each year, although that is 30 too many. The FDA watches for cases of salmonella infection in products under their jurisdiction for just this reason, and they have found it in Hydrolyzed vegetable protein (HVP), a substance commonly used as a flavor enhancer.

Hydrolyzed vegetable protein is found in many products

According to MSNBC, the latest FDA recall of HVP affects a wide variety of food products, from soup to sauces, dips and dressings; chili, stew and gravy; to hot dogs and other seasoned snack foods. Stop me if you need a loan for healthier food. The salmonella Tennessee infection occurs somewhere along the production line in at a Las Vegas factory for Basic Food Flavors that has produced the flavor enhancer. The FDA is not currently aware of any human illnesses as a result of food from the plant, but they are taking proactive steps to prevent possible outbreak.

Basic Food Flavors? I’ll take the upgraded flavors, thanks

HVP is produced in powder and paste form at the Basic Food Flavors factory. The FDA has found salmonella Tennessee in samples dating back as far as September 17, 2009. It appears lucky that no illness has been reported, but the FDA is disturbed that this wasn’t caught earlier.

“This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination,” Dr. Jeff Farrar of the FDA said to MSNBC.

What’s being done about already shipped HVP product?

The FDA is advising food manufacturers to destroy or “recondition” any product containing hydrolyzed vegetable protein from Basic Food Flavors. Meanwhile, investigations continue.

“We are proceeding with special studies to make sure foods containing those products are safe,” Farrar said. “We are working with food manufacturers and distributors to provide guidance on any products that will need to be recalled. We are also creating a Web page to find any recalled products that may be in their pantry.”

Watch for that Web page, folks

And keep your Internet connection running with help from same day cash loans if you need them.

Related Video: