Currently viewing the category: "Food and Drug Administration (FDA)"

Propecia Kills Baldness AND Libido

By On · Add Comment · In adverse side effects, ejaculation disorders, finasteride, Food and Drug Administration (FDA), libido disorders, orgasm disorders, propecia
Damned if you do, damned if ya don’t. A new report discloses that Propecia, the anti-baldness drug manufactured by Merck & Co, can leave men who take them hanging limp. Now ain’t that a… You grow the hair for the babes, but then ya got nothing left for them when all’s said and done. Dang that “no free-lunch” junk.

According to a report by the Food and Drug Administration (FDA), Propecia, along with another Merck drug, Proscar, used to treat enlarged prostates, share the same chemical compound. Finasteride, which is present in a concentration of 1 milligram per dose of Propecia, and 5 milligrams per dose of Proscar, is said to cause sexual problems in men. “Libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug,” to be exact; and the FDA is now requiring Merck to say that on the drugs’ labels.

Although the FDA says the drug has shown “decreased libido that continued after discontinuation of the drug,”  the labels of both drugs will also carry a description of reports of male infertility and/or poor semen quality that clears up or improves after the drugs are stopped.

No definitive causal relationship between the drug and the sexual disorders can be made, but a potential problem exists nevertheless. The FDA says the number of men experiencing adverse sexual effects from either drug is very small, so it still believes the drugs are safe to take for their approved uses. It does recommend that patients and their doctors consider the new information on the revised labels when weighing a best treatment option.

Well gents, here you see the dangers inherent in taking any external agent. It’s not that you should live your life scared, but I personally make it my habit to ask my doctor the following questions:

  • How long has the drug been in use?
  • Will I be using the drug for what it was intended, or are you prescribing it for something outside of what it was approved (don’t take this point lightly)?
  • What are the side-effects?
And even then I wouldn’t solely trust his answers. I then go to the internet and look up the drug, and it’s side-effects. Check out what you’d have found if you did this for either drug over the last three years: Finasteride adverse side effects (you could google this or “Propecia adverse side effects“)

Then I would ask myself: Is the risk of developing the side-effect worth the advertised benefit? If it’s no, then I’m not taking it, period. That’s exactly how I’ve approached my decision to not take statins. And I do this with every drug, herb, vaccination, and so on, for both me and my children.

True, we don’t always have all the information, and most consumers trust their doctors to a tee. Bad idea, folks. It’s not that your doctor is a bad person, or irresponsible, or greedy, or anything like that…but they are busy; and this busyness sometimes means that more than a few doctors get their drug information from the drug reps themselves, and well…they are greedy. Sorry, but I’ve got no other way to put it.

Okay, okay, perhaps they themselves don’t know…maybe even the company doesn’t know…just another reason to continue conducting studies on drugs even after they’ve been approved. So says Dr. Anthony D’Amico, chief of genitourinary radiation oncology at Brigham and Women’s Hospital in Boston.

[It] “points up the usefulness of post-marketing studies on drugs that have been studied, but not for long enough periods to know what can happen when large numbers of people use them and what happens when they are discontinued.”

Exactly. Just some food for thought, peeps.

Salmonella Outbreak: Recall on Yellowfin Tuna

By On · Add Comment · In Food and Drug Administration (FDA), recall, Salmonella Bareilly, salmonella poisoning, sushi, yellowfin tuna

Okay, fish lovers–more sushi news, and not in a good way. Looks like there’s been a recall on tuna, yellowfin to be exact, due to a salmonella outbreak in twenty states linked to the fish. This is a warning to be cautious if you’re out eating sushi over the next few weeks.

According to the Food and Drug Administration (FDA), 116 illnesses have been reported, including 12 people who have been hospitalized. No deaths have been reported.

The tuna was sold to groceries and restaurants by the Moon Marine USA Corp. of Cupertino, Calif., also known as MMI, and presumably for making sushi, not for individual consumption. The Northern California fish supplier is voluntarily recalling 58,828 pounds of frozen raw yellowfin tuna that was labeled as Nakaochi Scrape AA or AAA.

Because the fish was sold to groceries and restaurants, many of the people who became ill reported eating “spicy tuna,” said the FDA. The microorganism was Salmonella Bareilly, a rare salmonella subspecies. The illnesses hasve been reported in the following statesand the District of Columbia:

Alabama (2), Arkansas (1), Connecticut (5), District of Columbia (2), Florida (1), As Georgia (5), Illinois (10), Louisiana (2), Maryland (11), Massachusetts (8), Mississippi (1), Missouri (2), New Jersey (7), New York (24), North Carolina (2), Pennsylvania (5), Rhode Island (5), South Carolina (3), Texas (3), Virginia (5), and Wisconsin (12).

The FDA warns of a 30-day lag time between when people become sick and when cases are reported to health officials. In other words, there could be more people getting sick. Looks like New York, Wisconsin, and Maryland were hit the hardest, with Illinois not far off. The raw yellowfin tuna product may have passed through several distributors before reaching the restaurant and grocery market and may not be clearly labeled.

Symptoms of salmonella poisoning include diarrhea, abdominal cramps and fever within eight to 72 hours of eating the contaminated food. The illness can be severe or even life-threatening for infants, older people, pregnant women and people with weakened immune systems.

So stay away from the spicy tuna, peeps–nuff said.

New Warning on Statins

By On · Add Comment · In diabetes, Food and Drug Administration (FDA), healthy lifestyle, heart disease, high blood sugar, lifestyle modification, magic bullet, memory loss, number needed to treat (NNT), statins

Well, well, well…didn’t I just say so? Looks like statins–those mega-popular cholesterol lowering drugs pushed by every general practitioner in existence–are getting new safety warnings about risks of memory loss and elevated blood sugar. You don’t say? Why yes, looks like the ol’ magic-bullet is being knocked down a notch or two, and with good reason.

The Food and Drug Administration (FDA) reports that it’s making labeling changes to the statin drugs–like Lipitor, Crestor, and Zocor–that will warn of memory loss and confusion reported among certain patients taking statins. Although the feds reassure us that the brain effects are not permanent–apparently going away with discontinuation of the drug–still they find it best to label the drugs to warn us of the potential for waking up in Niagara Falls with no recollection of how we got there. Doh!

Further, the updated labels will also mention elevated levels of blood sugar, associated with diabetes, that have been reported in some patients taking statins. Wait…early onset Alzheimer’s-like symptoms and diabetes?! Wow, get some right away…thanks doc. Yes, although the increased risk is small, an increasing number of studies is showing it’s there nonetheless.

Cardiologists, however, are sticking to their guns, stating that the benefits of statins outweigh the risks. “Patients should not see this as a new danger with the drugs, but as a known abnormality that appears in blood testing and should be discussed with their doctor,” said Dr. Kevin Marzo, chief of cardiology at Winthrop-University Hospital in New York. He goes on to say that he doesn’t see the new warnings making much of a dent in how (read: how much) the drugs are prescribed.

Okay well this much we can assume, doctor; but let me paint a more complete picture for the generally trusting public. What cardiologists mean when they say “the benefits of statins outweigh the risks” pertains to a certain demographic, in reality a minuscule fraction of the tens of millions that are currently taking the drugs. Remember from a 2008 post on statins, the number needed to treat (NNT) for even one person to receive benefit from statins is 100. So in other words, for every person receiving benefit, 99 do not; or in bigger numbers: 9.9 million of every 10 million people on statins gets NO BENEFIT!

So what they really mean is the best ways to lower heart disease risk are (in descending order):

  • Lifestyle modification including exercise, healthy diet, omega 3 fatty acid consumption, healthy vitamin D levels, healthy gut microbiota
  • Statins + lifestyle modifications
  • Statins
  • Doing nothing

What cardiologists assume (and for some people correctly) is that many patients will do nothing. But that’s not you, right? No need to assume the risks associated with statins. Do the right things and you won’t have to, no matter how much your medical drug dealer pushes.

Easy Ain’t Always What it Seems

By On · Add Comment · In 60 Minutes, antidepressants, depression, Food and Drug Administration (FDA), placebo, prescription drugs, selective publication, selective serotonin reuptake inhibitors (SSRIs)

60 Minutes did a great piece over the weekend on the business of depression–that’s right, BIG business–and whether the product that’s being sold to America (and the rest of the western world) is actually doing what it’s supposed to. Some experts (myself included) believe that the popular (read: highly prescribed) depression drugs–the selective serotonin reuptake inhibitors (SSRIs)–don’t do a whole lot for people that are moderately depressed, and the data seems to back up that notion.

However, antidepressants continue to be some of the most prescribed drugs in the U.S., and most of those people fall in the center of a bell-shaped curve. In other words, most people taking antidepressants probably aren’t getting much from them, as Harvard psychologist and researcher, Irving Kirsch articulates in the video. According to his research, many of the studies that show antidepressants not doing much more than placebo have been hidden by the manufacturers who lead the studies.

We call this selective publication, and I’ve been reporting on this phenomenon within the antidepressant manufacturing industry for over four years. In 2008, research showed that only one third of the studies conducted on SSRI antidepressants ever made its way out to the public. Can you guess which third gets published?

In the 60 Minutes piece below, you’ll see Dr. Thomas Laughren, FDA Director of the Division of Psychiatry Products rationalize why it only takes two favorable studies–even if ten come back unfavorable–for a drug to get approval by the FDA. Oddly, he doesn’t mention “cha-ching $$$” anywhere in the piece. Hmmm…

Listen, I’m all for big business–a capitalist to the core–but there’s something wrong with pushing a drug onto millions of people, including children as young as six years old, when it isn’t doing exactly what it’s supposed to. And I wouldn’t care except there is also evidence that some of the side effects aren’t benign, or whether they are permanent. And that’s playing with people’s lives.

Again, I do not pull the public out of the equation because too many people are looking for an easy way out–and antidepressants sure promise that. Watch the piece below to see why easy ain’t always what it seems to be.

Share No Insulin Pens

By On · Add Comment · In blood-borne pathogens, Centers of Disease Control (CDC), Food and Drug Administration (FDA), hepatitis virus, HIV, insulin pens

Every junkie knows it’s unwise to share needles, but somebody needs to tell it to diabetics. Sharing insulin pens puts people at risk for infection with blood-borne pathogens such as hepatitis viruses and HIV. And here’s the kicker: Infection can occur even if an insulin pen’s needle is changed.

Insulin pens are injector devices that contain a reservoir for insulin or an insulin cartridge. They’re designed to enable patients to self-inject insulin and are intended for single-person use. But sharing is what some diabetics are doing. Not smart, folks. Check it:
In 2009, reports of improper insulin pen use in hospitals led the Food and Drug Administration (FDA) to issue an alert to health care workers (duh!) to remind them that pens are for single-patient use only. But despite the warning, there have been continuing reports of patients put at risk through inappropriate reuse and sharing of insulin pens, including an incident last year that required notification of more than 2,000 potentially exposed patients, said the Centers of Disease Control (CDC).
The CDC’s recommendations:

  • Insulin pens containing multiple doses of insulin are meant for use on a single patient only, and should never be used for more than one person, even when the needle is changed.
  • Insulin pens should be clearly labeled with the patient’s name or other identifying information to ensure that the correct insulin pen is used only on the correct patient.
  • Hospitals and other facilities should review their policies and educate staff regarding safe use of insulin pens and similar devices.
  • If re-use of an insulin pen occurs, exposed patients should receive immediate notification and be offered appropriate follow-up, including blood-borne pathogen testing.

The recommendations apply to any setting where insulin pens are used, including health care facilities, assisted living or residential care facilities, health fairs, shelters, detention centers, senior centers, schools and camps. Be safe, diabetics–share no insulin pens. Nuff said.

California Lettuce Recall–Possible Contamination

By On · Add Comment · In California lettuce recall, Food and Drug Administration (FDA), illness, listeria, True Leaf Farms of Salinas

What?!?!  Now recalled lettuce?  You got that right–a California farm has now recalled bags of chopped romaine lettuce because of possible contamination with listeria, although no illnesses have been reported. 

True Leaf Farms of Salinas announced the recall of 90 cartons that were shipped to an Oregon food service distributor. From the distributor, it might have gone to at least two other states, Washington and Idaho.  The Food and Drug Administration (FDA) notified the company that a sample from one bag taken as part of a random check tested positive for listeria.  Officials have said they’ve gotten better at detecting contamination, so they are seeing it more often now in produce.

This now amid the cantaloupe recall that has sickened 72, and killed up to 16 people, in 18 states.  

The recall covers packaged lettuce product with a use by date of Sept. 29. The bag and box code is B256-46438-8.  Please check your bagged lettuce and toss if necessary.  But seriously folks, how ’bout some fresh stuff?  Just wondering.

Today’s Healthcare: How it’s Done

By On · Add Comment · In Big Pharma, Food and Drug Administration (FDA), Medtronic, Medtronic's Infuse Bone Graft, recombinant human Bone Morphogenetic Protein (rhBMP), Senate Finance Committee, spinal surgery
Stop acting surprised!  Can’t you see that the bigger a thing gets, the more corrupt it becomes?  Wake up!…and welcome to today’s medical industry.  Yes, the same medical industry that has brought us Quackwatch, medical ethics, and the healthcare monopoly–oh, that medical industry.  Yes, yes, yes…not the glorified one depicted in Grey’s Anatomy or the talk show circuit, but the real deal.  Oh you really don’t know?  Hmmm..all right, check it:Device manufacturing giant Medtronic, and doctors paid by the company to carry out research, are under investigation by the Senate Finance Committee to determine whether the company failed to report serious side effects from the bone-growth agent Infuse in clinical studies.

The product was introduced in 2002 to help bones heal after spinal surgery and has been used in about 500,000 patients.  Since its arrival on the market, it has also been linked to some cases of cancer, male sterility, throat swelling and leg pain.  Some doctors in the spinal community believe that a “small number, fewer than five” fatalities may have even resulted from its use, though no published data points to any deaths.

Medtronic, its paid researchers, and its practices were attacked by a prominent US medical journal, The Spine Journal, its authors alleging that they failed to report adverse events to the journals that publish them.  Through thirteen trials involving 780 patients, “industry-funded researchers did not report a single adverse advent involving Medtronic’s Infuse Bone Graft,” said the three US-based doctors that co-authored the review article.

The reviewers went on to point out that the paid researchers of “nearly all the trials had financial ties with the manufacturer, with investigators earning as much as $26 million per study.”  The product brings in about $900 million in annual revenues for Medtronic, according to US media.

In 2008, the US Food and Drug Administration (FDA) issued a public health notice about “life-threatening complications” associated with the product, also known as recombinant human Bone Morphogenetic Protein (rhBMP), when used in the upper or cervical spine.  According to the FDA:

“FDA has received at least 38 reports of complications during the last four years with the use of rhBMP in cervical spine fusion.  These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking.”

Last week the Senate Finance Committee sent a letter to Medtronics asking it to “produce documents related to its controversial bone growth product Infuse.”  The senators raised concerns that the company knew of the adverse effects of Infuse but failed to report them.  Now why would a medical device company do that?  Here are $900 million reasons, which is the annual revenue brought in by Infuse.

Here’s the game, folks: Big Daddy medical device manufacturer invents product promising billions.  Doctors are hired to conduct research and make it look promising; they are compensated handsomely.  Adverse effects are…whoops…left out of publication, and research papers sent to journals.  Journals rave, FDA approves manufacture and sales to the ever trusting American, then world, markets.  Company makes beaucoup bucks, some people get sick, some die; company pays out restitution or go-away money; everybody happy.

Listen, I’m not a “medicine and Big Pharma are evil” kind of guy.  On the contrary, I believe strongly that both industries are invaluable to human life and progress.  However, anything that gets too big, gets corrupt; and modern medicine is not immune.  Bravo to to the doctors calling out Medtronic for its heinous practices.  They knew, and they hid, the truth–that deserves the highest punishment…whatever that is.

But don’t for a second think that as western medicine grows to its behemoth monstrosity that it is above influence, corruption and greed.  We all are.  The bigger we get, the more we think we are above the rules…and doing what’s right.  The medical industry is all of us, our potential unleashed.  Let us be the ones, then, to rein it in.

Half Staph: Bacteria Found on Supermarket Meat

By On · Add Comment · In American Meat Institute, Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Methicillin-resistant staph aureus (MRSA), Translational Genomics Research Institute

Hold on to your hats, peeps, but your butcher might be a chronic nose picker.  What?!?!  Yah man, diggin’ for diamonds…a snotter.  That’s because a new report says that half the meat and poultry sold in supermarkets may be tainted with the staph germ.

The Translational Genomics Research Institute in Arizona found that more than half of 136 samples of beef, chicken, pork and turkey purchased from grocery stores in Chicago, Los Angeles, Washington, D.C., Flagstaff, Ariz. and Fort Lauderdale, Fla. contained Staphylococcus aureus, a bacteria that can make people sick.  Even worse is that some meats were found to contain a dangerous antibiotic resistant strain, methicillin-resistant staph aureus (MRSA).  If ingested it could kill ya!  The study is being published in the journal Clinical infectious Diseases.

© Dennis Kunkel Microscopy, Inc.

© Dennis Kunkel Microscopy, Inc.

Staph germs are commonly found on the skin and in the noses of up to 25% of healthy people. The bacteria can be spread in many settings, including the packing plant or in the kitchen.  Although the bugs are killed during the cooking process, and can be thwarted with good ‘ol fashioned hand-washing, it still kind of grosses me out…how ’bout you?

The Centers for Disease Control and Prevention estimates that staph accounts for roughly 240,000 cases of food poisoning a year.  The researchers found MRSA in three of the 136 samples.  Food and Drug Administration (FDA) officials say meat does not seem to be a significant route for MRSA transmission, but health officials continue to watch and study the issue.  Scuse me while I puke.

The government doesn’t routinely check retail meat and poultry for staph bacteria; however, a two fairly recent studies showed their might be reason for concern.  One FDA pilot study in the Washington area looked at more than 1,100 meat and poultry samples and found staph in 280 of them.

The other, a study out of Louisiana State University, looked at 120 meat samples and found staph in almost half of pork chops and 20% of beef steak samples. That study, published in 2009, calculated the superbug MRSA was in about 5% of pork samples and 3% of beef.  Is nothing safe?

OK, so well now I’m grossed out.  I’m certain that we should be relatively safe…but the rotating wheel of MRSA roulette–no matter how small the risk–is of concern to me.  Stay away from the roast, Grandpa…you’re vegan now.

The only way to really sum up this story is to note that the American Meat Institute says the study is misleading.  Of course it is….but check your butcher’s nose anyway?

Cookie Recall

By On · Add Comment · In Centers for Disease Control and Prevention (CDC), E. coli, Food and Drug Administration (FDA), Nestle's Toll House Cookies

Here we go again: Nestle’s is recalling its popular Toll House Cookies due to a possible bacterial outbreak. According to the U.S. Food and Drug Administration (FDA), various Nestle’s Toll House refrigerated products may be contaminated with E. coli causing food poisoning in people who eat the raw cookie dough.

Nestle’s said the FDA and Centers for Disease Control and Prevention (CDC) were investigating reports of 66 illnesses across 28 states tied to E. coli O157:H7. Twenty five people have been hospitalized, but no one has died. A spokesperson from the company has strongly advised people to not eat raw cookie dough–a warning prominently displayed on the packaging. Food poisoning from E. coli can cause cramping, vomiting and diarrhea.

The following Nestle’s Toll House products are being recalled: refrigerated Cookie Bar Dough, Cookie Dough Tub, Cookie Dough Tube, Limited Edition Cookie Dough items, Seasonal Cookie Dough and Ultimates Cookie Bar Dough. If you currently have any of these products in your home, throw them away. The FDA advises against trying to cook the product as handlers may get the bacteria on their hands or cooking surfaces.

I never did get the fascination with cookie dough; I’ve always thought it was nasty. Saying that, I never considered that it was raw food. Duh, in hindsight. Of course it’s raw food and can harbor bacteria, so safety requires cooking it. Bet all those ice cream manufacturers feel dumb now–I sure would. So toss out the Toll House products sitting in your fridge, peeps–you’ll have to settle for Pepperidge Farms this weekend.

Warning: Antibiotic May Cause Tendon Rupture

By On · Add Comment · In antibiotic, black box warning, Cipro, fluoroquinolones, Food and Drug Administration (FDA), tendons

If you’re currently taking the antibiotic Cipro, here’s something you might want to know: it can cause tendons to rupture. So says a consumer group called Public Citizen that wants the Food and Drug Administration (FDA) to add a “black box” warning to the antibiotic.

Cipro is in a class of antibiotics called fluoroquinolones, and as of 1997, the FDA has received 336 reports of tendon rupture in patients treated with these compounds. Public Citizen claims that the numbers might actually be higher since not all side effects are reported to the FDA. Cipro is often prescribed for gastrointestinal, respiratory and urinary tract infections. It also was brought to the surface of American consciousness during the anthrax scare of the early part of the decade. Cipro can also cause liver damage, kidney damage and rhabdomyolysis (muscle wasting and pain), so it’s not something to be taken lightly.

Well…tendon ruptures suck–they’re horrible; some of the hardest things to recover from. I’ve referred patients with this condition orthopedists, and when the tendons are frayed like string cheese, they are very difficult to reattach. The weaker the tendon, the more likely it will be torn during a routine activity, like running for the bus, or stepping off of a chair–something simple. I guess if you’re exposed to anthrax, then you’ll need a bunch; but if there is an alternative–and you’d be wise to ask your doctor–I’d consider it.

Leave Salt Alone

By On · Add Comment · In blood pressure, Food and Drug Administration (FDA), high fructose corn syrup, hypertension, MSG, processed foods, salt, salt sensitivity
You probably think from the title of this piece that I’m going to push the same old “salt is bad for you” junk. Well I’m not, cuz it just ain’t a fact. As much as we are being brainwashed into believing this myth, the science isn’t there to support it yet. So put this one right up there with “fat is bad for you” and “masturbation will give you hairy palms”.

Unfortunately, the powers that be keep jumping into the act. According to recent reports, the Food and Drug Administration (FDA) is considering tightening regulations on salt labeling, especially in processed foods. I’ve got no problem with this except that it doesn’t mean dink. It isn’t the salt in processed foods that’s bad for you, but the processing–that is, the chemicals and sythetic foods (MSG, high fructose corn syrup, maltodextrin, hydrolysed soy bean product, and the like) and the all around poor quality of the food.
These regulations are based on the rationale that lowering salt intake decreases blood pressure in hypertensives—that’s true; it does. However, there is no conclusive evidence that lowered salt intake has beneficial effects in healthy people. This public health fallacy came about when researchers found that some people are salt sensitive. Salt sensitive people do have a dangerous increase in blood pressure when they eat too much salt (i.e. too much for them). Interestingly, public health officials found that it would be a lot easier, and less costly, to recommend salt reduction for all people rather than test the entire population for salt sensitivity. And thus the birth of the low dietary salt fallacy.
Now here’s what I want to get across to you: I couldn’t care less about whether people eat less salt or the government decides to tighten labelling. What I’ve got an issue with is the dissemination of false information. Why should we all direct our lives based on a non-truth? And why should I (or any other salt lover) be forced to eat bland food because of the uninformed public’s desire to be healthy? Get my point? I’m the first one to cheer healthiness…when it’s based on truth. But when somebody tries to feed me bullshot and tells me it’s caviar, I’m sorry, but that shot don’t fly. I’m happy to curb my habits when sound science shows them to be dangerous, but I just don’t like the taste of bland caviar. Now put that in you salt shaker and sprinkle it.
For more on the fallacies of lowered salt intake and lowered blood pressure, please read this great article from Scientific America.
Copyright © 2013 Dr. Nick Campos - All Rights Reserved.