FDA Panel Revokes Avastin for Breast Cancer Treatment Despite Patient Outcry

This week, an FDA Panel made up of independent experts unanimously voted that the cancer-treatment drug Avastin (bevacizumab) no longer be sold as a treatment for breast cancer in the United States. It will now be up to the FDA Commissioner, Margaret Hamburg, M.D., to review and decide upon the panel's recommendation - and if the Commissioner agrees, then the FDA will remove Avastin from the market.

Last December, as we detailed in our post, "Today's Recall of Breast Cancer Drug Avastin: Scandalous FDA Drug Recall That Many Deem "Death Panel" Decision," there was a recall of the drug - which was met by huge patient outcry and many pointing to Avastin as the first example of Death Panels in this country.

Despite that huge backlash in December, this FDA panel has issued its conclusion that Avastin offers "no substantial benefits" while it has "substantial risks" to victims of breast cancer. Interestingly, the panel okayed Avastin for other cancer treatments, such as lung cancer, colo-rectal cancer, renal cell carcinoma, and cancerous brain tumors.

Want to make a comment to the FDA Director on Avastin?

You can email her at margaret.hamburg@fda.hhs.gov.

By Bryant Esquenazi on June 30, 2011 1:15 PM

How Safe is Your Diabetes Drug, Miami? Three Popular Diabetes Drugs Being Questioned by Government Agencies This Week

What diabetes drug are you or a loved one depending upon to control diabetes safely? According to recent news reports, more and more of the diabetes drugs prescribed by doctors and previously okayed by the Food and Drug Administration (FDA) are now being questioned for their dangers.

Potentially unsafe and dangerous drugs for diabetes include:

1. Avandia (rosiglitazone)

Avandia was revealed to be risky last fall and instead of helping diabetes sufferers, too many Avandia users were experiencing heart attacks and dying from heart disease that may be tied to the diabetes drug rosiglitazone. A class action lawsuit was filed by 43 diabetes sufferers who are now Avandia victims just this week in Illinois.

2. Actos (pioglitazone)

This week, the diabetes drug Actos was pulled from the market in France and Germany because of concernes that this diabetes drug might be causing bladder cancer in those taking Actos. A research study done in France found that Actos users were 22% more likely to have bladder cancer as compared to diabetics using other prescriptions.

3. Victoza (liraglutide)

Liraglutide is used by diabetes sufferers who have been unsuccessful with first-line therapy, and is injected once a day. Yesterday, the FDA issued a warning that liraglutide injections (Victoza, Novo Nordisk) may be connected to thyroid C-cell tumors and acute pancreatitis.

We Must All Be Aware of Dangerous Drugs and Not Blindly Trust Medicine as Being Safe

Diabetes is a national epidemic - and here in South Florida, more and more diabetes sufferers are diagnosed every day. Dangerous drugs, unfortunately, are another huge national problem and it is not enough to trust your doctor or your pharmacy to give you or your loved one safe medicine.

Be aware of what you are taking - and if you are taking these diabetes drugs, please check with your doctor. Maybe you need to find another method to control your diabetes.

And if you or a loved one suffers from diabetes and now has a diagnosis of cancer, heart disease, or other life-threatening illness, then perhaps it's time to check with a lawyer, too. Don't trust a doctor to always let you know that you have a potential lawsuit.

By Bryant Esquenazi on June 14, 2011 1:27 PM

South Florida Kava Bars May Be Trendy - and Dangerous: New Study Warns Against Kava Tea

Here in South Florida, like it or not, we're usually on the cutting edge of new trends. Maybe it's because of the cosmopolitan flair of Miami. Maybe it's because of all the celebrities that love to vacation here.

Kava Bars a Popular Favorite Here in South Florida

Whatever the reason: it was almost a year ago to the day that the Palm Beach Post was reporting about the latest thing: a surge in Kava Bars popping up in South Florida. Allison Ross blogged in an article entitled, "Kava Bars Popping Up in South Florida," that kava tea was the new drink for bars in the Miami area - and this was true even though kava does not have an alcohol content.

Today, if you google "kava bars south florida" you'll find a long list of establishments serving Kava Tea from which to choose. They seem to be so competitive, in fact, that they've got promotions to draw you into their bar and away from their competition down the street, as well as different atmospheres to tempt you.

Read through the various South Florida kava bars and you find cozy ones. Friendly ones. Ones with live music. Ones that are more restaurant than bar, more bar than restaurant.

Kava Bars are a big deal here in Miami Beach.

What is Kava? It's something originating in the South Pacific that is a plant revered for its properties. Kava threads itself through social and cultural traditions as well as medicinal and religious ones in a large number of Southern Pacific islands, such as Tonga, Fiji, Hawaii, the Federated States of Micronesia, and Vanuatu. In fact, Kava is a grown as a cash crop in Vanuatu and Fiji.

Some folk chew the Kava root or take a Kava pill, but drinking Kava tea appears to be the most popular way to imbibe Kava. You can buy Kava Tea at your local store or online, it's not expensive. You can also go to your local Kava Bar and order a specially prepared Kava drink just for you. Cold or hot.

New Research Study Warns Against Kava Tea

It's not the first warning that Kava may hurt you, but the latest study warning against the dangers of Kava tea is getting lots of attention and respect. Last week, the American Journal of Emergency Medicine published a study released by the University of Rochester Medical Center on the dangers of Kava Tea.

The case study even supports its assertion of the growing popularity of Kava Tea by pointing to three new Palm Beach Kava Bars that have opened recently here in South Florida.

This case study is heralded as the first piece of scientific literature dealing with Kava tea. (Hence, the notoriety that this study is getting around the world). Here's the citation to the study if you wish to purchase the complete research study online in pdf format: Ryan Bodkin, Sandra Schneider, Donna Rekkerth, Linda Spillane, Michael Kamali. Rhabdomyolysis associated with kava ingestion. The American Journal of Emergency Medicine, 2011; DOI: 10.1016/j.ajem.2011.01.030.

What's the big deal?

Seems that this case study began when a 34-year-old guy was riding his bike along some roadway in or near the University of Rochester when he collapsed on the side of the road. Wham. When he arrived at the E.R., they discovered that he had recently injested Kava Tea and tied the Kava to his episode where he had nearly suffered complete kidney failure as well as a muscle breakdown.

The guy up in New York recovered, he's okay. However, the University of Rochester study is being waved like a big, big red flag by all sorts of folk: doctors, researchers, media outlets, and of course, Big Pharma who don't like herbal remedies and the like.

So, will Kava Tea -- which has been a popular beverage among South Pacific Islanders for over 3000 years -- be found dangerous to drink here in South Florida?

Who knows. This same media scare hit South Florida back in 2005 --see the USA Today story back then, covering the Nacava Bar in Boca Raton, and discussing the FDA warnings of 2002 on Kava.

South Floridians will probably continue to frequent Kava Bars. And, here's the thing: if you do suffer symptoms of harm due to drinking Kava, then Florida laws do exist to protect you.

Personal injury laws are on the books for just this sort of thing. Kava may not be an alcoholic beverage, but those who manufacturer, distribute, and sell this herb or drink are still responsible for its safety.

 Bryant Esquenazi on May 5, 2011 1:49 PM

Oscar Parties in Miami: Miami Beach Film Society Hosts Local Oscar Night America

The Oscars will be given out this Sunday, February 27, 2011, by the Academy of Motion Picture Arts and Sciences - and odds are high that you already know this.

For one thing, it's been reported that the Oscars are the highest non-sporting event for gamblers in this country. Lots of people are betting on Colin Firth winning this year, apparently. (You can follow the Oscar odds here.)

Miami Beach Film Society Chosen by Academy to Host Oscar Night America Party

Since 1994, the Academy has helped non-profits and charities across the country in their fund-raising efforts by designating certain organizations as hosts of Oscar Night America parties, where glitzy parties take place as the ceremonies occur over in Hollywood. According to the Academy's web site, the Oscar Night America program has raised around $27,000,000 for these local organizations. This year, the Miami Beach Film Society has been designated to host Miami's Oscar Night.

Want details on the party? Read all about it in Miami Beach Magazine, where they report:

Tickets to the 2011 Oscar Night America Miami Beach are available for $125 or $110 for Miami Beach Film Society & Cinematheque and MIFF members. Ticket prices include food and beverages, tax and gratuity, a $25 Escopazzo gift certificate, the official 83rd Annual Academy Awards® program booklet and other event memorabilia. Please visit www.MBCinema.com for tickets. For sponsorship opportunities or press inquiries, contact Gino Campodonico at TARA, Ink., 305.864.3434 ext. 120.

Let's hope that the Miami Beach Film Society has a great success with its shindig this weekend.

Want to Start Your Oscar Party Now? Join the Folks at the Miami Herald

Luisa Yanez of the Miami Herald isn't waiting for the weekend: she's inviting everyone to join with her on Twitter and Facebook to start gearing up for the big event now.

Interested? Go over to her article that gives all the details.

Here's a list of the main Oscar nominations this year:

Actor In A Leading Role: Javier Bardem in "Biutiful", Jeff Bridges in "True Grit", Jesse Eisenberg in "The Social Network", Colin Firth in "The King's Speech", James Franco in "127 Hours"

Actress In A Leading Role: Annette Bening in "The Kids Are All Right", Nicole Kidman in "Rabbit Hole", Jennifer Lawrence in "Winter's Bone", Natalie Portman in "Black Swan", Michelle Williams in "Blue Valentine"

Actor in a Supporting Role: Christian Bale in "The Fighter", John Hawkes in "Winter's Bone", Jeremy Renner in "The Town", Mark Ruffalo in "The Kids Are All Right", Geoffrey Rush in "The King's Speech"

Actress in a Supporting Role: Amy Adams in "The Fighter", Helena Bonham Carter in "The King's Speech", Melissa Leo in "The Fighter", Hailee Steinfeld in "True Grit", Jacki Weaver in "Animal Kingdom"

Directing: "Black Swan" Darren Aronofsky, "The Fighter" David O. Russell, "The King's Speech" Tom Hooper, "The Social Network" David Fincher, "True Grit" Joel Coen and Ethan Coen

Best Picture: Black Swan, The Fighter, Inception, The Kids Are All Right, The King's Speech, 127 Hours, The Social Network, Toy Story 3, True Grit, Winter's Bone.

And one last thing ....

Miami is a fun, happy community and no one wants that to change. However, on another big party weekend, it's only responsible for this warning to be given again: partying can turn bad for some, with alcohol poisoning, drug overdoses, car crashes, slips and falls, etc.

No one thinks that a personal injury or wrongful death lawsuit is in their future. If this were true, you wouldn't be reading this personal injury law blog because it wouldn't be here.

Make sure you and your friends keep safe while you're having Oscar fun, and be careful out there.

By Bryant Esquenazi on February 24, 2011 2:56 PM

Miley Cyrus and Justin Bieber: Can Teens Get Legally Free From Parents? Yes via Emancipation Laws Like Florida Stat. 743.015

Justin Bieber is getting lots of criticism this week over an interview he gave to Rolling Stone magazine; apparently, there are those that believe that the interviewer, Vanessa Grigoriadis, took advantage of having 16-year-old Bieber alone as he gave her a ride around Atlanta in his fancy Range Rover.

Seems that Justin Bieber was asked about some controversial issues by Ms. Grigoriadis, she reported his answers in the article entitled, "Justin Bieber Talks Sex, Politics, Music and Puberty In New 'Rolling Stone' Cover Story," and now there is a controversy. Some of which involves the fact that Justin Bieber is not a legal adult and where were his parents, who are supposed to protect him from inappropriate stuff.

Meanwhile, Miley Cyrus is now 18 years old and her father is making news as he talks about how her Disney Channel TV show, "Hannah Montana," ruined their family and how worried he is now - now that Miley is a legal adult and out of his legal control - that she will be doomed to the fates of Anna Nicole Smith and Michael Jackson because of the bad influences she has chosen to be her friends and supporters.

Meanwhile, in Miami and elsewhere there are lots of teenagers who are 16 years old or older, who feel that they can handle their own lives - or maybe they feel that their parents cannot handle the job of being parents - and they'd like to cut the cord, as it were, and become legally independent.

Something that Miley Cyrus is now, because she turned 18 years old, and something that Justin Bieber is not, since he is just 16.

Does the law allow for kids to essentially divorce their parents? Yes. State laws may differ in the details, things like what must be proven to the court, but there are "emancipation laws" that allow children to be considered legal adults before the standard "age of majority."

In Florida, we're probably more aware of this law because of the continuing news coverage of the Ohio teenager who ran to Orlando from Ohio, escaping her Muslim parents whom she accused would harm or kill her because she converted to Christianity.

The case of Rifqa Bary is currently before the Florida Supreme Court. Meanwhile, her case began a challenge to Florida's emancipation statutes as being in need of change. Florida Statute Section 743.015 was labelled outdated as a result of Rifqa Bary's situation, and there was a call for it to be amended in 2009.

The current version of Florida's emancipation law, amended in March 2010, states as follows, and if you are a teenager who believes that the law applies to you, then you can file a lawsuit to emancipate, or free yourself, from parental control. The full text of the statute appears after the jump....

743.015 Disabilities of nonage; removal.

(1) A circuit court has jurisdiction to remove the disabilities of nonage of a minor age 16 or older residing in this state upon a petition filed by the minor's natural or legal guardian or, if there is none, by a guardian ad litem.

(2) The petition shall contain the following information:

(a) The name, address, residence, and date of birth of the minor.

(b) The name, address, and current location of each of the minor's parents, if known.

(c) The name, date of birth, custody, and location of any children born to the minor.

(d) A statement of the minor's character, habits, education, income, and mental capacity for business, and an explanation of how the needs of the minor with respect to food, shelter, clothing, medical care, and other necessities will be met.

(e) Whether the minor is a party to or the subject of a pending judicial proceeding in this state or any other jurisdiction, or the subject of a judicial order of any description issued in connection with such pending judicial proceeding.

(f) A statement of the reason why the court should remove the disabilities of nonage.

(3) If the petition is filed by the natural or legal guardian, the court must appoint an attorney ad litem for the minor child, and the minor child shall be brought before the court to determine if the interest of the minor will be fully protected by the removal of disabilities of nonage. The attorney ad litem shall represent the child in all related proceedings.

(4) If the petition is filed by the guardian ad litem or next friend, service of process must be perfected on the natural parents.

(5) If both parents are not jointly petitioning the court for the removal of the disabilities of nonage of the minor, service of process must be made upon the nonpetitioning parent. Constructive service of process may be used, provided the petitioning parent makes an actual, diligent search to discover the location of, and provide notice to, the nonpetitioning parent.

(6) The court shall consider the petition and receive such evidence as it deems necessary to rule on the petition. If the court determines that removal of the disabilities of nonage is in the minor's best interest, it shall enter an order to that effect. An order removing the disabilities of nonage shall have the effect of giving the minor the status of an adult for purposes of all criminal and civil laws of the state, and shall authorize the minor thereafter to exercise all of the rights and responsibilities of persons who are 18 years of age or older.

(7) The court shall consider the petition and, if satisfied that the removal of the disabilities is in the minor's best interest, shall remove the disabilities of nonage; and shall authorize the minor to perform all acts that the minor could do if he or she were 18 years of age.

(8) The judgment shall be recorded in the county in which the minor resides, and a certified copy shall be received as evidence of the removal of disabilities of nonage for all matters in all courts.

By Bryant Esquenazi on February 17, 2011 2:37 PM

Florida Pharmacy Gets National Recognition for Fighting Big Pharma and Drug Fraud

In today's Los Angeles Times, the spotlight is being shown on a small pharmacy here in Florida that is serving as a role model for other drug stores across the country, to do their part in fighting fraud in the system. And there's a lot of fraud, as you know if you've been reading the news or following this blog. Billions of dollars scarfed up in overbilling Medicare and Medicaid on drug charges, for example.

Which is where Ven-a-Care's story comes in.

This Florida drug store is acting as a whistleblower in a simple way that is having complex repercussions. For example, the attorney general for the State of California attributes this Florida pharmacy's efforts with enabling his office in 2005 to file suit based upon one drug, vancomycin, against 39 drug companies with recovery efforts totalling almost $100 million thus far.

What is Ven-A-Care is doing?

Florida's own Ven-A-Care is taking the time to check into drug prices on the market and compare what Ven-A-Care is paying for certain drugs with the amounts that the drug manufacturers (read that: Big Pharma) is listing on their reimbursement requests to the federal and state governments. When there is a big, fat discrepancy then Ven-A-Care files a whistleblower suit (filed pursuant to special laws that allow an individual plaintiff to file a lawsuit against wrongdoing on behalf of the governmental entity being wronged).

They are soon joined by the appropriate governmental entity (federal or state) that has been defrauded, and the courtroom battles begin.

Not bad, for a little drug store here in Florida. Wonder if Pfizer and the other Big Pharma powerhouses know the name Ven-A-Care yet?

Of course they do. In today's PharmaLot article, they're already calling for caps on the amount of money that can be given to whistleblowers in these kinds of suits -- and pointing to the recognition given Ven-A-Care in the Los Angeles Times article as the reason to do so.

By Bryant Esquenazi on January 25, 2011 1:43 PM

More Americans Die From Drugs Than From Guns or Booze: Take Note, Miami

This is bad news for the entire country, but for Miami and the rest of South Florida, this is particularly disturbing news.

Not only do we have a trendy and growing retirement community that necessarily uses a variety of drugs - from pain killers to cardiac aides to stroke prevention, etc. - Miami and the rest of our tourist meccas see lots of folk taking drugs for recreational purposes, or using drugs for their intended use but drinking alcohol along with them. In fact, Miami has the honor of being named the "best party town in the United States" by Buzzle.

What's the scoop? Can drugs in America really be this dangerous? (Yes.)

The Center for Disease Control has released its study this week that shows drug-induced deaths in the United States exceed those who die from gunshot wounds or injuries related to alcohol consumption. Drugs kill more people in the United States than bullets. Think about that.

And here, we're talking about over the counter medicines and prescription drugs right along side illegal drugs like heroin and cocaine. Drugs like those for sale on the shelves of WalMart and CVS are killing people -- people who had years of life ahead of them, folk with families and loved ones who miss them still.

Once again, Miami -- drugs in this country aren't to be blindly trusted or respected. Take any drug with caution and care. And if you have any gut instinct that something's not right, get help from a health care professional. Be safe, not sorry.

By Bryant Esquenazi on January 20, 2011 1:06 PM

Miami - Do You Take Aleve, Advil, Tylenol or Other Pain Pills? British Study Reveals How Safe (or Dangerous) They Really Are

Here in Miami, as well as South Florida and the rest of the country, we all take pills to get rid of aches and pains. We give them to our kids; we keep bottles of them in our homes, cars, briefcases, purses, and desk drawers. You know what these are, these over-the-counter pain medications called nonsteroidal anti-inflammatory drugs (NSAIDs) though they go by many different names, and aren't exactly the same, chemically-speaking:

• Advil (ibuprofen)
• Aleve (naproxen)
• Arcoxia (etoricoxib)
• Cataflam (diclofenac)
• Celebrex (celecoxib)
• Motrin (ibuprofen)
• Prexige (lumiracoxib)
• Vioxx (rofecoxib)
• Voltaren (diclofenac)

And we've all heard the stories. Heart attacks. Strokes. Tummy troubles. Maybe these things aren't so safe after all, and we need to be very careful when taking them.

Well, a new British study published in the prestigious British Medical Journal deals with the most common NSAIDs in their generic forms, and it's got good news and bad news. Good news is that generic Aleve is pretty safe for your heart. And, generic ibuprofen (Advil and Motrin) carries the most risk for a heart attack.

According to the study, "Naproxen seemed least harmful." So, if you believe the British researchers, then pick Aleve for your aches and pains. Of course, it isn't the risk-free (check out the warnings about Aleve before taking or giving to your children).

By Bryant Esquenazi on January 13, 2011 7:21 PM

FDA Warning Issued: Beware Scam by Fake FDA Agents Calling Buyers of Online Drugs - Should You Stop Buying Drugs From Overseas?

The Food and Drug Administration (FDA) issued a news release earlier this week warning the public about a big scam where people are being taken for thousands of dollars. Beware: it's apparently pretty popular, and well organized.

Seems that evildoers in the Dominican Republic and perhaps other countries have gained access to the names, addresses, and phone numbers of folk who have purchased drugs online or over the phone. They are calling up these folk, identifying themselves as FDA agents or FDA investigators, and scaring the beegeebers out of the people with patter that includes "buying drugs over the phone is against the law" or "purchasing drugs online is a crime," stuff like that.

Then, of course, they're asking for money. Calling it a "fine," they are seducing their victims with fear and then manipulating them into sending money. Sometimes, it's lots of money. Victims are terrified, and they are sending cash via wire transfer to these villians.

The FDA reports that some have been duped to sending anywhere from $100 to $250,000 to these ne'er-do-wells.

So, Miami, don't you be swindled. Here are some tips for you in case you get contacted by one of these scammers (from the FDA):

1. They are tracking people who are buying drugs and medicine online or through a telepharmacy. You don't need to stop buying drugs this way - but be careful. They use GoogleMaps and other online resources to drop information that suggests that they're local - but they're not. They're just sneaky.

2. Check anything you get in the mail that claims to be from the federal government. Call and ask if it's really from the FDA by calling 1-800-INFO-FDA.

3. Be wary of any emails that you receive claiming to be from the FDA. If the email address doesn't end in ".gov" then it's not from the feds. Forward that email to the FDA's Office of Criminal Investigations.

Should You Stop Buying Medicine From Other Countries (Mexico, Canada)?

Of course, the FDA also includes its warnings against buying drugs overseas, citing quality issues as well as the higher risk for creditcard fraud as well as identity theft and scams like this one. From its press release, the FDA apparently urges everyone to buy their drugs here in the USA.

However, the truth is that for many Americans -- particularly seniors here in South Florida and elsewhere, buying their medicines in Mexico or Canada makes good financial sense.

They're unbelievably cheaper.

Interestingly, President Obama created a budget that was sent to Congress in 2009 that included encouraging the ability of Americans to purchase drugs via foreign suppliers. Who knows what's happened to that one.

So, Miami, what does this mean? Well, don't get scammed. Be careful as you purchase your meds overseas. Use a separate card just for those purchases, perhaps. Maybe have a disposable cellphone for those purchases. Investigate ways to protect yourself as you buy from online overseas pharmacies.

And, remember: here's the real risk. You buy the drugs, maybe they aren't the quality that you need. They're old. They're fake. Or you do get scammed.

Odds are not high that the law will be able to bring you justice. The same products liability and fraud laws that protect you here in the USA -- the ones that you would use in a suit against an American drug store or drug maker -- will not apply to foreign suppliers.

Only you can decide if these risks balanced against your budget make buying your drugs (or those of your loved ones) from foreign sources worth your while.

By Bryant Esquenazi on January 11, 2011 7:40 PM

Big Pharma Drug Companies Shown to Commit More Fraud on Government Than Any Other Industry

This month, well-respected national watchdog organization Public Citizen released its study of fraud on the federal government (specifically, those fraud claims pursued by the Department of Justice under the Fraud Claims Act) and found that drug companies overwhelming lead the pack in businesses that have been found to be defrauded the federal government.

From the report itself:

"U.S. spending on prescription drugs has increased from $40 billion in 1990 to $234 billion in 2008. In this era of rapidly rising drug costs, the illegal pharmaceutical company activities that have contributed to such inflated spending have garnered a significant amount of media attention. Recent billion-dollar settlements with two of the largest pharmaceutical companies in the world, Eli Lilly and Pfizer, provide evidence of the enormous scale of this wrongdoing. However, the total size, varied nature, and potential impact of these illegal and potentially dangerous activities have not been previously analyzed. This study examined trends from 1991 to the present in federal and state criminal and civil actions against pharmaceutical companies in order to address these questions."

And, no surprise to this blog's readers, there are FOUR companies that are responsible for over half of the $20 billion in fraud settlements paid to the feds:

1. Eli Lilly
2. GlaxoSmithKline
3. Pfizer
4. Schering-Plough.

In fact, one out of ever four dollars collected in fraud settlement proceeds came from Big Pharma, and these drug companies are just having somewhat of a free-for-all it seems: the study went back to 1991, but it's been within the last 5 years that 75% of that money has been paid.

Which may tie into another revelation from the Public Citizen study: it's been within the past five years that 73% of these cases have been pursued.

Read the report in its entirety here.

By Bryant Esquenazi on December 30, 2010 9:28 PM

Mylanta Recall by Johnson & Johnson - A Company With 12+ Product Recalls in Recent History. Wow.

Well, Miami, this is great news -- right after the Thanksgiving feast and just before the New Year's Eve blowouts, Mylanta's been recalled. That's right: over 12 million bottles of Mylanta, that popular over the counter heartburn medication, were pulled from shelves yesterday, along with 85,000 bottles of AlternaGel antacid, in a voluntary recall by Johnson & Johnson.

What's the problem? Seems Mylanta and AlternaGel have small amounts of alcohol in them, but that's not reported on the product label.

This would be a serious recall for any drug manufacturer, but consider this: in recent history, Johnson & Johnson has issued over 12 recalls that have involved over 60 products. This totals to 200,000,000+ bottles of Johnson & Johnson products that have been put out for sale in the marketplace and then recalled by the manufacturer. And, this was for very popular stuff, too: Tylenol, Motrin, Rolaids ....

Miami, remember: recalls are one thing - actually being safe from this stuff is another. Check your shelves at home in case your bottle of Tylenol or your box of Rolaids - or now, your bottle of Mylanta - is part of the recalled product list. Because recalls don't pull all these products: importantly, they don't cover those that have already been SOLD.

Once again, another fact to add to the warning that we've been giving the Miami community and elsewhere for a couple of months now: we cannot blindly trust prescription drugs or over the counter medicines in this country.

By Bryant Esquenazi on December 2, 2010 11:58 AM

ER Visits by Babies Dropped by 50% After Infant Cold Medicine Recalls - Read the New CDC Study Just Published in Pediatrics

A new CDC report was published online by Pediatrics magazine yesterday, revealling that the Centers for Disease Control and Prevention (CDC) have found that after drug manufacturers recalled all those infant cold medicine products from the marketplace, emergency rooms (ERs) across the country saw the number of visits by babies and infants up to 2 years old DROP BY HALF. (Read the full CDC report in Pediatrics here as a pdf download.)

Remember the Infant Cold Medicine Recalls?

Around three years ago (2007), after more and more chatter about the dangers of infant cold and cough over the counter medicines, there was a huge voluntary recall by the drug companies taking all the OTC medications for kids from newborn to 4 years old off the shelf.

Seems the Food & Drug Administration was becoming more and more suspicious that these children cold and cough medicines were harmful to the growing respiratory systems of tiny ones -- and issued its opinion that infants, babies, or toddlers shouldn't be given OTC cold and cough medicine. The FDA didn't recall, though: the companies voluntarily did this pulling of product - the FDA opinion came out MONTHS AFTER the companies recalled their products themselves.

Another Example of Our Message: Do Not Blindly Trust Over the Counter Medicines

These new CDC findings are important and worthy of our concern and consideration -- but the bigger message remains: Miami, drugs and medicines are simply products made and sold by big companies for a profit. You cannot blindly trust that they are safe. It's a fact proven time and again.

If you or a loved one has taken a prescription drug or over the counter medicine and you have a gut call that something's not right -- don't dismiss it. Get to a doctor or an ER and make sure that everything's okay, or get help if it's not.

And, once again, Miami -- there are laws out there that apply to bad drugs and greedy drug companies. Use them.

By Bryant Esquenazi on November 23, 2010 12:45 PM

GlaxoSmithKline Lawyer Lauren Stevens Charged With Federal Crimes: Miami, Can We Blindly Trust the Drugs We Take?

The blind trust in prescription drugs (and OTC medicines) that we here in Miami Beach as well as elsewhere across the country have may be very much misplaced, and the more lawsuits that are filed, the more obvious the scullduggery appears to be.

Last week, we were pondering the number of cases filed by former drug company employees, whistleblowing about the bad stuff they were seeing happening regarding both prescription drugs as well as over the counter medicines. Part of that involved GlaxoSmithKline admitting guilt to a crime and paying over $750,000,000 in settlement of both criminal and civil claims against it.

Miami and the Nation - We Are All So Dependent Upon the Integrity of Doctors and Drug Companies

Drugs that we take, and give our loved ones, we're thinking that doctors know best and that these medicines will help them get better, and have less pain as they recover. We're all so dependent upon the kindness (and integrity) of strangers here, aren't we?

Well, now there's a new battlefield in the war against dishonest drug companies as the federal government has brought a criminal action against Lauren Stevens, 60, in-house attorney for Glaxo Smith Kline. (Read the complete news release by the Justice Department here.) According to the New York Times, filing criminal charges against Ms. Stevens is part of the federal government's "long-promised crackdown" on pharmaceutical company executives.

Glaxo Smith Kline's lawyer has been charged by the Department of Justice with:

• one (1) count of obstructing an official proceeding
• one (1) count of concealing and falsifying documents to influence a federal agency and
• four (4) counts of making false statements to the Food and Drug Administration (FDA).

The first two charges each carry a maximum penalty of 20 years in prison. The four charges of making false statements each carry a maximum penalty of 5 years in prison.

Meanwhile, GlaxoSmithKilne wasn't named in the indictment and so far, hasn't been charged with a crime by the feds.

Do you use drugs made by GlaxoSmithKline? Odds are high that you do.

Curious about whether or not you or a loved one takes a drug or medicine manufactured by GlaxoSmithKline? Easy enough to check, just go down the list of drugs and vaccines they have listed on their web site. On there, you will see such well-known drug products as:

• Advair
• Amoxil
• Avandia
• Boniva
• Dexedrine
• Flonase
• Lamictal
• Paxil
• Valtrex
• Wellbrutin
• Zantac

Miami - Be Safe and Be Careful

As always, please remember that if you have a gut instinct that something isn't right with a pill or capsule or syrup - call your doctor. (Don't just automatically stop taking the medication until you speak with a health care professional, however, because cold turkey might have its own damaging repercussions.)

If harm has occurred take care of it first - safety and security are number one. After that, consider calling a lawyer. It's becoming glaringly obvious that lawsuits and money damages are what these drug companies respect, not the basic concepts of doing the right thing because it's the right thing to do.

By Bryant Esquenazi on November 11, 2010 1:01 PM

Maybe Dangerous Drugs - the FDA's AERS Online Database: Miami, Are You Aware of This List?

Here in Miami, I'm betting this list is news to many - not to mention folk living elsewhere in the country. However, there it is online and ready for viewing on the FDA's website: the Adverse Events Registry Service (AERS ), where drugs that might be dangerous are listed. That's right -- they're not recalled, they're not pulled from the stores, but they ARE listed here for possible bad juju as reported by someone who had a very bad experience with the prescription drug or over the counter medicine.

The AERS - Adverse Events Registry Service - Reports of Bad Drug Experiences Every Three Months

Online, the federal government is giving you notice of possible bad drugs or OTC medicine by listing reports coming in over a three-month period. Here's the list of medications from April to June 2010 (the latest one available when this post was published):

• Clindamycin injection (Cleocin)
• Dronedarone hydrochloride (Multaq)
• Etonogestrel implant (Implanon)
• Everolimus (Afinitor)
• Febuxostat (Uloric)
• Ferumoxytol injection (Feraheme)
• GnRH Agonists (Androgen Deprivation Therapy)
• Lanthanum carbonate (Fosrenol)
• Omeprazole products
• Simvastatin (Zocor)
• Saquinavir mesylate (Invirase)
• Tapentadol hydrochloride (Nucynta)
• Tetracycline products
• Trastuzumab (Herceptin)

These things sound pretty serious: hallucinations (Nucynta), convulsions (Implanon), "Serious cardiac disorders," (Feraheme) - whatever that means. Wow.

FDA Warns About Its Warning

Of course, above this listing there's lots of verbiage explaining things like "[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk." Not to worry, right?

Because, the list just "...means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk." Testing, testing, testing for that causal link - gotcha.

And, of course: "... [the] FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate."

Obviously, the FDA has lawyers, too.

Meanwhile, once again please remember that a drug is simply a product entering into the marketplace from a for-profit manufacturer. It can be defective, just like a child's car seat or a car's tire. There are laws in place to protect you and your loved ones from defective drugs -- but most importantly, if you or someone in your family has a concern that an over the counter medication or a prescribed drug is not doing as it should, then get to a doctor and get things checked out.

Be careful out there. It's not smart to be paranoid, but it's equally foolish to be too trusting of a drug these days.

By Bryant Esquenazi on November 4, 2010 2:30 PM