St. Cloud Personal Injury Lawyer - FDA & Prescription Drugs

H1N1 Means All Sorts Of Charlatans

Mike Bryant — Thu, 22 Oct 2009 20:45:00 GMT

The FDA is warning the public about the number of fake offers for preventing or curing people form H1N1. Right now there are large number of websites that offer miracle protections. These offers include fake "Tamiflu" pills from India.

The FDA reported that they ordered one of these offers:

One order, which arrived in an unmarked envelope from India, consisted of unlabeled white pills that contained talc and the common pain reliever acetaminophen, the FDA said. Others contained various amounts of oseltamivir but were not approved for use in the United States.

The FDA has also ordered doctor Andrew Weil to stop marketing his Immune Support Formula to protect against the H1N1 flu virus.

"Claims that a dietary supplement can prevent, treat or cure human infection with the H1N1 virus must be supported by well-controlled human clinical studies," the regulatory agencies said in a warning letter to Weil.

At present shots are the only approved method for prevention and oseltamivir or another antiviral drug, zanamivir -- an inhaled medicine produced as Relenza by GlaxoSmithKline Plc can help relieve the severity after an infection.

Originally posted at InjuryBoard by Mike Bryant

Insure Lasik Safety With Better Reporting

Mike Bryant — Mon, 19 Oct 2009 15:35:00 GMT

Lasik is a procedure that has benifited thousands of Americans They have regained the ability to see better without the aid of glasses. Many have seen it as a miracle. But, as with other procedures, there have been problems. Considering the procedure affect your vision, the most important of your five senses, even small errors can lead to major problems.

The U.S. Food and Drug Administration is conducting a study to find the percentage of patients who experience serious quality-of-life problems after Lasik eye surgery. After a brief look at the topic, they have issued warning letters to a number of Lasik facilities that weren't properly reporting problems with the procedure.

This past month, the FDA sent warning letters to 17 Lasik ambulatory surgical centers because they each were suspected of having inadequate systems for reporting specific problems suffered by patients.

"Many people in the U.S. undergo Lasik procedures. Ambulatory surgical centers that perform Lasik must maintain a robust reporting system as required by law," Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health, said in the news release. "Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in Lasik procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

As part of their release the FDA provided the additional advice:

Things to think about ...

Find the right doctor. (see below)

Cost --Most medical insurance will not pay for this surgery

LASIK won't work well if your sight changes often. Have you needed a change in your contact lenses or glasses in the past year? Vision changes are more likely if you are:

In your early 20s

Diabetic or have certain other diseases

Pregnant or breast-feeding

Taking medicines that cause vision changes, such as steroids

Laser eye surgery is not a good choice for people who do contact sports. Examples: boxing, wrestling, martial arts

Laser surgery is not approved for anyone under age 18.

Some jobs do not allow workers to have certain kinds of eye surgery. Check with your boss to make sure.

Things Your Doctor Must Look for Before Surgery
Your doctor needs to find out if you have any of these conditions:

Past or current eye diseases, such as glaucoma and ocular hypertension.

Eye injuries or other laser eye surgery.

Large pupils, thin corneas, or dry eyes.

Finding the Right Doctor is Very Important
Ask these questions before choosing a doctor:

Experience: How many LASIK eye surgeries has this doctor done with the same laser?

Equipment: Does this doctor use an FDA-approved laser?

Information: Does this doctor take the time to answer all your questions? Do you feel at ease giving and getting information with this doctor?

If You Choose LASIK Before surgery:

Your doctor should give you an informed consent form. Read and understand it. Get answers to all your questions.

Have a detailed eye exam.

Plan not to drive or work right after the surgery.

After surgery:

Take at least two days off work to rest and get better.

You will have some pain for a few days.

You will not be able to see clearly for a few days. Final results could take months.

Originally posted at InjuryBoard by Mike Bryant

Pharmaceutical Company Writing Good Stuff About Their Product

Mike Bryant — Sun, 06 Sep 2009 09:19:00 GMT

Usually when pharmaceutical companies are writing good stuff about themselves they are called advertisements. But, when they write it about themselves, except do so in ghostwritten "scientific papers", it should be called fraud. I guess it was a way to save money from just paying doctors to make up test results.

This past week, the New York Times reported the recently released court documents show that Wyeth Pharmaceuticals produced 26 scientific papers backing the use of hormone replacement therapy in women. They hired a medical communications firm to publish their papers in medical journals between 1998 and 2005.

Addressing the hormone drugs Premarin (conjugated estrogens) and Prempro (conjugated estrogens/medroxyprogesterone acetate), the papers emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. At the same time, Wyeth saw sales rise to nearly $2 billion in 2001.

These were companies that until recently were protected by federal preemption from many lawsuits. Companies that paid defense lawyers millions of dollars to question the honesty and integrity of injured plaintiffs. It's to bad none of this evidence was available before too uncover the lies so many of these cases were based on.

Originally posted at InjuryBoard by Mike Bryant

Are Killing Pain Killers Better Than Chiropractic?

Mike Bryant — Thu, 30 Jul 2009 09:54:00 GMT

I am amazed when talk comes up at the legislature or with individual insurance claims about whether chiropractic should be paid under the no fault act. Usually it involves discussions about limiting the coverage or adding treatment parameters. There is no real talk about how to deal with the person's pain if you take away their chiropractic treatment, which works for so many.

One of the options has to be pain killers. Has there been a single one that hasn't been looked at for significant damage to organs or causes for potential death? Let's see what's out there:

An advisory panel of the FDA voted to recommend a ban on Percocet and Vicodin. The panel noted that patients who take Percocet and Vicodin for long periods often need higher and higher doses to achieve the same effect. More than 400 people die and 42,000 are hospitalized every year in the United States from overdoses.

The FDA advisory panel, made up of scientists, doctors and consumer representatives, voted 21 to 6 in favor of lowering the maximum daily dose of nonprescription acetaminophen for adults, which is currently set at 4,000 mg; the panel did not specify a new maximum dosage. They also voted 24 to 13 to reduce the maximum single adult daily dose to 650 mg from the current maximum of 1,000 mg, or the equivalent of two tablets of Extra Strength Tylenol. Finally, the members recommended 26 to 11 that the 1,000-mg over-the-counter dose be switched to a prescription-only status.

In a separate vote, the panel recommended 36 to 1 that if acetaminophen-containing prescription drugs continue to be sold they be sold with a black-box warning.

Far more people are harmed by regular use of aspirin and ibuprofen (Nsaids). 100,000 Americans are hospitalized each year with complications associated with Nsaids and 15,000 to 20,000 die from ulcers and internal bleeding linked to their use.

The U.S. Food and Drug Administration has called for a black box warning for Darvon, Darvocet and other painkillers containing the drug propoxyphene because of overdose risks.

You look at this list and it makes you wonder why the discussion isn't about how do we use more alternative medicines? Why are painkillers given out like candy? Now, I represented enough people with serious pain, so I know that many of the concerns that the loss of these drugs may cause. But, despite that it seems like anything that is done to limit their use is for the better.

Originally posted at InjuryBoard by Mike Bryant

Congress Reaffirms And Finances A Better FDA

Mike Bryant — Thu, 09 Jul 2009 07:33:00 GMT

Search "Food Safety" here at the Injuryboard site and you will find all sorts of alerts. Search "FDA" and you will find the list of failures by the organization over the last eight years. It's been an underfunded arm of the government that has been asked to look the other way from what has been happening. To actually write laws that make the world less safe for the consumer.

This past week, changes in congress hopefully signals a new direction. The House Energy and Commerce Committee approved legislation that would give the Food and Drug Administration significantly more funding and power to police food safety.

The legislation would give the FDA authority to order food recalls, impose new civil penalties and require companies to follow food-safety standards. It also would require the agency to inspect so-called high-risk food facilities at least once a year and make companies keep detailed records to help the FDA more quickly trace the distribution of tainted foods and track the course of the contamination.

To help fund the work, the bill would require some 378,000 food facilities, including 223,000 overseas, to pay an annual registration fee of $500. The legislation exempts farms that raise meat and poultry and other facilities regulated by the U.S. Department of Agriculture

This is great news for the consumer and will hopefully get the FDA back to what it's supposed to be doing. Less food problems and quick effective response when something does happen will make a big difference.

Originally posted at InjuryBoard by Mike Bryant

Nestle Toll House Refrigerated Cookie Dough Recalled Due To E.Coli

Mike Bryant — Sun, 05 Jul 2009 20:06:00 GMT

In mid June, the United States Food and Drug Administration announced the recall of refrigerated Nestle Toll House cookie dough because it may be contaminated with E. coli O157:H7. The products involved all varieties of Nestlé TOLL HOUSE refrigerated Cookie Bar Dough, Cookie Dough Tub; Cookie Dough Tube; Limited Edition Cookie Dough items; Seasonal Cookie Dough and Ultimates Cookie Bar Dough.

Description Consumer Unit Code (UPC)

Nestle Toll House Cookie & Brownie Dough

COOKIE & BROWNIE DOUGH BAR

Chocolate Chip bar 16.5oz 0 50000 62231 3

Chocolate Chip bar 16.5oz 0 50000 11308 8

Chocolate Chunk bar 16.5oz 0 50000 62235 1

Walnut Chocolate Chip bar 16.5oz 0 50000 62233 7

Jumbo Chocolate Chip bar 16.5oz 0 50000 62237 5

Oatmeal Raisin bar 16.5oz 0 50000 06219 5

Sugar Cookies bar 16.5oz 0 50000 62244 3

Sugar Cookies bar 16.5oz 0 5000012178 6

Mini Chocolate Chip bar 16.5oz 0 50000 62242 9

Mini Chocolate Chip bar 16.5oz 0 5000012188 5

Mini Brownie Bites bar 16oz 0 50000 62227 6

Fudgy Brownie With Peanut Butter Filling 19oz 0 50000 00820 9

COOKIE DOUGH TUB

Chocolate Chip tub 40oz 0 50000 62246 7

Chocolate Chip tub 80oz (5 lb) 0 50000 00934 3

Sugar tub 40oz. 0 50000 62253 5

Gingerbread tub 40oz 0 50000 44060 3

Peanut Butter tub 40oz 0 50000 44062 7

TUBE (CHUB) DOUGH

Chocolate Chip tube 16.5oz 0 50000 62239 9

Chocolate Chip tube 32oz 0 50000 00400 3

ULTIMATES COOKIE BAR DOUGH

Ultimates Peanut Butter Cups, Chips & Chocolate Chunks bar 16oz 0 50000 00922 0

Ultimates White Chip Macadamia Nut bar 16oz 0 50000 00923 7

Ultimates Chocolate Chip & Chunks with Pecans bar 16oz 0 50000 00925 1

Ultimates Chocolate Chip Lovers 16oz 0 50000 00926 8

Ultimates Turtles bar 16oz 0 50000 00928 2

Ultimates Peanut Butter Lovers bar 16oz 0 50000 00507 9

Ultimates Chocolate Chip with Caramel Filling bar 16oz 0 50000 44066 5

Ultimates Chocolate Chip with Chocolate Filling bar 16oz 0 50000 44069 6

SEASONAL COOKIE & BROWNIE DOUGH

Valentine Hearts Sugar Cookie Shapes 15.5oz 0 50000 12009 3

Valentine Swirled Chocolate Chip bar 16oz 0 50000 00931 2

Fudgy Brownies With Raspberry Filling 19oz 0 50000 20090 0

Easter Eggs Sugar Cookie Shapes 15.5oz 0 50000 52009 1

Easter Swirled Chocolate Chip bar 16oz 0 50000 00932 9

Easter Swirled Mini Brownie Bites bar 18 oz 0 50000 20093 1

Red, White & Blue Swirled Choc Chip bar 16oz 0 50000 00937 4

Halloween Pumpkin Pals Sugar Cookies 13.5oz 0 50000 06217 1

Halloween Swirled Chocolate Chip bar 16oz 0 50000 00929 9

Halloween Swirled Fudgy Brownies bar 18oz 0 50000 00088 3

Christmas Shapes Sugar Cookies 15.5oz 0 50000 00505 5

Christmas Swirled Chocolate Chip bar 16oz 0 50000 00930 5

Christmas Swirled Fudgy Brownies bar 18oz 0 50000 00089 0

Limited Edition Mint Swirled Chocolate Chip 16oz 0 50000 00827 8

Discontinued Varieties

Valentine Hearts Sugar Cookies 13.5oz 0 50000 44056 6

Easter Brownie Bar 18oz 0 50000 00518 5

Easter Bunnies Sugar Cookies 13.5oz 0 50000 44058 0

Halloween Sugar Shapes 15.5oz 0 50000 00829 2

Christmas Sugar Cookie Tube 16oz 0 50000 00448 5

Oatmeal Cranberry Cookie Tub 48 oz.0 50000 62229 0

The warning is based on an ongoing epidemiological study conducted by the CDC and several state and local health departments. Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome (HUS). There have been 6 cases reported in Minnesota. No one has died. Consumers who have additional questions about these products should contact Nestle consumer services at 1-800-559-5025 and/or visit their Web site at www.verybestbaking.com.

If you suffer from food poisoning, you need to get immediate medical care. If it continues or there are long term affects, you should contact an attorney concerning the problem. Early investigation can include the collection of samples, checking for health alerts, and the proper notifying of those who caused the problem.

Originally posted at InjuryBoard by Mike Bryant

Seroquel Information To See The Light Of Day This Week

Mike Bryant — Sat, 23 May 2009 22:45:51 GMT

Previously, I blogged on the topic of the need for full disclosure of information about the drug Seroquel. The issue was the marketing that was being done to patients suffering from depression and anxiety. The question was what did the testing show, and what were the known side effects?

This week, it is expected that we may have some answers. Particularly, we may find out:

What was done to promote the drug.
If it was promoted unapproved uses in children and the elderly.
The proof is expected to be a public-relations blueprint, strategic plan and other materials.

It was through plaintiff attorneys who took on the fight and the resulting litigation that much of this will be coming to light. Hopefully, with full disclosure the answer can be gained and those who were harmed can find justice. Stay tuned and let's see what has been finally uncovered.

Originally posted at InjuryBoard by Mike Bryant

Hydroxycut Recall Is Another Example Of The FDA's Problems

Mike Bryant — Sat, 16 May 2009 12:40:00 GMT

At the Injuryboard, many of the writers have discussed the horrid state of the FDA during the Bush Administration. The reality seems to be that there was either no oversight of products or there was work to continue to weaken consumer protections and to allow free wheeling for the pharmaceutical companies.

This recall is of particular interest because the report of death and many of the injuries have been reported for some time. Why didn't the FDA do something earlier? Also, there is a jurisdictional issue of if the FDA has authority to regulate the dietary supplement industry.

Presently, dietary supplements do not need FDA sanction to go on sale. Hopefully, a review of what happened in these cases and the importance of protecting the consumer will get Congress to look at adding the power.

If you or a family member is injured by a product, you need to get immediate medical care. If there is a significant affect or injury, you should contact an attorney concerning the problem. Early investigation can include the collection of product, checking recall alerts, and the proper notifying of those who caused the problem.

Originally posted at InjuryBoard by Mike Bryant

Hydroxycut Recalled By FDA

Mike Bryant — Thu, 14 May 2009 15:37:00 GMT

Hydroxycut the weight-loss supplement is recalling 14 products after reports of liver damage and one death linked to the product. The Food and Drug Administration urged consumers to immediately stop using the products, which are made by Iovate Health Sciences Inc and marketed for weight loss, boosting energy and other uses.

A 2007 death of a 19-year-old boy living in the Southwest is linked to the over-the-counter diet pill, plus there are reports of 23 serious injuries. Consumers reported liver injuries including jaundice, elevated liver enzymes, permanent liver damage, and liver transplant. Seizures, cardiovascular disorders, and rhabdomylosis were also reported. Retailers nationwide must remove the products from their consumer shelves and people are instructed to stop using all Hydroxycut products immediately.

The recalled 14 Hydroxycut products, including :

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Originally posted at InjuryBoard by Mike Bryant

Is Big Pharma Drugging Our Water?

Mike Bryant — Wed, 29 Apr 2009 09:55:00 GMT

This past week, the Associated Press released a startling study concerning our drinking water. Apparently, at least 271 million pounds of 22 pharmaceutical compounds was found in the tested water. The compounds come from two governmental lists: the EPA monitors them as industrial chemicals that are released into rivers, lakes and other bodies of water under federal pollution laws, while the Food and Drug Administration classifies them as active pharmaceutical ingredients.

For a long time, Injuryboard members have been identifying the issues out there with pharmaceutical companies:

Buying doctors loyalties.
Questionable drug testing and marketing.
Involvement in faking tests.
Attacking of Doctors who questioned their products.
Benefiting from the Bush years.

Some of the information is quite troubling, but adding the dumping into our water should create nightmares. Think about being drugged and not even knowing it. Emerging research also has shown that human cells fail to grow normally in the laboratory when exposed to trace concentrations of certain drugs. This has caused some scientists to believe that even exposure to small amounts of the drugs, over decades, could cause harm to humans.

The investigation will hopefully continue as to the source of all of this drugging. There are indications that some of it comes from consumers disposing of their drugs. 250 million pounds of pharmaceuticals and contaminated packaging are thrown away each year by hospitals and long-term care facilities. But, "It doesn't pass the straight-face test to say pharmaceutical manufacturers are not emitting any of the compounds they're creating," said Kyla Bennett, a former 10-year EPA enforcement officer and current ecologist and environmental attorney.

Originally posted at InjuryBoard by Mike Bryant