Wednesday, March 05, 2008

Fake Doctors Notes, May Make That Time Off Easy

An Internet marketer from Saint Paul, MN, has found a steady yet controversial second income - selling fake doctor’s notes on the Internet. BestFakeDoctorNotes.com, offers fabricated doctor’s notes for ‘entertainment use only.’

The site, which has been online since November 2007, portrays itself as a colorful sales letter from a fictional, sunglasses-wearing doctor named Dr. E.Z. Streat. For a small price, ($14.97) the “doctor” will instantly email you the twelve authentic looking doctor notes. Once received, the notes can be edited and signed.

The site isn’t the first to sell fake doctor notes on the internet. Throughout the past year several sites have sprung up for business. Marquisi claims to stand out from the pack by creating higher quality notes of better value. The medical logos and graphics, he explains, are what make his notes look legitimate.

Many consider using fake doctor notes to be unethical, however Marquis feels differently.

“I simply saw a demand on the internet and created a product to fulfill that demand. My products are for entertainment use only, but if someone chooses to use them in other ways, that is their decision. I do not encourage illegal use of my products,” Marquisi states.

The website has a slightly different statement. Early in the sales page, “Dr. E.Z. Streat” explains that Americans are overworked, overstressed, and simply “Need a Damn Break.”


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The U.S. Coast Guard Updates Carbon Monoxide Status For Recreational Boaters

The Coast Guard has conducted an investigation to determine what carbon monoxide (CO) detection devices are available to recreational boaters, such that, when installed and activated could reduce the risk of being exposed to high levels of CO -THAT SILENT KILLER. A variety of technologies is available for detecting the presence of CO on boats and should be considered by recreational boaters to reduce their risk of injury or death while boating.

CO-DetectorForMarineUseInformation11Feb2008.pdf
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Two More Nevada Clinics Tied To hepatitis exposure scare Closed

The Henderson and North Las Vegas offices of a clinic at the center of a massive health alert were shut down by officials in the cities Tuesday.

Citing the public health emergency, officials in both cities ordered the Gastroenterology Center of Nevada to cease operations, effectively shuttering all but one of the group's facilities in the valley.

A Las Vegas office of the Gastroenterology Center of Nevada, 3150 Tenaya Way, remained open as of late afternoon Tuesday.

Clark County officials on Monday shut down three clinics owned by the medical group. Three days earlier, Las Vegas officials closed an endoscopy center on Shadow Lane where investigators found that staff reused syringes, contaminating vials of medication and infecting six people with hepatitis C.
Health officials have sent 40,000 letters to that clinic's patients, urging them to get tested for hepatitis C and B and HIV, the virus that causes AIDS.

Henderson's action came after a city inspector was locked out of the medical group's office at 2610 W. Horizon Ridge Parkway, Suite 105.
City spokeswoman Cindy Herman said the inspector was allowed inside at first, but when he went out to his vehicle to get some business cards and other information, the office's front door was bolted shut behind him.

The city immediately moved to suspend the office's business license after that, Herman said. Within hours of Henderson's action, North Las Vegas officials ordered a similar office at 1815 E. Lake Mead Blvd., Suite 207, to close its doors.

The cease and desist order, signed by city Business License Manager Lana Hammond, said in part, "Your demonstrated willful failure to observe long accepted and mandated medical sanitary protocols jeopardizes the health and safety of all citizens of the City of North Las Vegas."
Read More at Las Vegas Review-Journal.
Review-Journal writer Jennifer Robison contributed to this report. Contact reporter Henry Brean at hbrean@reviewjournal.com or (702) 383-0350. Contact reporter Lynnette Curtis at lcurtis@reviewjournal.com or (702) 383-0285.


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Tuesday, March 04, 2008

CDC Warns On Safty Problems At Clinics, Arising From Nevada Hepatitis C Case.

WASHINGTON (AP) — An outbreak of hepatitis C at a Nevada clinic may represent "the tip of an iceberg" of safety problems at clinics around the country, according to the head of the Centers for Disease Control and Prevention.

The city of Las Vegas shut down the Endoscopy Center of Southern Nevada last Friday after state health officials determined that six patients had contracted hepatitis C because of unsafe practices including clinic staff reusing syringes and vials. Nevada health officials are trying to contact about 40,000 patients who received anesthesia by injection at the clinic between March 2004 and Jan. 11 to urge them to get tested for hepatitis C, hepatitis B and HIV.

Senate Majority Leader Harry Reid, D-Nev., met Monday with CDC head Dr. Julie Gerberding, and on a media conference call after their meeting both strongly condemned practices at the clinic.

Health care accreditors "would consider this a patient safety error that falls into the category of a 'never event,' meaning this should never happen in contemporary health care organizations," said Gerberding.

"This is the largest number of patients that have ever been contacted for a blood exposure in a health-care setting. But unfortunately we have seen other large-scale situations where similar practices have led to patient exposures," Gerberding said.

"Our concern is that this could represent the tip of an iceberg and we need to be much more aggressive about alerting clinicians about how improper this practice is," she said, "but also continuing to invest in our ability to detect these needles in a haystack at the state level so we recognize when there has been a bad practice and patients can be alerted and tested."

Reid said he would work with Gerberding to try to get the CDC more resources in an emergency spending bill Congress is to take up in April.

State health officials said they weren't sure how many of the 40,000 patients they'd been able to contact since making the risk public last Wednesday. At least initially they didn't have correct addresses for 1,400, officials said.

The head of the clinic, Dr. Dipak Desai, purchased space for an open letter in the Las Vegas Review-Journal on Sunday in which he expressed "my deepest sympathy to all our patients and their families for the fear and uncertainty that naturally arises from this situation."

Desai offered no apology but said a foundation was being set up to cover testing costs. He also defended practices at his clinic, which performs colonoscopies.

"The evidence does not support that syringes or needles were ever reused from patient to patient at the center," Desai wrote.

A spokeswoman, Nancy Katz, declined Monday to comment further.

The Clark County district attorney is investigating, as are various health agencies, including the Nevada State Board of Nursing. Several lawsuits already have been filed and a hearing is scheduled for Thursday before a Nevada legislative committee.

It may never be known how many people contracted hepatitis C because of unsafe practices at the endoscopy center, state health officials said. Brian Labus, head epidemiologist of the Southern Nevada Health District, said that because 4 percent of the population has hepatitis C, he expects to get numerous positive results after the at-risk clinic patients are tested and it may be impossible to determine which of those were infected at the clinic.

Of the six cases that health officials did trace to the clinic, five of them happened on the same day and genetic testing was used to make the connection, Labus said.

Hepatitis C can cause fatal liver disease as well jaundice and fatigue, but 80 percent of people infected show no symptoms. Hepatitis B is a more rare and serious disease that attacks the liver.

Meanwhile, state health officials are still looking at a second clinic with connections to the first, called Desert Shadow Endoscopy Center. At Desert Shadow, officials had been found to reuse anesthetic vials but not syringes and so far no patients have been notified of potential risk. That determination could still be made, said Lisa Jones, head of the Nevada State Health Division's bureau of licensure and certification.


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FDA's Q & A on Chattem, Inc. “Icy Hot Heat Therapy Air Activated Heat”

FDA has provided Questions and Answers session on recent recall Of “Icy Hot Heat Therapy Air Activated Heat”

What is “Icy Hot Heat Therapy Air Activated Heat”?

Icy Hot Heat Therapy Air Activated Heat is an adhesive patch that generates heat. The patch comes in a red sealed plastic pouch. Once the pouch is opened and the patch is exposed to air, the chemicals contained in the patch activate to produce heat. It is then applied to body surfaces to relieve muscle and joint pain associated with arthritis, backache, muscle strains and sprains.

What is the problem with Icy Hot Heat Therapy Air Activated Heat products?

Chattem, Inc. chose to recall their Icy Hot Heat Therapy products because they received consumer reports of first, second and third degree burns as well as skin irritation and skin removal resulting from the use of the Icy Hot Heat Therapy Air Activated Heat patch. As part of FDA's recall classification process, we will be reviewing the firm's root-cause analysis on what caused the burns.

What is the difference between first, second and third degree burns?

The type of burn is determined by how deeply it penetrates into the skin. There are two main layers of skin, and the degree of burn is based on how each layer is affected. First degree burns are the least severe and third degree burns are the deepest or most severe.

First Degree Burns: Means the top layer of skin (the epidermis) is damaged but not destroyed and turns bright pink or very red. Pain from first degree burns ranges from mild to extreme. No skin comes off and there are no blisters. Mild sunburns are a good example of first degree burns.

Second Degree Burns: Means burn damage has gone through the top layer (the epidermis) and into the 2nd layer of skin (the dermis). The top layer of skin is destroyed and may slide off or blister. Blisters are the first sign of a second degree burn. The wound appears red or pink and moist. Second degree burns are the most painful kind of burn.

Third Degree Burns: Means the burn has destroyed both the first and second (epidermis and dermis) layers of the skin. The exposed wound appears white, gray, yellow, brown or black and is usually dry. There may be little or no pain or the area may feel numb because of nerve damage.

When were the Icy Hot Heat Therapy Air Activated Heat patches produced and sold?

The firm issued a press release, dated February 8, 2008, for their voluntary recall involving 2.3 million Icy Hot Heat Therapy Air Activated Heat patches distributed in the United State since December 2006. The products were manufactured between December 2006 and February 2008 and sold over the counter through food, drug and mass merchandisers. You can find a listing of retailers on Chattem, Inc.’s website at http://www.chattem.com/wheretobuy/icy.asp.

What products are affected by the recall?

All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:

  • Icy Hot Heat Therapy Air Activated Heat - Back
  • Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
  • Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg in single-use “samples” that were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat." This recall only involves the above listed Icy Hot Heat Therapy products and does not involve any other Icy Hot products such as the medicated patch, cream, or balm/stick that also use the “Icy Hot” name.

If the product was removed from the original carton, what does it look like?

The product inside the carton is in a red plastic pouch that says Icy Hot Heat Therapy and either Back or Arm/Neck and Leg. If you are unsure you have an affected product, you should asked the retailer where you purchased it whether your product is affected by this recall, or contact Chattem as indicated below.

What steps should I take if my patches are affected by the recall?

If you have one of the recalled products, you should stop using it immediately, and discard or return it to Chattem, Inc. Product may be returned for a full refund (average retail price) by calling Chattem’s Consumer Affairs Department at 1-888-442-4464 or via their website at www.Chattem.com.

To read more about the recall:

Consumers with questions may contact:

  • Chattem’s Consumer Affairs Department at 1-888-442-4464 (M-F 8am to 4pm EST).

How do I report adverse events to FDA?

If you have experienced burns, skin irritation or other adverse reactions with the use of this product or any medical device, we encourage you to report this to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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FDA's Recent Generic Drug Approvals

Each year, FDA approves scores of generic drugs that treat a variety of conditions and help consumers save money.

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they're administered to patients.

Significant approvals granted by FDA's Office of Generic Drugs during the past year include

  • Alendronate Sodium Tablets
    Used for: Treating and preventing types of osteoporosis
    Originally marketed as: Fosamax, by Merck & Co.
    Date approved: Feb. 6, 2008
  • Carvedilol Tablets
    Used for: Treating hypertension and heart failure
    Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
    Date approved: Sept. 5, 2007
  • Cetirizine HCl Tablets
    Used for: Treating symptoms of allergies
    Originally marketed as: Zyrtec, by Pfizer
    Date approved: Dec.12, 2007
  • Granisetron Tablets
    Used for: Preventing nausea and vomiting related to chemotherapy and radiation
    Originally marketed as: Kytril, by Roche
    Date approved: Dec. 31, 2007
  • Oxcarbazepine Tablets
    Used for: Treating certain kinds of seizures and epilepsy
    Originally marketed as: Trileptal, by Novartis
    Date approved: Oct. 9, 2007
  • Pravastatin Sodium Tablets
    Used for: Treating elevated cholesterol and preventing coronary events.
    Originally marketed as: Pravachol, by Bristol-Myers Squibb
    Date approved: Apr. 23, 2007
  • Zolpidem Tartrate Tablets
    Used for: Treating insomnia
    Originally marketed as: Ambien, by Sanofi Aventis
    Date approved: Apr. 23, 2007

Drug manufacturers develop their new drugs under patents that protect their firms' investment in the products. When patents or other periods of exclusivity on the drugs expire, manufacturers can apply to FDA to sell generic versions.

In October 2007, FDA launched the Generic Initiative for Value and Efficiency (GIVE) to help increase the number of approvals of generic products.

GIVE will use existing resources to help FDA modernize and streamline the generic drug approval process. GIVE will also increase the variety of generic drug products available.

For More Information

FDA's GIVE Initiative
http://www.fda.gov/oc/initiatives/advance/generics.html

FDA's Office of Generic Drugs
http://www.fda.gov/cder/ogd/

Generic Drug Approvals (by month)
http://www.fda.gov/cder/ogd/approvals/default.htm

Date Posted: March 3, 2008


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Tamiflu (oseltamivir phosphate) Advise For Patients With Influenza.

Tamiflu (oseltamivir phosphate)
Audience: Pediatric and infectious disease healthcare professionals
[Posted 03/04/2008] Roche and FDA informed healthcare professionals of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza. These symptoms, as described in post marketing reports mostly from Japan, include delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated.

[February, 2008 - Dear Healthcare Professional Letter - Roche]
[January, 2008 - Tamiflu Prescribing Information - Roche]

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