ATTORNEY GENERAL CUOMO ANNOUNCES EXPANSION OF INDUSTRY-WIDE INVESTIGATION INTO PREDATORY HEALTH CARE LENDING THAT IS PUSHING CONSUMERS NATIONWIDE INTO DEBT

Health care credit card scheme preys on seniors and vulnerable patients ~Cuomo subpoenas health care clinics and credit card companies including Chase Health Advance, Citi Health, and GE Money's CareCredit

Yesterday, Attorney General Andrew M. Cuomo announced the expansion of an industry-wide investigation into predatory health care lending where consumers, especially seniors and vulnerable patients, are misled about financing, causing them to be pushed into debt.

An investigation by Attorney General Cuomo found that some health care providers use fast-talking sales pitches to pressure and deceive consumers into applying for health care credit cards such as Chase Health Advance, Citi Health, and GE Money's CareCredit. The investigation also found that CareCredit pays kickbacks in the form of rebates to the providers based on how much business they charge consumers on CareCredit cards.

The investigation was based in part on hundreds of consumer complaints received by the Attorney General's Office. Consumers reported that health care providers promised that the credit card had "no interest, " when it often carried retroactive interest of over 25 percent if not paid in full during a promotional period. Consumers were also unknowingly charged up front for services they never received, and their attempts to obtain refunds were often thwarted or ignored. Meanwhile, the credit card companies typically paid the health care providers in full within 48 hours of the charge.

The investigation also found that CareCredit charges the providers a fee for the right to offer the cards, and then rebates part of the fee based on the amount of money the providers generated through CareCredit sales. This kickback arrangement, plus CareCredit's payment in full to providers within two days of the charge, creates an incentive for providers to push consumers to use CareCredit rather than other methods of payment. In fact, providers pushed CareCredit over cash.

"Our ongoing investigation has uncovered conflicts of interest and predatory practices in the health care industry that are hurting New Yorkers and patients across the country," said Attorney General Cuomo. "Patients are being misled into paying for services they never received by the people they should be able to trust the most - their doctors. Doctors are supposed to represent patients, not credit card companies, no matter what kind of kickbacks they are offered."

Cuomo issued subpoenas to 14 dental and health care clinics that promote CareCredit, as well as to GE's CareCredit, Chase Health Advance, and Citi Health Card. The subpoenas seek marketing materials, applications, terms of credit, contracts and rebate agreements, policies and procedures, consumer complaints, and regulatory inquiries. This investigation is ongoing.

In addition, Cuomo is asking several nationwide and state-based medical associations, including the American Dental Association and the New York State Dental Association, to explain why they endorsed CareCredit and whether they received compensation for doing so.

CareCredit is accepted by more than 125,000 health care practices nationwide. The New York State Dental Association asserts that more than 8 million dental patients and 80,000 dental practices use CareCredit nationwide. The credit card is advertised as a way to pay for services often not covered by insurance, including:

• Chiropractic procedures
• Cosmetic procedures
• Dental procedures
• Infertility treatment
• Hearing procedures
• Vision procedures
• Weight loss procedures
• Veterinary services

In recent years, Attorney General Cuomo's Office received hundreds of complaints from consumers indicating that they were lured and misled by providers into applying for, accepting, and using health care credit cards. Among the complaints received by the Attorney General's Office regarding the scam:

• A Nassau county woman went to a dental provider covered by her insurance for a root canal. The dentist told her that she had serious dental problems and needed $14,000 worth of work. When the consumer told the dentist she could not afford $14,000, the dentist said he would not do the root canal unless she applied for CareCredit. The following day, the consumer received a bill for $13,900 even though none of the work was performed.
• An elderly Brooklyn resident was advised by her dentist that she needed extensive dental work. The consumer agreed to allow the dentist to check her credit. A few days later, she received a bill from CareCredit for $6980. No dental work was performed.
• A Bronx resident had $17,500 worth of implants charged to a CareCredit account up front by a dental provider. The provider went out-of-business before completing the work. CareCredit repeatedly refused the consumers requests to refund the money.

Chuck Bell, Programs Director for Consumers Union, nonprofit publisher of Consumer Reports, said, "Attorney General Cuomo's investigation shines a badly-needed spotlight on deceptive practices used to market health care credit cards to elderly and low-income consumers. We are concerned that some health care providers are aggressively marketing these high-interest credit cards to patients, without providing appropriate disclosures, protections, or refunds. Consumers Union strongly supports the Attorney General's investigation, and applauds his ongoing efforts to protect consumers across the nation."

Catherine Dunham, President of The Access Project, a resource center for local communities working to improve health and health care access, said, "With the cost of health care already an enormous burden on Americans, we must do everything we can to filter out abusive or deceptive practices in how providers take payment for care. Attorney General Cuomo's investigation into health care credit cards will help protect millions of patients across the country who are struggling with debt. We applaud his efforts and look forward to continuing to partner with him to protect patients."

Consumers wishing to file complaints regarding deceptive health care credit card practices are urged to contact the Attorney General's Office at HealthCreditCards@ag.ny.gov or 800-428-9071. Consumer tips and more information about the investigation, including an example of the letters sent to trade groups, can be found online at www.ag.ny.gov.

The investigation is being conducted by Assistant Attorney General Carol Hunt of the Health Care Bureau under the supervision of Special Counsel to the Attorney General Linda A. Lacewell.

Subpoenas to Health Care Providers:

• Allcare Dental Management Inc. - Buffalo
• American Laser Centers - Farmington Hills, MI
• Aspen Dental Management, Inc. - East Syracuse
• East Syracuse Family Dental Arts - East Syracuse
• Laser Cosmetica - New York City
• Lifestyle Lift - Troy, MI
• Northern Lights Chiropractic - Watertown
• S & Y Diamond Dental P.C. - Brooklyn
• Sunshine Dental - Watertown
• Toothsavers - New York City
• Gentle Dentistry - East Aurora
• Judd Lesser, DDS - Hewlett
• Concerned Dental Care of Westchester P.C.
• Bernie Fialkoff DDS - Queens

Letters to Groups Endorsing CareCredit:

• American College of Eye Surgeons
• Society for Excellence in Eyecare
• American Dental Association
• Academy of General Dentistry
• American Academy of Periodontology
• American Association of Oral & Maxillofacial Surgeons
• New York State Dental Association
• American Society of Plastic Surgeons
• American Society of Dermatologic Surgery
• American Animal Hospital Association
• New York State Veterinary Medical Society
• American Hearing Aid Associates
• American Society of Bariatric Physicians
• Lite and Hope

Posted by Lucas A. Ferrara, Esq. at 9:00 AM | Permalink | TrackBacks (0) | Comments (0)

Health Department Reports First Human Case of West Nile Viral Disease for 2010 Season

Late last week, the Health Department confirmed the season's first human case of West Nile viral disease in a 61-year-old Bronx man who was hospitalized with meningitis. In response to this case, and the growing number of mosquitoes testing positive for the virus, the Health Department is strongly urging New Yorkers to take steps to prevent infection.

"This first case of West Nile viral disease in New York City provides a vital reminder to protect ourselves against mosquito bites," said Dr. Thomas Farley, New York City Health Commissioner. "Wearing mosquito repellent when you are outdoors, and long sleeves and pants in the morning and evening, will reduce your risk of infection. New Yorkers age 50 and older should be especially careful as they are more likely to become seriously ill, and in rare instances die, if infected."

West Nile virus infections typically begin to occur around this time in the summer. To date, 199 New Yorkers have been diagnosed with West Nile viral disease since it was first found in the United States in 1999, including 3 in 2009 and 15 in 2008.

The Health Department uses an "integrated pest management" approach to monitors the city for West Nile Virus and control its spread by mosquitoes. The agency inspects and treats standing water sites with non-chemical larvicides to kill larval mosquitoes before they emerge as flying adults. When necessary, the agency also applies small amounts of chemical pesticides (adulticides) to kill adult mosquitoes. A schedule of mosquito control activities is available online at nyc.gov/health or by phone from the 311 call center.

Reducing Exposure to Mosquitoes

• Use an approved insect repellent containing DEET, picaridin, oil of lemon eucalyptus (not for children under three), or products that contain the active ingredient IR3535.
  
• Make sure windows have screens, and repair or replace screens that have tears or holes.
  
• Eliminate any standing water from your property, and dispose of containers that can collect water. Standing water is a violation of the New York City Health Code.
  
• Make sure roof gutters are clean and draining properly.
  
• Clean and chlorinate swimming pools, outdoor saunas and hot tubs. Keep them empty and covered if not in use; drain water that collects in pool covers.
  
• Report standing water by calling 311 or visiting http://www.nyc.gov/health/wnv.

About West Nile virus

West Nile virus infection can cause a mild or moderate flu-like illness, or sometimes no symptoms at all. But in some people, particularly those 50 and older, it can cause a serious and potentially fatal infection of the brain and spinal cord. The most common symptoms are headache, fever, muscle aches and extreme fatigue. Symptoms of more severe illness can also include changes in mental status and muscle weakness. If you think you have symptoms of West Nile Virus, see your doctor right away. For more information about West Nile Virus, and how to avoid it, visit nyc.gov/health or call 311.

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Posted by Lucas A. Ferrara, Esq. at 9:30 AM | Permalink | TrackBacks (0) | Comments (0)

Keep Kids, Pets Away From Skin Sprayed With Evamist

The Food and Drug Administration (FDA) says children and pets should not be exposed to Evamist, a drug for women that is sprayed on the skin to treat hot flashes caused by menopause.

The agency also wants consumers to take precautions to ensure that children and pets do not make contact with skin where Evamist has been sprayed.

Evamist contains the estrogen hormone estradiol. It is sprayed inside the forearm between the elbow and wrist.

FDA, which issued its warning on July 29, 2010, says it is reviewing reports of adverse events in children and pets who were inadvertently exposed to Evamist.

Adverse events reported in unintentionally exposed children include

• premature puberty, nipple swelling, and breast development in girls
• breast enlargement in boys

FDA has also received reports of inadvertent exposure in pets. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling.

"Women using Evamist need to be aware of the potential risks to children who come in contact with the area of skin where this drug is applied," says Julie Beitz, M.D., a director of drug evaluation with FDA. "It is important that people know to keep both children and pets away from the product to minimize exposure."

Advice for Consumers

FDA recommends that women using Evamist

• not allow children to come in contact with the area of the arm where Evamist was sprayed
• not allow pets to lick or touch the arm where Evamist was sprayed. Small pets may be especially sensitive to the estrogen in Evamist. Contact a veterinarian if your pet shows signs of nipple and/or vulvar enlargement, or any other sign of illness
• wear a garment that covers the arm where Evamist was sprayed if they know they cannot keep a child or pet from making contact with it
• talk with their health care professional if they have questions about the possibility of exposing a child to Evamist
• read the patient package insert when picking up a prescription for Evamist

If Contact Occurs

If a child comes in contact with the part of the arm where Evamist was sprayed, FDA recommends

• washing the child's skin with soap and water as soon as possible
• contacting the child's health care professional if the child begins to have any of the following signs or symptoms: nipple or breast swelling or breast tenderness in girls, or breast enlargement in boys. Be sure to tell the health care professional that the child may have been exposed to Evamist

You can report any side effects from the use of Evamist to FDA's MedWatch Adverse Event Reporting Program online or by mail, fax, or phone.
Regular Mail: Use postage-paid, pre-addressed FDA form 3500
Fax: 1-800-FDA-0178
Phone: 1-800-332-1088

At this time, it is unknown whether unintended exposure can occur with other topical (applied to the skin) estrogen products.

FDA continues to review adverse event reports and evaluate ways to reduce unintended exposures.

Posted by Lucas A. Ferrara, Esq. at 1:00 PM | Permalink | TrackBacks (0) | Comments (0)

HHS Awards $159.1 Million to Support Health Care Workforce Training

Funds will Support Programs to Train Nurses, Geriatric Specialists and Improve the Performance and Recruitment of Underrepresented Minority Students

Yesterday, HHS Secretary Kathleen Sebelius announced $159.1 million in grants to health care workforce training programs.  These grants build on the multimillion dollar investments made under the Affordable Care Act and Recovery Act to strengthen and grow our primary care workforce. The grants will target three types of programs: Nursing Workforce Development programs; interdisciplinary geriatric education and training programs; and Centers of Excellence programs for underrepresented minority students.

"We cannot build a healthier America if our country continues to face a growing health professions shortage," said Secretary Sebelius. "A well-trained, educated and diverse workforce is critical to meeting future healthcare demands, and to reforming the nation's health care system."

"These grants target key workforce needs," said Health Resources and Services Administration (HRSA) Administrator Mary K. Wakefield, Ph.D., R.N. "In addition to training new health care workers, these grants will support efforts to better prepare health care workers to care for our diverse and aging population, improving health care quality for all Americans."

Nursing Workforce Development

Nursing Workforce Development programs will receive $106 million in grants to support all levels of nursing education.

• Advanced Education Nursing ($42 million) supports 153 infrastructure grants to increase advanced education to train nurses as primary care providers and/or nursing faculty.
• Advanced Education Nursing Traineeship ($16 million) supports 351 schools of nursing and individuals preparing to be many types of nurse specialists requiring advanced education.
• Nurse Anesthetist Traineeship ($1.3 million) funds 83 nurse anesthetist training programs to provide traineeships that pay tuition, books, fees, and a living stipend for registered nurses who have completed at least 12 months in a master's or doctoral nurse anesthesia program.
• Nurse Education, Practice, Quality and Retention ($29.9 million) supports 108 infrastructure grants to expand the capacity of the nursing pipeline, promote career mobility for individuals in nursing, prepare more nurses at the baccalaureate level, and provide continuing education training to enhance the quality of patient care.
• Nursing Workforce Diversity ($14.3 million) supports 44 grants that increase nursing education opportunities for individuals from disadvantaged backgrounds, including racial and ethnic minorities underrepresented among registered nurses.
• Faculty Development: Integrated Technology into Nursing Education and Practice Initiative ($2.5 million) supports nine grants for faculty development projects in information and other technologies to expand the capacity of collegiate schools of nursing to educate students for 21st century health care practice.

Interdisciplinary Geriatric Education and Training

Eighty-five awards totaling $29.5 million will fund three geriatric education and training programs at accredited health professions schools.

• Geriatric Education Centers (GEC) ($17.2 million) supports 45 awards to improve training of health professionals in geriatrics; develop curricula relating to treating health problems of the elderly; and support faculty training and continuing education for health professionals in geriatric care.
• Geriatric Training for Physicians, Dentists, and Behavioral and Mental Health Professionals (GTPD) ($8.1 million) supports 13 grants to geriatric training projects that will train health professionals who plan to teach geriatric medicine, geriatric dentistry, or geriatric behavioral or mental health.
• Comprehensive Geriatric Education Program (CGEP) ($4.2 million) supports 27 grants for projects to train and educate individuals in providing geriatric care for the elderly, including curriculum development, faculty training and continuing education for geriatric providers.

Centers for Excellence Grants

Eighteen awards totaling $23.6 million were announced to support Centers of Excellence programs that are designed to improve the recruitment and performance of underrepresented minority students preparing for health professions careers.

The program supports activities to develop an educational pipeline to enhance academic performance of underrepresented minority students, support underrepresented minority faculty development, facilitate research on health issues particularly affecting underrepresented minority groups, and provide training to students at community-based health facilities for providing health services to underrepresented minority individuals. The awardees are schools of allopathic medicine, osteopathic medicine, dentistry, pharmacy, and allied health (including designated Historically Black Colleges and Universities (HBCUs); graduate programs in behavioral health; and other public and nonprofit health or educational organizations.

Secretary Sebelius will highlight the grants, which include both new and continuing grants, at the National Health Service Corps Conference today. The National Health Service Corps is another HRSA program which has seen new resources under the Obama Administration to invest in America's health care workforce in underrepresented areas.

State by state charts of the grant awards are available at http://www.hhs.gov/news/press/2010pres/08/state_charts.html.

For more information on HRSA's health professions programs, go to http://bhpr.hrsa.gov/

The Health Resources and Services Administration is part of the U. S. Department of Health and Human Services. HRSA is the primary federal agency responsible for improving access to health care services for people who are uninsured, isolated, or medically vulnerable. For more information about HRSA and its programs, visit www.hrsa.gov

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Posted by Lucas A. Ferrara, Esq. at 11:00 AM | Permalink | TrackBacks (0) | Comments (0)

ATTORNEY GENERAL CUOMO LAUNCHES INDUSTRY-WIDE INVESTIGATION INTO PREDATORY HEALTH CARE LENDING THAT IS PUSHING CONSUMERS NATIONWIDE INTO DEBT

Health care credit card scheme preys on seniors and vulnerable patients ~Cuomo subpoenas health care practices and credit card companies

Yesterday, Attorney General Andrew M. Cuomo announced an industry-wide investigation into predatory health care lending where consumers, especially seniors and vulnerable patients, are misled about financing, causing them to be pushed into debt.

An investigation by Attorney General Cuomo found that some health care providers pressure consumers into using GE Money's CareCredit, a health care credit card, through fast-talking sales pitches and deceit. The investigation also found that CareCredit often pays kickbacks in the form of rebates to the providers based on how much business they charge consumers on CareCredit cards.

The investigation was based in part on hundreds of consumer complaints received by the Attorney General's Office. Consumers reported that health care providers promised that the credit card had "no interest," when it often carried retroactive interest of over 25 percent if not paid in full during a promotional period. Consumers were also unknowingly charged up front for services they never received, and their attempts to obtain refunds were often thwarted or ignored. Meanwhile, CareCredit pays the health care providers in-full within 48 hours of the charge.

The investigation also found that CareCredit charges the providers a fee for the right to offer the cards, and then rebates part of the fee based on the amount of money the providers generated through CareCredit sales. This kickback arrangement, plus CareCredit's payment in full to providers within two days of the charge, creates an incentive for providers to push consumers to use CareCredit rather than other methods of payment. In fact, providers pushed CareCredit over cash.

"Health care debt is the number one cause of individual bankruptcy, and this scheme is contributing to the economic burden being felt by consumers," said Attorney General Cuomo. "People are being tricked by misleading offers that have them paying for services they never received as well as interest charges they never knew about - and they are ignored and given the runaround when they try to get their money back."

Cuomo issued subpoenas to 10 providers that promote CareCredit, as well as to the companies that manage CareCredit, Chase Health Advance, Visa Health Benefits, and Citibank Health Card. The subpoenas seek marketing materials, applications, terms of credit, contracts and rebate agreements, policies and procedures, consumer complaints, and regulatory inquiries. This investigation is ongoing.

In addition, Cuomo is asking several nationwide and state-based medical associations, including the American Dental Association and the New York State Dental Association, to explain why they endorsed CareCredit and whether they received compensation for doing so. 

CareCredit is accepted by more than 125,000 health care practices nationwide. The New York State Dental Association asserts that more than 8 million dental patients and 80,000 dental practices use CareCredit nationwide. The credit card is advertised as a way to pay for services often not covered by insurance, including:

• Chiropractic procedures
• Cosmetic procedures
• Dental procedures
• Infertility treatment
• Hearing procedures
• Vision procedures
• Weight loss procedures
• Veterinary services

In recent years, Attorney General Cuomo's Office received hundreds of complaints from consumers indicating that they were lured and misled by providers into applying for, accepting, and using CareCredit. Among the complaints received by the Attorney General's Office regarding the scam: 

• A Williamsville resident went to a dental provider with a toothache and was told he needed $9,000 in work done. He told the practice's office manager that he had the ability to pay for the service in cash, but he was still persuaded to sign up for financing through CareCredit. He ended up having the work done elsewhere, but the full amount of charges was billed to his card, despite receiving no services from the practice.
• An Onondaga County woman was told by a dental practice she needed a variety of procedures, and to get them she would have to sign a CareCredit agreement. After only having one $400 procedure done, which she paid for, she received a bill for $2,600. Her attempts to get a refund were rejected by both the provider and CareCredit.
• An Oswego woman was given a $6,000 estimate for dental procedures. She was urged to sign up for CareCredit, and was told this was an interest-free, monthly payment plan. However, she was charged up-front before the procedures were done, plus interest.
• A Monroe County man signed up for CareCredit to pay for an estimated $5,600 in services from his provider, but it was not made clear he was agreeing to a credit card. He left the medical office and sought treatment elsewhere, but continued to receive bills from CareCredit, which insisted he was delinquent on payments, resulting in a negative credit report and the reduction of his other lines of credit.
• A Syracuse-area consumer was told by his chiropractor that he needed two years of treatment and he was signed up for a CareCredit card without his consent. He was charged $3,000, which CareCredit refused to rescind. When the consumer switched to a different provider because the treatments at his chiropractor worsened his condition, the practice refused to release his medical records, claiming he still owed them money. 
• A woman from Tioga County went to a provider where an application to CareCredit was "thrown in (her) face." No other financing options were offered to her, and she was charged $5,000 for a procedure that failed multiple times and for which another provider later charged only $1,200.

Chuck Bell, Programs Director for Consumers Union, nonprofit publisher of Consumer Reports, said, "Attorney General Cuomo's investigation shines a badly-needed spotlight on deceptive practices used to market health care credit cards to elderly and low-income consumers. We are concerned that some health care providers are aggressively marketing these high-interest credit cards to patients, without providing appropriate disclosures, protections, or refunds. Consumers Union strongly supports the Attorney General's investigation, and applauds his ongoing efforts to protect consumers across the nation."

Catherine Dunham, President of The Access Project, a resource center for local communities working to improve health and health care access, said, "With the cost of health care already an enormous burden on Americans, we must do everything we can to filter out abusive or deceptive practices in how providers take payment for care. Attorney General Cuomo's investigation into health care credit cards will help protect millions of patients across the country who are struggling with debt. We applaud his efforts and look forward to continuing to partner with him to protect patients."

Consumers wishing to file complaints regarding deceptive health care credit card practices are urged to contact the Attorney General's Office at HealthCreditCards@ag.ny.gov or 800-428-9071. Consumer tips and more information about the investigation, including an example of the letters sent to trade groups, can be found online at www.ag.ny.gov.

The investigation is being conducted by Assistant Attorney General Carol Hunt of the Health Care Bureau under the supervision of Executive Deputy Attorney General for Social Justice Mylan Denerstein and Special Counsel to the Attorney General Linda A. Lacewell. 

Subpoenas to Health Care Providers:

• Allcare Dental Management Inc. - Buffalo
• American Laser Centers - Farmington Hills, MI
• Aspen Dental Management, Inc. - East Syracuse
• East Syracuse Family Dental Arts - East Syracuse
• Laser Cosmetica - New York City
• Lifestyle Lift - Troy, MI
• Northern Lights Chiropractic - Watertown
• S & Y Diamond Dental P.C. - Brooklyn
• Sunshine Dental - Watertown
• Toothsavers - New York City

Letters to Groups Endorsing CareCredit:

• American College of Eye Surgeons
• Society for Excellence in Eyecare
• American Dental Association
• Academy of General Dentistry
• American Academy of Periodontology
• American Association of Oral & Maxillofacial Surgeons
• New York State Dental Association
• American Society of Plastic Surgeons
• American Society of Dermatologic Surgery
• American Animal Hospital Association
• New York State Veterinary Medical Society
• American Hearing Aid Associates
• American Society of Bariatric Physicians
• Lite and Hope

Posted by Lucas A. Ferrara, Esq. at 9:00 AM | Permalink | TrackBacks (0) | Comments (0)

Do it for the people you care about

From the U.S. Department of Health and Human Services, I'm Ira Dreyfuss with HHS HealthBeat.

Many people don't go to the doctor as much as they should, and don't take care of themselves as well as they should. And middle aged men for sure have that problem.

HHS' Agency for Healthcare Research and Quality, AHRQ, reviewed health care use. AHRQ's Dr. Francis Chesley:

"As a result, men are about 30 percent more likely than women to be hospitalized for preventable conditions such as congestive heart failure or complications from diabetes." (10 seconds)

Another example: Men are 24 percent more likely than women to be hospitalized for pneumonia that could have been prevented by getting an immunization.

These are prime family-supporting years, so AHRQ has an outreach campaign asking men to take care of themselves so they can be there for their loved ones.

Learn more at hhs.gov.

Posted by Lucas A. Ferrara, Esq. at 3:00 PM | Permalink | TrackBacks (0) | Comments (0)

MAYOR BLOOMBERG AND FIRE COMMISSIONER CASSANO ANNOUNCE LIFE-SAVING HYPOTHERMIA TREATMENT NOW BEING ADMINISTERED BY CITY PARAMEDICS

Posted by Lucas A. Ferrara, Esq. at 9:00 AM | Permalink | TrackBacks (0) | Comments (0)

22 Million Cataract Cases Will Be Prevented by Stronger Ozone Layer Protection

The U.S. Environmental Protection Agency marked the beginning of Cataract Awareness Month by announcing a new peer-reviewed report predicting that more than 22 million additional cataract cases will be avoided for Americans born between 1985 and 2100 due to the Montreal Protocol. The environmental treaty, signed by 196 countries, was designed to reduce and eventually eliminate ozone depleting substances. Too much UV radiation not only increases the risk for skin cancer, but also increases the risk for cataracts -- a clouding of the eye's lens that affects more than 20 million Americans age 40 and older.

"Since the 1970s, we have prevented millions of skin cancer cases and deaths through our work protecting the ozone layer," said Gina McCarthy, assistant administrator for EPA's Office of Air and Radiation. "I am excited to kick off Cataract Awareness Month by announcing that the science has now enabled us to estimate our impact on cataracts."

Due to the success of the Montreal Protocol, the ozone layer is predicted to recover to pre-1980 levels after 2065. In the meantime, under a compromised ozone layer, more ultraviolet (UV) radiation reaches the Earth's surface. While treatment for cataracts is widely available in the U.S., the costs are high, with direct medical costs estimated to be $6.8 billion per year

For the first time, EPA is able to include data on cataract risk by gender and skin type in the report. However, all people, regardless of gender and skin type, are at risk for cataracts. This is why it is important for adults and children to use eyewear that absorbs UV rays and to wear a wide-brimmed hat.  

The following changes in vision may be signs of cataracts:

·         Blurred vision, double vision, ghost images, the sense of a "film" over the eyes

·         Lights seem too dim for reading or close-up work, or feeling "dazzled" by strong light

·         Changing eyeglass prescriptions often, and the change does not seem to help.

Information on the report:

http://www.epa.gov/ozone/science/effects/index.html.

More information on eye damage: http://www.epa.gov/sunwise/doc/eyedamage.pdf.

More information on the Montreal Protocol:  http://www.epa.gov/ozone/intpol/

Posted by Lucas A. Ferrara, Esq. at 3:00 PM | Permalink | TrackBacks (0) | Comments (0)

Combating Misuse and Abuse of Prescription Drugs: Q&A with Michael Klein, Ph.D.

Pharmacologist Michael Klein, Ph.D., is director of the Food and Drug Administration (FDA) Controlled Substance Staff.

During more than 30 years of federal service, he has amassed extensive experience with issues related to drug regulation, abuse, misuse, and addiction. Prior to joining FDA 20 years ago, Dr. Klein worked as a senior scientist with the Drug Enforcement Administration (DEA).

Q: What is misuse and abuse of prescription drugs?

A: When a person takes a legal prescription medication for a purpose other than the reason it was prescribed, or when that person takes a drug not prescribed to him or her, that is misuse of a drug. Misuse can include taking a drug in a manner or at a dose that was not recommended by a health care professional. This can happen when the person hopes to get a bigger or faster therapeutic response from medications such as sleeping or weight loss pills. It can also happen when the person wants to "get high," which is an example of prescription drug abuse.

Q: What's the difference between misuse and abuse?

A: It mostly has to do with the individual's intentions or motivations. For example, let's say that a person knows that he will get a pleasant or euphoric feeling by taking the drug, especially at higher doses than prescribed. That is an example of drug abuse because the person is specifically looking for that euphoric response.

In contrast, if a person isn't able to fall asleep after taking a single sleeping pill, they may take another pill an hour later, thinking, "That will do the job." Or a person may offer his headache medication to a friend who is in pain. Those are examples of drug misuse because, even though these people did not follow medical instructions, they were not looking to "get high" from the drugs. They were treating themselves, but not according to the directions of their health care providers.

However, no matter the intention of the person, both misuse and abuse of prescription drugs can be harmful and even life-threatening to the individual. This is because taking a drug other than the way it is prescribed can lead to dangerous outcomes that the person may not anticipate.

Q: What are the dangers linked to misuse and abuse of prescription drugs?

A: It's important to note that all drugs can produce adverse events (side effects), but the risks associated with prescription drugs are managed by a health care professional. Thus, the benefits outweigh the risks when the drug is taken as directed.

However, when a person misuses or abuses a prescription drug, there is no medical oversight of the risks. A person can die from respiratory depression from misusing or abusing prescription painkillers; for example, opioids. Prescription sedatives like benzodiazepines can cause withdrawal seizures. Prescription stimulants such as medications for attention deficit hyperactivity disorder (ADHD) can lead to dangerous increases in blood pressure. The risks from these drugs are worse when they are combined with other drugs, or alcohol.

Additionally, when a person misuses a prescription drug, even on a single occasion, that individual might enjoy the experience so much that they begin to seek out the drug more often. Thus, drug abuse and drug dependence are serious risks of misusing prescription drugs.

Q: Why do people misuse and abuse prescription drugs?

A: Prescription drugs are often readily accessible in the home, so it's easy to take more of them than recommended for a therapeutic reason, or to sneak a few from someone else's bottle to see if you can "get high."

One feature of prescription drug abuse is when a person continues to take the drug after it's no longer needed, medically. This is usually because the drug produces euphoric responses. Prescription drugs are often preferred for abuse because of the mistaken belief that the drugs provide a "safe high." But as I mentioned before, all drugs carry risks, and if these risks are not being managed by a health care professional, people can get into serious trouble.

Q: How big is this problem?

A: The prevalence of misuse and abuse of prescription medications is concerning. The Substance Abuse and Mental Health Services Administration (SAMHSA), a federal health agency, reports that in 2008, 52 million persons in the United States age 12 or older had used prescription drugs nonmedically at least once in their lifetime, and 6.2 million had used them in the past month. SAMHSA also reported that between 1998 and 2008, there was a 400 percent increase in substance abuse treatment admissions for opioid prescription pain relievers.
 
A recent Centers for Disease Control and Prevention (CDC) survey found that one in five high school students had taken a prescription drug without a doctor's prescription. According to SAMHSA, the majority of these teenagers are obtaining the drugs from friends or relatives for free. Most concerning, the perception of risk of prescription drug abuse declined 20 percent from 1992 to 2008, based on data from a National Institute on Drug Abuse survey.

Q: What prescription drugs are being misused and abused?

A: SAMHSA reports that in 2008, nonmedical use of psychotherapeutic prescription drugs fell into four major classes: pain relievers, tranquilizers, stimulants, and sedatives.

Nearly 35 million Americans reported that they had nonmedical use of prescription pain relievers--including opioid-containing drugs such as hydrocodone (Vicodin), oxycodone (OxyContin, Percodan, Percocet), and fentanyl (Duragesic)--at least once during their lifetime.

Approximately 21.5 million Americans have used prescription tranquilizers for nonmedical purposes at least once. These include drugs prescribed for anxiety or insomnia, such as benzodiazepines--including diazepam (Valium), alprazolam (Xanax) and clonazepam (Klonapin)--and non-benzodiazepines such as zolpidem (Ambien), zaleplon (Sonata) and eszopiclone (Lunesta).

Similarly, about 21.2 million Americans have used prescription stimulants nonmedically at least once. These include drugs prescribed for ADHD such as amphetamine (Adderall), methylphenidate (Ritalin, Concerta, and Daytrana), and methamphetamine. Notably, almost 13 million people reported they had used prescription methamphetamine at least once during their lifetime.

Finally, nearly 9 million Americans have used prescription sedatives nonmedically at least once. These sedatives include barbiturates such as amobarbital (Amytal), pentobarbital (Nembutal), and secobarbital (Seconal).

Q: Who is misusing and abusing these medications?

A: Prescription drugs are being misused and abused by a wide variety of people. According to SAMHSA, about 26 million Americans between the ages of 26 and 50 report they have used prescription drugs non-medically at some point in their life. Other age groups have lower lifetime incidents: 13 million who are age 50 or older, 9 million who are age 18 to 25, and 3 million who are 12 to 17 years of age.

There also appears to be regional differences across the U.S. For example, SAMHSA reports that the highest past-year rates of nonmedical use of prescription pain relievers occur in Arkansas, Kentucky, Nevada, Oklahoma, Oregon, Tennessee, and Wisconsin.

Q. Should a person's health care professional tell them about the risks associated with a medication with abuse potential?

A: Yes. The health care professional should talk to a patient about all of the warnings and precautions listed in the drug label for the medication being prescribed. In addition, if a medication guide is available, it will explain the risks of the drug in plain language. The pharmacy will provide the medication guide when a person picks up the prescription.

FDA also recommends that patients be vigilant when it comes to matters of their health. Reading information and asking questions are good practices, though they are only the first steps. For instance, individuals may not realize they are developing a drug abuse problem with a prescription drug, especially if they were initially using the drug as directed when they were patients.

Health care professionals should encourage patients to be aware of early signs of drug abuse, which can include using the prescription more frequently or at higher doses, but without medical direction to do so. Using the drug compulsively or not being able to carry out normal daily activities because of drug misuse are also signs of abuse.

Finally, health care professionals and pharmacists have a responsibility to remind patients not to share their medications with friends or family. Not only is this a dangerous practice health-wise, it is also illegal.

Q: How does FDA help prevent misuse and abuse of prescription medicines?

A: FDA works hard to meet the challenges of preventing misuse and abuse of prescription drugs, while making sure that medically appropriate drugs are available for the patients who need them.

The primary way FDA works to prevent misuse and abuse is through educating patients, caregivers, and health care professionals. This often occurs through the information FDA provides to each of these groups, such as in drug labels, medication guides, and alerts.

But long before a patient can obtain a prescription, FDA has already evaluated whether the drug is safe and effective for a particular medical condition. FDA only approves those drug applications that have been shown to be safe and effective for a specific indication, and the data from this review is then used to create informational materials.

FDA is also part of the wider national strategy involving other government agencies, the pharmaceutical industry, medical organizations, and community groups, among other entities. This combined effort addresses improved treatment, prevention, enforcement, and emerging drugs of abuse.

Q: How is a prescription medication classified as having potential for abuse?

A: During FDA's drug review process, certain data can give indications that a drug has abuse potential. The chemical structure may be similar to a known drug of abuse. When the drug is given to animals, it may produce behaviors that are like those produced by abusable drugs. In humans, the drug may produce a high rate of euphoria.

FDA considers these and all abuse-related data to make a determination regarding abuse potential, which is a part of the safety evaluation of a drug. If a drug is deemed to have abuse potential, DEA is informed and they may add the drug to the list of substances covered by the Controlled Substances Act (CSA).

In addition, FDA can become aware that a drug has abuse potential through other means. For example, there may be epidemiological reports of abuse that only became evident after the drug was marketed. Also, DEA informs us that there is an increase in law enforcement actions related to a specific drug. In both cases, FDA reviews all available data and makes a scientific and medical assessment of whether the drug has abuse potential. If it does, DEA is informed and may schedule the drug under the CSA.

Q: What are the keys to preventing abuse of prescription medicines?

A: Be informed about the effects of prescription drugs and be vigilant. Know what medications your loved ones are taking and watch for signs of changes in behavior. For instance, have you noticed negative changes in your child's behavior or grades? Is your spouse evasive about how much medication he or she is taking? Do you have friends that you suspect might be pilfering prescription drugs from your medicine cabinet?

SAMHSA has a great website on signs of prescription drug abuse.

If you are taking medications that have abuse potential, use the drugs only as directed. Don't share them, and store them in a safe, secure place. Count the pills regularly to make sure no one else is using them. If you are having a house party or an open house, make sure the medications are properly secured.

Finally, all drugs should be disposed of properly after they are no longer needed. If no specific disposal directions are given with the medication, discard the drugs by mixing with undesirable substances, sealing them in a container, and placing them in the trash. You can also call your local DEA office for advice on alternative disposal methods.

Q: What can I do if I find that someone I know is abusing prescription drugs, or if I find myself becoming dependent on them?

A: SAMHSA has a website (www.samhsa.gov) and a telephone hotline (800-662-HELP [4357]) to aid in finding treatment facilities in different areas of the country.
I recommend contacting them and a health care professional, as no single type of treatment is appropriate for everyone who is abusing prescription drugs.

Posted by Lucas A. Ferrara, Esq. at 1:00 PM | Permalink | TrackBacks (0) | Comments (0)

COMMUNITY BOARD 2 PASSES RESOLUTION CALLING FOR A HOSPITAL AT THE SITE OF ST. VINCENT'S AND A LOCK ON LAND TO ENSURE IT

Over one hundred members of the Coalition for a New Village Hospital came out to the Community Board 2 Full Board Meeting at Elizabeth Irwin High School on Thursday July 22nd to demand a resolution that would protect land use at the St. Vincent's Hospital Campus to ensure it is used for a hospital.

After hours of testimony, in a showing of solidarity with the community, the Board passed a resolution calling on elected officials and the Bankruptcy Court to protect the existing land use by opposing any changes to the zoning, use and occupancy or any other law that would eliminate hospital use at the site.  The board also called on the Bankruptcy Court to set up a Community Council, with the aid of the New York City Corporation Counsel, to represent the community in the Bankruptcy Court's procedures.

Yetta Kurland, a civil rights attorney and member of the Coalition stated "This is an incredible victory for our Community.  Thanks to the courage and leadership of many Community Board members and the continued hard work of so many who have been fighting since the hospital closed on April 30th, we now have a resolution that our elected officials must listen to.  We will settle for nothing less than a hospital at the St. Vincent's site."

The strong language that "opposes all changes in land use" was not initially on the agenda for the meeting.  But after hearing testimony from members of the Coalition for a New Village Hospital and other community members speaking in favor of a land lock, the Board changed course and demanded that the resolution be amended to include such language.  Arthur Schwartz, a civil rights attorney and member of Community Board 2 negotiated the language for the amendment to the resolution which was passed by a vote of 29 for and only 6 opposed.

Another Coalition member and St. Vincent's Physician, David Kaufman, MD stated "The hundreds of thousands of residents that live and work on the Lower West Side and the physicians who serve them desperately need a full service hospital and emergency room.  I congratulate and thank Community Board 2 for their support and recognition of this critical need."

Eileen Dunn RN, a St. Vincent's nurse and member of the Coalition thanked the members of Community Board 2 stating  "Community Board 2 has shown its true commitment to those they represent and I thank them for acknowledging, through this resolution, the importance of the health and safety of the people of the Lower West Side."

The Board's resolution puts them on record opposing any changes to the zoning, certificate of occupancy or other part of the land use that would eliminate the hospital use.  Community Boards, while advisory, are considered an essential part of the ULURP process required to achieve such changes.  Speaker Christine Quinn who also plays a vital role in the ULURP process is also recently on record stating that she "will continue our push for a full service hospital here."  A full copy of the resolution is included below.

FULL TEXT OF RESOLUTION:

At its Full Board meeting on July 22, 2010, Community Board 2 (Manhattan) adopted the following resolution:

RESOLUTION STATING CB 2'S SUPPORT FOR THE CONTINUATION OF HEALTH CARE SERVICES ON THE FORMER ST. VINCENT'S CAMPUS
 
WHEREAS, the closure of St. Vincent's Hospital has resulted in the community's loss of an emergency room, in-patient hospital, Level 1 trauma center and the capacity to address a widespread public health emergency such as a natural disaster or act of terrorism, creating a significant gap in the health care services available to the residents of this community board and the entire Lower West Side of Manhattan; and
 
WHEREAS, as heard by the community board during the June 14 and July 15, 2010 public hearings and at previous community meetings, there is widespread public support for the re-establishment of a full-service, acute care hospital on the former St. Vincent's campus, and the community board reiterates its strong support for such a hospital at such location, as well; and
 
WHEREAS, all or part of the current St. Vincent's campus is the most logical, cost-effective, and central location for the re-establishment of such a hospital or other health care facility that will adequately address the community's myriad health care needs, and, in fact, may be the only location suitable for such a facility, which compounds the urgency of this resolution.
 
THEREFORE BE IT RESOLVED that Community Board No. 2 opposes all changes in land use laws, zoning rules, landmarks laws, or any other laws that would eliminate hospital uses at the site of the former St. Vincent's; and

THEREFORE BE IT RESOVED that CB2 shall seek to petition the Bankruptcy Court and create a community committee to explore in a publicly transparent manner, all options for the St. Vincent's campus, and requests assistance from the NYC Corporation Counsel to assert such a petition; and

THEREFORE BE IT RESOLVED that CB2 urges our elected officials to join the Community Board in this petition.

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Possible Increased Risk of Bone Fractures With Certain Antacid Drugs

There is a possible increased risk of fractures of the hip, wrist, and spine if you take certain drugs for heartburn, acid reflux, or ulcers, warns the Food and Drug Administration (FDA).

The drugs belong to a class of medications called proton pump inhibitors (PPIs), which work by reducing the amount of acid in the stomach. They are available both as prescription and as over-the-counter (OTC) medications.

The prescription PPIs treat conditions such as gastroesophageal reflux disease (GERD), ulcers in the stomach and small intestine, and inflammation of the esophagus. The PPIs available over-the-counter are used to treat frequent heartburn.

The prescription PPIs are

• Nexium
• Dexilant
• Prilosec
• Zegerid
• Prevacid
• Protonix
• Aciphex
• Vimovo

The over-the-counter PPIs are

• Prilosec OTC (omeprazole)
• Zegerid OTC (omeprazole)
• Prevacid 24HR (lansoprazole)

Advice for Consumers

• Do not stop taking your PPI unless you are told to do so by your health care professional. PPIs are effective in treating a variety of gastrointestinal disorders.
• Be aware that an increased risk of fractures of the hip, wrist, and spine have been reported in some studies of people who use PPIs. The greatest increased risk for these fractures was seen in those who receive high doses of these medications or use them for a year or longer.
• Read and follow the directions on the "Drug Facts" label when considering the use of an over-the-counter PPI.
• Be aware that the over-the-counter PPIs should only be used as directed for 14 days for the treatment of frequent heartburn. If your heartburn continues, talk to your health care professional. No more than three 14-day treatment courses should be used in one year.
• Talk to your health care professional about any concerns you may have about using PPIs.
• Report any side effects from the use of PPIs to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
  • Online
  • Regular Mail: Use postage-paid, pre-addressed FDA form 3500
  • Fax: 1-800-FDA-0178 
  • Phone: 1-800-332-1088

FDA Actions

FDA has reviewed seven published studies, six of which reported an increased risk of fractures of the hip, wrist, and spine with the use of PPIs. Based on the available data, it is not clear at this time if the use of PPIs is the cause of the increased risk of fractures seen in some studies. FDA is working with the manufacturers of PPIs to further study this possible risk.

Most of the studies evaluated individuals 50 years of age or older, and the increased risk of fracture was seen mainly in this age group.

As a precaution, FDA is revising the labels for both the prescription and the over-the-counter PPIs to include new safety information about the possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

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Preventing hepatitis

From U.S. Department of Health and Human Services, I'm Ira Dreyfuss with HHS HealthBeat.

Viral hepatitis kills up to 15,000 Americans a year, but there are vaccines to prevent hepatitis A and B, although there is no vaccine for the third type, hepatitis C.

At the Centers for Disease Control and Prevention, John Ward says kids ought to get both vaccines - after one year for hepatitis A, and as infants beginning at birth for hepatitis B.

Ward says adults should get the hepatitis A vaccine if they are at higher risk for the disease, such as before traveling to areas where it's more common. And he says adults should get the hepatitis B vaccine:

``Vaccine coverage is very low still for adults with risks for hepatitis B, relative to children. And this is hampering our efforts to eliminate hepatitis B transmission in the United States.'' (10 seconds)

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I'm Ira Dreyfuss.

Posted by Lucas A. Ferrara, Esq. at 2:00 PM | Permalink | TrackBacks (0) | Comments (0)

Office of the Press Secretary

Weekly Address: President Obama Praises New Wall Street Reform Law; Says GOP Plan Will Take Us Backward

WASHINGTON - In this week's address, President Obama praised the Wall Street reform bill that he signed into law on Wednesday and explained how it fits into the greater strategy to bring the country out of recession and build an economy for the long run.  The president's plan is aimed at strengthening the middle class and gives tax breaks to small businesses that creates jobs here, invests in homegrown, clean energy, and cuts taxes for working families.  Unfortunately, when the Republican leader in the House offered his plan to create jobs this week, he presented the same policy ideas that led to this recession - ideas that will kill jobs instead of create them, and will add $1 trillion to the deficit, not reduce it.

Remarks of President Barack Obama
As Prepared for Delivery
Weekly Address
The White House
July 24, 2010

This week, I signed into law a Wall Street reform bill that will protect consumers and our entire economy from the recklessness and irresponsibility that led to the worst recession of our lifetime.  It's reform that will help put a stop to the abusive practices of mortgage lenders and credit card companies.  It will end taxpayer bailouts of Wall Street firms.  And it will finally bring the shadowy deals that caused the financial crisis into the light of day.

Wall Street reform is a key pillar of an overall economic plan we've put in place to dig ourselves out of this recession and build an economy for the long run - an economy that makes America more competitive and our middle-class more secure.  It's a plan based on the Main Street values of hard work and responsibility - and one that demands new accountability from Wall Street to Washington. 

Instead of giving tax breaks to corporations that ship jobs overseas, we want to give tax breaks to small business owners who are creating jobs right here in America.  Already, we've given small businesses eight new tax cuts, and have expanded lending to more than 60,000 small business owners.  

We're also investing in a homegrown, clean energy industry - because I don't want to see new solar panels and wind turbines and electric cars manufactured in some other country.  I want to see them made in America, by American workers.  So far, we've provided new tax credits, loan guarantees, and investments that will lead to more than 800,000 clean energy jobs by 2012.  And throughout America, communities are being rebuilt by people working in hundreds of thousands of new private sector jobs repairing our roads, bridges, and railways.

Our economic plan is also aimed at strengthening the middle-class.  That's why we've cut taxes for 95% of working families.  That's why we've offered tax credits that have made college more affordable for millions of students, and why we're making a new commitment to our community colleges.  And that's why we passed health insurance reform that will stop insurance companies from dropping or denying coverage based on an illness or pre-existing condition.   

This is our economic plan - smart investments in America's small businesses, America's clean energy industry, and America's middle-class.  Now, I can't tell you that this plan will bring back all the jobs we lost and restore our economy to full strength overnight.  The truth is, it took nearly a decade of failed economic policies to create this mess, and it will take years to fully repair the damage.  But I am confident that we are finally headed in the right direction.  We are moving forward.  And what we can't afford right now is to go back to the same ideas that created this mess in the first place. 

Unfortunately, those are the ideas we keep hearing from our friends in the other party.  This week, the Republican leader in the House of Representatives offered his plan to create jobs.  It's a plan that's surprisingly short, and sadly familiar. 

First, he would repeal health insurance reform, which would take away tax credits from millions of small business owners, and take us back to the days when insurance companies had free rein to drop coverage and jack up premiums.   Second, he would say no to new investments in clean energy, after his party already voted against the clean energy tax credits and loans that are creating thousands of new jobs and hundreds of new businesses.  And third, even though his party voted against tax cuts for middle-class families, he would permanently keep in place the tax cuts for the very wealthiest Americans - the same tax cuts that have added hundreds of billions to our debt.

These are not new ideas.  They are the same policies that led us into this recession.  They will not create jobs, they will kill them.  They will not reduce our deficit, they will add $1 trillion to our deficit.  They will take us backward at a time when we need to keep America moving forward.

I know times are tough.  I know that the progress we've made isn't good enough for the millions of Americans who are still out of work or struggling to pay the bills.  But I also know the character of this nation.  I know that in times of great challenge and difficulty, we don't fear the future - we shape the future.  We harness the skills and ingenuity of the most dynamic country on Earth to reach a better day.  We do it with optimism, and we do it with confidence.  That's the spirit we need right now, and that's the future I know we can build together.  Thank you.

Posted by Lucas A. Ferrara, Esq. at 11:00 AM | Permalink | TrackBacks (0) | Comments (0)

FDA Cautions Against Using Unapproved IUDs

Federal health officials are warning medical practitioners around the country not to use unapproved intrauterine devices (IUDs).

In a July 22 letter, the Food and Drug Administration (FDA) reminds health professionals that using unapproved IUDs raises concerns about effectiveness and safety--as well as the potential for fraud and counterfeiting.

"Federal law requires that IUD/IUSs (intrauterine systems) be FDA-approved prior to marketing. This law is designed to protect patients from products that are unsafe and ineffective," Theresa Toigo, FDA's liaison with health professionals, says in the letter. "The recent issue with patients in Rhode Island unknowingly receiving imported, unapproved IUD/IUSs highlights the unacceptable risk patients may be exposed to when a product's identity, purity, source, handling, and storage cannot be verified."

Still, patients can use their FDA-approved IUDs with confidence, Toigo says.

FDA experts say women who received unapproved IUDs from practitioners in Rhode Island, Massachusetts, and Kentucky could be at an increased risk for unwanted pregnancy.

The small, T-shaped devices--often made of flexible plastic or copper wire--are inserted into a woman's uterus to prevent pregnancy. Some IUDs also deliver small amounts of hormone as added protection from pregnancy.

FDA says women should not try to remove IUDs by themselves. The agency is advising women who think they may have an unapproved IUD to use another form of birth control--such as condoms, birth control pills, or the patch--and contact their health care professional. Women may want to ask:

• What advantages are there for keeping my IUD in?
• Should I think about having my IUD removed?
• If I keep my IUD in, how long should I use another form of birth control?
• If I want my IUD removed, can I get a new, FDA-approved one?
• I don't want to use condoms. Will other birth control products, such as the pill, patch, or ring, be equally effective?
• Will this affect my ability to get pregnant in the future?
• What should I do if I think I'm pregnant?

Nationwide Problem

What started out as a Rhode Island investigation has spread beyond the state's borders. The FDA is aware of the use of these unapproved products in several states and is continuing to investigate.

FDA says doctors, nurses, midwives--and possibly patients themselves--might buy unapproved products from what appear to be Canadian or other foreign websites in a bid to save money. Purchasing medical products from websites that are outside of the U.S. may be illegal and may increase the risk of receiving a potentially harmful product, since many websites sell products that are not FDA-approved and could be manufactured in other countries.

"Unapproved products bring a lot of unknowns into the equation," says FDA compliance officer Kathleen Anderson. "An Internet ad may claim to sell IUDs made in Canada, but there's no way to be sure. They might have been made anywhere in the world and in unsanitary or undesirable conditions."

Advice for Consumers

FDA investigators routinely monitor the Internet for the sale of unapproved drugs and devices in an effort to protect the public, but the rapidly growing number of websites trafficking in fraudulent medical products means consumers must remain alert.

Experts advise consumers to learn how to buy health-related products safely over the Internet. Legitimate Internet pharmacies are licensed by the appropriate state board of pharmacy and follow laws and regulations of the state where they operate.

Legitimate Internet pharmacies will also display a seal from the National Association of Boards of Pharmacy--known as VIPPS seal or Verified Internet Pharmacy Practice Sites. VIPPS pharmacies are listed at vipps.nabp.net/verify.asp⁴.

FDA is also asking the public to report information about the distribution of unapproved IUDs. To contact the agency's criminal investigators visit www.fda.gov/oci⁵.

This article appears on FDA's Consumer Updates page⁶, which features the latest on all FDA-regulated products.

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Using Malaria Medication for Leg Cramps is Risky

People who use the drug Qualaquin to treat or prevent nighttime leg cramps may be at risk for serious and life-threatening reactions, according to the Food and Drug Administration (FDA).

Qualaquin (quinine sulfate) is FDA-approved only to treat a certain type of malaria (uncomplicated malaria) caused by the parasite Plasmodium falciparum.This infection, which is rare in the United States, is found mainly in travelers who have been to countries where malaria occurs.

However, most of Qualaquin's use in the U.S. is for the treatment or prevention of nighttime leg cramps--a use not approved by FDA.

FDA has received reports of side effects--two resulting in death--after people used Qualaquin to prevent or treat leg cramps or restless leg syndrome. Side effects included

• serious bleeding due to a severe lowering of blood cells called platelets (thrombocytopenia)
• a condition that may result in permanent kidney damage
• heart and blood vessel (cardiovascular) problems
• hearing loss
• electrolyte imbalance

Advice for Consumers

• If you take Qualaquin for nighttime leg cramps, you should discuss other treatment options with your health care professional.
• Contact your health care professional immediately if you experience easy bruising, severe nose bleeding, blood in your urine or stool, bleeding gums, or the appearance of unusual purple, brown, or red spots on your skin.
• Read the medication guide given to you at the pharmacy when you pick up a prescription for Qualaquin.
• Report any side effects with the use of Qualaquin to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
• Online
• Regular Mail: Use postage-paid, pre-addressed FDA form 3500
• Fax: 1-800-FDA-0178
• Phone: 1-800-332-1088

FDA Action

As part of a risk management plan, FDA requires that patients receive a medication guide at the pharmacy when they pick up a prescription for Qualaquin. The medication guide explains what the drug is and is not approved for, as well as its potential side effects.

Posted by Lucas A. Ferrara, Esq. at 3:00 PM | Permalink | TrackBacks (0) | Comments (0)

Bristol-Myers Squibb Initiates a Nationwide Voluntary Recall of Coumadin® 1 mg Tablet Blister Packs

-Recall Involves 1 mg Physician Sample Blister Packs and 1 mg Hospital Blister Packs Only-

Bristol-Myers Squibb initiates a voluntary recall of 3 lots of physician sample blister packs of Coumadin® 1 mg tablets and 5 lots, of Coumadin 1 mg tablet hospital unit dose (HUD) blister packs. The following lot numbers are included in this recall: Physician Sample Blister Packs: Lot# 9A48931A, 9A48931B, 9A48931C, expiration January 2012; HUD Blister Pack: Lot# 8F34006B, 8K44272A, 8K46168A, 9F44437A and 9K58012B with expiry dates between June 2011 and November 2012. The recall is a precautionary measure based upon the company's determination that some of the tablets, over time, may not meet specification for isopropanol. Isopropanol is used to maintain the active ingredient, Coumadin, in the crystalline state, and could affect the therapeutic levels of the active ingredient.

Coumadin is prescribed to treat or prevent blood clots. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke and if there is too much active ingredient, there is an increased risk of bleeding.

The recall only involves Coumadin 1 mg tablet blister-packs distributed in the U.S. This recall does not involve Coumadin 1 mg supplied in bottles or any other strengths and dosage forms of the product. Patients who may have product from the subject lots should contact their physicians to ensure that their anticoagulation therapy is not interrupted.

To date, the company has not received any reports of adverse events related to this issue. Bristol-Myers Squibb is committed to ensuring patient safety and is working to resolve this issue quickly and appropriately. The company has notified the U.S. Food and Drug Administration (FDA), and has issued recall communications to all physicians⁹ and other customers¹⁰ involved.

Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov¹¹.

Healthcare professionals and customers may call the following for assistance if they have further questions about the recall:

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Health Department Reports 75% of New Yorkers Living with HIV/AIDS Are 40 or Older and More than a Third Are over 50 Women over 50 comprise growing percentage of new HIV diagnoses among older adults HIV/AIDS and the risky behaviors that spread it are often associated with youth. However, in the wake of the White House unveiling its first formal national HIV/AIDS strategy, the Health Department reports that 30 years into New York City's epidemic older adults now account for a growing percentage of people living with the disease. Some 75% of HIV-positive New Yorkers are now 40 or older, and more than a third are 50 or older. Younger adults still account for most new infections - 17% of the city's new HIV diagnoses occur in older adults each year. But, as people with HIV live longer, the number of HIV-positive New Yorkers aged 50 and older continues to grow. Learn more

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Yetta Kurland | 304 Park Avenue South | New York | NY | 10010

I want to remind you to come tonight at 6:30pm to the Community Board 2 St. Vincent's Omnibus Committee Meeting.  It is important we keep showing up to talk about why a hospital at the site of St. Vincent's is possible and necessary.

Also below I have attached a link to an article covering last month's meeting for the St. Vincent's Ominbus Committee Meeting by the Westview:

http://www.westviewnews.org/cms/index.php?option=com_content&view=article&id=901:hospital-update-a-raucous-meeting-at-the-little-red-school-house&catid=43:articles&Itemid=170

What:  Community Board 2 St. Vincent's Omnibus Committee Meeting
Where:  PS 41 on 11th Street at 6th Avenue
When: 6:30pm

Hope to see you all there.
Yetta

# # #

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Office of the Press Secretary

White House Announces National HIV/AIDS Strategy

$30 Million of Prevention Fund Dedicated to Implementation of Strategy

WASHINGTON, D.C. - In the United States, approximately 56,000 people become infected with HIV each year and more than 1.1 million Americans are living with HIV.  To combat this growing epidemic, the White House today released the National HIV/AIDS Strategy (NHAS) and accompanying NHAS Federal Implementation Plan. 

Secretary Sebelius also announced that $30 million of the Affordable Care Act's Prevention Fund will be dedicated to the implementation of the NHAS.  This funding will support the development of combination prevention interventions.  It will also support improved surveillance, expanded and targeted testing, and other activities. 

"We can't afford complacency - not when in the ten minutes I've been talking to you, another American has just contracted HIV," Secretary Sebelius said.  "That's why our strategy calls for aggressive efforts to educate Americans about how dangerous this disease still is and the steps they can take to protect themselves and their loved ones."

The vision of the National HIV/AIDS Strategy is to make the United States "a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance will have unfettered access to high-quality, life-extending care, free from stigma and discrimination."
               
The NHAS has three primary goals:

1) Reducing  the number of new infections;
2) Increasing access to care and optimizing health outcomes for people living with HIV;
3) Reducing HIV-related health disparities;

To accomplish these goals, the NHAS  calls for a more coordinated national response to the HIV epidemic and includes a NHAS Federal Implementation Plan that outlines key, short-term actions to be undertaken by the federal government to execute the outlined recommendations.  Additionally, the White House issued a Presidential Memorandum directing agencies to take specific steps to implement this strategy.   

Since taking office, the Obama Administration has taken extraordinary steps to engage the public to evaluate what we are doing right and identify new approaches that will strengthen our response to the domestic epidemic.  The Office of National AIDS Policy hosted 14 HIV/AIDS Community Discussions with thousands of Americans across the U.S. and reviewed suggestions from the public via the White House website.  ONAP also organized a series of expert meetings on several HIV-specific topics, and worked with Federal and community partners who organized their own meetings to support the development of a national strategy. 

Go to www.AIDS.gov and www.whitehouse.gov/onap for more information and resources.

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Cigarette Prices Hit $11 per Pack in New York City

Quitting Now Will Protect Your Health and Wealth

Starting July 1, New York City smokers will have to pay $11 or more for a pack of cigarettes. The $1.60 New York State tax increase will push the cost of cigarettes to more than $300 a month and $4,000 a year for people smoking a pack a day. Although New York City has reached its lowest rate of smoking on record (15.8%), nearly a million New York City adults are still putting themselves, and often the people closest to them, at increased risk of cancer, heart disease, emphysema and many other deadly and disabling illnesses by continuing to smoke. The Health Department encourages New Yorkers to take this occasion to quit. Smokers can get help by calling 311 or 866-NY-QUITS.

Learn more

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Tanyayette Willoughby, a patient at Mount Sinai Hospital from January 21 to February 3, 2003, claimed that she was falsely imprisoned during her stay and sued the institution.

When the New York County Supreme Court denied the hospital's request to dismiss the case, an appeal to the Appellate Division, First Department, followed.

The AD1 was of the view that the hospital had the right under New York State law -- Mental Hygiene Law § 9.39 -- to hold Tanyayette for involuntary care and treatment for up to 15 days, if doctors believed she suffered from a qualifying "mental illness."

In addition to failing to counter the medical diagnosis, it didn't help her case that she had signed a "Seventy-Two Hour Retraction Letter," which indicated she had been voluntarily hospitalized.

Did anyone tell Tanyayette?

To view a copy of the Appellate Division's decision, please use this link: Willoughby v. Mount Sinai Hosp.

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Secretary Sebelius Visits Grand Isle Beach and New Orleans to Assess Health Impact of Gulf Oil Spill

Meets with Residents, Community Leaders, Workers and Responders

Today Health and Human Services Secretary Kathleen Sebelius visited Grand Isle Beach and New Orleans, Louisiana as part the Department's ongoing efforts to to address the public health and mental health aspects of the Gulf oil spill. She was joined by HHS officials Dr. James Galloway, health liaison to the National Incident Command, and Dr. Eric Broderick, Deputy Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA).

"We aim to protect the overall health of the people in the Gulf states," said Secretary Sebelius. "Our priority at HHS is to prevent injuries and other health consequences, including mental and behavioral health impacts, and to support state and local efforts to address any health threats faced by workers, volunteers, and Gulf coast residents.

We are especially concerned about mental health, as it is clear from past experiences and from all our discussions today that mental health and substance abuse issues are likely to be some of the most long-lasting effects of this oil spill."

In Grand Isle Beach, Secretary Sebelius toured the beach and discussed health and safety issues with cleanup workers. Later, Sebelius met with local business owners and area residents to discuss the medical, economic, and emotional impacts of the oil spill on this Gulf coast community.

In New Orleans, Sebelius and other HHS officials participated in a community discussion, moderated by the Deep South Center for Environment Justice at Dillard University.

"We are committed to working with state, local, and community partners to ensure people here have access to needed services," added Sebelius.

The Obama Administration is involved in ongoing efforts to prevent injuries, Illnesses and exposure to hazardous substances among response personnel and the general public; ensure the safety of seafood from areas affected by the oil spill; monitor the potential short- and long-term health impacts of the oil spill; facilitate access to care to those impacted by the spill; and address stress and mental health issues in conjunction with state and local health agencies.

For more information on the federal government's response efforts, visit www.restorethegulf.gov.

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Pancreatic cancer and lots of drinking

From the U.S. Department of Health and Human Services, I'm Maurice Scott with HHS HealthBeat.

A study indicates heavy alcohol use can raise the risk of pancreatic cancer. Researchers looked at data on 532 men with pancreatic cancer and more than 1,700 without the disease.

At UT Southwestern Medical Center in Dallas, Samir Gupta says men who drank more had a higher risk - up to 6 times for those who had the most alcohol, compared with men who had one drink a month or less. And binge drinkers had a 3.5 times higher risk than non-binge drinkers.

Dr. Gupta says the study suggests a possible way to head off the disease:

"Our findings may be considered an additional health reason why people should avoid heavy alcohol consumption." (6 seconds)

The study in the journal Cancer Causes and Control was supported by the National Institutes of Health.

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I'm Maurice Scott.

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HHS Provides $390.5 million to Improve Hospital Preparedness and Emergency Response

States, territories, and large metropolitan areas will receive grants totaling $390.5 million this month to help hospitals and other health care organizations strengthen the medical surge capability across the nation.

The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response will provide the funds through the Hospital Preparedness Program. The grants enhance community resilience by increasing the ability of hospitals and healthcare facilities to respond to the public health and medical impacts of any emergency, such as natural disasters, disease outbreaks, or acts of terrorism.

All states, territories and the metro areas of New York City, Chicago, Los Angeles County and Washington, D.C., will receive the 2010 Hospital Preparedness grants. The funds will be used by state and local governments to boost the readiness of hospitals and other healthcare facilities in their jurisdictions by finalizing development or improving:

• Interoperable communication systems
• Systems to track available hospital beds
• Advance registration of volunteer health professionals
• Processes for hospital evacuations or sheltering-in-place
• Processes for fatality management
• Strengthening health care partnerships at the community level
• Strengthen hospital participation in statewide and regional exercise programs.

The 2010 awards are as follows:

The grant cycle aligns with the state fiscal year of July 1 - June 30.

The Pandemic and All-Hazards Preparedness Act requires accountability of the use of the Hospital Preparedness Program funds.  These funds can be withheld from awardees if they fail to meet established state-level performance measures.

For more information on the Hospital Preparedness Program grants, go to: http://www.phe.gov/preparedness/planning/hpp/pages/default.aspx.

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FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients

Device designed to help those with end-stage, age-related macular degeneration

Yesterday, the U.S. Food and Drug Administration announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times.

AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

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Avoiding dengue

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From the U.S. Department of Health and Human Services, I'm Ira Dreyfuss with HHS HealthBeat.

There's hardly any dengue fever in the United States - at least, for now. But you can find a lot elsewhere - it's the world's most common viral disease carried by mosquitoes. This means travelers can get infected in other countries, and bring the disease back with them.

Although dengue rarely kills people, it can make them awfully sick, with flu-like symptoms and worse, such as shock and bleeding. So, at the Centers for Disease Control and Prevention, Christopher Gregory says the best strategy is to keep from being infected:

"Wearing long-sleeved clothing, using DEET-containing repellents, eliminating potential mosquito breeding sites by routinely emptying water-filled containers, and having screened windows and doors are effective means of reducing the risk of contracting dengue."  (12 seconds)

Learn more at hhs.gov.

HHS HealthBeat is a production of the U.S. Department of Health and Human Services. I'm Ira Dreyfuss.

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Got this e-mail from the White House earlier today:

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Pharmacy Owner Sentenced to Over 4 Years for Health Care Fraud, Aggravated Identity Theft and Conspiracy to Misbrand Drugs

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CDC Injury Center and Lifetime Television Partner to Raise Awareness about Traumatic Brain Injury

On a recent episode of Lifetime Television's show Army Wives, lead character Joan was diagnosed with a Traumatic Brain Injury (TBI) sustained from a bomb blast while on active duty in Iraq. The leading cause of injury among U.S. forces serving in Afghanistan and Iraq is TBI.

CDC subject matter experts consulted with Army Wives writers and producers on TBI signs and symptoms and the importance of rest during recovery from a TBI. The upcoming storyline covering Joan's recovery is an example of a partnership between CDC, Hollywood Health & Society, and Lifetime Television to help raise public awareness and improve prevention, recognition, and response to TBI.

TBI is an important public health issue that has far-reaching consequences--impacting the daily lives of those injured, as well as the lives of their families--and it is not just a risk for our service men and women. An estimated 1.7 million civilian deaths, hospitalizations, and emergency department visits related to TBI occur in the United States each year.

Learn more about TBI and share your stories with other brain injury survivors at www.facebook.com/cdcheadsup.

Related Links

• A recent CDC report shows that nearly a third of all injury-related deaths in the United States involve TBI.
• Visit the Defense and Veterans Brain Injury Center to learn more about efforts to ensure that military service members and veterans with TBI receive the best evaluation, treatment and follow-up.
• Army Wives Supports Traumatic Brain Injury (TBI) Awareness

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Applications for Early Retiree Reinsurance Program Now Being Accepted

Affordable Care Act to Provide Financial Relief for Businesses, Unions, State and Local Governments Who Provide Health Insurance for Early Retirees

The Department of Health and Human Services' Office of Consumer Information and Insurance Oversight (OCIIO) today announced that it will begin accepting applications for the Early Retiree Reinsurance Program (ERRP).  Created by the Affordable Care Act as a bridge to the new health insurance marketplace established by the Exchanges in 2014, this $5 billion program will provide much needed financial assistance for employers, including businesses, unions, state and local governments, and nonprofits, so retirees can get quality, affordable insurance.

"The Affordable Care Act not only helps consumers cut their health care costs and have more access to quality care, it also is designed to help employers afford coverage. The Early Retiree Reinsurance Program will help employers continue to provide much-needed health insurance to their retirees," said Secretary Kathleen Sebelius. "Today, Americans who have retired but are not yet eligible for Medicare are often unable to find coverage that is affordable and meets their health needs on the individual market.  This program will help both retirees and employers facing spiraling health care costs, and ensure more Americans have access to the health care they need."

Many Americans who retire without employer-sponsored insurance and before they are eligible for Medicare are denied coverage or see their life savings disappear because of exorbitant rates in the individual market. Until Americans have access to affordable insurance plans through health insurance Exchanges in 2014, this program will make it easier for retirees and their families to maintain their employer-based coverage. 

The Early Retiree Reinsurance Program will reimburse employers for medical claims for retirees age 55 and older who are not eligible for Medicare, and their spouses, surviving spouses, and dependents. Employers, including state and local governments and unions, who provide health coverage for early retirees are eligible to apply.

Reimbursements will be available for 80 percent of medical claims costs for health benefits between $15,000 and $90,000.  Program participants will be able to submit claims for medical care going back to June 1, 2010. 

Yesterday was the first day applications were accepted.  A draft application was made available June 7, and OCIIO has hosted several stakeholder outreach calls to explain the program.  Additional application assistance, including a webinar, will be available on-line this week.

Applications for the program, as well as fact sheets and application assistance can be found at: www.hhs.gov/ociio

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Governor Paterson and North General Hospital Announce Comprehensive Solution to Preserve Quality Health Care

Yesterday, Governor David A. Paterson joined the Board of Trustees of North General Hospital (NGH), the New York State Department of Health (DOH), the Dormitory Authority of the State of New York (DASNY) and the City of New York in announcing a comprehensive solution to preserve quality health care and save jobs at NGH's facility in Harlem.  The plan calls for new health services to take over and expand the current NGH facility. A "Super Urban" Federally Qualified Health Care (FQHC) site extension facility will open in the first week of July, and will be operated by the Institute for Family Health to ensure and expand available primary care at the NGH facility. Those services will be complemented by a newly constructed skilled nursing facility and a new long term acute care facility to be operated by the NYC Health and Hospitals Corporation in what is now the main hospital building.  "Thirty years ago, North General Hospital was a pioneer in the health care industry; a private hospital opening while public hospitals were failing. However, with the hard work, determination and vision of Eugene McCabe, Randolph Guggenheimer and the entire Harlem community, North General became a key resource for health care," said Governor Paterson. "Today's announcement will reinvent that vision by allowing North General to be a pioneer once again and continue to provide for the health care needs of Harlem."  Like many stand-alone hospitals, NGH has seen a decline in both patient admissions and payor reimbursements. Over the past 12 months, the Board has worked with the Governor, DOH, DASNY and the City of New York to reach a consensual resolution to the historical and persistent financial challenges NGH has endured.  NGH Board Chairman Reverend Dr. Calvin O. Butts, III considers the plan to repurpose NGH for new health care facilities a wonderful outcome for both NGH and Harlem. He said: "This almost seamless landing was not easy to achieve, but it underscores the good will and creativity that exists at state, federal, city, local and community levels, both public and private. While it saddens us all to face closing the doors of a hospital that's been an integral part of our neighborhood for thirty years, we see this as an opportunity to not only continue to use the North General facility to maintain the health of the people of this community, but as a way to allow the facility to continue to be an economic asset to the Harlem community".  The new FQHC is expected to serve as a new model for such facilities in urban areas because of the scope of the primary care services it can provide to an estimated 80,000 people a year. The new FHQC is expected to open in North General's former Diagnostic and Treatment Center in July 2010 and operate there until its new state-of-the-art facility is completed at NGH's Annex Building. It will provide Urgi-care (urgent care for minor injuries and illnesses) for area residents as well as primary care, mental health, dental and school-based health services currently provided by NGH. The City of New York and the New York City Health and Hospitals Corporation (HHC) have reached agreement with the Governor, State Department of Health, and North General Hospital to relocate more than 200 long term acute care beds and related services from the Coler/Goldwater Specialty Hospital on Roosevelt Island to the Harlem community. With capital financing from the City, HHC will also build a state-of-the-art skilled nursing facility to replace its outdated facilities on the Goldwater campus. In order to accelerate and facilitate the transfer of the various hospital properties to the new health care providers, NGH will file for court-supervised Reorganization under Chapter 11. NGH will begin winding down operations on or before July 2, 2010. Neighboring hospitals, including Mount Sinai, St. Luke's, New York-Presbyterian, Harlem and Metropolitan are prepared to serve the community's acute care hospital and emergency room needs. Congressman Charles Rangel said: "This announcement is great news for not just for people in Upper Manhattan, but for all those who care about health care access. Thanks to the hardwork of so many, we have been able to leverage available federal, state and city resources to ensure that health care delivery is maintained and expanded in our community." Mayor Michael Bloomberg said: "North General Hospital and its facilities will continue to house critical health care services for the Harlem community and all of New York City. The relocation of some of the City's long term care services to Harlem will ensure a continuing vibrant health care presence there while simultaneously improving New York City's Health and Hospital Corporation's long-term care facilities." Neil Calman MD, President and CEO of the Institute for Family Health, which will operate the FQHC, said: "It is a privilege to be asked by Reverend Butts and the Board of North General to develop an FQHC in this historic community. We are honored to have the support of Governor Paterson and the New York State Department of Health as well as the U.S. Department of Health and Human Services. We look forward to offering our patients a new level of care, supported by the latest technology, in their new Medical Home."  State Health Commissioner Richard F. Daines, M.D., said: "This transformation is a vote of confidence for improved health care for the community. It is clearer than ever that effective, quality health care should not begin with a hospital visit. Our communities need well-developed primary and preventive care to improve the community's health status and avoid hospitalization when appropriate. The Governor, North General's Board and management, DASNY and the Department of Health address this with the important partnership with the FQHC and the exploration of redevelopment options."  DASNY President Paul T. Williams, Jr. said: "DASNY has participated in workout solutions for troubled hospitals before. As a partner with Governor Paterson, the Department of Health and North General's Board, we will all work with the local community, elected representatives and stakeholders to maintain health care, economic development and community services for the residents of Harlem consistent with our obligations to bondholders." HHC President Alan D. Aviles said: "HHC, through its Harlem Hospital, Metropolitan Hospital, and Renaissance Health Care Diagnostic and Treatment Center, has a long standing commitment to serving the needs of the Harlem community. We are very pleased to be in partnership with the City, Governor Paterson, Congressman Rangel, DASNY, the State Department of Health, and North General Hospital's Board to develop a full continuum of health care in this community."  It is anticipated that simultaneous with the cessation of NGH's operations, the Institute for Family Health's FQHC will be opened and operational so that health care services will continue to be available to the Harlem Community throughout this process.   ###   The Institute for Family Health is a federally qualified health center network with 24 practice sites in New York State. The Institute also operates two family medicine residency programs; leads several community health promotion programs focused on the elimination of racial disparities in health outcome; engages in primary care health services research; participates in health policy development at the national, state, and local levels; and is a leader in the use of health information technology to improve public health. In 2009, all Institute centers received the highest recognition from the National Committee for Quality Assurance as Patient Centered Medical Homes. For more information, visit www.institute2000.org.

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Mapping Flu's Trek through Our Cells

With just 11 proteins of its own, an influenza virus particle needs a lot of help from you in its quest to make more of itself. The cells in your respiratory tract are unwilling hosts, forced to aid the virus at each stage of its progress: getting in; making copies of itself (replication); and getting all the new viruses out of the infected cell. Cells fight this hostile take-over and the flu virus, in turn, has ways to avoid the defensive maneuvers.  Now, new details of the jousting match between virus and cell are revealed in research by three groups of NIAID-supported scientists.

How the Host Helps

	An interaction map showing more than 4,000 interactions between 181 confirmed virus-host factors (green circles), virus proteins (red circles), and 184 additional cellular proteins (orange). Credit: Dr. Chanda, Burnham Institute

A team led by Sumit Chanda, Ph.D., of Burnham Institute for Medical Research, and Megan Shaw, Ph.D., of Mount Sinai School of Medicine, used a technique called genome-wide RNA interference (RNAi) to detect the human genes involved in the flu infection process. RNAi allows scientists to see which of the many thousands of human proteins the flu virus uses at various points in the infection cycle.

The investigators screened more than 19,000 human genes and turned up nearly 300 that the flu virus couldn't do without. They used a modified influenza virus that could not complete its full infection cycle, so their RNAi screen revealed the parts of the host cell's machinery that get tapped in early stages of the cycle, such as when a virus attaches to an uninfected host cell.

In theory, drugs that could temporarily dampen the activity of the identified factors would also put the brakes on any flu virus trying to take advantage of them. Current flu drugs are aimed directly at the influenza virus. But the flu virus mutates readily and these frequent changes allow it to gain resistance to antiviral drugs. However, if a drug were to be targeted to factor in the human host instead of being aimed directly at the virus, the pathogen's ability to escape through mutation would be thwarted.

Many of the host factors revealed in the screen had not previously been known to be exploited by the influenza virus in its replication. Of note, the scientists found that they could greatly inhibit the growth of influenza virus by blocking certain of the newly identified host factors with small molecules. This work was done in test tube experiments, not in animals or people, but the investigators now have fresh avenues to explore in developing host-directed antiviral drugs.

"Armed with this large panel of required host factors, our next challenge is to characterize their involvement in the flu virus life cycle in more depth," says Dr. Shaw.  "Those factors that possess enzyme activities are prime candidates to use as targets for new antiviral drugs for flu, so this is an area we will be exploring further."

The paper was published in the journal Nature in February 2010. 

Found: Flu-Fighting Proteins

How IFITM proteins may block influenza infection. The IFITM proteins are shown in purple, red, and yellow. A) IFITM may bind to the virus and prevent it from entering the cell. B) IFITM may block the cell surface receptor needed by the virus to gain entry. C) IFITM may stop the virus from being internalized at the cell surface (endocytosis). D) IFITM may inhibit the internalized virus from fusing with the cell's membrane thereby preventing entry of the virus' genetic material into the cell's interior. Credit: Dr. Brass, Ragon Institute

In another NIAID-supported genetic screening effort, scientists discovered that a family of human proteins--called interferon-inducible transmembrane (IFITM) proteins--plays a dramatic role in protecting our cells from attack by flu virus. IFITMs were discovered 25 years ago, but until now no one knew that they form part of an inherent anti-viral defense system. The team was led by Abraham L. Brass, M.D., Ph.D, of the Ragon Institute of Massachusetts General Hospital, MIT, and Harvard University, and Stephen J.  Elledge, Ph.D., of Brigham and Woman's Hospital and Harvard Medical School (HMS) in collaboration with Michael Farzan, Ph.D., of the New England Primate Research Center, HMS.

In the new study, the researchers used a whole-genome RNAi screen to find more than 130 host proteins needed by flu, and also found that lowering the levels of the IFITM proteins enhanced viral infections.  They then selectively raised or lowered IFITM protein levels in the presence of influenza and other viruses.  When the proteins weren't present, viruses could easily enter the cell and multiply rapidly. Conversely, "when we boosted protein levels, virus replication went down strikingly" says Dr. Brass.

The scientists focused on one member of the protein family, IFITM3, which not only hindered flu virus entry or replication, but also protected cells from other viruses, including those that cause West Nile fever and dengue fever.  As their name indicates, the interferon-inducible proteins react to interferon, a potent immune system protein. Interferon is produced in response to viral or other infections and orchestrates a wide array of additional immune responses.  Interferon does help you fight off infection, but it also makes you feel achy. According to Dr. Elledge, if levels of IFITM3 could be artificially boosted in the absence of interferon, it might be possible to fend off certain viral illnesses without suffering interferon's unpleasant effects.

Although many details of IFITM virus-blocking activity are still unknown, the proteins do appear to act very early in the infection cycle and may be a potential new way to stop viral invasion, notes Dr. Brass. "We may have found a key gatekeeper," he says. In fact, variations in the amount of IFITM production between individuals may help explain why some people are more resistant to influenza illness than others, Dr. Brass adds. If the IFITMs are frontline defenders, as these findings suggest, individuals who naturally produce more of these proteins may be able to avoid full-blown illness because flu viruses are unable to gain a foothold.        

One of the biggest surprises in the recent research, says Dr. Brass, is that IFITM3 is just as effective against flu virus strains that originally circulated in the 1930s as it is against viruses that emerged in the past few years. Why hasn't the virus evolved any defenses against the human protein? "That's one question we will explore next," says Dr. Brass.

The study was published in the journal Cell in December 2009.  

A Global View of Flu

Aviv Regev, Ph.D., of the Broad Institue of MIT and Harvard. Credit: Broad Institute

A third team of scientists recently completed the most comprehensive map to date of the many thousands of interactions between flu virus and host cell. The group was led by NIAID grantee Nir Hacohen, Ph.D., of Massachusetts General Hospital and Harvard Medical School and computational biologist Aviv Regev, Ph.D., of the Broad Institute of MIT and Harvard.  

Because flu virus has so few of its own proteins, each one must be multifunctional, like a Swiss army knife, says Dr. Regev. One layer of the new map highlights the physical interactions between these multitasking flu proteins and the human proteins they contact.  Amazingly, the flu's proteins connect, directly or indirectly, with more than 1,750 human proteins. There are twice as many flu-human protein interactions in the course of the infection cycle as there are human-human protein contacts in a typical cellular process.

Once invaded, the cell reacts. The researchers sketched another map layer to identify the regulatory pathways triggered by entry of a flu virus into a lung cell. They used siRNA to switch off, one by one, the host genes identified in the first screen as playing some role in the influenza infective process.  By measuring how seriously the virus was hurt by the loss of access to each human gene, the researchers gradually developed a "responsiveness" map of the most important pathways in the flu-host interplay.

Nir Hacohen, Ph.D., of Massachusetts General Hospital and Harvard Medical School Credit: Massachusetts General Hospital

"Our screens turned up some expected and some unexpected findings," says Dr. Hacohen. "Some flu proteins were previously known to interact with human proteins, but this new map showed that flu proteins we didn't expect would interact with human proteins actually did."

Finally, the investigators integrated the map of physical interactions and the one of regulatory pathways and revealed a picture with some surprising features.  For example, the combined map showed that flu virus taps into a set of human proteins involved in embryonic development. The map allowed researchers to see a connection that was otherwise unpredicted.

"We also discovered that certain flu proteins appear to 'moonlight.' Their main job is to assist in replication but, as the functional map revealed, they also have a second job of manipulating signaling pathways in a way that makes the cell more hospitable to the virus."

The scientists stress that the new map is a rough first draft. There is much more exploration ahead, says Dr. Hacohen. With this guide in hand, he says, investigators will have more confidence in filling in the missing pieces.

The research was published in the journal Cell in December 2009.

References:

R Konig et al. Human host factors required for influenza virus replication. Nature DOI: 10.1038/nature08699 (Feb. 11, 2010)

AL Brass et al. The IFITM proteins mediate cellular resistance to influenza A H1N1 virus, West Nile virus, and dengue virus. Cell 139: 1243-54. (Dec. 24, 2009)

SD Shapira et al. A physical and regulatory map of host-influenza interactions reveals pathways in H1N1 infection. Cell 139:1255-67. (Dec. 24, 2009)

Posted by Lucas A. Ferrara, Esq. at 5:00 PM | Permalink | TrackBacks (0) | Comments (0)

New Proposed Rules to Ensure Equal Visitation Rights for All Hospital Patients

On April 15, 2010, the President issued a Presidential memorandum to the U.S. Department of Health and Human Services (HHS) calling for the initiation of rulemaking that would ensure that hospitals that participate in Medicare or Medicaid respect the rights of patients to designate visitors, regardless of whether the visitors are legally related to the patients.  The President's directive clearly instructed HHS to propose that a participating hospital not deny visitation privileges on the basis of race, color, national origin, religion, sex, sexual orientation, gender identity, or disability.  It also directed that the rulemaking take into account the need for a participating hospital to restrict visitation in medically appropriate circumstances.

At the direction of the President, Secretary Kathleen Sebelius and her team at the Ce