Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Sunday, December 12, 2010

Expired Medications Sold Illegally at Queens Flea Market | NBC New York

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The FDA says it’s illegal, but it’s being sold to anyone right out in the open, and the people doing it don't seem to care that selling illegal and expired medications put lives at risk.

NBCNewYork.com went undercover at the aqueduct flea market in Ozone Park, Queens, where these kind of medications are sold for a steal.

On a bitingly cold Saturday afternoon, the flea market at the Aqueduct Race Track is packed with people buying everything from makeup, old candy, and clothing.

But taking a closer look at the goods being hawked you’ll find a more nefarious lineup of goods -- expired, over-the-counter medications like Robitussin, Claritin, and even children's medications, like Dimetapp.

The expiration dates range anywhere from a few months past the guaranteed safety date to years expired.

Pediatrician Greg Yapalater says the main concern with meds like these is not so much that they are expired, but rather the uncertainty of where they come from – whether they’ve been stored properly or if they’ve been tampered with.

Buying junk for a dollar is still junk. Buying poison for a dollar is still poison. Why go that route? There are other ways. Go with the generics in the pharmacy. They're always going to be cheaper”, says Yapalater.

To watch video report...click here




News 4 confronted the vendors and asked why they were selling illegal goods and where they got the medications.

In response the reporter and cameraman were called named and screamed at to leave. No one could tell us the origin of the products.

The Flea Market’s managers told News4 the vendor in charge of stand selling the illegal drugs is a man named Pat Flynn.

Flynn denied he was in charge and would not answer questions.

By the time News 4 alerted the Market’s authorities the goods were quickly swept into a box and taken away.

Aqueduct Flea Market says they will revoke Pat Flynn’s permit. The market maintains that it checks twice a day for illegal products being sold. Still customers say they see the stuff being sold every market day – out in the open for anyone to see. State officials assure us that the proper authorities will be by the flea to stop vendors like Flynn from continuing to sell expired meds.

Thursday, November 19, 2009

Robert F. Kennedy, Jr. - The Government Mercury Autism Scandal - MSNBC

Robert F. Kennedy, Jr. - Deadly Immunity

Click either link below to read the full article:

Read article at Rollingstone.com
Read article at Salon.com


In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session -- only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly "embargoed." There would be no making photocopies of documents, no taking papers with them when they left.

The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency's massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines -- thimerosal -- appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. "I was actually stunned by what I saw," Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants -- in one case, within hours of birth -- the estimated number of cases of autism had increased fifteen-fold, from one in every 2,500 children to one in 166 children.

Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. "You can play with this all you want," Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results "are statistically significant." Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting's first day, was even more alarmed. "My gut feeling?" he said. "Forgive this personal comment -- I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on."

Thursday, February 19, 2009

State Senator Klein, Mayor Bloomberg and Health Commissioner Frieden Announce New Resturant Inspection Program

Public Posting of Sanitary Grades Gives Customers More Information Up Front

Klein and Bloomberg unfurl new initiative to implement a letter grading system whereby diners may easily access the results of an establishment's latest health inspection.


Mayor Michael R. Bloomberg and Deputy Senate Majority Leader Jeff Klein announced on Saturday, January 31st, that New York City is updating its restaurant inspection system to improve sanitary conditions and give consumers more information. Under the new model, the Health Department will increase inspections for less sanitary restaurants and require all establishments to conspicuously post letter grades – a measure championed by Senator Klein to keep the public better informed about inspection results. The new system will be phased in over the next two years. This approach will concentrate city resources on the restaurants that pose the greatest risk to public health and place no additional burden on establishments that maintain sanitary conditions. Dr. Thomas R. Frieden, New York City Health Commissioner, and State Assemblyman Steve Cymbrowitz joined Mayor Bloomberg and Senator Klein at the New York Marriott at the Brooklyn Bridge for today's announcement.


"We know New York City's restaurants are the best in the world and we want them to also be the cleanest," said Mayor Bloomberg. "This new system will encourage the less sanitary restaurants to clean up – and won't punish the good guys. As sanitation improves, so will business. The more residents and tourists can trust the food they buy in New York City restaurants, the more likely they are to patronize them."


"Today's announcement is a great step forward toward improving the overall public health of all New York City residents," said Senator Jeff Klein (D-Bronx/Westchester). "As someone who has spent years advocating for a more consumer friendly system, I am thrilled that New York City diners will finally have easy access to the latest inspection results of their favorite restaurants. Having a letter grade posted for all diners to see will provide a real incentive for restaurants with a 'C' hanging in the doorway to clean up their act."


Senator Klein will again introduce legislation in the 2009 Legislative Session to require local departments of health state-wide to implement a letter grading system. "Whether New Yorkers are dining out for a routine meal or to celebrate a special occasion, their only reservations should be to book a table. I applaud the Mayor and the Health Department's outstanding efforts to improve the well being of all New Yorkers," said Senator Klein.


Food-related illness is a source of growing public concern in New York City. Complaints about food-borne illness have increased in recent years, and rodent infestations are a common problem in restaurants. The Health Department reports signs of rodents in 25 percent of the establishments inspected. Food poisoning causes missed work and school, emergency room visits, hospitalizations, and even deaths. In fact, based on national estimates, more than 11,000 New Yorkers are treated in emergency departments each year for restaurant-related food related illnesses, and thousands of people are hospitalized as a result. The cost of these hospitalizations and emergency room visits is more than $130 million annually.


"By requiring restaurants to publicly post grades, the new food safety initiative will help consumers make more informed choices about where to eat, while increasing restaurant operators' motivation to stay clean," said Dr. Frieden. "New York City will have safer restaurants and fewer cases of food poisoning."


Senator Klein has been releasing regular reports, Enough to Make you Sick, on the sanitary conditions of supermarkets and New York City restaurants since 2000. Senator Klein's 2008 report studied a subset of New York City's 20,000 restaurants with the 100 worst inspection reports, with violation point scores ranging from 69 to 600 – far exceeding the 28 points that prompt re-inspection. Of the bottom 100 restaurants, 87 percent had at least one category of pest cited in their most recent inspection.


Research from other jurisdictions suggests that public posting of inspection findings has the following outcomes:


Business improves at restaurants with higher grades. When sanitation grades are conspicuously posted at food service establishments, customers use the information to seek out establishments with higher grades. Among Los Angeles restaurants, improvements in grades are associated with increased sales.


Restaurants improve their sanitary standards. When Los Angeles County started posting grades in 1987, only 40 percent of its food service establishments received "A" grades. By 2006, 83percent were meeting that standard.


Fewer people get sick. Although the association is not proven, Los Angeles has recorded a 20 percent decline in hospitalizations for food-borne illnesses since it started posting sanitary grades in food service establishments.


The new model will also bring New York City closer to the FDA recommended schedule of at least three full inspections every year for full service restaurants. At present, most New York City restaurants receive only one.

Friday, October 10, 2008

Addabbo Lays Out 3 Point Healthcare Plan at Ozone Park Pharmacy...

Doctors Council SEIU Endorses Addabbo for Senate


Dr. Frank Proscia, Executive Director of Doctors Council SEIU, Joe Addabbo and John Rossi of Rossi Pharmacy, Ozone Park

Gathered at Rossi Pharmacy (84 01 101 Ave, Ozone Park) with the Vice President of the Doctors Council SEIU, Councilman Joe Addabbo laid out his 3 Point Healthcare Plan to address the rising cost of healthcare. Having also earned the endorsement of the New York State Nurses Association, Addabbo has made healthcare a central platform of his campaign.

“Healthcare is one of the primary concerns of the 21st century as the cost of coverage escalates and insurance companies continue to encroach upon the clinic. We need to put health care back into the hands of the doctors and nurses who think first about the patient, and second about the bottom line. But we also need to take steps to improve existing programs and expand our options. In these tough economic times, working families need real solutions to their basic concerns. We must to more and I have a plan,” said Councilman Addabbo.

“Doctors Council SEIU is the largest union of attending physicians and dentists in the country, representing over 3,000 doctors from the public and private sectors in the New York City area. Joe Addabbo has been a strong advocate for the rights of workers. And the proposals he’s making today demonstrate his commitment to providing all New Yorkers with the best possible healthcare. We have worked with Councilman Addabbo in the past and look forward to working with him as a member of the State Senate. Now more than ever, we need elected officials who believe that access to healthcare is a priority,” added Dr. Frank Proscia, Executive Director of Doctors Council SEIU.

With that in mind Addabbo explained his 3 point plan:

1) Convert Life Insurance to Long Term Care Coverage

Addabbo supports a proposal which would allow New Yorkers to convert the anticipated value of their whole life insurance policies into immediate, but discounted, cash to pay for the long term care they require either at the end of their lives or in the event of a disabling health crisis.

This measure would reduce state Medicaid expenditures by providing more liquid assets that New Yorkers can use to pay for their nursing home and home health care needs.

2) Expand the Income Threshold for EPIC (Elderly Pharmaceutical Insurance Coverage)

EPIC is a New York State program that helps seniors pay for their prescription drugs. More than a of a quarter million EPIC enrollees are saving an average of 90 % of the cost of their medicines. Most enrollees have Medicare Part D or other drug coverage, and use EPIC to lower their drug costs even more by helping them pay the deductibles and co-payments required by their other drug plan. EPIC also helps members pay for Medicare Part D premiums.

Currently, the eligibility requirements for EPIC are capped at 35K for an individual and 75K for a couple. Addabbo supports existing legislation (S2257) to expand the income threshold to 50K for an individual and 75K for a couple.

If coverage were expanded, an additional 35,172 seniors in Queens County would be eligible for EPIC.

All of these approximately 35,000 newly eligible seniors would be protected from the gap in Medicare Part D coverage which totals $1,650, the Medicare Part D “blackout” period between $2,400 and $4,050 in prescription expenses.

However, historical trends in EPIC enrollment show that, at the high end of income eligibility, only a small percentage, 10%, of eligible seniors enroll in EPIC. This is primarily due to the availability of alternative coverage and high deductibles at the upper end of EPIC coverage.

Using the historical EPIC participation rate of 10% of those eligible, approximately 3,500 of the 35,000 newly eligible would enroll in EPIC.

However, if only 3,500 Queens seniors were to enroll, they could still see aggregate savings of $5.8 million due to EPIC coverage of the Medicare Part D gap.

The measure would also obviously result in considerable Medicaid savings as well.

3) Single Source Drug Coverage

Addabbo expressed the need for better coverage for all New Yorkers, but emphasized the negative effects of the three-tier drug pricing system on minority communities. According to the NYC Dept. of Health Southwest Queens has one of the highest percents of uninsured adults among the 42 neighborhoods in NYC (23%), and foreign-born residents in this community are less likely to have health insurance than those born in the U.S. Similarly, in Southwest Queens, 23% of residents do not have a regular doctor, which means greater reliance on emergency rooms, and less emphasis on preventative care.

A May report released by Senator Jeff Klein (D-Bronx/Westchester) revealed that New York’s biggest HMOs are denying or restricting access to single source drugs with no generic equivalent. Drugs like Lipitor, Plavix, Lexapro, and Advair treat common conditions such as high cholesterol, cardiovascular disease, diabetes, depression, and asthma.

Lipitor, for example, is the most commonly prescribed prescription drug to reduce cholesterol and prevent heart disease. It is also a single-source drug with no generic equivalent. While there are other medications (called “statins”) that reduce cholesterol, it is believed that Lipitor’s unique active ingredient makes it especially effective for certain patients, particularly those with acute coronary syndrome or those that have already had a heart attack

In many cases, minority communities are disproportionately impacted by the practice. According to the Center for Disease Control and Prevention’s Summary Health Statistics for U.S. Adults: 2006, 31.6% of non-Hispanic blacks, age 18 and over suffer from heart disease as compared to only 22.4 %of non-Hispanic whites. The American Hearth Association lists diseases of the heart and stroke as the No. 1 killer of Latino/Hispanic Americans. They claim the lives of 28.6 percent of the more than 122,000 Hispanics or Latinos who die each year, with cancer follows, at19.7 percent. On average, Hispanic Women develop pre-hypertension indicators such as obesity ten years earlier than White women, at a rate of 32% contrasted to the incidence in White women at 17%.

Similarly, there is repeated evidence of the connection between poverty and poor health such as obesity, a high sugar diet which can lead to diabetes and heart disease, exposure to pollution and other toxins which contribute to respiratory ailments and asthma, as well as depression.

Insurance companies use formularies to categorize drugs. Formularies are typically comprised of three tiers with Tier 1 consisting of generic medications, Tier 2 consisting of proprietary (brand name) medications, and Tier 3 including proprietary drugs for which no generic exists as well as other more expensive medications.

Patients pay the least for Tier 1 drugs, while paying more for Tier 2 drugs, and even more for Tier 3 drugs which are typically called non-preferred. For some employee and individual benefit plans, Tier 3 drugs may not be covered. Other restrictions include: Medical Exception; whereby a patient and doctor request a medical exception, which must then be granted by the insurance company; Prior Authorization/Pre-Certification of the drug by the insurance company, Quantity Limitations, and Step Therapy (Step Protocol): prerequisite medications (one or more) prior to approval of the physician-prescribed drug.

Of the major HMOs operating in New York, 14 place restrictions on medications that are disproportionately required by African-American and Hispanic-American New Yorkers.

Of the largest Insurers, Oxford had the most restrictions on drug coverage, placing restrictions on 13 of the 19 single source drugs needed to treat conditions from which African Americans and Hispanic Americans disproportionately suffer, and 18 restrictions overall.

Aetna and Health Net are tied at second place with a total of 17 restrictions each on 10 and 13 drugs respectively. Finally, Independent Health Association restricts access to 12 drugs for a total of 16 restrictions overall.

Oxford and Independent had the most drugs listed under the expensive third tier, 9 and 4 drugs respectively.

GHI, Aetna, and Excellus listed the largest requirement of step therapy, while Independent required prior authorization most frequently.

Health Net had the highest incidence of quantity restrictions, placing limits on 13 medications, followed by Aetna (10) and Oxford (9).

Of the drugs surveyed Lipitor and Singulair are the most restricted. Lipitor was restricted by 8 of the 15 companies, with a total of 19 restrictions. Singulair, a preventative medication for asthma, has 14 restrictions by 11 companies that limit access.

For the 9 medications for mental health-related conditions, 12 companies had restrictions in place. There was a total of 14 restrictions placed on Lexapro by 10 different companies. Abilify and Cymbalta were restricted by 8 HMOs totaling 10 and 11 restrictions each.

Addabbo supports existing legislation, which would require that all medically necessary prescription medications approved by the FDA be covered by the insurance company.