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Ever since the FDA approved the HPV vaccine two years ago…

admin — Sun, 30 Aug 2009 17:06:17 +0000

Dr. Shobha S. Krishnan, M.d. asked:

Ever since the FDA approved the HPV vaccine two years ago, its introduction into the health community has been embroiled in a medical, social, cultural and political controversy. At first glance, the debut of a vaccine to fight most cervical cancers looks like an exciting advance in the history of women’s health. However, many people are unable to separate the ethics from the basic scientific facts: the virus is transmitted through sexual contact and hence the vaccine is recommended for 11 or 12-year-old girls, before they first become sexually active. The perceived possibility that administering such a vaccine to prevent a sexually transmitted disease could promote sexual promiscuity has trumped all other ethical debates, leading some people to cast its benefits aside. As a mother, I can understand why many parents are concerned about this issue and put off vaccinating their daughters. However, in addition to being a mother, I am a physician, and I therefore believe that by putting off vaccination, we effectively strip our daughters from their chances of protecting themselves from the two major cancer causing HPV types.

According to a Newsweek article from February 25, 2008, only two out of every 10 women in the U.S. in the approved age group have received the vaccine so far. In another new survey of almost 10,000 parents, only 49 percent said they would get their daughters vaccinated with the HPV vaccine at the recommended age of 9 to 12 years. Even though 68 percent planned to vaccinate their daughters at 13 to 15 years of age, and 86 percent said they would vaccinate at 16 to 18 years of age, they might be too late — because the vaccine can only prevent and not cure HPV. The National Survey of Family Growth (NSFG), an agency that collects data on the sexual behavior of American teenagers, reports that teenage girls are already sexually active: 13 percent of them by the time they are 15, 43 percent of them by age 17, and 70 percent of them by age 19. Of the sexually active 13-21 year age group, 70 percent show evidence of HPV infections within a few to several months of when they start having *** — most of which could easily be prevented by vaccinating preadolescent girls. In addition, many parents are uncomfortable talking to their preadolescents about sexual issues; meaning uneducated teens could make problematic sexual choices not only without realizing the consequences of their actions, but also without the protection from HPV that the vaccine provides.

Again, bear in mind that the vaccine is preventive — it is only effective if administered prior to exposure to the virus. Therefore, the vaccine will not treat the existing infections. This is why it’s so crucial to administer the vaccine when girls are young, before any chance of sexual activity, including sexual contact without ***********. In addition, there are several other scientific reasons why the vaccine is recommended in the 11-12 year old groups. Unfortunately, it is beyond the scope of this article to discuss those facts.

But, won’t vaccinating young girls against a STD cause them to become less sexually inhibited and more promiscuous by giving them a license not to worry about the consequences of ***? Won’t it eliminate a deterrent to teenage *** and therefore encourage it? Highly unlikely: because teens rarely factor the possibility of getting HPV into their decisions to have ***.

Current research in adolescent sexual behavior shows that not one, but a variety of factors influence teenage sexual behavior, such as their socio-economic status, their moral and religious values, their sexual attitudes, and the influence of family, friends, and the society they live in. Therefore, it is highly unlikely that a vaccine against a single kind of STD would play a more significant role in adolescent decision making than these factors paired with their responsibility, good judgment, and the boundaries of accepted sexual behavior.

According to NSFG, the top two factors influencing teenagers who choose to remain virgins are fear of pregnancy (94 percent) and contracting HIV/AIDS (92 percent). Since knowledge and awareness of HPV in this age group is poor to begin with, teens will not view this vaccine as a reason to become sexually active at an age sooner than intended. And parents who worry about the vaccine causing promiscuity should remind themselves of the two most dangerous and important factors that influence teenagers to become sexually active and engage in high-risk behaviors: peer pressure and the use of alcohol and/or drugs.

Parents who worry about their teens becoming promiscuous can also focus on a crucial method to keep them from becoming sexually active too soon: raising their awareness. Research has shown that parental guidance is one of the most important factors in delaying teenage sexual activity — teenagers who do not have involved parents are most likely to engage in high-risk behaviors. The HPV vaccine can actually help parents guide their teens’ sexual decisions by giving them a window of opportunity to talk about the topic, and to get health care providers involved in the discussion. There is no reason why parents cannot, without any hypocrisy, inform their daughters that the vaccine is not a green light for them to immediately have ***. Rather, it is a strong message that you, their parents, care about their health, and that it’s important to take proactive steps to become a healthy adult. Think of it this way: Getting a car with an airbag, traction control and anti-lock brakes means that the car is safer in the long-run, but these features aren’t a reason to drive recklessly — accidents are still possible. No matter what, the vaccine will not, cannot and should not take the place of good, solid parental guidance.

The bottom line is we as we as parents want to do what is best for our children. We all want to teach them well while they are still in our protective cocoon so that we can trust them with their own judgment when they become independent. If they always followed our best wishes, we wouldn’t need to worry about administering the vaccine at all. However, even teens with the best judgment can face peer pressure and fall victim to bad decisions or other reasons that may cause them to engage in risky sexual behavior, and this makes the case for vaccinating all the more compelling.

Author Bio

Dr. Shobha S. Krishnan, M.D., is a Staff Physician at Columbia University’s Barnard College Health Services. A board certified gynecologist and family practice physician, she has also worked as a surveillance physician for the federal Centers for Disease Control and Prevention. Prior to joining Barnard, she was in private practice for 10 years. In addition, Dr. Krishnan has worked as a physician at the Institute on Aging and as Chief Resident in the Family Practice Department at St.Vincent Hospital, Indianapolis. Her new book: The HPV Vaccine Controversy: Sex, Cancer, God and Politics — A Guide to parents, women, men and teenagers is scheduled to be published on August 30, 2008 by Greenwood Publications. The book presents the most up to date information about the vaccine without the influence of pharmaceutical companies or other interest groups. Visit http://www.greenwood.com/catalog/C35011.aspx for more inormation.

The book can also be purchased at Amazon.com, Barnes and Noble .com and Borders.com.

Ever since the FDA approved the HPV vaccine two years ago… is a post from: Pharmacy in jobs, news, schools

FDA Panel Backs Denosumab As Osteoporosis Treatment > AMGN

admin — Thu, 13 Aug 2009 21:45:07 +0000

   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES

WASHINGTON (Dow Jones)–A U.S. Food and Drug Administration panel on Thursday unanimously backed the use of denosumab, a proposed Amgen Inc. (AMGN) drug, to treat osteoporosis in postmenopausal women.

The panel is currently voting on a series of questions including whether denosumab should be approved to prevent osteoporosis and whether the drug should be used in patients undergoing hormone therapy to treat breast or prostate cancer. Hormone therapy increases the risk of bone loss.

The panel voted 15-to-0 on a question that asked if there were a population of postmenopausal women with osteoporosis in which the benefit of treatment with denosumab is likely to outweigh the risks. The panel is currently discussing whether the population should be limited to a subgroup at higher risk for fracture or for women who have failed treatment with other therapies.

The outcome of the panel votes will amount to a recommendation about whether it thinks the FDA should approve denosumab.

About 10 million Americans have osteoporosis, or bone weakness that places people at high risk of suffering bone fractures while another 34 million have low bone mass that puts them at risk for developing osteoporosis.

Investors have high expectations for denosumab to grab a share of the roughly $7 billion market for osteoporosis drugs, which has helped boost Amgen’s stock price by about 30% in recent months. Approval of denosumab, which would be injected twice yearly, is key for Amgen’s growth.

While the FDA said denosumab was effective at increasing bone-mineral density and reducing the risk of fractures, it raised concerns about the product’s impact on the immune system and whether that, in turn, raises risks for serious infections and cancer.

In order to treat or prevent osteoporosis, denosumab is designed to inhibit a protein known as RANK Ligand that is involved with bone destruction. However, the same protein also plays a role in the body’s immune system.

The agency said clinical trials involving denosumab showed a slightly higher rate of serious infections and the development of certain types of cancer. The agency also said there is a “potential for tumor progression in patients with cancer.” While clinical data showed numerical differences for infections and cancer, the data didn’t reach statistical significance, meaning the differences could be a chance finding.

Amgen officials said there was no evidence seen in clinical trials that denosumab suppresses the immune system and increases risks for infections and cancer.

Catherine Stehman-Breen, Amgen’s vice president of global development, told the panel that denosumab has a “favorable safety profile,” with most adverse events being “mild-to-moderate” as well as balanced between patients who received denosumab and patients who received placebo.

Amgen officials said they already have long-term studies in progress that can be used to track safety issues. They also said they plan additional studies if denosumab were to be approved.

The FDA usually follows its panel’s advice but isn’t required to do so. The agency has a deadline to make by mid-October but that time table could be delayed if the agency decides to implement a post-marketing safety plan formally known as a Risk Evaluation and Mitigation Strategy, or REMS.

If approved, the drug would be sold under the brand name Prolia.

Denosumab is the first type of drug in its class and acts in a different manner than many other drugs, such as Boniva, Fosamax, and Reclast, that are considered bisphosphonates in order to prevent bone loss. Bisphosphonates, which are delivered orally or through an infusion, have their own side effects, including a risk of rare jaw decay problem.

Ethel Siris, director of the Toni Stabile Osteoporosis Center at Columbia University who presented on behalf of Amgen, said more than half of patients who are prescribed daily oral pills aren’t taking them more than a year later partly because of gastrointestinal side effects.

“Adherence is a critical issue” in treating osteoporosis, Siris said, noting that doctors can determine if patients are compliant with medication if they have to come in to the office to receive their medication.

Reclast, made by Novartis AG (NVS), is an infusion that is given once a year and would be the most direct competitor to denosumab, if approved. That drug has a wholesale cost of $1,000; the generic version of Fosamax is less than $20 a month. Amgen said it was too early to discuss pricing details.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

FDA Panel Backs Denosumab As Osteoporosis Treatment > AMGN is a post from: Pharmacy in jobs, news, schools

FDA warns of e-cigarette risks

admin — Wed, 12 Aug 2009 07:38:58 +0000

The Food and Drug Administration is warning consumers about potential health risks associated with electronic cigarettes.

Also known as “e-cigarettes,” electronic cigarettes are battery-operated devices designed to look like and be used in the same manner as conventional cigarettes.

Sold online and in many shopping malls, the devices generally contain cartridges filled with nicotine, flavor and other chemicals. They turn nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

The FDA said it is concerned that e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products, including conventional cigarettes. In addition, the products may contain ingredients that are known to be toxic to humans because clinical studies about the safety of these products for their intended use have not been submitted to the FDA.

Of particular concern, the FDA said, is that e-cigarettes are sold without any legal age restrictions and are available in different flavors such as chocolate, strawberry and mint, which may appeal to young people.

In addition, the devices do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes.

Consumers may report serious problems with e-cigarettes to the FDA through the MedWatch program, online or at 800-FDA-1088.

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FDA Head Promises Stronger Enforcement Of Food/Drug Safety

admin — Sat, 08 Aug 2009 12:25:30 +0000

Food and drug companies that commit safety violations will face faster and more aggressive action, the new commissioner of the U.S. Food and Drug Administration said Thursday.

“The agency must show industry and consumers that we are on the job,” Margaret Hamburg told an audience of food and drug industry lawyers, the Associated Press reported. “Companies must have a realistic expectation that if they are crossing the line, they will be caught.”

Hamburg said the FDA’s efforts in recent years “have been hampered by unreasonable delays” that left many safety violations unpunished.

Since Hamburg was confirmed as commissioner in May, the agency has launched a number of enforcement actions against companies selling fake or dangerous products, the AP reported. This type of enforcement will become routine in the future, Hamburg said.

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UPDATE 2-US FDA chief vows to speed up inspections, warnings

admin — Fri, 07 Aug 2009 12:04:32 +0000

* FDA to streamline warning letter process

* Agency to act more aggressively in some cases

* Changes may trigger more warning letters -Hamburg (Adds FDA comments, details on new letter policy, background, byline)

By Susan Heavey

WASHINGTON, Aug 6 (Reuters) – The U.S. Food and Drug Administration’s top official vowed on Thursday to warn companies more quickly about problems found during inspections and act more aggressively in serious cases that could directly harm consumers and patients.

The move “will help to ensure that violations are taken seriously, that warning letters and enforcement actions occur in a timely manner,” FDA Commissioner Margaret Hamburg said in remarks at a Food and Drug Law Institute event.

Hamburg said the agency would no longer require all warning letters be reviewed by the agency’s top lawyer before being sent to manufacturers except in certain, more legally complex cases.

That system caused “unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long” and put the public’s health at risk, she said.

The FDA began funneling all warning letters through its chief counsel’s office during the Bush administration. Critics said the move was a favor to makers of drugs, medical devices and other products as it slowed the process and reduced the number of warnings.

Hamburg told reporters after her speech that her decision to revert to the agency’s prior policy was “simply an issue of looking at what makes sense.” More warning letters could be issued as result, at least in the near term, she added.

Companies are supposed to follow the agency’s manufacturing guidelines with FDA inspectors making periodic checks.

The agency can later issue warning letters to drugmakers and other manufacturers for everything from unsanitary conditions and faulty equipment to problems with record-keeping and other processes. It also issues them for misleading advertising.

Warning letters are often routine, with companies resolving the problems without the agency taking further action such as fines and injunctions. But in more serious cases, the warnings can dent a company’s stock and lead to product seizures or other penalties.

“Our expectation is that companies will work to quickly and thoroughly correct deficiencies and ensure safety. Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act, we will,” Hamburg said in her speech.

Under the new policy, companies will have no more than 15 working days to respond to the FDA before the agency issues a letter or takes other action.

The FDA also will move quickly to close cases after a company fixed any problems uncovered during an inspection and it would make such information public, which would help make it clear when a company’s issues are resolved, Hamburg said.

UPDATE 2-US FDA chief vows to speed up inspections, warnings is a post from: Pharmacy in jobs, news, schools

APhA Advises Consumers on Acetaminophen Use – FDA

admin — Mon, 03 Aug 2009 21:56:29 +0000

Patients Urged to Take Acetaminophen Products as Recommended on the Labeling

WASHINGTON, DC – The American Pharmacists Association (APhA) advises consumers to take acetaminophen products as recommended on the labeling and seek guidance from pharmacists or other healthcare providers on evaluating medication options. This recommendation comes as the Food and Drug Administration (FDA) convened a public advisory committee meeting on June 29 and June 30, 2009 regarding acetaminophen use in both over-the-counter (OTC) and prescription (Rx) products, the potential for liver injury, and potential interventions to reduce the incidence of liver injury.

The committee recommended a range of options for the FDA to consider from putting warning labels on products to pulling certain medicines from the market. The FDA will take the recommendations into consideration before taking any action and is not obligated to follow the recommendations of the advisory committee.

“Acetaminophen is an effective, long utilized medication in relieving patient pain and fever, and is considered safe when used according to the directions on product labeling,” said Ed Hamilton, PharmD, FAPhA, and APhA President. “As the FDA considers the recommendations made by the committee, we urge consumers not to panic, but to take acetaminophen containing products and any other medicines as directed by the product label or prescription label. Consumers are also encouraged to ask questions. Pharmacists are here to answer consumers questions about medications and can help them identify which ones may have acetaminophen.”

What should consumers do?

If taking acetaminophen containing products (commonly referred to as Tylenol® or APAP), always take according to current directions and dosing instructions.
Healthy adults should not exceed 4 grams (4000mg) of acetaminophen per day. Others should seek advice from their pharmacist or other health care provider for appropriate dosing limits.
Always read OTC and Rx medication labels before each use, follow the directions, and if you have questions, ask the pharmacist or other health care provider.
If a dosing device is included with a specific medication, use only that device for that medication.
Check the active ingredients of OTC and Rx medications to ensure that multiple products do not contain acetaminophen. Generally, taking multiple products containing acetaminophen is not advisable due to the risk of exceeding the maximum daily dose and liver damage.
Store all medications appropriately, keep all medications out of the reach of children, and always return medications to a proper storage location following each use.
Seek medical advice immediately if you or someone you know may have taken too much acetaminophen.
Advise your health care providers of all Rx, OTC, herbal and dietary supplement products taken regularly or on an as needed basis.

About the American Pharmacists Association (APhA)
The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, jobs.pharmacy-bg.com/”title=”pharmacy” >pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States. APhA members provide care in all practice settings, including community pharmacies, health systems, long-term care facilities, managed care organizations, hospice settings, and the uniformed services.

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CDC presents H1N1 update

admin — Mon, 03 Aug 2009 19:15:17 +0000

Novel influenza virus is still active in off-season; vaccine is in development.

Widespread or regional activity involving novel H1N1 influenza virus is evident in 20 American states, CDC told reporters in a news conference on Friday. As schools begin reopening next week, the rapid spread of the virus in summer camps in the United States could portend greater problems. “It’s very unusual for that kind of illness to be occurring at this time of the year,” explained Anne Schuchat, MD, Director of the National Center for Immunization and Respiratory Diseases. “The novel H1N1 viruses are making up 98% of all the subtyped viruses we have, subtype influenza A viruses, and we’re seeing them dominate here in the U.S.,” she said. In the Southern Hemisphere, where seasonal influenza is occurring, novel H1N1 has been found in many countries, Schuchat explained, adding, “This virus is capable of causing a range of illness: severe life-threatening disease that requires intensive care unit and mechanical ventilation and also milder illness that gets better on its own. And this is really important for people to know this virus is out there, it’s circulating, it causes a range of illness, and we in the United States have to get ready for the fall.”

Schuchat emphasized the importance of health care workers getting immunized, especially during this season with the presence of the novel H1N1 virus. She said, “We do expect seasonal influenza viruses to circulate as well, and we need to be prepared for both of them.”

FDA anticipates that the novel H1N1 vaccine, once it is developed, will be given in a two-step dosage. Pharmacists should be prepared to advise patients about getting the single dose of vaccine against seasonal influenza and a possible two doses of vaccine against H1N1. For the latest in H1N1 statistics, check CDC’s FluView Web page: www.cdc.gov/flu/weekly.

FDA is working now to update its guidance to schools on the handling of H1N1 viruses. Schuchat stated, “We’re in the process of reviewing all the information learned from the spring and what are the benefits and unintended consequences of school dismissals, and what are the best ways to keep kids healthy and learning and to minimize disruption, as well as to minimize the real impact that this new virus can have.” Schuchat discouraged the use of Tamiflu or other antivirals as a preventive measure. Instead, she recommended more traditional methods of good handwashing and hygiene.

In other influenza-related developments, CDC on Friday released recommendations for seasonal influenza vaccine and FDA approved an additional diagnostic test for the 2009 H1N1 influenza virus.

Carli Richard (crichard@aphanet.org)

Posted July 27, 2009

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FORTEO – FDA approves new drug indication for Forteo

admin — Sun, 02 Aug 2009 21:53:57 +0000

On July 23, Eli Lilly and Company announced that the Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug Forteo (teriparatide) to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture. Glucocorticoid therapy is the most common cause of secondary osteoporosis, leading to bone loss and an increased risk for fracture, according to a statement from Eli Lilly. Glucocorticoid-induced osteoporosis, or GIO, is associated with chronic use of glucocorticoid medications, which are often prescribed for inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease. Data indicate that glucocorticoid medications are used by up to three out of every 100 adults over age 50.

Approximately 50 percent of individuals who are prescribed chronic glucocorticoid therapy will eventually have an osteoporotic fracture. The use of glucocorticoid medications can lead to a reduction in bone formation, the company said. Forteo has been shown to counter this effect by stimulating bone formation.

In the course of the FDA’s review of the new indication, Lilly provided data from a clinical study which showed that in patients with glucocorticoid-induced osteoporosis, Forteo increased bone mineral density (BMD) from baseline to 18 months of treatment by 7.2 percent at the lumbar spine, 3.6 percent at the total hip, and 3.7 percent at the femoral neck.

“Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis,” said Kenneth G. Saag, MD, MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. “The approval of teriparatide for this new indication offers healthcare providers and patients a new treatment option that effectively increases bone mineral density in a different way than anti-resorptives.”

FORTEO – FDA approves new drug indication for Forteo

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FDA approves vaccines for upcoming flu season

admin — Sun, 02 Aug 2009 21:51:39 +0000

The U.S. Food and Drug Administration has announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States. The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009.

The FDA continues to work with manufacturers, international partners, and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus. Although this year’s seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for Americans in high-risk groups to receive the seasonal influenza vaccine.

No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths. “The approval of this year’s seasonal influenza vaccine is an example of the FDA’s important responsibility to assure timely availability of vaccine to help protect the health of the American public,” said FDA Commissioner Margaret A. Hamburg, MD. “A new seasonal influenza vaccine each year is a critical tool in protecting public health.”

The six vaccine brand names and manufacturers are: Afluria, CSL; Fluarix, GlaxoSmithKline; FluLaval, ID Biomedical; Fluvirin, Novartis; Fluzone, Sanofi Pasteur; and FluMist, MedImmune.

Each year, experts from the FDA, WHO, U.S. Centers for Disease Control and Prevention (CDC), and other institutions study virus samples and patterns collected from around the world in an effort to identify strains that may cause the most illness in the upcoming season. On the basis of those forecasts and recommendations of the FDA’s Vaccine and Related Products Advisory Committee, the FDA determines the three strains that manufacturers should include in their vaccines for the U.S. population.

According to the CDC, between 5 percent and 20 percent of the U.S. population develops influenza each year.

More than 200,000 are hospitalized from its complications and about 36,000 people die. Older people, young children, and people with chronic medical conditions are at higher risk for influenza-related complications. Vaccination of these groups is critical. In addition, immunization of healthcare personnel is important in protecting them and others from influenza.

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Generic Plan B approved by FDA

admin — Sun, 02 Aug 2009 21:43:07 +0000

Jul 14, 2009
By: Alaina Scott, Senior Editor
Drug Topics E-News

The Food and Drug Administration has approved the first generic version of the 0.75 mg Plan B emergency contraceptive tablets. For women ages 17 and under, levonorgestrel, the generic product, will be available by prescription only.Plan B, manufactured by Duramed Pharmaceuticals of Cincinnati, was first approved in 1999 for prescription use only by women of all ages. In 2006, Plan B was approved for nonprescription use by women ages 18 and older, remaining available by prescription only to women ages 17 and under.

The latest approval permits marketing of a prescription-only generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use by women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity for nonprescription use held by Duramed expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories in Corona, Calif.

Levonorgestrel can prevent pregnancy after unprotected intercourse and after known or suspected contraceptive failure. It is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

Generic Plan B approved by FDA is a post from: Pharmacy in jobs, news, schools