NoPrescriptionDrugstore.com Order Status FAQ Online Drugstore Affiliate Program Contact NoPrescriptionDrugstore.com No Prescription Drugs Newsletter Refer a Friend
 
Saturday, June 17, 2006  
Doctors warn of worst flu in years
General practitioners and pharmacists are saying they have been inundated with patients requiring medical attention and medication to treat what they are calling the "worse case of flu" in years.

Umlazi GP Dr Dumisani Mkize said his practice had seen a 40 percent increase in patients being treated for the flu.

"This year's flu is especially bad and very virulent. Patients need combination antibiotics for treatment," he said.

"We are seeing more than 40 viral strains right now and the usual vaccines we get cover about three of those strains."

Pharmacists have also reported an influx of people coming through for "over the counter" flu medication.
Musthaq Patel, a pharmacist at the Chatsworth Sparkport Pharmacy, said: "Patients are suffering from fevers, diarrhoea, pain and colds.

"Patients are also suffering from severe acute effects and the flu is taking at least three weeks to be totally cured."

For people wanting to take the flu injection now, Patel advised against it, saying that it was too late in the year.

"People now need to take preventative measures by taking vitamins and immune system boosters," said Patel.

"They also need to maintain healthy eating habits and not get into close contact with people who have contracted the flu," he said.

Another pharmacist, in Pietermaritzburg, said that this year's flu was so bad that some patients were getting viral pneumonia and needed nebulising.

South African Medical Association councillor Dr Mohamed Bayat, from Mooi River, agreed that the situation has been "much worse than previous years".

"The best thing you can do is get into bed for two to three days until you feel better," he said.

Bayat attributed the steep rise in flu symptoms to the colder weather patterns.

Leon Mbangwa, spokesperson for the KwaZulu-Natal Department of Health advised the public not to panic as there was always an expected escalation in the number of flu cases around this time of the year.

"This is why we are now seeing an increase in the number of people visiting our hospitals and clinics with flu symptoms.

"Children, the elderly and people who have a compromised immune system are at a higher risk," he said.

Labels: , ,


 
Erectile dysfunction drugs produce beneficial results

Erectile Dysfunction Drugs like Viagra (sildenafil) Levitra (vardenafil) and Cialis (tadalafil) have become household names and have provided answers to many men. Ernst R. Schwarz, M.D., Ph.D., a cardiologist at Cedars-Sinai Medical Center who specializes in therapies for men who suffer from erectile dysfunction (ED) and have heart problems, diabetes, high blood pressure or other related conditions says it is becomng increasingly important for Doctors of various specialities to become proficient in the mechanisms and systemic effects of these medications.

A recent research by Schwarz and colleagues to determine about the effects of long-term use of this class of drugs on various organ systems found that the drugs, called phosphodiesterase-5 inhibitors (PDE-5i), produce mostly beneficial results, and not just for erectile dysfunction. The FDA recently approved a reformulation of sildenafil for the treatment of primary pulmonary hypertension, a disease that tends to occur in young women, causing elevated blood pressures in the lung that can lead to heart failure and early death.

"When we look at all the different organ systems – the blood, the heart, the lungs, blood flow in the brain – there are hardly any negative side effects. In fact, just the opposite is true. There are beneficial effects for primary pulmonary hypertension, as well as for conditions such as heart failure and lack of oxygen in the heart," said Schwarz. The drugs have been on the market for several years now and there have been no reports of negative long-term effects, adds Schwarz.

While there are some differences among the three medications, they have many properties in common and work by limiting the activity of the enzyme phosphodiesterase-5, which is found in tissues and vessels of the penis, blood platelets, and smooth muscle of blood vessels. For the treatment of erectile dysfunction, the drugs' constraint of the enzyme's action results in increased levels of cyclic guanosine monophosphate (cGMP) and nitric oxide (NO), biochemicals that promote smooth muscle relaxation and increased blood flow in erectile tissue.

According to the research PDE-5 inhibitors can be effective in treating erectile dysfunction even for many men who also have diabetes, those who are older, and those who have co-existing ischemic heart disease (reduced blood flow to the heart caused by plaque buildup in the arteries). Furthermore, say the authors, "since PDE-5 is found in smooth muscles of the systemic arteries and veins throughout the body, use of PDE-5i has been associated with various cardiovascular effects."

"The original intention was to develop PDE-5 inhibitors as a treatment for angina, chest pain that occurs when the heart is starved for oxygen," Schwarz said. "As such, their effects on the heart appear to be all beneficial. Nitrates and other substances commonly used to improve blood flow and oxygenation to the heart muscle have a side effect that we call the 'steal phenomenon,' in which blood is taken away from underperfused (flow-restricted) areas to improve blood flow in normal areas. In contrast, PDE-5 inhibitors actually improve blood flow even in areas where there is a blockage of an artery, thereby having a protective effect on the heart muscle."

Speaking about the drugs' potential impact on visual function that became a matter of controversy when a suspected link between PDE-5 inhibitors and vision loss led to lawsuits filed last year against the maker of Viagra, the researchers observed that analysis of clinical trial data in more than 13,000 men and on more than 35,000 patient-years of observation found occurrence of the visual disorder to be similar to that of the general population.

The research concluded, "Experimental and human studies indicate that PDE-5 inhibitors are effective and well tolerated, and there is evidence that they are not being used to their utmost potential. We suggest that these drugs may prove beneficial in treating a wide variety of disorders."

Labels: , ,


Wednesday, June 14, 2006  
India: "VIAGARA.IN" Goes Back To Pfizer

Pfizer Products Inc., leading pharmaceutical company and manufacturers of VIAGRA filed an application for the grant of an interim injunction to restrain Altamash Khan and another party from using its registered trademark as under the domain name 'viagra.in' and URL www.viagra.in. Altamash Khan claims to have acquired the domain name for sale and not to launch his own website. A latter application prayed that the domain name " viagra.in" be transferred back to Pfizer, subject to the condition that incase the suit went against Pfizer, they would retransfer the domain name back to Altamash Khan. Pfizer also stated that in such an occurrence, they would bear all costs and expenses for the use of the domain name during the pendency of the suit and that they would suitably compensate them as may be determined by the Court.

The Counsel for Pfizer stating the nature of Viagra as a drug enhancing male potency, submitted that they were the owners of the mark. They contended that the Oxford dictionary too described the drug as stated alongside describing it as a trademark. They further submitted that the mark was registered in 147 countries and that their application in India was pending. The product's recent launch further made it essential for the domain name to be available in order to respond to various queries regarding the product and to facilitate commercial transactions on the Internet. The counsel strengthened this contention by stating that just as businesses have physical addresses, they have a place in cyber space known as domain names. Placing reliance on Eicher Limited v. Web Link India, wherein the domain name was transferred back to Eicher Ltd., the Plaintiff prayed for similar relief.

Pfizer stated that the domain name, viagra.in was already registered and that they possessed further domain name registrations, all of which prominently involved the trademark 'VIAGRA'. They further contended, citing downloads from the .IN registry website, that .IN was a unique symbol of India; procedures for registering under the .IN domain were indicated in the Policy Framework and Implementation brought out by the Govt. of India under the Dept. of Information Technology.

Referring to various print outs from the IN Registry, he pointed out that the process of applications for registration of .IN domain names were divided into two periods. The first "Sunrise period" enabled registered trademark owners, companies and owners of intellectual property to protect their Domain names after verification. Thereon, the second period, enabled the general public to register their domain names. "DirectI", an accredited Registrar, had authorized Altamash Khan as its reseller. Altamash Khan had acquired the domain name in contention for this very resale purpose.

In order to prevent hoarding, auctioning, or selling .IN domain names at prices higher than usually charges, and to resolve other related disputes, a scheme known as .IN Domain Name Dispute Resolution Policy (INDRP) had been formulated. Any person who considered his legitimate rights or interests to be conflicted by a certain domain name could file a complaint under this scheme. The dispute though must have been referred to the arbitrators under INDRP; this system not having been in place was brought forth the High Court of Delhi.

The counsel for Altamash Khan contended that Pfizer though was aware of its capability to register in the 'Sunrise' period, such a procedure not being carried out was a failure on their part. It was further contended that the scheme been thrown open to the general public, Altamash Khan had taken quick action. Further it was contended that the registrations under the second module were made through accredited registrars, on a 'first come first serve' basis, and the same was done for and on the instructions of a customer. Altamash Khan stated that he had nothing more to do with the domain name except that he was a channel for the customer to register the same.

Altamash Khan further stated that the status of the domain 'viagra.in' applied for, was shown to be inactive. They further submitted that it was not that Pfizer did not get any domain name, rather was capable of registration under the viagra.co.in domain, and that too under the general policy. They also stated that the domain viagra.gen.in was registered with another applicant. They concluded that the domain names were open to the public and hence no order directing them to transfer the said domain name ought to be passed.

The Court took note of the fact that Pfizer was the owner of the trademark VIAGRA in 147 countries and its application in India was pending. Admitting that Pfizer had spent a lot of time, money and effort in developing the product and the trademark worldwide. The court held that with such genuine reputation worldwide and being the registered owner of the domain name www.viagra.com, Pfizer did possess a legitimate interest in protecting its brand.

The court further stated that Altamash Khan had no interest in the domain name apart from putting it up for sale. Neither Altamash Khan nor his customer possess any interest whatsoever in VIAGRA as a product. The domain name viagra.in was said to be confusingly similar to Pfizer's viagra.com and that they held no legitimate interest in respect of the domain viagra.in

The domain name 'viagra.in' being inactive, it was stated by the Hon'ble court that Altamash Khan was cyber squatting, over an address over which the rights and interests of Pfizer outweighed those of Altamash Khan. On these accounts, the domain name was ordered to be transferred back to Pfizer during the pendency of the suit, since no damages as such would be caused to Altamash khan. On the other hand, Pfizer in the event of the transfer being denied would have suffered serious injury in the shape of lost opportunity of commerce, development of the product, and interaction with Internet users, which might not be quantified in monetary terms.

Stating that Pfizer had a strong prima facie case, and the balance of convenience being in its favour, the court ordered the transfer of the domain name subject to the final decision. A condition was laid down that in case the final suit got decided against Pfizer, they would be liable to re-transfer the same and compensate the opposing party as directed by the Court. The Court also directed Pfizer to reimburse all costs and expenses incurred by Altamash Khan in obtaining the said domain name.

Labels: , ,


 
AMA seeks waiting period for ads for new prescription drugs
After wrestling for years over whether to endorse banning prescription drug ads, the American Medical Association is taking a softer approach.A-M-A delegates meeting in Chicago today adopted a new policy that says new drugs shouldn't be advertised until physicians learn about them.

That approach by the nation's largest doctors' group is in line with guidelines the pharmaceutical industry adopted last year when it pledged to educate doctors before beginning consumer ad campaigns.

The new policy was adopted on a voice vote on the final day of the A-M-A's annual policy-making meeting.

The A-M-A's president-elect, Doctor Ronald Davis of Detroit, says the measure would let physicians review the pros and cons of certain drugs before prescribing them.

Labels: , ,


 
Drugs may not help anorexics
A common anti-depressant often prescribed for anorexia nervosa does not reduce patients' risk of relapsing or help them keep weight on once they have recovered, a new study shows.

Almost two-thirds of patients with the eating disorder, which primarily affects young women, are prescribed anti-depressants but the largest study of its kind, based in Toronto and New York, found they had no more effect than a placebo, said the study published yesterday in the Journal of the American Medical Association.

"This is not what we anticipated," said Dr. Allan S. Kaplan, head of the eating disorders program at Toronto General Hospital and co-author of the study. "We looked at the data upside down and we could not find the drug was any more effective than a dummy pill."

Anorexia is a very serious psychiatric disorder with a relapse rate of between 30 and 50 per cent in the first year and few treatment options, said Kaplan, who co-authored the study with Dr. Timothy Walsh of the New York State Psychiatric Institute.

Most anorexics who suffer from depression or anxiety problems are given anti-depressants, but no study has looked at their effectiveness, he said.

"Physicians are trying to do their best to help patients," he said, "and if the only tool you have in your toolbox is a hammer, you use a nail. This is a field desperate for new innovative treatment approaches."

The study looked at 93 girls and women between 16 and 45 in Toronto and New York who had recovered enough to be at normal weight. Half of them were then prescribed the selective serotonin reuptake inhibitor fluoxetine, initially marketed as Prozac, and the other half a placebo and both groups also received intensive psychotherapy.

After a year, 55 per cent of the placebo group and 57 per cent of the fluoxetine group had suffered a relapse.

People with other mood disorders improve on the drug, said Kaplan. "This tells you the brains of anorexics are different and we need to understand this condition better."

Anorexia has a mortality rate as high as any other psychiatric condition including schizophrenia. Most die of medical complications from not eating.

Research increasingly is indicating that anorexia is genetically based, he said, although society's emphasis on thinness plays a role.

"Genes load the gun and the environment pulls the trigger," he said. The onset of the disease is also spreading across age groups and is now commonly seen in pre-teens as well as women in their 30s and 40s.

While eating disorders are rising, most of that is in bulimia, where girls typically overeat and purge and do respond to treatment with anti-depressants, Kaplan said. About 80 per cent of bulimics recover with treatment, compared to 30 per cent of anorexics.

The study concludes that doctors would be better to use psychological and behavioural treatment for anorexics "for which there is some, albeit modest, evidence of efficacy," until better treatments are devised.

Labels: , ,


 
Pfizer, Bayer Partner on Obesity Drugs

According to the licensing agreement, Bayer will receive an upfront fee, milestone payments and royalties on sales of the drugs. The companies did not disclose specific financial terms of the deal, which is subject to antitrust approval but expected to close in the second half of the year.

"Obesity and diabetes are expanding hand-in-hand at near epidemic levels throughout the world. The need for new treatment options for patients has never been greater," said Dr. Martin Mackay, head of Pfizer's worldwide research and technology group. "We are excited about the potential of the DGAT-1 inhibitors in the areas of obesity and type 2 diabetes which complement Pfizer's ongoing metabolic disease research programs," Mackay said.

Pfizer's shares lifted 4 cents Wednesday, to $23.08.

The drugs, called DGAT-1 inhibitors, could potentially treat obesity, type 2 diabetes and related disorders by modifying fat metabolism. The lead drug in that class, BAY 74-4113, is currently in phase I trials, the earliest stage of human testing, which involve studying a drug's safety and looking for an indication of efficacy in patients.

Through the agreement, Pfizer is joining a number of drug developers that recognize that the obesity market is ripe for a new treatment since concerns have surfaced regarding the side effects and limited efficacy of Roche's Xenical and Abbott's

Labels: , ,


 
Over 38 Million People With Medicare Now Getting Prescription Drug Coverage

HHS Secretary Mike Leavitt today announced that 38.2 million people with Medicare are now receiving comprehensive prescription drug coverage, in many cases even better coverage than they ever had before. A surge in enrollment took place in the closing weeks of the enrollment period, with more than 2 million beneficiaries signing up between May 1 and the May 15th deadline.

"Introduction of the Medicare prescription drug benefit created an unprecedented opportunity and a breathtaking challenge," Secretary Leavitt said. "The challenge has been met, and today, for over 38 million Americans - 90 percent of people with Medicare - the promise is being fulfilled, day in and day out, prescription by prescription. In fact, more than 3.5 million Part D prescriptions are being filled each day and the cost of monthly plan premiums is nearly 40 percent lower than original estimates."

The average premium in 2006 for beneficiaries, not counting retiree coverage, is less than $24. In addition, 87 percent of beneficiaries chose plans other than the standard benefit, according to the Centers for Medicare & Medicaid Services (CMS).

"With help from thousands of partners across the country, and personalized assistance from 1-800-MEDICARE and www.medicare.gov, people with Medicare and their family members were able to get the drug coverage they prefer at a far lower cost than expected," said CMS Administrator Mark B. McClellan, M.D., Ph.D. "Thanks to Medicare beneficiaries making informed choices to meet their needs, the costs of Medicare drug coverage are way down - and we will continue to support effective competition to provide high-quality, low-cost coverage."

Total enrollment in Medicare Advantage plans increased by over 26 percent (1,249,041 self enrollees) during the six month enrollment period, bringing the total number of beneficiaries enrolled in Medicare Advantage plans to 7.4 million. Included in that total are about 4.8 million who chose to enroll in these plans before January, 2006.

About 87 percent of all beneficiaries who enrolled in a prescription drug plan chose a plan that offers coverage other than the standard benefit, such as no deductibles or coverage in the "donut hole." Most beneficiaries enrolled in Medicare Advantage plans are also getting more comprehensive drug coverage than in the standard plan. In addition, almost 10 million low-income beneficiaries are getting comprehensive drug coverage for little or no cost.

Among the 38.2 million beneficiaries who are now receiving prescription drug coverage, approximately 32.8 million have coverage from Medicare and 5.4 million have coverage from other sources, including the Department of Veterans Affairs (VA), primary coverage from an employer (from beneficiaries who are working after age 65), and state prescription drug programs that are not yet combined with Medicare Part D. Based on the latest information on the choices of veterans with VA benefits and Medicare coverage, almost 40 percent are enrolled in Medicare Part D, a much larger number of VA beneficiaries than previously expected.

Enrollment for the new Medicare prescription drug coverage began on November 15, 2005 and ended on May 15, 2006.

Overall prescription drug coverage enrollment figures as of June 11 are:

Stand-Alone Prescription Drug Plans (PDPs): 10.4 million people with Medicare have enrolled in stand-alone prescription drug plans, including 2.2 million enrollees receiving the low income subsidy (LIS).

Medicare Advantage with Prescription Drugs (MA-PDs): 6 million beneficiaries receive coverage through Medicare Advantage plans with drug coverage (MA-PDs), including 1.2 million new enrollees. Medicare Advantage includes 925,000 enrollees receiving the LIS. About 478,000 of these are full Medicare/Medicaid beneficiaries. About 1.1 million beneficiaries are currently enrolled in MA-only plans; many of these beneficiaries in private fee-for-service plans are receiving Part D through a separate PDP and therefore included in the enrollment totals for PDPs.

Medicare/Medicaid: 6.1 million Medicare/Medicaid beneficiaries were automatically enrolled in prescription drug plans. An additional 478,000 Medicare/Medicaid beneficiaries enrolled in Medicare Advantage plans with prescription drug coverage and are counted in the MA-PD total above.

Retiree Coverage: 6.9 million retirees are enrolled in the Medicare retiree subsidy. In addition, about 1.5 million retirees are in employer and union-sponsored coverage that incorporates Medicare group drug coverage and about 400,000 retirees are in employer and union-sponsored coverage that wraps around Medicare drug coverage - these beneficiaries are counted in the PDP and MA-PD totals above.

Federal retiree coverage: 3.5 million

TRICARE: Estimated 1.9 million beneficiaries with TRICARE retiree coverage, based on data that was provided by the Department of Defense (DoD). This number excludes nearly 7 percent who were found to be enrolled in Part D plans based on a person-level data match.

FEHB: Estimated 1.6 million beneficiaries with FEHB retiree coverage, includes both retirees and spouses, and excludes 2 percent who might be enrolled in Part D plans (based on information from OPM).
Additional Sources of Prescription Drug Coverage for Medicare Beneficiaries: HHS estimates that approximately 5.4 million Medicare beneficiaries have alternative sources of "creditable" prescription drug coverage:

VA: There are an estimated 2 million beneficiaries with creditable drug coverage through the VA who have not signed up for Part D. About 1 million VA beneficiaries enrolled in a Part D plan, and about 400,000 are receiving drug coverage from an employer receiving the Part D subsidy. These numbers are based on a sample person-level match provided by the VA.
Indian Health Service (IHS): There remains 0.1 million beneficiaries with creditable drug coverage through the IHS being served by I/T/U pharmacies in 28 states.

Active Workers with Medicare Secondary Payer: Nearly 2.6 million beneficiaries receive creditable drug coverage through an employer group health plan based on a person level match of our coordination of benefits files and Part D enrollment files.
Other Retiree Coverage: An estimated 0.1 million retirees are continuing in retiree coverage who are not already included in the other retiree coverage categories. Some of these retiree plans may apply for the Medicare retiree subsidy in their next full plan year, while others may have only a limited number of eligible retirees so that the financial impact of the RDS is small.

State Pharmaceutical Assistance Programs (SPAP): An estimated 0.59 million beneficiaries are continuing to receive creditable coverage through SPAPs. The estimate is based on information from four SPAP programs that have creditable coverage and are currently not requiring enrollment in Part D plans in order to retain SPAP coverage (NJ, NY, PA, and WI), and a person level match of SPAP files with Part D enrollment files.

Of the approximately 4.4 million Medicare beneficiaries who do not have secure, quality drug coverage, approximately 3.2 million are estimated to be eligible for the extra help. As President Bush announced, enrollment for these beneficiaries with limited incomes will continue throughout the year, with no late enrollment penalty.

HHS and CMS are continuing to work closely with the thousands of local organizations, whose efforts helped to inform and enroll the millions of Medicare beneficiaries across the country who enrolled in a prescription drug plan before the deadline, to reach these remaining beneficiaries. New outreach efforts include:

Collaboration with several intergovernmental partners including SSA; HUD; USDA; AoA; HRSA; and ACF to raise awareness and coordinate outreach events.

Enhanced outreach with many external partner organizations. For example, CMS is collaborating with minority groups including the NAACP to target federal outreach grants to the areas with greatest number of LIS eligibles.
New targeted outreach activities, including collaborations with NCOA to inform partners of best practices regarding data driven outreach methods.

"People with Medicare are already seeing significant savings through the new drug coverage, and beneficiaries with limited incomes have even more to save," said Dr. McClellan. "It's imperative that we reach as many of them to make sure that they are able to get the drugs they need."

Labels: , ,


 
pharmacists make $98,300
Mercer's 2006 Pharmacy Compensation Survey-Spring Edition found that the median total cash compensation for a staff pharmacist position, which includes base salary and annual bonus, rose 5.4 percent. Compensation for pharmacy team managers, pharmacy technicians and pharmacy graduates all increased more than 4.2 percent.

Pay levels were found to vary widely by geography. Salaries were $84,000 for staff pharmacists in Pittsburgh; $86,600 in Omaha, Neb.; $107,700 in San Francisco; and $109,100 in San Jose, Calif.

"The demand for pharmacists is skyrocketing due to the aging population, expansion of retail pharmacies and the development of new medications," said Eric Michael, a senior consultant with Mercer's Managed Pharmacy Benefit business.

"As the need for pharmacists outpaces supply, pharmacy operators are compensating competitively to fill open positions."

The survey is conducted semi-annually and reflects data submitted by 180 organizations covering more than 209,500 pharmacy employees. Survey participants include major retail pharmacy operators (drugstore and supermarket chains) as well as mail-order/online pharmacy companies and hospital/health-care systems.

Labels: , ,


Tuesday, June 13, 2006  
Prescription generics are huge industry in U.S.

You won't only find generic drugs in the pain relief aisle at your local pharmacy.

They're also increasingly found in the prescriptions doled out by your local pharmacist. Generic drugs account for about 50 percent of all prescription drugs purchased in the United States, according to the Food and Drug Administration.

Like their over-the-counter counterparts, generic prescription drugs must be equivalent to brand-name prescription drugs in dose, strength and quality. The active ingredient must be the same in the generic as in the brand-name, although inactive ingredients

Labels: , ,


 
Prescription drugs find place in teen culture
When a teenager in Jan Sigerson's office mentioned a "pharm party" in February, Sigerson thought the youth was talking about a keg party out on a farm.

"Pharm," it turned out, was short for pharmaceuticals, such as the powerful painkillers Vicodin and OxyContin. Sigerson, program director for Journeys, a teen drug treatment program in Omaha, soon learned that area youths were organizing parties to down fistfuls of prescription drugs. Since February, several more youths at Journeys have mentioned that they attended pharm parties, Sigerson says.

"When you start to see a pattern, you know it's becoming pretty widespread," she says. "I expect it to get worse before it gets better."

Drug counselors across the USA are beginning to hear about similar pill-popping parties, which are part of a rapidly developing underground culture that surrounds the rising abuse of prescription drugs by teens and young adults.

It's a culture with its own lingo: Bowls and baggies of random pills often are called "trail mix," and on Internet chat sites, collecting pills from the family medicine chest is called "pharming."

Carol Falkowski, director of research communications for the Hazelden Foundation, says young abusers of prescription drugs also have begun using the Internet to share "recipes" for getting high. Some websites are so simplistic, she says, that they refer to pills by color, rather than their brand names, content or potency.

That, Falkowski says, could help explain why emergency rooms are reporting that teens and young adults increasingly are showing up overdosed on bizarre and potentially lethal combinations of pills.

Overdoses of prescription and over-the-counter drugs accounted for about one-quarter of the 1.3 million drug-related emergency room admissions in 2004, the federal Substance Abuse and Mental Health Services Administration reported last month.

The abuse of prescription and over-the-counter drugs — which barely registered a blip in drug-use surveys a decade ago — is escalating at what Falkowski and other analysts say is an alarming rate.

In a 2005 survey by the Partnership for a Drug-Free America, 19% of U.S. teenagers — roughly 4.5 million youths — reported having taken prescription painkillers such as Vicodin or OxyContin or stimulants such as Ritalin or Adderall to get high.

Vicodin has been particularly popular in recent years; a study by the University of Michigan in 2005 found that nearly 10% of 12th-graders had used it in the previous year. About 5.5% said they had used OxyContin. Both drugs are now more popular among high school seniors than Ecstasy and cocaine.

Marijuana is still the most popular drug by far; about one-third of the 12th-graders surveyed said they had used it in the previous year.

More socially acceptable

Falkowski, whose foundation is a treatment center based in Center City, Minn., says prescription pills have become popular among youths because they are easy to get and represent a more socially acceptable way of getting high than taking street drugs.

Some kids, she says, are self-medicating undiagnosed depression or anxiety, while others are using stimulants to try to get an edge on tests and studying.

Falkowski says prescription drugs are familiar mood-altering substances for a generation that grew up as prescriptions soared for Ritalin and other stimulants to treat maladies such as attention-deficit disorder. "Five million kids take prescription drugs every day for behavior disorders," she says.

"It's not unusual for kids to share pills with their friends. There have been incidents where kids bring a Ziploc baggie full of pills to school and share them with other kids."

Pharm parties, she says, are "simply everyone pooling whatever pills they have together and having a good time on a Saturday night. Kids ... don't think about the consequences."

Lisa Cappiello, 39, of Brooklyn, N.Y., says that seemed to be the case with her son, Eddie. She says she knew that he had tried marijuana at 15 and sneaked beers at school.

But it wasn't until after he graduated from high school and took a year off before college that Cappiello realized the extent of her son's drug use — and the hold prescription drugs had on him.

"In what seemed like the blink of an eye, it went from marijuana and an occasional beer to so much Xanax that (one day) my husband had to pick him up when he feel asleep on a street corner waiting for some friends," she said. "He hid his drug use from me so well."

The next day, Eddie Cappiello admitted to his parents that he had taken 15 pills of Xanax, a brand name for benzodiazepine that acts as a sedative. He told his parents Xanax helped him deal with anxiety and depression.

Eddie rejected professional help and vowed to stop taking pills, his mother says. He was clean for 10 months, she says, before he was hospitalized in July 2005 after overdosing.

Two months later, he entered a 28-day treatment program, his mother says. After he was discharged, he stayed clean for about two months — then relapsed into weekend binging: 40 to 50 pills and a quart of Jack Daniel's, sometimes by himself, sometimes with friends, Lisa Cappiello says.

Eddie Cappiello, 22, died in his bed on Feb. 17 after overdosing on a mix of pharmaceuticals. He left behind a girlfriend and two young children.

A toxicology report said he had 134 milligrams of Xanax — the equivalent of 67 pills — and an opioid derivative in his system, his mother says.

"Before four years ago, I never even heard the word Xanax," Lisa Cappiello says. "Now ... I know kids as young as 12 are using it. Then I found out that Vicodin was a very big party drug. Before school, after school, at parties. Kids mixed them with alcohol and Ecstasy. It was baffling to me."

Cappiello says police, teachers and parents are so fixated on street drugs such as marijuana, cocaine and Ecstasy that they are missing the start of an epidemic.

"Eddie was not the first kid to die in this neighborhood from prescription drugs," she says.

'Troubling trend'

In recent months, federal anti-drug officials have acknowledged that they didn't anticipate the quick escalation of prescription-drug abuse. Most government-sponsored drug prevention programs focus on marijuana, tobacco, alcohol and methamphetamine.

"We were taken by surprise when we started to see a high instance of abuse of prescription drugs," says Nora Volkow, director of the National Institute of Drug Abuse (NIDA), which is collecting information about how teens perceive, get and use prescription drugs so it can try to craft an effective prevention campaign.

In a bulletin last year, NIDA called the increase in pharmaceutical drug abuse among teens "disturbing" and said pharm parties were a "troubling trend."

The increasing availability of prescription drugs is a big reason for the rise in their abuse, Volkow and other drug specialists say.

Pharmaceutical companies' production of two often-abused prescription drugs — hydrocodone and oxycodone, the active ingredients in drugs such as Vicodin and OxyContin — has risen dramatically as the drugs' popularity for legitimate uses has increased. Drug companies made 29 million doses of oxycodone in 2004, up from 15 million four years earlier. Hydrocodone doses rose from 14 million in 2000 to 24 million in 2004.

The 2005 Partnership survey found that more than three in five teens can easily get prescription painkillers from their parents' medicine cabinets. And as Falkowski says, the rising number of youths being treated with stimulants has made it easier for kids to use such drugs illicitly. About 3% of children are treated with a stimulant such as Adderall or Ritalin, up from less than 1% in 1987.

Almost all of the 13 youths at Phoenix House's intensive outpatient treatment program on New York City's Upper West Side have dabbled in prescription drugs, director Tessa Vining says.

"There's definitely easy access," she says. "Maybe a parent had some surgery and took one or two painkillers from a bottle of 10, and the rest are just hanging out in the medicine cabinet."

After her son died, Cappiello says she wondered how kids in her area were getting pills. She says she learned from police that one local dealer got Xanax from his mother, who had been given a prescription for the drug. Instead of taking the pills, she gave them to her son to sell for $2 to $3 each.

Paul Michaud, 18, of Boston, says he got his first taste of OxyContin pills — he calls them OCs — from a friend during his freshman year in high school.

Until then, Michaud says, he had smoked marijuana daily and taken a Percocet pill occasionally. Michaud's father had recently died of cancer, and Michaud says he was depressed and feeling like an outsider at school. The prescription painkiller made him feel like nothing could faze him, he recalls.

"The first time I did it, I was hooked," says Michaud, who is four months into a yearlong drug treatment program at Phoenix House in Springfield, Mass. He says he quickly became a daily OxyContin user, breaking apart the time-release capsules, crushing pills and snorting the powder from five 80-milligram pills a day.

"They're not very hard to get. I could find OCs easier than I could find pot," Michaud says. "There were plenty of people who sold them," including some dealers who got pills illicitly by mail order.

Cutting off the supply

To try to reduce the supply of prescription drugs on the black market, authorities have shut down several "pill mills" — where doctors prescribe inordinate amounts of narcotics — as well as Internet pharmacies that ship drugs with little medical consultation, says Catherine Harnett, chief of demand reduction for the Drug Enforcement Administration (DEA).

Last September, DEA agents arrested 18 people allegedly responsible for 4,600 such pharmacies.

A tricky part of the prescription-drug problem, Harnett says, is addressing the perception among youths that pills are safe because they are "medicine." Many teens don't equate taking such pills with using drugs such as heroin or cocaine, she says.

"If you start with pills, it seems fairly sanitary and legitimate," she says. "Kids have been lulled into believing that good medicine can be used recreationally."

Two in five teens in the Partnership study said prescription medicines, even if they are not prescribed by a doctor, are "much safer" to use than illegal drugs.

'A lot to live for'

Phil Bauer of York, Pa., believes his son, Mark, 18, an avid weight lifter, started using prescription drugs to relieve chronic back pain and didn't appreciate the potential risks of taking the drugs.

Bauer says his son never behaved as he imagined a drug addict would. "He wasn't hanging out all night. He had parents who wouldn't let him do that."

Mark Bauer died of an overdose on May 28, 2004. The toxicology report found morphine, oxycodone and acetaminophen — the active ingredient in Tylenol but also an ingredient in Vicodin — in his system, Phil Bauer says.

Before his son's death, "we didn't see a bleary-eyed guy. He wasn't slurring his words," the father says. "He seemed to have a lot to live for. I did not know prescription-drug abuse was a problem. There's so much guilt in that. I don't know if I stuck my head in the ground. I did not see this coming."

Michaud says he didn't equate his OxyContin addiction with hard-core drug abuse. "Where I come from, OC is a rich boys' drug," he says. "I thought, heroin abuse, that's pretty low. I'd never stick a needle in my arm."

However, Michaud says he eventually switched to heroin. "I sniffed it and a week later, I was shooting," he says. "I thought I wasn't like other people doing heroin. I wasn't that low. Come to figure out, it all leads to the same place."

Labels: , ,


 
Medicare Prescription Plan Could Be Hurting Pharmacies

For many of the people in the Belmond retirement community, Medicare's prescription program is working like they hoped it would.

Robert V. Nelson tells KIMT Newschannel Three, "Yeah, saved me money so far, on the little stuff it does."

But the manager of the Pharmacy just down the street is singing a different tune when it comes to some of the changes that Part D has triggered.

Terri Havens, Pharmacy Manager, tells KIMT, "Reimbursement was drastically reduced to the independent pharmacies and it is a major concern that we have."

Reduced to the point where the pharmacy will only make a few cents on certain prescriptions, because insurance companies pay them so little. And now Terri and several others are turning to local lawmakers to try and get some results.

Terri adds, "Changes have to come, that's all there is to it. Reimbursement has to change otherwise a lot of independents probably won't be able to stay open."

But for people like Robert, he just hopes any changes wouldn't mean passing the buck onto him.

"I live on Social Security and I gotta make every penny count."

But at the same time, pharmacists want insurance companies to recognize all the hard work they put in to making their patients happy.

"We are more than just dispensing a product, we're offering a service that's critical in a patients care."

But the question remains, who will pay the price to make everyone happy?

Labels: , ,


 
New device finds fake drugs quickly
New analytical chemistry techniques can detect fake anti-malarial drugs and get them off the market fast, researchers said Tuesday.

One technique, called desorption electrospray ionization (DESI), was developed at Purdue University.

Another technology, direct analysis in real time (DART), was created by the Japanese company JEOL.

The new detection methods eliminate preparation time and can analyze a sample in five seconds, compared to the more than two hours needed by liquid chromatography and mass spectrometry when used for the same purpose. Their speed makes high-throughput analysis a reality, the technologies' developers said.

DESI is currently used to quantify the amount of the active ingredient in some anti-malarial drugs, artesunate. A high-speed, charged spray made up of alcohol, an alkylamine compound to stabilize the artesunate, and water is sprayed on a tablet to pick up molecules from its surface and transfer them to a detector.

In contrast, DART directs an ionizing beam of marginally stable helium atoms generated by an electric discharge at a sample.

Researcher Facundo Fernandez and his colleagues the Georgia Institute of Technology are combining the technique with other instruments, such as an ion mobility spectrometer used in airports to detect explosives, to define the chemistry involved and create a successful field tool.

The Georgia researchers said they are adapting the techniques to analyze anti-malarials, adding that the technology might be used to test a variety of medications in the future. A report on their work will appear this summer in the journal ChemMedChem.

Labels: , ,


Monday, June 12, 2006  
Depression Drugs May Up Diabetes Risk
Taking antidepressants seems to dramatically increase the risk of developing type 2 diabetes among people who are already at risk for the disease.

That is the finding from a major government-funded study designed to determine the role of lifestyle and drug therapy in preventing diabetes.

Researchers from the Diabetes Prevention Program, sponsored by the National Institutes of Health, reported that depression alone did not predict progression to diabetes in people at risk for the disease. But taking antidepressants was associated with a two- to threefold increase in risk.

The increase was not seen, however, in people at high risk for diabetes who were taking both antidepressants and the blood-sugar-regulating drug glucophage (metformin).

The findings were reported at the American Diabetes Association's 66th Annual Scientific Session, held in Washington.

Antidepressants and Diabetes

While some antipsychotic drugs are known to raise diabetes risk, the new research is the first to find that antidepressant drugs may also increase risk.

"We have to keep in mind that this occurred in a population at very high risk for diabetes so we don't know whether the findings would apply to the general population, but this should be explored further," says American Diabetes Association president Richard R. Rubin, PhD.

While the stresses and health problems that accompany diabetes can certainly bring on depression, there is also some suggestion that the metabolic factors that drive diabetes also play a role in diabetes.

Depression's Role in Diabetes

Several other studies presented at the ADA meeting addressed the chicken and egg issue of whether depression causes diabetes or vice versa.

In one such study, researchers from Emory University School of Medicine in Atlanta examined blood sugar control, or glucose tolerance, of 443 healthy adults without known diabetes or glucose intolerance who were and were not being treated for depression. Glucose intolerance is the major indicator of diabetes.

The researchers thought they would find that depressed patients had higher levels of prediabetes and undiagnosed diabetes disease than people who were not depressed, but this is not what they found.

After adjusting for diabetes risk factors such as weight, age, and race, little association was seen between depression and glucose intolerance. Although diabetes was associated with depression, unrecognized glucose intolerance was not.

"Since these results suggested that awareness of the health risks conferred by diabetes may contribute to depression, patients with newly diagnosed glucose intolerance should be counseled appropriately and monitored for development of depression, researcher Lawrence S. Phillips, MD, and colleagues wrote.

Role of Hormonal Changes

But other research suggests that depression predisposes people to diabetes. In a presentation at the ADA meeting Johns Hopkins School of Medicine epidemiology professor Sherita Hill Golden, MD, suggested that hormonal changes seen with depression could also cause diabetes.

Specifically, the stress hormones adrenaline and cortisol could be the culprits, she tells WebMD.

"Both of these hormones are increased in people who have depression, and we also know that these two stress hormones also alter glucose metabolism as well," she says.

Stress hormones are also thought to play a role in cardiovascular risk.

If the theory is correct, then medications being developed to keep these hormones in check may prove to be effective diabetes and heart-disease-prevention drugs, she says.

Labels: , ,


 
Asthma Drugs May Boost Cataract Risk for Elderly
Elderly patients taking anti-asthmatic medications to treat their asthma or lung disease may be more likely to develop cataracts, a new study finds.

A Canadian research team studied data compiled over 14 years from more than 100,000 patients with either asthma or chronic obstructive pulmonary disease (COPD). The data came from a provincial health database and included diagnosis and prescription information for each patient.

"We found that people over the age of 65 who take a cortisone-like medication called inhaled corticosteroids to lower their risk of asthma or COPD attacks are actually raising their risk of developing cataracts," study author Dr. Samy Suissa, an epidemiologist at McGill University Health Centre in Montreal, said in a prepared statement. "This important information to physicians and patients will help in the management of patients using these drugs."

For patients who took an inhaled corticosteroid each day, researchers found that their risk of developing cataracts was 24 percent higher than patients who did not use the drugs. Researchers also noted an increase in patients who took half the typical daily dose of a prescribed inhaled corticosteroid. Of all the patients studied, over 10,000 of them developed severe cataracts.

"We recommend that elderly asthma sufferers keep using these very effective medications, but make efforts to reduce the dose of inhaled corticosteroids as much as possible," Suissa said.

If patients are prescribed an inhaled corticosteroid, Suissa recommends a long-acting bronchodilator or anti-leukotriene combination therapy to reduce the risk of cataracts.

Labels: , ,


 
Pushing back on 'morning-after' access

Considering that the Food and Drug Administration has chosen to engage in political and religious pandering instead of its real job, it was heartening last week to see the Oregon Board of Pharmacy push back against efforts to restrict access to the so-called "morning-after pill."

The pharmacy board said it was a matter of professional responsibility for pharmacies to fill prescriptions for the pill and, if individual pharmacists object, a pharmacy must offer an immediate alternative to allow patients to fill their prescriptions.

The Oregon board's position statement also prevents pharmacists from sermonizing to patients on the subject and requires pharmacy operators to adopt policies to make sure these things happen.

All of this is a good thing, even though it illustrates the larger problem involved here, which is that there is no need for pharmacists to be in the loop at all.

Three FDA offices and one advisory panel have concluded that the "Plan B" contraceptive is safe and effective for over-the-counter sale. The FDA's governing board, however, has refused to take the necessary step to release the drug for easy access.

This has everything to do with sexual politics and nothing to do with the medical facts involved or expanding society's ability to minimize the number of abortions.

In Oregon, the pharmacy board's executive director, Gary Schnabel, believes that the new rules are more a matter of easing the minds of patients than a response to any widespread problem.

"The net effect is that people will sleep easier," Schnabel told The Oregonian's Patrick O'Neill. "I think a lot of people were worried about what might happen more than what was actually happening."

We'd disagree simply because there's no real way to measure the extent to which women may forgo seeking the drug if doing so might subject them to the disapproval of an overbearing pharmacist.

Oregon law doesn't require pharmacists to simply fill legitimate prescriptions in this area, thus the pharmacy board's ability to do the right thing is limited. That law should be changed. If the FDA won't act, we'd prefer a state approach that would require pharmacists simply to stay out of the doctor-patient relationship in this area.

Pharmacists who believe their role extends to judging their customers on moral and religious grounds are simply in the wrong business.

Labels: , ,


 
FDA wants prescription drugs tracked

The Food and Drug Administration plans to require drug manufacturers to start tracking distribution of high-priced drugs throughout the pharmaceutical supply chain this December, using technology it calls the most promising, radio frequency identification (RFID).

But the FDA said the use of RFID technology to create an electronic pedigree to trace the sale of all prescription drugs from manufacturer to corner pharmacy will not be adopted in 2007, as the FDA had anticipated.

Congress originally passed the Prescription Drug Marketing Act, which calls for the pharmaceutical industry to track drug shipments, in 1987, but the FDA has delayed enabling regulations since then because of complaints from secondary wholesalers, congressional overseers and technological hurdles.

The FDA planned to use RFID to detect counterfeit drugs since 2004. In a report released last week, the agency said it "had expected this technology to be in widespread use in the drug supply chain by 2007…. It now appears that FDA's expectations for adoption of the technology by 2007 will not be met.''

The FDA Counterfeit Drug Task Force recommended in its report to FDA Acting Commissioner Andrew von Eschenbach last week that it was time for the agency to institute regulations in a nearly 20-year-old legislation. Von Eschenbach approved with a phased approach.

The FDA issued a draft Compliance Policy Guide (CPG) last week that states that the agency intends to focus its enforcement of drug tracking on those most vulnerable to counterfeiting or diversion, including drugs with a high sales volume such as cholesterol-reducing Lipitor, expensive specialty drugs, or high-demand drugs such OxyContin, an often-abused painkiller and Tamiflu, whose use could skyrocket in a pandemic.

Paul Chang, an associate partner at IBM Business Consulting Services, said pharmaceutical companies whose products fall in the categories the FDA outlined in its CPG have already started to trace and track the drugs.

Pfizer, for example, started tracking all shipments of Viagra last December, while Purdue Pharma has tagged shipments of OxyContin since 2004.

The entire pharmaceutical supply chain should be able to use e-pedigrees in the near future, the June 2006 FDA Counterfeit Drug Task Force Report states.

The task force understands the complexity of the pharmaceutical industry's adopting e-pedigrees overnight and recognized that using a combined paper and electronic approach may be needed during a transitional period, the report states.

The task force report called RFID the most promising technology for tracking and tracing the drug supply chain with hybrid RFID/bar code systems achievable in the near future.

Labels: , ,


 
Pharmacy board adopts policy on Plan B pill

Women who want emergency contraception pills got more assurance this week that they'll be able to buy their medication without undue delay or a lecture from a disapproving pharmacist.

Oregon law does not require pharmacists who object to dispensing the morning-after pill to do so. But the Oregon Board of Pharmacy will require pharmacies to make sure there's a way for patients to get their pills despite a pharmacist's objections.

On Wednesday, the board adopted a position statement forbidding pharmacists from lecturing their patients on religious or moral beliefs or confiscating, destroying or tampering with a patient's prescription. Such behavior would be considered "unprofessional behavior," according to the statement.

The statement allows pharmacists who object to emergency contraception to follow their conscience. But if they refuse to dispense the pill they must quickly refer patients to a pharmacist who will.

The statement, which modifies one adopted in August, emphasizes a pharmacist's "duty" to provide care in the patient's interest and requires each pharmacy to write procedures to address pharmacists' moral, ethical and professional responsibilities.

Gary Schnabel, executive director of the pharmacy board, said the changes came at the request of the Northwest Women's Law Center in Seattle on behalf of Planned Parenthood of the Columbia Willamette and Naral Pro-Choice Oregon, an abortion-rights group.

"The net effect is that people will sleep easier," he said. "I think a lot of people were worried about what might happen more than what was actually happening."

The pharmacy board has received two complaints from women concerning the morning-after pill, he said -- both of them after an April meeting in which law center representatives addressed the board.

Rebecca Green, spokesperson for Naral Pro-Choice Oregon, said the organization is "really happy with the . . . decision. We've been working on this issue for a good couple of years, focusing on emergency access."

The pill, Plan B, also known as the "morning-after pill," has been available since 1999. If taken within 72 hours of sex, it dramatically cuts the chance of pregnancy. Proponents say because of the time limit it's essential to make it easy to acquire.

Gayle Atteberry, executive director of Oregon Right to Life, which opposes abortion, said she is disappointed in the pharmacy board "for failing to stick up for their pharmacists who are morally opposed to this pill."

Atteberry said she fears the new policy statement will force some pharmacists to violate their consciences by requiring them to refer patients to other pharmacists who will dispense the pill.

Schnabel said pharmacy employers should discuss their expectations with prospective employees before they are hired.

He said policies should spell out exactly what a pharmacist who objects to dispensing the morning-after pill should do when presented with a prescription.

One alternative is for the objecting pharmacist to "take himself out of the equation" and hand off the patient to a colleague who will fill the prescription. The procedures should specify who would fill the prescription or where the patient could be sent to get the drugs, he said.

Labels: , ,


Sunday, June 11, 2006  
FDA TARGETS UNAPPROVED PRESCRIPTION DRUGS

Thousands of prescription drugs never approved by the Food and Drug Administration are on the market, and some pose clear health risks to patients, the agency said yesterday as it announced an effort to force the manufacturers either to seek approval or to stop selling their products.

The FDA focused particularly on a group of antihistamines that contain the active ingredient carbinoxamine. Agency officials said that the ingredient, which is widely used and advertised under a variety of brand names, has been linked to the deaths of more than 20 young children, although a definitive connection has not been established. Makers of the unapproved antihistamines were given 90 days to come to the agency and apply for approval.

"Right now, many unapproved drugs represent a public health threat, because consumers wrongly assume that these widely marketed and available drugs are approved and have been found to be safe and effective by the FDA," said acting FDA Commissioner Andrew C. von Eschenbach.

"While we want to ensure continued patient access to necessary treatments, as a physician I feel strongly that patients expect and deserve all their prescription medicines to be FDA-approved," he said in a statement. "These unapproved drugs have bypassed the agency approval process through which FDA ensures that marketed drugs are safe, effective, properly manufactured, and accurately labeled."

Although some unapproved products have been on the market for decades, others are relatively new, FDA officials said. The agency estimated that 2 percent of the prescription drugs now for sale have never been reviewed or formally determined to be safe and effective, as required by law.

Unapproved carbinoxamine products are often labeled for cough and cold treatment in children, the FDA said in a statement on its Web site. But the compound's safety has never been studied in young children, and the agency said there is concern that it could be harmful.

FDA officials said that the unapproved carbinoxamine medications include Histex, Rondec and Cardec. Makers of these and other unapproved drugs often advertise their products, and many are listed in the Physicians' Desk Reference, which doctors use as a guide in prescribing drugs. In documents made public yesterday, the FDA said the labels of unapproved drugs often do not mention that they were never reviewed by the agency.

There are two approved drugs containing carbinoxamine, both manufactured by Atlanta-based Mikart Inc. The two are not affected by the FDA action because they were deemed safe.

The issue of unapproved drugs has been before the FDA for years, and it had earlier focused on an anti-malaria drug, quinine sulfate. One drugmaker, Mutual Pharmaceutical Co., won approval from the agency to sell quinine sulfate as an "orphan drug" last year, but it has not yet gotten its product to the market. The president of the company wrote to the FDA last month to complain that the agency had taken "a disturbingly laissez-faire approach to the issue of the safety of unapproved quinine sulfate" sold by other companies.

Steven K. Galson, head of the FDA's Center for Drug Evaluation and Research, said the agency's more aggressive approach to unapproved drugs is part of a drug-safety initiative and "will be a significant focus for us going forward."

The FDA has come under sharp criticism for its handling of numerous drug-safety issues -- notably the sudden withdrawal in 2004 of the blockbuster painkiller Vioxx because of evidence it was causing heart problems -- and the agency has since been beefing up its safety oversight.

Galson said the agency will not go after all unapproved drugs at once, but would set priorities based on the seriousness of safety concerns and whether competing companies could provide FDA-approved versions of the medication.

Labels: , ,


 
FDA says rules on prescription drug tracking will take effect in December
The US Food and Drug Administration [official website] said Friday that new rules [press release] requiring wholesalers to be able to track prescription drugs will take effect in December. The rules stem from the Prescription Drug Marketing Act of 1987 [summary], a law aimed at combating drug counterfeiting [FDA backgrounder]. The FDA has so far been unable to fully enforce this law due to a lack of practical means to do so. Certain regulations requiring distributors to document the "pedigree" of drug products [draft compliance policy guide] had been delayed due to a concern about their impact on small wholesalers, but in a report [text] Friday, the FDA said that "it can no longer justify not implementing these regulations." The advent of radio frequency identification tags technology (RFID) [Wikipedia backgrounder] now allows wholesalers to more effectively and efficiently track individual bottles.

According to the
World Health Organization [official website], counterfeiting involves between 8 and 10 percent of all drugs sold. FDA acting Commissioner Dr. Andrew C. von Eschenbach [official profile] has said that the use of RFID tags will help to reduce the risk that these counterfeit drugs will enter the US market. The New York Times has more.

Labels: , ,


 
Millions Vulnerable to Counterfeit Drugs
Rick Roberts knows first-hand about counterfeit drugs.

Roberts, an AIDS patient, questioned his pharmacist after injecting himself with a drug that was supposed to help him keep weight on. Almost immediately, he felt painful stinging. He soon found out that the medication was counterfeit.

"For me, the most present problem was not knowing and having nightmares about what was in the vials that I injected," Roberts said.

The nearly identical-looking counterfeit was a fertility drug. Luckily, it was discovered before doing any harm.

Counterfeiters often copy drugs that are expensive or popular. That has included Viagra and the cholesterol-lowering drug Lipitor. The Food and Drug Administration estimates that 1 percent of prescription drugs may be counterfeit.

"They're looking for the best profits — either very expensive biotechnology drugs, injectable drugs, or big volume sellers like Lipitor, which is the number-one selling drug in America," said Katherine Eban, an investigative journalist and author of the book "Dangerous Doses: How Counterfeiters are Contaminating America's Drug Supply." "Generally, those are the targets of counterfeiters."

Eban said if they are careful, patients can often spot imposters on their own. In fact, that is how most counterfeit medications are detected.

"When you're taking pills, put them in the palm of your hand and look at them in the light," she said. "See if they look different. Notice packaging differences and notice strange side effects. Is anything different? If you're taking injectible medicine, do you feel a stinging upon injection? A rash at the injection site? That way, if you see something that is unusual, you can talk to your pharmacist.

If people suspect that they are taking fake medicine, Eban said they should first visit their pharmacist, who often gets alerts from drug makers about whether counterfeits exist on the market. She added that most drug manufacturers have 1-800 numbers for customer complaints.

Labels: , ,


 
Breast cancer drugs' side effects examined
Although two breast cancer prevention drugs are equally effective at lowering a woman's chance to develop the disease, experts say deciding which drug to take may be difficult.

At a meeting of cancer specialists Monday, researchers released data showing that women taking the standard treatment drug tamoxifen reported more gynecological problems, hot flashes, leg cramps and bladder-control problems than those taking the osteoporosis treatment drug raloxifene. The women on tamoxifen also reported better sexual function.

Women taking raloxifene had more musculoskeletal problems, pain during intercourse and weight gain, the study showed.

"It does us no good if a woman doesn't take the drug, so the effects on quality of life are important," said Patricia Ganz, the director for cancer prevention and control research at Jonsson Comprehensive Cancer Center at UCLA, who presented the findings.

Thus, women should take one of the drugs and discuss quality of life with their physician after three months to decide if a switch is needed, she said.

The quality-of-life differences are the latest finding in the STAR (Study of Tamoxifen and Raloxifene) trial, which included nearly 20,000 participants; the quality-of-life study subset had 1,983 participants. Researchers released results in April that found raloxifene worked just as well as standard treatment using tamoxifen in preventing breast cancer.

Tamoxifen is taken for five years. It blocks the effects of estrogen, a hormone that can fuel rapid cell growth and certain cancers. However, it increases the risk of developing uterine cancer or a life-threatening blood clot.

Raloxifene has the same side effects as tamoxifen, but those taking the drug had 36 percent fewer uterine cancers and 29 percent fewer blood clots, that study showed.

Both studies were presented at the American Society of Clinical Oncology meeting and are published this week in the Journal of the American Medical Association.

"These studies give physicians and patients options about which drugs are best to use for particular indications," said Robert Ozols, senior vice president of the medical science division at Fox Chase Cancer Center in Philadelphia. Still, it's up to primary care physicians to prescribe the medication, said D. Lawrence Wickerham, an author of the STAR trial.

He expects that most will prescribe raloxifene because of their familiarity with the drug.

Another study presented Monday found that women at high risk for breast and ovarian cancer could lower their disease risk by having their ovaries and fallopian tubes removed.

The study found that surgery reduced ovarian cancer risk best in patients with the BRCA1 gene mutation, whereas those with the BRCA2 gene mutation had more benefit in their breast cancer risk. After about three years of follow-up, surgery reduced breast cancer risk by 72 percent in women with the BRCA2 mutation, compared with 39 percent in those with the BRCA1 mutation.

The surgery reduced ovarian cancer risk in women with the BRCA1 mutation by 87 percent. So far no ovarian cancer has been observed in those with the BRCA2 mutation.

About 5 percent to 10 percent of breast cancers are caused by inherited mutations in a single gene. Women with mutations in BRCA1 or BRCA2 have about an 80 percent chance of getting breast cancer in their lifetimes.

"Although these are healthy women without disease, their lifetime risk is 10 to 60 times greater than what's seen in the general population," said Noah Kauff, author of the study and an assistant attending physician at Memorial Sloan-Kettering Cancer Center.

And since many of the women have watched their loved ones die from cancer, that option, while drastic, is a good one, he said.

Labels: , ,