Showing posts with label Counterfeit drugs. Show all posts
Showing posts with label Counterfeit drugs. Show all posts

Wednesday, June 6, 2018

FDA takes action against 53 websites marketing unapproved opioids

FDA News Release
FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.
Companies who fail to correct the violations, as outlined in the warning letters, may be subject to enforcement action, including product seizure or injunction.

"The FDA is taking additional steps to protect U.S. consumers from illicit opioids by targeting the websites that illegally market them and other illicit drugs. The internet is virtually awash in illegal narcotics and we’re going to be taking new steps to work with legitimate internet firms to voluntarily crack down on these sales. As part of that effort, we’re hosting a summit with internet stakeholders to find new ways to work collaboratively with them to address these issues. At the same time, we’ll be taking action against firms whose websites deliberately break the law," said FDA Commissioner Scott Gottlieb, M.D. "This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis. Today’s warning letters go right to the source of this illegal activity to let online network operators know that marketing illegal and unapproved opioids directly to U.S. consumers will not go unchallenged by the FDA. Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives. The new warning letters are part of a comprehensive campaign to target illegal sales of unapproved opioids. We’ll be following these actions with additional steps in coming months to crack down on the flow of illegal, unapproved opioids sold online and shipped through the mail."

Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol and oxycodone, in violation of the Federal Food, Drug, and Cosmetic Act.

This is particularly concerning considering that FDA-approved tramadol and oxycodone carry boxed warnings, which is the FDA’s most prominent warning, indicating that the drugs carry a significant risk of serious or even life-threatening adverse effects. The boxed warnings address risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, their use may result in coma or death.

The networks receiving warning letters include:
AnonShop
Eassybuyonline
Instabill ECS-Rx
Medstore.biz
One Stop Pharma
RemedyMart
RxCash.Biz
TramadolHub
XLPharmacy

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder. We will continue to aggressively pursue these criminals and take swift action to protect the American public."

The FDA requested responses from each of the companies within 10 working days. The companies are directed to inform the agency of the specific actions taken to address the agency’s concerns.

Opioid addiction is an immense public health crisis. Addressing it is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. One critical step to addressing this public health emergency is the adoption of a more proactive approach by internet stakeholders to crack down on internet traffic in illicit drugs. Illegal online pharmacies, drug dealers and others are increasingly using the internet to further their illicit distribution of opioids, where their risk of detection and repercussions is significantly reduced.

As part of this effort, Commissioner Gottlieb has invited internet stakeholders and thought-leaders, government entities, academic researchers and advocacy groups to an Online Opioid Summit on June 27 to discuss ways to collaboratively take stronger action in combatting the opioid crisis by reducing the availability of illicit opioids online. Topics to be addressed during the Summit include: research into the ease with which illicit opioids can be purchased online and industry approaches to addressing opioids marketed online, followed by a roundtable discussion to identify gaps and new solutions.

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft, and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation. The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Wednesday, September 27, 2017

FDA conducts global operation to protect consumers from rogue online pharmacies


FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
September 25, 2017
Illegally marketed opioids are among the products targeted, along with the websites that sell them, during international Operation Pangea X

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

These actions were part of a major global operation that the FDA participated in to target illegal drugs being marketed online, and shipped and distributed through the postal system, directly to American consumers. Among other actions, the FDA also issued warning letters to the operators of a majority of the illegal websites that were targeted in the operation and worked with internet registrars to confiscate certain websites. Patients who buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk by individuals who put financial gains above patient safety,” said FDA Commissioner Scott Gottlieb, M.D. “The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids. As part of a broader effort to target this illegal activity, in addition to the operation that we are announcing today, the FDA is also working on a comprehensive Enforcement Operations Work Plan that’s focused on combating the sale of foreign unapproved drugs to U.S. consumers and aimed at increasing the scope of our operations related to these risks.”

This effort was part of Operation Pangea X, as part of the 10th annual International Internet Week of Action (IIWA), a global cooperative effort led by Interpol, to combat the unlawful sale and distribution of illegal and potentially counterfeit or substandard medical products on the internet. The IIWA ran from Sept. 12 to Sept. 19, 2017. The goal of Operation Pangea X was to identify the makers and distributors of illegal prescription drug products and to remove these products from the supply chain. Commissioner Gottlieb joined efforts to kick off the operation with a visit he made to the International Mail Facility (IMF) in New York on Aug. 25, 2017.

During Operation Pangea X, the FDA sent 13 warning letters to the operators of 401 websites. The FDA also seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com. FDA inspectors, in collaboration with other federal agencies, screened packages suspected of containing illegal drug products at IMFs in Chicago, Miami and New York during the IIWA. These screenings resulted in nearly 500 parcels being detained for appropriate FDA compliance follow up. Parcels found in violation of the Federal Food, Drug, and Cosmetic Act will be refused entry into the country.

“The FDA is proud to partner with our international counterparts on this important operation,” Commissioner Gottlieb said. “However, our work to fight illegal online pharmacies is not over. In addition to the multifaceted work plan we will soon unveil, we’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations. These efforts are part of a much broader work plan that the FDA is developing aimed at beefing up our efforts to interdict illegal drugs.”

In addition to health risks, illegal online pharmacies can pose other risks to consumers, including credit card fraud, identity theft and computer viruses. The FDA encourages consumers to report suspected criminal activity to the FDA’s Office of Criminal Investigation.

The FDA also provides consumers with information to identify an illegal online pharmacy and information on how to buy medicine safely online through BeSafeRx: Know Your Online Pharmacy.

The IIWA is a collaborative effort between the FDA, the U.S. Attorney’s Office for the District of Colorado, the U.S. Department of Homeland Security, National Intellectual Property Rights Coordination Center, Interpol, the World Customs Organization, the Permanent Forum of International Pharmaceutical Crime, the European Heads of Medicines Agencies Working Group of Enforcement Officers, the U.S. Drug Enforcement Administration, the pharmaceutical industry and national health and law enforcement agencies from 115 participating countries.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Friday, July 21, 2017

Chemical analysis of counterfeit hepatitis C drug found in Japan.

Chemical analysis of counterfeit hepatitis C drug found in Japan.
Uchiyama N1, Kamakura H1, Masada S1, Tsujimoto T1, Hosoe J1, Tokumoto H1, Maruyama T1, Goda Y1, Hakamatsuka T1.
Author information 1National Institute of Health Sciences (NIHS). Citation Yakugaku Zasshi. 2017 Jul 19. doi: 10.1248/yakushi.17-00136. [Epub ahead of print]

Advance Publication July 19, 2017

In January 2017, counterfeits of the hepatitis C drug 'HARVONI® Combination Tablets' (HARVONI®) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI® (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVARDI® Tablets 400 mg (SOVARDI®), was detected. In sample 4A, sofosbuvir and ledipasvir, the active components of HARVONI®, were found. A direct comparison of the four samples and genuine products showed that three samples (2A, 3, 4B) are apparently SOVARDI® and that sample 2A is HARVONI®. In samples 1 and 5, several vitamins but none of the active compounds usually found in HARVONI® (i.e., sofosbuvir and ledipasvir) were detected. Our additional investigation indicates that these two samples are likely to be a commercial vitamin supplement distributed in Japan. Sample 2B, looked entirely different from HARVONI® and contained several herbal constitutents (such as ephedrine and glycyrrhizin) that are used in Japanese Kampo formulations. A further analysis indicated that sample 2B is likely to be a Kampo extract tablet of Shoseiryuto which is distributed in Japan. Considering this case, it is important to be vigilant to prevent a recurrence of distribution of counterfeit drugs.

Full website
https://www.ncbi.nlm.nih.gov/m/pubmed/28724837/?i=7&from=hepatitis c

Tuesday, February 14, 2017

Discovery of counterfeit hepatitis C drug is another example of why importation is bad for patients

Discovery of counterfeit hepatitis C drug is another example of why importation is bad for patients
Nicole Longo
The manufacturing and trafficking of counterfeit drugs is not just a U.S. concern but a growing threat globally. Governments around the world are working together to try to prevent these fake products from reaching and harming patients. While the U.S. market is the most secure with a closed supply chain, there remains the threat of counterfeit and adulterated drugs reaching U.S. patients. This risk increases dramatically if medicines are imported from and travel through other countries before reaching the United States because there would be no way to ensure the safety and efficacy of those products

Tuesday, May 31, 2016

FDA warns against fake Hepatitis C medicines

FDA warns against fake Hepatitis C medicines

The Philippines' Food and Drug Administration (FDA) has warned against a fake Hepatitis C medicines circulating in Southeast Asia.

The FDA said the fake medicine brands include: Sofosbuvir + Ledipasvir (Ledso) 400 mg/ 90 mg capsule Daclatasvir (Dakavir) 60 mg capsule It said that based on an advisory from the World Health Organization (WHO) the fake medicines have been circulating around South Est Asia and "may reach the Philippine market."

Continue reading....


Monday, March 7, 2016

Holiday time delaying crackdown on counterfeit hepatitis medication

Counterfeit Versions of Gilead’s Blockbuster Hepatitis C Drug Found in Israel
Counterfeits of Gilead’s mega-blockbuster hepatitis C treatment Harvoni, which is generating billions per quarter in sales for the company, are emerging in Israel.

Switzerland’s drug regulator Swissmedic said over the weekend that the plastic bottles of the counterfeits, which originated in India, were imported via a Swiss trading company and “contain white instead of genuine yellow film-coated tablets,” the regulator said.

Holiday time delaying crackdown on fake medicine
By Shwe Yee Saw Myint | Monday, 07 March 2016
A health official on leave is causing a hold-up in the government’s response to counterfeit hepatitis medication.

The Food and Drug Administration said is waiting for approval to clampdown on the distribution of fake pills in the wake of a World Health Organization alert sent out at the end of February.

“We got information from the WHO and planned to respond quickly to this alert but we still do not have any permission from the health department of the Ministry of Health yet,” Dr Theingi Zin, director of drug control at the FDA, told The Myanmar Times.

She said the FDA wants to issue a public alert about the drugs through state media outlets.

“This is a really big issue because patients are buying and taking this medicine to help their disease but according to the WHO alert this medicine is fake,” she added.

The WHO warned hepatitis C patients to avoid the drug brands “Ledso” and “Dakavir”. The medications were packaged in bottles that listed the manufacturer as a pharmaceutical company named PHARCO based in Alexandria, Egypt. The company denied making drugs under either name or in the combination of compounds listed on the bottles....
Continue reading....

WHO warns of fake drugs
By Laignee Barron | Friday, 04 March 2016
Beware of fake hepatitis medication ​The World Health Organization has warned hepatitis C patients that counterfeit medications are being sold in Myanmar.

Drugs branded as “Ledso” and “Dakavir” are fakes, according to an alert put out by the WHO.

Factory making fake Hepatitis C drug raided
Mar 1
Assisted by the Federal Investigation Authority (FIA), personnel of the Drug Regulatory Authority of Pakistan (DRAP) raided one of the local industries in Islamabad’s Kahuta industrial area here Saturday, leading to the discovery of unlawful manufacturing of Sofasbuvir tablets, which are used for the treatment of Hepatitis C, and Everlong tablets, the registration of which has long been withdrawn.
Continue reading....

Thursday, March 27, 2014

CAIRO:CPA warns of adulterated hepatitis C drugs

CPA warns of adulterated hep. C drugs

CAIRO: The Customer Protection Agency (CPA) warned Wednesday against buying adulterated drugs for hepatitis C virus (HCV) or liver disease, saying such drugs are not registered at the Ministry of Health.

The agency received complaints from patients about the HCV drug AFA-KLAMATH, which costs 1,300 to 2,100 EGP (U.S. $ 186 to 301), CPA chairperson Atef Yaqoub said in a press statement. The drug was falsely advertised on satellite channels as “a German product” and a “substance taken from a plant cell that looks like a human cell,” the Yaquob said.

In coordination with the Egyptian Drug Authority (EDA) of the Ministry of Health, the agency managed to seize nine bottles of the drug, as well as other illegal aphrodisiacs drugs and expired medicine in two pharmacies in Cairo and Giza, the statement said.

When asked if seizing the drugs came in framework of a campaign launched by the CPA, Amir Koumy, head of CPA branch in Cairo, told The Cairo Post that the agency moved after receiving patient complaints that the drug was ineffective.

Usually the CPA launches campaigns on specific products at time and is currently, for instance, conducting a campaign on plastics, Koumy added.

Around 18 million people are infected with HCV and 7.5 million have kidney failure in Egypt, according to statistics from institutes of live disease and kidney failure, Koumy noted.

WHO reports around 20 percent of Egyptian blood donors are infected with HPV, or “anti-HCV positive,” while around 150 million persons are infected worldwide.

Combating the false advertising of drugs, CPA established a year and half ago a media observer to keep an eye on advertisements in order to removed fraudulent drugs from the market, Koumy said.

Koumy said the government was planned to address the problem, and that ”there will be a meeting with the Prime Minister Ibrahim Mahlab within the coming ten days to discuss this issue,” he said.

Source

Wednesday, July 17, 2013

Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health


Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health
Posted on July 15, 2013 by FDA Voice

By: John Roth

On July 12, I was in Missoula, Montana when Paul Bottomley, 48, was sentenced as a result of his participation in the wholesale marketing of unapproved and misbranded cancer medications. Many Americans may not know Bottomley or his criminal activities. But his sentencing was another victory in FDA’s ongoing fight to safeguard Americans from misbranded, adulterated and counterfeit pharmaceuticals. This case is part of an agency-wide effort to ensure that consumers have access to high quality drugs – and that these medicines are traveling safely through increasingly complex supply chains.

Getting such predatory opportunists off the streets may be only a small part of what we do at the FDA’s Office of Criminal Investigations, but it is critical to protecting the public health. Our investigation found that Bottomley imported misbranded and unapproved cancer drugs from foreign countries – in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) – and sold those drugs to American physicians.

Bottomley is one of those people you hope never to meet. He sold unapproved and misbranded cancer drugs through Montana Health Care Solutions (MHCS), which began operating in 2008. In 2010, Bottomley sold MHCS to Rockley Ventures, a subsidiary of Canada Drugs, Ltd.,, but remained associated with the company as a consultant. After its sale to Rockley, MHCS began selling Avastin, a prescription drug that at the time cost nearly $2,300 a vial, approximately $600 more than what MHCS charged. In 2010, the Food and Drug Administration learned from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) about a potential counterfeit oncology drug being marketed as Avastin. Our investigation led us ultimately to Bottomley, MHCS, and others. Numerous physicians and the officials who operated their practices confirmed that the drugs they received came from MHCS.

Cancer patients in the United States count on certain drugs to treat their disease and often to keep them alive. Sadly, some of the Avastin sold by MHCS was counterfeit. In fact, when tested, the counterfeits did not contain any of the active drug ingredient bevacizumab that is found in legitimate versions of the drug. Tragically, not only did these patients pay a high price for a worthless drug, but they didn’t get the treatment they needed or expected.

But that is not all. In fact, one of the foreign sources of supply was Richard J. Taylor of Warwickshire, England. On July 11, 2012, Taylor was sentenced to 18 months in prison and a fine of $800,000 for distributing adulterated prescription drugs used for cancer treatment from the United Kingdom to multiple physicians in the United States. Like Bottomley, Taylor didn’t care about the law or the patients he was short-changing. He certainly knew what was happening to them. On May 10, 2011, Taylor was notified that two patients “who had been on Avastin for a while started to shake in the middle of being transfused and had to be disconnected from treatment.” A nurse advised that she had been administering such cancer drugs for years and had never seena patient react like this before.

Taylor and Bottomley both acted out of greed. In April, the U.S. Attorney for the District of Montana, Michael W. Cotter, made just that point, saying that Bottomley was motivated by nothing more: “Bottomley . . . sold potentially dangerous unapproved and misbranded pharmaceuticals at discounted prices to American physicians all for a healthy profit.”

All of us who work in enforcement at the FDA have seen this pattern too often – criminal offenders seeking to profit from distributing substandard or ineffective drugs that are ultimately administered to unsuspecting and vulnerable patients. So when people like Bottomley and Taylor are sentenced, we know this is a victory for all of us, especially those who are victimized by opportunists. OCI’s determined work continues to produce results. These prosecutions help deter others from such reprehensible conduct and from breaking the laws intended to protect us all.

FDA takes all reports of suspect counterfeits seriously and, in order to combat counterfeit medicines, is working with other agencies and the private sector to help protect the nation’s drug supply from the threat of counterfeits. Together, we are fighting a global battle, working with our regulatory counterparts throughout the world, utilizing new tools to safeguard the public health, and prosecuting those who seek to profit at the public’s expense.

http://blogs.fda.gov/fdavoice/index.php/2013/07/counterfeit-drugs-prosecuting-the-profiteers-protecting-the-public-health/

Wednesday, May 30, 2012

Fake ADHD drug Adderall sold online, U.S. FDA warns

WASHINGTON | Tue May 29, 2012 6:34pm EDT

(Reuters) - Some websites are peddling fake versions of Adderall, a treatment for attention deficit hyperactivity disorder that is currently in short supply in the United States, federal regulators warned.

The U.S. Food and Drug Administration on Tuesday said it has learned of at least two cases in which people received counterfeit versions of the 30-milligram dose of the drug with the wrong active ingredients -- ones that treat acute pain, not attention problems. The fake pill is ineffective and may be harmful, the FDA said.

The popular stimulant, made by Teva Pharmaceutical Industries and others, has been in shortage since at least last year, which may make it a target for rogue websites and distributors, the FDA said.

"Consumers should be extra cautious when buying their medicines from online sources," the FDA said in a statement.

Teva informed the FDA about the counterfeit pills after learning of the problem from people who bought the drug online. The FDA said it is uncertain how many people in total may have received counterfeit medicine, or which websites were involved.

Teva, when asked for comment, said it found out about the counterfeit Adderall from a consumer who noticed misspellings on the packaging.

Adderall is made from a controlled substance, meaning it is addictive and has the potential to be abused. The Drug Enforcement Administration tightly regulates how much of the drug's active pharmaceutical ingredient can be distributed to manufacturers each year in order to prevent diversion of the drug for inappropriate uses -- such as by students who want to increase focus to improve test scores.

The DEA authorizes a certain amount of Adderall's active ingredients - mixed amphetamine salts - to be released to drugmakers each year. But companies are saying that amount may not be enough to meet soaring demand for the drug.

In 2010, more than 18 million prescriptions were written for Adderall, up 13.4 percent from 2009, according to IMS Health. ADHD is one of the most common childhood disorders, with an average of 9 percent of children between the ages of five and 17 diagnosed with it each year, according to the Centers for Disease Control and Prevention.

The FDA said Adderall is in short supply because of problems getting active ingredients to make the drug.

Adderall is made in several doses and formulations, but it is the shorter-acting, instant release forms of the drug that are in shortest supply. These are made by Teva, as well as CorePharma LLC and Sandoz, a unit of Swiss drugmaker Novartis AG.

Normally, the drug has four active ingredients: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. But the FDA's tests found the counterfeit versions of Adderall had only two ingredients - tramadol and acetaminophen, often used to treat pain.

The fake pills often have misspellings on the packages, and are white and unmarked. Teva's real version of the pill is orange or peach-colored, and embossed with "dp" on one side and "30" on the other. The fake Adderall also comes in foil packages, instead of the bottles that Teva uses.

(Reporting by Anna Yukhananov; Ediing by Steve Orlofsky)

Thursday, May 24, 2012

Viagra Ordered Online Typically Counterfeit-May contain potentially dangerous chemicals

Medscape Medical News from the:
This coverage is not sanctioned by, nor a part of, the American Urological Association.

From Medscape Medical News

Viagra Ordered Online Typically Counterfeit
Emma Hitt, PhD

May 24, 2012 (Atlanta, Georgia) — Sildenafil (Viagra, Pfizer) purchased online was found to be counterfeit in more than three quarters of cases, according to a study that analyzed the content and origin of medication ordered over the Internet.

Irwin Goldstein, MD, from Alvarado Hospital, in San Diego, California, and colleagues from Pfizer presented their findings in a moderated poster session here at the American Urological Association 2012 Annual Scientific Meeting.

"I was very surprised by these findings," Dr. Goldstein told Medscape Medical News during the session. As physicians, "we give patients approved drugs using a prescription, and we tend not to think that this issue exists," he explained.

Dr. Goldstein and colleagues analyzed the chemical content, origin, and cost of sildenafil purchased from 22 unique Web sites claiming to sell the drug. Web sites were identified using Google or Bing search engines, and multiple purchases were made from each Web site.
"Of the 22 Web sites assessed, 100% did not ask for a prescription, as is required by law," the researchers note.

Of the 22 sample tablets analyzed, 77% were counterfeit. The counterfeit pills were found to contain 30% to 50% of the active pharmaceutical ingredient concentration found in the sildenafil formulation approved by the US Food and Drug Administration. Of the pills that were not counterfeit, 17 (15%) were authentic and 5 (4%) were generic.

The cost per pill ranged from $3.28 to $33.00. Products were shipped most often from Hong Kong (11 Web sites), the United States (6 Web sites), and the United Kingdom (2 Web sites), but also came from Canada, China, and India.

"This issue is relevant to both clinicians and consumers," Dr. Goldstein said. "People are relatively careful about what they put into their mouths when it comes to grocery stores and restaurants," he said. "But when it comes to these drugs, people may be embarrassed; there may also be financial motivations."

According to Dr. Goldstein, there are 50 known counterfeit Pfizer products circulating. "The counterfeit drug industry is a $100 billion industry; perpetrators are not being sought by government enforcement agencies because it is not opium or cocaine."

"People have died from taking these counterfeits," Dr. Goldstein said. "Beyond the fact that they don't have the real drug in it, they can be very dangerous."

One way to identify authentic products online, study author Vera Stecher, PhD, clinical director at Pfizer, said after the presentation is to go to the National Board of Pharmacy Web site and look for pharmacies with VIPPS approval.

According to Graham Jackson, MD, from London Bridge Hospital in the United Kingdom, who researches counterfeit medications, the content of the tablets can vary wildly and can contain potentially dangerous chemicals.

This study adds to the concerns we have that men, by avoiding healthcare professionals, do not have associated conditions assessed," he told Medscape Medical News. "All clinicians should emphasize that prescription-only meds are just that; if offered without a script or by an Internet doctor, they are not legal and are potentially dangerous."

The study was supported by Pfizer. Dr. Goldstein reports receiving research support from Pfizer. Dr. Stecher is employed by Pfizer. Dr. Jackson has disclosed no relevant financial relationships.

American Urological Association (AUA) 2012 Annual Scientific Meeting: Abstract 1486. Presented May 22, 2012.

http://www.medscape.com/viewarticle/764461

Thursday, February 16, 2012

News Ticker: Fake Drugs - All At a Pharmacy Near You!

The Newspaper Boy - Christian Krohg


New On The Blog 

New On The Web Site
 In The News
Henry I. Miller, Contributor
 The FDA has increased the number of its investigations of domestic counterfeiting (which can involve ingredients from abroad) several-fold during the past decade. The perpetrators include not only greedy businessmen trying to increase their profit margins, but also big-time organized crime entities, such as the Russian mafia, Chinese triads and Columbian drug cartels, as well as terrorist groups such as Hezbollah, the Irish Republican Army and Spain’s separatist organization ETA.
Some products, such as the fake “generic Tamiflu,” are completely bogus. In dozens of drugs in the United States — including anti-HIV medicines, cholesterol-lowering agents, and anti-arthritis medications — dangerous substances have been substituted for the active ingredient.
 Continue Reading Here
.
Specialty Pharmacy Reveals Early Incivek, Victrelis Data:

‘It’s Looking Good’ for Many
 Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products.
 .
By Angela Maas, Managing Editor - February 2012Volume 9 Issue 2
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When the FDA approved Incivek (telaprevir) and Victrelis (boceprevir) for the treatment of hepatitis C last May, many in the industry hailed them as game-changers. Not only are Merck & Co., Inc.’s Victrelis and Vertex Pharmaceuticals Inc.’s Incivek the first oral hepatitis C therapies and the first protease inhibitors approved for the condition (SPN 5/11, p. 1), but new data just released echo the clinical trials data that indicate the drugs also show much more promise than the previous regimen of pegylated interferon and ribavirin did of actually clearing the virus.

The drugs could cut the current 48-week treatment time down to 24 weeks for certain patients if they achieve an early viral response. However, both drugs are used with pegylated interferon and ribavirin to create a triple therapy that is fairly complicated (SPN 9/11, p. 1). People taking Incivek stop that treatment after the initial 12 weeks and continue the regimen only with pegylated interferon and ribavirin, while people on Victrelis do not take it for the initial four weeks of treatment.

Patient adherence to the rigid treatment regimen is critical to the drugs’ success, and many people are expected to clear the virus, meaning they are essentially cured. Compliance with the regimen also can have a huge impact on health plans’ bottom lines. Merck set Victrelis’ weekly price at $1,100, or $26,400 to $48,400 for a course of treatment. Vertex gave Incivek a price tag of $49,200 for a 12-week regimen. Those prices mean that treatment costs for the condition have basically doubled.

Steve Burman, CEO of Burman’s Medical Supplies and Specialty Pharmacy and president of Burman’s Pharmacy, points to a study that shows each patient in which an early viral response is identified “can save the health system a minimum of $16,200 via shortened duration of treatment. With approximately 400,000 naïve/relapsed patients in the U.S., that represents the potential of reducing the cost burden to the health system by over $4 billion.

Additional saving opportunities exist when you consider identifying those less-fortunate patients by applying the FDA futility rules,” which apply when patients are not responding, and the FDA recommends halting the therapy.

With patients who were among the first to be dosed recently hitting the 24-week mark in their regimens, Burman has shared exclusive data with SPN on what his specialty pharmacy has seen so far among about 700 people it has treated with Incivek and Victrelis.

Among the people taking Incivek, “50% of referrals were for patients who were naïve” to previous hepatitis C treatment, which is exactly what Vertex had estimated, he notes. Nineteen percent were relapsers, 17% were partial responders to prior therapy, and the rest were nonresponders.
Among those taking Victrelis, “63% of the patients were naïve,” with the remainder of the patients equally divided among the other three demographic groups.

Within the naïve patient population on Victrelis, “66% achieved an early viral response; therefore, they have the opportunity for response-guided therapy,” meaning the shortened duration of treatment.
Among a sample of 77 patients taking Incivek, 75% of the naïve patients were eligible for response-guided therapy, a percentage that is “actually a little bit better than controlled studies,” he says. And 91% of prior relapsers were eligible for response-guided therapy, which is “pretty much what’s expected. Relapsers have a really great chance of clearing the virus. The only thing we can do now is compare ourselves to the clinical trials data.”

With Incivek, “if people were partial or nonresponders to previous therapy, they are not eligible for response-guided therapy and instead need to go for 48 weeks of treatment.” However, says Burman, “there are some patients who are partial responders who qualify for response-guided therapy with Victrelis.”

People treated for hepatitis C with the previous two-drug regimen have always been at risk of stopping treatment because of the dreadful flu-like symptoms they cause. Adherence is even more at risk with the addition of Incivek and Victrelis, though, which bring additional side effects.
Among those people who discontinued therapy, 30% of them discontinued Incivek due to not responding to the drug, while 44% of those patients halted therapy because they were “unable to tolerate the side effects.”

In addition, “twice as many discontinued from Victrelis due to severe anemia than Incivek,” says Burman, adding that “this is what we expected.”

“We haven’t seen any problems with patient compliance on Victrelis,” which “was an industry concern because it’s a complicated regimen,” he tells SPN.

In an interesting twist, the drugs’ rigid regimens may work in favor of patient compliance. People need to go in for lab work four weeks after starting therapy. Burman’s keeps track of the date patients start their therapy — which often may not be the same day they receive their medications — through direct communication with patients. They also have certified counselors on staff who are experts on drug and alcohol recovery for patients with a history of abuse to help them stay adherent. Then through calls, emails or text messages, the company makes sure patients come back for their four-week labs on schedule.

Following the lab results, “at four weeks, at eight weeks, they’ll have a good idea of if they will clear the virus.” Bolstered with positive results, these patients “are motivated to finish therapy.”
With clinical trials data available for only the approved regimens, some of Burman’s patients have detoured from those paths slightly but are still on the triple therapy, so he’s curious to see their final outcomes.

For example, “even though we consulted with all of the patients before they started the regimen, there were a few patients who skipped the four-week lead-in with Victrelis and started right away, but their physicians kept them on the regimen,” he says. Burman says he thinks there were two patients who did this, both naïve to prior therapy. “One was negative for the virus after four weeks,” and he is unsure of the other patient’s status.

The specialty pharmacy also had “one patient who basically had cleared the virus, and he had to go in for emergency surgery that was unrelated to the hepatitis C, which meant he had to go off the medications for one week. His doctor started him back up [on Victrelis], so it will be interesting to see what happens.”

As far as side effects of the drugs, “we have slightly more anemia with Victrelis, which was expected,” Burman says. “In most of these cases, we’ve seen physicians use ribavirin dose reductions to treat the anemia.” Ultimately, though, his specialty pharmacy has seen “a little more anemia but not as many side effects with Victrelis.”

Among people taking Incivek, “a very low percentage — less than 1% of patients — were discontinued because of a rash, although we have seen a rash on quite a few of these patients.”
One troubling trend that Burman has noticed is that “about 5% of our patients are getting triple therapy from two pharmacies.” He says he’s been told by larger PBMs that “You fill the ribavirin and interferon, and we’ll fill Incivek” — which can be $17,000 for each fill, he notes.
This kind of situation, though, can cause a “continuity of care issue,” he contends. “It doesn’t seem to be cost-effective,…and it’s disruptive to the patient.”

Burman explains that “about 25% to 30% of patients we set up and trained switched to mail order after one or two months of the six-month therapy.” But within that “complicated” six-month treatment, “there’s no room for error.”

However, some patients almost have had their adherence impacted through no fault of their own, says Burman. He tells SPN that he’s gotten calls from patients who are receiving their drugs from other PBMs through mail order but haven’t gotten their next dose as scheduled, so they’re trying to find a pharmacy that can help. Because patients cannot miss a dose, his company has driven medications to patients an hour or so away to make sure they stay compliant.

Burman expects to have final outcomes for initial patients in May or June. “The first batch of patients just finished therapy. We need to wait six months to retest them, and if they’ve still cleared the virus, we’ll consider them cured. It’s looking good for a lot of patients.…This is a new lease on life for some of these people.”
We usually think of Hepatitis C as a virus that is passed from person to person. However, most infections occur via an intermediary, inanimate object. Thus, determining the length of time Hepatitis C can survive outside the body is crucial to prevent transmission of this virus. 


Cancer

New Defense Mechanism Against Viruses and Cancer Identified

ScienceDaily (Feb. 15, 2012)
A team of scientists from the Charité and German Rheumatism Research Center Berlin and the University of Geneva has found a fundamentally new mechanism how our defense system is ramped up when facing a viral intruder. Exploitation of this mechanism in vaccines sparks new hope for better prevention and therapy of infectious diseases and cancer.
"T killer cells" (CD8 T cells) represent an important element of our body's defense system. They have the capacity to specifically identify and kill cells, which harbor viruses and bacteria or form a cancer. T killer cells would therefore represent an important component of yet unavailable vaccines against infections like HIV/AIDS, hepatitis C virus and malaria, and also for the treatment of cancer.
It has been a longstanding observation that there is no match to the overwhelming T killer cell armada, which is triggered when a viral infection invades our body. Scientists had generally accredited this observation to "pathogen-associated molecular patterns" (PAMPs) on viruses and other microbes. PAMPs, i.e. the "foreign look" of viruses, alert so-called "dendritic cells," which serve as policemen coordinating the T killer cell response.

In a report now published in the journal Science, researchers led by Prof. Max Löhning (Charité-University Medicine & DRFZ Berlin) and Prof. Daniel Pinschewer (University of Geneva) describe an additional general mechanism by which viral infection triggers potent T killer cells: "Dying virus-infected cells themselves ring the alarm bells to T killer cells.," Löhning says. Viruses cause infected cells to die, resulting in the release of cell components, which normally are not be visible to the outside -- analogous to an injured individual loosing blood. Such substances, heralding injury when released, are referred to as "alarmins." The scientists found that T killer cells can sense an alarmin called "interleukin 33" (IL-33). IL-33 is contained in cells, which form the scaffold of the T killer cells' home, the spleen and lymph nodes, and is released when such scaffold cells die.

Mice lacking the gene encoding IL-33 failed to form a large T killer cell army upon viral infection. The few remaining cells had very poor fighting skills. Such mice were therefore exquisitely sensitive to several types of viral infections. Conversely, IL-33 could be used to artificially increase the T killer cell army, which was generated in response to vaccination. As Max Löhning and Daniel Pinschewer explain, PAMPs and alarmins apparently have complementary and non-redundant functions in shaping our T killer cell defense: "The "foreign look" of viruses (PAMPs) activates the "dendritic cell" policemen to engage T killer cells. T killer cells, however, remain lousy fighters unless alerted by a cell death in their neighborhood (alarmins)." These new findings could provide a key to effective vaccination against infectious diseases and cancer.

Organ Donation

Lack of donor organs and poor access to treatment mean mortality rates for liver disease destined to rise
Source-TORONTO, Feb. 16, 2012 /CNW/ -
When you ignore a health issue, it only tends to get worse. Liver disease has been lurking in the dark gaining strength while individuals and governments devote their attention elsewhere. Reports from Statistics Canada and most recently the Canadian Institutes for Health Information (CIHI) however are revealing glimpses of what the future may hold for liver disease patients if action is not taken soon. With rising liver cancer rates and shortages of donor organs, that future looks bleak.

"The most common forms of liver disease - hepatitis B and C, liver cancer and fatty liver disease - are chronic conditions that move slowly and may have few symptoms," says Dr. Morris Sherman, Canadian Liver Foundation Chairman and practicing hepatologist. "In some cases these diseases may not be discovered until they reach an advanced stage when a transplant is the only option. What is more disturbing however is when diseases like hepatitis B or C are diagnosed at an early stage, patients cannot access the treatment they need to avoid the need for a transplant."

According to the CIHI report on organ transplantation released this week, hepatitis C remains the leading cause of liver transplants in Canada, followed by cholestatic liver disease. Liver cancer has taken over the number 3 spot from alcoholic cirrhosis - an indication that lack of diagnosis and intervention is allowing other forms of liver disease such as hepatitis B to progress to liver cancer.
"When the country is facing a chronic shortage of donor organs, we should be looking at ways to reduce the numbers of people who need them," says Dr. Sherman. "Livers are the second most frequently transplanted organ and in 2010 74 people died on the waiting list. This is almost as many as died waiting for kidneys despite the fact that there are six times as many people waiting for kidneys. Patients with failing livers do not have an option for dialysis."

The Canadian Liver Foundation believes that improving organ donor rates is only part of the solution for liver disease patients. "We have the means to significantly reduce the demand for liver transplants," says Dr. Sherman. "We have treatments for hepatitis B that can effectively control, and in some cases cure, hepatitis B before it turns into liver cancer but in many provinces, these treatments are not accessible to patients. In the case of hepatitis C, many people are still not diagnosed. For those that are, new treatment options are available but once again it comes down to accessibility. If governments do not cover the costs of these drugs, only patients with the financial means or independent coverage will be able to afford them."

The CIHI report is further evidence that now is the time to address liver disease in Canada. "There are an estimated 600,000 Canadians living with chronic hepatitis B or C. If there are not enough donor organs now, we should be doing everything we can to keep these people off the transplant list in the future. We hope that these statistics will motivate governments to implement policies regarding screening and treatment that will not only benefit patients but help reduce the demand for liver transplants."

For more information on hepatitis or the Canadian Liver Foundation's positions on liver-related issues, visit www.liver.ca
For further information: Melanie Kearns
Canadian Liver Foundation
416-491-3353 ext. 4923
mkearns@liver.ca
 

Living donor liver transplant varies with availability of deceased donor liver transplants
2/16/2012 GastroHep.com News
The most recent issue of Liver Transplantation reports that living donor liver transplantation varies with the availability of deceased donor liver transplantation.


HIV

AIDS Coalition Protests Merck Laboratories

The Harvard College Global Health and AIDS Coalition put a Valentine’s Day spin on the group’s campaign demanding that pharmaceutical company Merck’s increase access to its AIDS drug raltegravir in poor nations.

A group of 20 people—primarily members of the Coalition and several Medical School students—protested outside Merck’s research laboratories adjacent to Harvard Medical School on Monday afternoon.

The demonstration included pink, red, and white balloons—a play on Valentine’s Day colors with a symbolic message, Coalition member Nathan T. Georgette ’13 said.
“The implication [of the theme] is that their current policies are breaking the hearts of the millions of people who can’t afford their life-saving AIDS drugs,” Georgette said.



Non-alcoholic fatty liver disease (NAFLD)

Released: 2/16/2012 10:10 AM EST
Source: Johns Hopkins Medicine
Newswise — Menopausal women with non-alcoholic fatty liver disease (NAFLD) who don't consume enough of the essential nutrient choline appear to be at higher risk for liver scarring, according to research led by scientists at Johns Hopkins Children's Center.

The findings of a multicenter study, which compared liver damage and choline consumption among 664 children and adults with NAFLD, were published online Feb. 15 in The American Journal of Clinical Nutrition.

Choline-rich foods include dairy, eggs, cod, broccoli, peanut butter, lean beef, chicken breast, chicken liver, seed oils, leafy greens, cauliflower and legumes, such as peas, beans and lentils. Low choline intake was not linked to worse damage in children, women of childbearing age and men with NAFLD, a finding that underscores the existence of important age and gender differences in disease progression, the research team reports.

The scientists caution that the exact link behind low choline and liver damage remains unclear and emphasize that adding choline to one's diet may not halt disease progression.

Researchers speculate that one possible explanation behind the worse scarring seen among post-menopausal women is that estrogen may affect a subset of genes that regulate choline synthesis, and that declining levels of estrogen after menopause may interfere with this process.
Complicating the picture, they note, is that NAFLD has many causes and develops differently from patient to patient. However, the researchers say, the new findings do point to choline as one possible catalyst that may hasten liver damage in certain patients.

Because choline needs vary by age and gender, the Institute of Medicine recommends 425 mg daily choline consumption for non-pregnant, non-breastfeeding women and 550 mg daily for men. Teens should consume 400 mg daily and pre-teens 375 mg daily.

Children between ages 4 and 8 should get 250 mg per day, and children between ages 1 and 3 should consume 200 mg daily. Infants less than 1 year of age should receive between 125 and 150 mg daily via formula or breast milk.
"Physicians have long been fascinated by the unpredictable nature of fatty liver disease and the reasons some patients progress quickly to advanced stages of liver scarring while others have little to no inflammation for many years," says lead investigator Anthony Guerrerio, M.D., Ph.D., a pediatric gastroenterologist at the Johns Hopkins Children's Center.

"Our research illuminates one potential mechanism of liver scarring that portends worse outcomes in some but not all patients," he adds.

NAFLD affects one in three Americans, researchers estimate, and is marked by fatty build-up in the liver, with or without inflammation.

In its advanced form, known as non-alcoholic steatohepatitis, the disease causes cell death, irreversible scarring and liver failure. 

Physicians do not know why some patients develop the more severe forms of the disease fairly quickly while others remain relatively healthy, but nutrition, body weight, genes and environment are all believed to play a role in disease progression. Recent research shows that more children and adults are developing fatty livers, likely due to growing obesity rates, the investigators say.

In the current study, the researchers analyzed liver biopsy results and choline consumption, obtained from patient food diaries. None of the patients met the daily recommended intake, but only those eating less than half the recommended doses were deemed choline-deficient. 

Controlling for other risk factors, like body weight and alcohol consumption, menopausal women who consumed less than half the recommended daily choline had greater degrees of liver scarring, the researchers found. Advanced liver scarring was found in nearly half of the 63 postmenopausal women in the group with choline-deficient diets, compared with 30 percent of the 131 post-menopausal women with non-deficient diets. Differences were far less pronounced among men, children and women of child-bearing age. Advanced liver scarring was found in 18 percent of choline-deficient women of childbearing age and in 10 percent of those with non-deficient diets. Eighteen percent of choline-deficient males 14 years of age and older had advanced liver scarring compared with 16 percent among their non-deficient counterparts. Advanced liver fibrosis was seen in 10 percent of choline deficient children ages 9 through 13, while 17 percent of non-deficient ones had the same degree of liver scarring.

Other Johns Hopkins co-investigators on the study included Amy Schwartz, R.D., C.N.S.D., L.D.; Michael Torbenson, M.D.; and Ryan Colvin. Ann Scheimann, M.D., M.B.A., of Johns Hopkins was principal investigator.

Other institutions participating in the study included Indiana University School of Medicine, Seattle Children's Hospital, Duke University Medical Center, Children's National Medical Center, Washington, D.C., University of California-San Diego and Columbia University.
The research was funded by the National Institutes of Health.
Related links:

The American Journal of Clinical Nutrition
http://www.ajcn.org/content/early/recent
Institute of Medicine
http://www.iom.edu


Founded in 1912 as the children's hospital at The Johns Hopkins Hospital, the Johns Hopkins Children's Center offers one of the most comprehensive pediatric medical programs in the country, treating more than 90,000 children each year. Hopkins Children's is consistently ranked among the top children's hospitals in the nation.
Hopkins Children's is Maryland's largest children's hospital and the only state-designated Trauma Service and Burn Unit for pediatric patients. It has recognized Centers of Excellence in dozens of pediatric subspecialties, including allergy, cardiology, cystic fibrosis, gastroenterology, nephrology, neurology, neurosurgery, oncology, pulmonary, and transplant. For more information, please visit www.hopkinschildrens.org


Healthy You

COLUMBUS, Ohio --
According to a new study, smoking causes the body to turn against its own helpful bacteria, leaving smokers more vulnerable to disease.

Despite the daily disturbance of brushing and flossing, the mouth of a healthy person contains a stable ecosystem of healthy bacteria. New research shows that the mouth of a smoker is a much more chaotic, diverse ecosystem—and is much more susceptible to invasion by harmful bacteria.

As a group, smokers suffer from higher rates of oral diseases -- especially gum disease -- than do nonsmokers, which is a challenge for dentists, according to PurnimaKumar, assistant professor of periodontology at Ohio State University. She and her colleagues are involved in a multi-study investigation of the role the body’s microbial communities play in preventing oral disease.

“The smoker’s mouth kicks out the good bacteria, and the pathogens are called in,” said Kumar. “So they’re allowed to proliferate much more quickly than they would in a non-smoking environment.”

The results suggest that dentists may have to offer more aggressive treatment for smokers and would have good reason to suggest quitting smoking, Kumar said.

“A few hours after you’re born, bacteria start forming communities called biofilms in your mouth,” said Kumar. “Your body learns to live with them, because for most people, healthy biofilms keep the bad bacteria away.”

She likens a healthy biofilm to a lush, green lawn of grass. “When you change the dynamics of what goes into the lawn, like too much water or too little fertilizer,” she said, “you get some of the grass dying, and weeds moving in.” For smokers, the “weeds” are problem bacteria known to cause disease.

In a new study, Kumar’s team looked at how these bacterial ecosystems regrow after being wiped away. For 15 healthy nonsmokers and 15 healthy smokers, the researchers took samples of oral biofilms one, two, four and seven days after professional cleaning.

The researchers were looking for two things when they swabbed subjects’ gums. First, they wanted to see which bacteria were present by analyzing DNA signatures found in dental plaque. They also monitored whether the subjects’ bodies were treating the bacteria as a threat. If so, the swab would show higher levels of cytokines, compounds the body produces to fight infection.

“Smokers' mouths start getting colonized by pathogens—bacteria that we know are harmful—within 24 hours. It takes longer for smokers to form a stable microbial community, and when they do, it’s a pathogen-rich community.”

The results of the study were published in the journal Infection and Immunity.

“When you compare a smoker and nonsmoker, there’s a distinct difference,” said Kumar. “The first thing you notice is that the basic ‘lawn,’ which would normally contain thriving populations made of a just few types of helpful bacteria, is absent in smokers.”

The team found that for nonsmokers, bacterial communities regain a similar balance of species to the communities that were scraped away during cleaning. Disease-associated bacteria are largely absent, and low levels of cytokines show that the body is not treating the helpful biofilms as a threat.

“By contrast,” said Kumar, “smokers start getting colonized by pathogens—bacteria that we know are harmful—within 24 hours. It takes longer for smokers to form a stable microbial community, and when they do, it’s a pathogen-rich community.”

Smokers also have higher levels of cytokines, indicating that the body is mounting defenses against infection. Clinically, this immune response takes the form of red, swollen gums—called gingivitis—that can lead to the irreversible bone loss of periodontitis.

In smokers, however, the body is not just trying to fight off harmful bacteria. The types of cytokines in smokers’ gum swabs showed the researchers that smokers’ bodies were treating even healthy bacteria as threatening.

Although they do not yet understand the mechanisms behind these results, Kumar and her team suspect that smoking is confusing the normal communication that goes on between healthy bacterial communities and their human hosts.

Practically speaking, these findings have clear implications for patient care, according to Kumar.

“It has to drive how we treat the smoking population,” she said. “They need a more aggressive form of treatment, because even after a professional cleaning, they’re still at a very high risk for getting these pathogens back in their mouths right away.

“Dentists don’t often talk to their patients about smoking cessation,” she continued. “These results show that dentists should take a really active role in helping patients to get the support they need to quit.”

For Kumar, who is a practicing periodontist as well as a teaching professor, doing research has changed how she treats her patients. “I tell them about our studies, about the bacteria and the host response, and I say, ‘Hey—I’m really scared for you.’ Patients have been more willing to listen, and two actually quit.”

Kumar’s collaborators include Chad Matthews and Vinayak Joshi of Ohio State’s College of Dentistry as well as Marko de Jager and Marcelo Aspiras of Philips Oral Healthcare. The research was sponsored by a grant from Philips Oral Healthcare.

Contact: Purnima Kumar, (614) 247-4532; Kumar.83@osu.edu

Media Contact: Pam Frost Gorder, (614) 292-9475; Gorder.1@osu.edu

Written by Maureen Langlois.


Behind The Headlines

Behind the Headlines provides an unbiased and evidence-based analysis of health stories that make the news.

How our system works
  • Each day the NHS Choices team selects health stories that are making headlines.
  • These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information.
  • Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices.

Does a daily dose of dhal dispel dementia?
The Daily Mail reported today that “eating a curry once (or twice) a week could stave off dementia.”
Sadly, this mouth-watering headline is not a good representation of the research. The study in question tested the effects of curcumin (a chemical found in the spice turmeric) on fruit flies. It found that curcumin improved lifespan and activity in some genetically engineered fruit fly models of Alzheimer’s disease. However, some other fruit flies, including the normal fruit flies, those eating actually died more quickly.

This type of study is essential for the initial testing of chemicals that may be of some benefit to humans. Chemicals showing beneficial effects and sufficient safety in animal studies need to be tested in humans before we can know what their true effects on a disease are. However, the promising effects of many chemicals seen in animals are not replicated in humans.
Despite what the papers say, this study cannot tell us whether a weekly curry will stave off Alzheimer’s disease or other forms of dementia.

Where did the story come from?
The study was carried out by researchers from Linköping University in Sweden and was funded by The Knut and Alice Wallenberg foundation, Alice and Georg Olsson, the Swedish Foundation for Strategic Research, ‘Hjärnfonden’ (the Brain Foundation), the Swedish Research Council, the Gustaf V Foundation, and the European Union FP-7 Health project LUPAS.
The study was published in the peer-reviewed scientific journal Public Library of Science One.
The Daily Mail reported that the study was in fruit flies (Drosophila melanogaster) and used the chemical curcumin. However, its headline suggesting that eating a curry one or twice a week may stave off dementia is not representative of this research.

What kind of research was this?This was an animal study looking at the effect of the chemical curcumin on fruit fly models of Alzheimer’s disease. Curcumin is found in turmeric, a spice commonly used in curry recipes such as korma and jalfrezi. Previous studies have suggested that curcumin may be able to help reduce the build-up of toxic amyloid beta that occurs in the brain of people with Alzheimer’s disease.

Animal models of human diseases are used in the initial testing of chemicals that may be beneficial to humans. It is easier and safer to do these early tests in animals in the laboratory than in humans. These models replicate specific aspects of the disease in question, but due to differences between species, do not fully represent the human condition.

As fruit flies are not mammals like humans, any chemicals found to show promise would then also need to be tested in a mammal species such as mice. Although certain chemicals may be effective and safe when tested on mammals, they then need to be tested in humans to see if they are really beneficial to us and safe to use.

What did the research involve?
The researchers used fruit flies that had been genetically engineered to replicate (to a certain extent) what happens in the brains of people with Alzheimer’s disease. They used five different types of fruit flies engineered to produce different sections of the protein amyloid beta or another protein called tau. Both of these proteins build up and form abnormal insoluble deposits called plaques and tangles in the brains of people with Alzheimer’s disease. These fruit flies are less active than normal ones of the same age, and have a shortened lifespan.

The researchers carried out various experiments where they fed the genetically engineered and normal fruit flies different amounts of curcumin. They looked at the effect of the curcumin on the fruit flies’ activity and lifespan compared to the same types of flies not fed curcumin. They also looked at how curcumin affected the build-up of amyloid beta in the brains of the flies.

What were the basic results?
The researchers found that the effect of curcumin on lifespan depended on the concentration of curcumin used and the type of fly being tested:
  • increasing concentrations of curcumin reduced lifespan in normal (control) fruit flies
  • two of the five Alzheimer’s model fly strains also died sooner with high curcumin dose
  • three of the Alzheimer’s model fly strains lived longer with the low and intermediate doses of curcumin, although this was still shorter than the lifespan of the normal untreated flies
The greatest effect of curcumin observed was a 75% increase in lifespan with an intermediate dose of curcumin – from fewer than 10 days to more than 15 days on average, in one of the Alzheimer’s fruit fly models.

As all the different types of flies got older they became less active. Again, the effect of curcumin depended on the type of fruit fly tested:
  • curcumin reduced activity slightly in normal flies
  • curcumin had no effect on the activity one of the Alzheimer’s model fly strains
  • the other four Alzheimer’s model fly strains all showed some increase in activity with curcumin, but the extent of the increase varied
The Alzheimer’s model fruit fly strain that showed the greatest increase in lifespan did not show the greatest increase in activity.

The researchers found that curcumin did not decrease the build up of insoluble deposits of amyloid beta in the brains of the fruit flies. However, curcumin sped up the soluble beta amyloid sticking together to form larger bundles called ‘fibrils’.

How did the researchers interpret the results?
The researchers concluded that curcumin reduces the toxic effects of amyloid beta or tau protein in the brains of genetically engineered fruit fly models of Alzheimer’s disease.

Conclusion
Curcumin is found in the bright yellow spice turmeric, which is commonly used in curries. This study has shown that curcumin can improve lifespan and activity in some genetically engineered fruit fly models of Alzheimer’s disease. It is worth noting that this effect was not seen in all of the genetically engineered fruit fly models of Alzheimer’s disease, and that some fruit flies, including the normal ones, actually showed reduced lifespan with curcumin.

Chemicals showing beneficial effects and sufficient safety in animal studies need to be tested in humans before we can know what their true effects on a disease are. Sadly, the promising effects of many chemicals seen in animals are not replicated in humans.
Despite what the papers have reported, this study cannot tell us whether a weekly curry will stave off Alzheimer’s or other forms of dementia. However, it is worth noting that a high-fat diet is associated with some forms of dementia.
Analysis by Bazian.

Links to the headlinesHot new tip... eating a curry once (or twice) a week could stave off dementia, say scientists.
Daily Mail, February 16 2012
Having a curry could help ward off dementia.
The Daily Telegraph, February 16 2012

Links to the scienceCaesar I, Jonson M, Nilsson KPR, et al. Curcumin Promotes A-beta Fibrillation and Reduces Neurotoxicity in Transgenic Drosophila. Public Library of Science One. Published online February 13 2012

Tuesday, November 22, 2011

HCV News Ticker-How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

New On The Web Site

Ontario first province to reimburse new chronic hepatitis C treatment VICTRELIS™ Now Available for Eligible Patients in Ontario
The Canadian Liver Foundation is pleased that Ontario’s public drug program has agreed to reimburse boceprevir for the treatment of chronic hepatitis C,” says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation. “Boceprevir represents a major advance in our ability to cure this disease, and as a result, fewer patients will have to struggle with the consequences of end-stage liver disease, liver transplants and liver cancer. We applaud the research efforts that led to this breakthrough and hope other provinces will follow Ontario’s lead and rapidly reimburse this important treatment.”


Treatment Update


Source- CCO

The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

Review the current benefits and limitations with protease inhibitor-based HCV therapies, and the emerging data on potential future regimens and the advances they represent.


The New Elements of HCV Care: Practical Skills to Optimize Protease Inhibitor–Based Therapy

Review the approved indications and proper management of HCV-infected patients with the newly approved protease inhibitors.

* Free Registration Required


The American Association for the Study of Liver Diseases November 2011 Annual Meeting

Updates From NATAP

  • AASLD: Impact of Anemia and Ribavirin Dose Reduction on SVR to a Telaprevir-based Regimen in Patients with HCV Genotype 1 and Prior Peginterferon/Ribavirin Treatment Failure in the Phase III REALIZE Study - (11/21/11)

  • AASLD: Boceprevir/Merck HCV Presentations - AASLD, IDSA - (11/21/11)

  • AASLD: New HCV Drugs at AASLD - (11/21/11)

  • AASLD: MicroRNA Drug Safe in Ongoing HCV Study - (11/21/11)

  • AASLD: GSK's eltrombopag Platelet Booster Aids HCV Therapy - (11/21/11)

  • AASLD: Liver Cancer Therapy Positive in Early Trials - (11/21/11)

  • AASLD: Fatty Liver May Benefit from Mediterranean Diet - (11/21/11)


  • Fatty Liver Disease

    Researchers Surprised To Find Fatty Liver Disease Poses No Excess Risk For Death

    Non-alcoholic fatty liver disease (NAFLD) is a common condition associated with obesity and heart disease long thought to undermine health and longevity. But a new study by Johns Hopkins researchers suggests the condition does not affect survival.

    A report on the study was published online last week in BMJ, the British medical journal.

    "Physicians have considered fatty liver disease a really worrisome risk factor for cardiovascular disease," says study leader Mariana Lazo, M.D., Ph.D., a postdoctoral fellow at the Johns Hopkins University School of Medicine's Welch Center for Prevention, Epidemiology, and Clinical Research. "Our data analysis shows this doesn't appear to be the case. We were surprised to say the least because we expected to learn by how much non-alcoholic fatty liver disease increased the risk of death and instead found the answer was not at all."

    Using health information collected from 11,371 Americans between 1994 and 1998 and followed for up to 18 years as part of the Third National Health and Nutrition Examination Survey (NHANES III), the researchers checked liver enzyme levels and ultrasound tests for evidence of NAFLD, and ultimately looked at death rates associated with NAFLD. The participants ranged in age from 20 to 74 during the data collection years. Because the ultrasounds were originally taken to assess gallbladder health, Lazo and colleagues from Johns Hopkins looked at each recording to determine the presence of fat in each person's liver. People whose livers are 5 percent fat or more are considered to have NAFLD.

    The Johns Hopkins team found no increase in mortality among those with NAFLD, which was identified in approximately 20 percent of the NHANES participants. At the end of the follow-up period, mortality from all causes was 22 percent, or 1,836 individuals. Cardiovascular disease was the cause of death for 716 participants, cancer for 480 and liver disease for 44.

    Although the researchers found no increase in deaths, Lazo says further study is needed to determine whether more advanced NAFLD has serious long-term consequences for the liver, a vital organ that turns what we eat and drink into nutrients and filters harmful substances from the blood.

    NAFLD, which some researchers have called the nation's next epidemic, is characterized by the liver's inability to break down fats and fatty build up in the organ. Found in roughly one in three Americans, it is most prevalent in those who are obese, and those with diabetes and cardiovascular disease. The spectrum of disease ranges from simple fat build-up to inflammation to the scarring and poor liver function that characterize cirrhosis. Chronic liver disease has long been associated with long-term alcohol consumption, but as the name suggests, NAFLD is found in those who are not heavy drinkers.

    "We don't yet know why mortality is not affected or whether there might be some actual protective effect of non-alcoholic fatty liver disease," she says, "but it looks like the liver's ability to accumulate fat may somehow shield the body from the detrimental effects of other health problems such as obesity and diabetes," she says.

    There is no treatment for NAFLD, other than lifestyle changes, including weight loss, and only a liver biopsy can determine how serious NAFLD is. Lazo says she hopes new methods are developed that more easily identify more advanced stages of NAFLD, which may not be harmless.

    Still, she says, her research suggests that with respect to long-term survival of people with non-alcoholic fatty liver disease, "it may not matter if you have the disease or not."

    The research was supported by grants from the National Institute of Diabetes and Digestive Diseases and the American Diabetes Association.


    HIV


    Massive Scale Up In Access To HIV Treatment
    Written by Catharine Paddock PhD
    "We have seen a massive scale up in access to HIV treatment which has had a dramatic effect on the lives of people everywhere," Michel Sidibé, Executive Director of UNAIDS, told the press as a new report by the Joint..

    Social vulnerability associated with lack of satisfaction with health care; doctors need to provide more support
    Roger Pebody
    Published: 22 November 2011

    Patients who are socially disadvantaged or who lack social support tend to be less satisfied with the health care they receive, French researchers report in AIDS Care. The authors suggest that clinicians need to make extra efforts with such patients in order to achieve good outcomes.

    Several previous studies have shown that people who are satisfied with their health care have better quality of life, are more likely to adhere to their medication and less likely to drop out of contact with the health care system.

    Moreover an American study found that patients with HIV who were comfortable discussing personal issues with their doctor, who perceived their doctor as more empathetic or who perceived their doctor to be knowledgeable about HIV were more satisfied with their care..Continue Reading...


    Healthy You



    Study: Fight afternoon slump with protein, not sugar rush

    To combat mid-afternoon energy crashes, new research suggests reaching for a protein-rich snack instead of sugar-laden treat is the way to go.

    It’s a common habit among workers who hold day jobs: come 3 pm or so, candy bars are unwrapped and sugar-laden beverages pried open. The objective? A sugar rush to fend off mid-day drowsiness.

    But scientists out of the University of Cambridge have found that protein -- not sugar -- is what activates the cells that make people alert and burn calories. The study was published in the November 17 issue of the journal Neuron.

    Orexin cells secrete an important stimulant in the brain called orexin/hypocretin. When the body doesn't have enough, it can lead to narcolepsy and weight gain. After comparing how different nutrients affect these cells, researchers found that amino acids -- which are found in proteins like egg whites -- stimulate the orexin neurons more than others while glucose lowers their activity.

    Moreover, the amino acids also worked by preventing glucose from blocking the activity of orexin cells. In other words, the amino acids worked as a defensive shield against the sugar's offensive assault.

    The new findings may explain why protein-rich meals can make people feel less calm and more alert than carbohydrate-heavy meals, researchers added.

    "Sleep patterns, health, and body weight are intertwined. Shift work, as well as poor diet, can lead to obesity," said lead researcher Denis Burdakov in a release.

    Meanwhile, a study out of the University of Missouri this spring also found that eating a protein-rich breakfast can increase satiety and help stave off hunger pangs throughout the day.

    "To combat obesity and insomnia in today's society, we need more information on how diet affects sleep and appetite cells. For now, research suggests that if you have a choice between jam on toast, or egg whites on toast, go for the latter,” Burdakov said.


    Big Pharma



    Source- Pharmalot

    Former Synthes Execs Jailed For Fatal Clinical Trial
    Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced yesterday to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. A fourth exec will be sentenced later. All four pleaded guilty to one misdemeanor count of shipping an adulterated and misbranded product in interstate commerce.

    Gilead Is Paying How Much For Pharmasset?
    Investors, though, are mixed. Here is what some of the wags are saying
    … The Pharmasset “HCV franchise is clearly in the lead with a very attractive clinical profile,” writes Leerink Swann analyst Joshua Schimmer. “…While we understand the strategic rationale, the price tag is lofty for a pre-commercial asset and not aligned with what we would like to see from Gilead, in terms of capital allocation…While over the long-term this deal may prove to be value-creative, we will not have clarity on this front for a number of years.”

    Counterfeit Drugs

    Source- Spoonful Of Medicine

    Harsher penalties proposed to counter counterfeit drug peddlers
    Congress is, yet again, throwing a fit about counterfeits. Now, US lawmakers from both political parties are proposing a new measure to increase the criminal penalties for the manufacture, sale or trafficking of counterfeit medicines.

    Currently, prison times and fines for dealing in counterfeits are the same as any other illegal trade. But “counterfeit medication poses a grave danger to public health that warrants a harsher punishment,” the legislation’s co-sponsor Senator Patrick Leahy, a Democrat from Vermont, wrote in a statement. The Counterfeit Drug Penalty Enhancement Act, introduced yesterday in both houses of Congress, would increase the maximum penalties for first-time offenders to 20 years in prison with a $4 million fine; repeat offenders could be dinged as much as $8 million.

    But, if precedent on Capitol Hill means anything, this bill is not set to go far. Tim Fagan’s Law, named after a teenager who was injected with counterfeit medicine after a live transplant, was first proposed in 2003 to increase penalties for dealing in counterfeit drugs. However, the legislation has been sitting pretty in committee for six years now, and is reintroduced every year with no advance.

    For more on counterfeits, read our April 2010 news focus on the subject.


    The Fight Against Counterfeit Drugs

    Below is a video from the March 2011 60 minutes story called "The Fight Against Counterfeit Drugs," narrated by America's favorite medi-journalist Dr. Sanjay Gupta.





    Buying Prescription Medicine Online: A Consumer Safety Guide

    Make sure a Web site is a state-licensed pharmacy that is located in the United States. Pharmacies and pharmacists in the United States are licensed by a state's board of pharmacy. Your state board of pharmacy can tell you if a Web site is a state-licensed pharmacy, is in good standing, and is located in the United States. Find a list of state boards of pharmacy on the National Association of Boards of Pharmacy (NABP) Web site at www.nabp.net

    The NABP is a professional association of the state boards of pharmacy. It has a program to help you find some of the pharmacies that are licensed to sell medicine online. Internet Web sites that display the seal of this program have been checked to make sure they meet state and federal rules. For more on this program and a list of pharmacies that display the Verified Internet Pharmacy Practice Sites™ Seal, (VIPPS® Seal), go to www.vipps.info

    Look for Web sites with practices that protect you

    A safe Web site should:

    1. be located in the United States and licensed by the state board of pharmacy where the Web site is operating (check www.nabp.net for a list of state boards of pharmacy)

    2. have a licensed pharmacist to answer your questions

    3. require a prescription from your doctor or other health care professional who is licensed in the United States to write prescriptions for medicine

    4. have a way for you to talk to a person if you have problems

    BE SURE YOUR PRIVACY IS PROTECTED

    Look for privacy and security policies that are easy-to-find and easy-to-understand.

    Don’t give any personal information (such as social security number, credit card, or medical or health history), unless you are sure the Web site will keep your information safe and private.

    Make sure that the site will not sell your information, unless you agree


    Complementary Medicine / Alternative Medicine


    No Double Standards For Natural Health Products
    Natural health products and medicinal foods should be subject to the same regulations as pharmaceutical drugs to ensure safety and efficacy, states an editorial in CMAJ (Canadian Medical Association Journal).

    While pharmaceutical drugs are subject to rigorous evaluation and must provide significant evidence of their therapeutic effects and that the benefits outweigh risks, natural health products in Canada are not. Many contain active pharmacological substances that can have potent effects and interactions which should have warnings.

    "The multibillion-dollar natural health products industry sells the perception that because its products are "natural," they must also be safe, such that comprehensive testing like that required for pharmaceuticals is not required," write guest author Dr. Stuart MacLeod with CMAJ editor Dr. Matthew Stanbrook and colleagues. "However, it is a near-universal truth that any substance that exerts a beneficial effect on a biological system will also have the potential for adverse effects."

    Health Canada created the Natural Health Products Directorate 10 years ago, but the regulatory framework that governs it does not protect the consumer.

    "All health claims for any product should be subject to a common set of regulations, starting with consistent and easily understood standards of evidence proportional to health risks and benefits," conclude the authors.

    "Uniform regulations are the best way to protect consumers while still allowing choice."


    'If only a rub down with rose petals could cure ill health'

    We know that the history of medicine is in part a history of brutalism.

    Surgery was torture without the interrogation. Psychiatry was masochism in a different coat and pharmaceuticals an experiment in chemistry.

    We are at a more fortunate point and benefit from a medical sophistication that borders on miraculous. However, even now some interventions can seem brutal, almost primitive in their ability to make patients feel worse. From a distance, they can seem toxic, even violent; close up, we can see that they can appear harmful, invasive. Medicine sometimes wages a war on illness, and who likes war?

    So we have complementary therapies. Let’s face it, we would like it to be the case that a dab behind the ears with some ylang ylang and a rub down with rose petals would cure all our ails. We would like to find a cure for cancer by humming like a giant bee or by sipping the diluted wee of elves through a straw made of goats’ horn. However, most clinical trials - and I don’t want to give the impression of rushing to judgement here - seem to suggest that not only do these interventions not work but also there are no such things as elves.......Continue Reading...