MHRA – Brief Summary Of Reclassifications That Have Been Approved In The Past 12 Months, UK
Please see the relevant entry in List C (consolidated list of substances present in authorised products which have been reclassified since 1 April 2002) for full details.
Recent reclassifications – Updated December 2008
POM to P (Prescription only medicine to pharmacy)
– Azithromycin: azithromycin 500mg tablets may now be supplied for the treatment of confirmed asymptomatic Chlamydia trachomatis genital infection in individuals aged 16 years and over, and for the epidemiological treatment of their sexual partners
– Diclofenac potassium: tablets containing 12.5mg diclofenac potassium may be supplied without a prescription for the short term relief of headache, dental pain, period pain, rheumatic and muscular pain, backache and the symptoms of colds and flu, including fever, in adults and children aged 14 years and over
– Naproxen: naproxen 250mg tablets may now be supplied without a prescription for the treatment of primary dysmenorrhoea in women aged between 15 and 50 years
P to GSL (Pharmacy to general sale list)
– Nicotine: nicotine patches releasing 25mg over 16hours of continuous application may now be supplied on general sale as an aid to smoking cessation.
– Sodium cromoglicate: sodium cromoglicate 2% eyedrops may be supplied on general sale for the relief and treatment of the eye symptoms of hay fever, in adults and children aged 6 years and over.
– Paracetamol: paracetamol 5% oral suspension, for use in children aged 6 to 12 years, may now be supplied GSL in multidose containers in a quantity not exceeding 80ml.
– Paracetamol: The maximum strength of GSL liquid paracetamol preparations for adults and children aged 12 years and over, has been increased from 2.5% to 5%.
– Loperamide hydrochloride: an additional indication for GSL medicines containing 2mg loperamide hydrochloride has been introduced. The products may now be supplied on general sale for the symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome in adults aged 18 years and over following initial diagnosis by a doctor.
– Diclofenac diethylammonium: the maximum pack size of diclofenac diethylammonium 1.16% gel that may be supplied on general sale has been increased from 30g to 50g.
– Nicotine: nicotine inhalator may now be supplied on general sale as an aid to smoking cessation and as an aid to smoking reduction prior to cessation.
Additional product information requirements
– Azithromycin: the additional product information requirements for azithromycin have been updated.
– Ibuprofen: the additional product information requirements for P and GSL ibuprofen, and for P and GSL ibuprofen lysine, have been amended following an update of MHRA guidance on the minimum clinical particulars for P and GSL ibuprofen for systemic administration
– Sumatriptan: the additional product information requirements for P sumatriptan have been updated following successful validation of the common diagnostic protocol.
– Cetirizine: the additional product information requirement for GSL cetirizine, that tablet preparations should have a brand name rather than a generic name, has been removed.
Change to List B (Consolidated list of substances which are present in authorised medicines for general sale)
The entry for formaldehyde solution in List B has been amended; it now includes products for external use other than dentifrices. This amendment corrects an earlier administrative oversight and reflects products first authorised as GSL in 1990. This opportunity has been taken to amend the entry title from ‘formaldehyde solution’ to ‘formaldehyde’.
Applications withdrawn
The P to GSL application which was the subject of ARM 27, has been withdrawn by the marketing authorisation holder, for commercial reasons.
Applications turned down
Following concerns raised during the public consultation exercise, Commission on Human Medicines (CHM) have advised against the reclassification of fluconazole 150mg capsules from P to GSL.
http://www.mhra.gov.uk
American Medical Student Association Applauds Pharmaceutical Industry For Voluntary Ban; Continues To Call For Federal Regulation
The American Medical Student Association (AMSA), the nation’s oldest and largest, independent association for physicians-in-training, applauds the pharmaceutical industry for implementing a voluntary ban on gifts to physicians, which began on January 1, 2009. Enacted by the Pharmaceutical Research and Manufacturers of America (PhRMA), the ban will prohibit pens, coffee mugs and other branded gifts. AMSA has called for a comprehensive ban on gifts and all marketing efforts to medical professionals since 2002, when it initiated the PharmFree campaign (www.pharmfree.org). AMSA’s PharmFree campaign has educated and trained thousands of medical students across the country to interact professionally and ethically with the pharmaceutical industry. “Banning gifts from the drug companies is a good first step,” says Dr. Brian Hurley, AMSA’s national president. “There is no role for marketing masquerading as education when our patients’ lives are at stake.”
Home to the next generation of physicians, AMSA also calls for federal regulations to govern the pharmaceutical industry’s interactions with medical institutions. Specifically, AMSA supports passage of the Physician Payment Sunshine Act of 2008 (S.2029), which would require disclosure of payments to physicians by the pharmaceutical industry.
“Given that pharmaceutical companies have a fiduciary responsibility to their shareholders, and given that they are a business that must take profits into consideration, the pharmaceutical industry cannot be expected to self-regulate,” continues Hurley. “Congress must fight to ensure the quality of medical education, which necessitates non-biased, evidence-based information about medications and medical devices. This is the only way to produce a medical system that can provide quality, affordable patient care for everyone.”
AMSA’s PharmFree campaign encourages medical schools and academic medical centers to develop policies that limit the access of pharmaceutical company representatives to campuses and hospitals and to prohibit medical students and physicians from accepting gifts of any kind from these representatives. In June 2008, AMSA released its PharmFree Scorecard (www.amsascorecard.org), a comprehensive ranking of conflict-of-interest policies across the country, as well as an in-depth, school-by-school look at policies that govern industry interaction with medical school faculty and trainees.
About the American Medical Student Association
The American Medical Student Association (AMSA), with more than a half-century history of medical student activism, is the oldest and largest independent association of physicians-in-training in the United States. Founded in 1950, AMSA is a student-governed, non-profit organization committed to representing the concerns of physicians-in-training. With more than 67,000 members, including medical and premedical students, residents and practicing physicians, AMSA is committed to improving medical training as well as advancing the profession of medicine. AMSA focuses on four strategic priorities, including advocating for quality, affordable health care for all, global health equity, enriching medicine through diversity and professional integrity, development and student well being. To learn more about AMSA, our strategic priorities, or joining the organization, please visit us online at http://www.amsa.org.
Dentist Links Fosomax-type Drugs To Jaw Necrosis
Researchers at the University Of Southern California, School Of Dentistry release results of clinical data that links oral bisphosphonates to increased jaw necrosis. The study is among the first to acknowledge that even short-term use of common oral osteoporosis drugs may leave the jaw vulnerable to devastating necrosis, according to the report appearing in the January 1 Journal of the American Dental Association (JADA).
Osteoporosis currently affects 10 million Americans. Fosomax is the most widely prescribed oral bisphosphonate, ranking as the 21st most prescribed drug on the market since 2006, according to a 2007 report released by IMS Health.
“Oral Bisphosphonate Use and the Prevalence of Osteonecrosis of the Jaw: An Institutional Inquiry” is the first large institutional study in the U.S. to investigate the relationship between oral bisphosphonate use and jaw bone death, said principal investigator Parish Sedghizadeh, assistant professor of clinical dentistry with the USC School of Dentistry.
After controlling for referral bias, nine of 208 healthy School of Dentistry patients who take or have taken Fosamax for any length of time were diagnosed with osteonecrosis of the jaw (ONJ). The study’s results are in contrast to drug makers’ prior assertions that bisphosphonate-related ONJ risk is only noticeable with intravenous use of the drugs, not oral usage, Sedghizadeh said. “We’ve been told that the risk with oral bisphosphonates is negligible, but four percent is not negligible,” he said.
Most doctors who have prescribed bisphosphonates have not told patients about any oral health risks associated with the use of the drugs, despite even short-term usage posing a risk due to the drug’s tenacious 10-year half life in bone tissue. Lydia Macwilliams of Los Angeles said no one told her about the risk posed by her three years of Fosamax usage until she became a patient of Sedghizadeh at the School of Dentistry. “I was surprised,” she said. “My doctor who prescribed the Fosamax didn’t tell me about any possible problems with my teeth.”
Macwilliams was especially at risk for complications because she was to have three teeth extracted. The infection is a biofilm bacterial process, meaning that the bacteria infecting the mouth and jaw tissues reside within a slimy matrix that protects the bacteria from many conventional antibiotic treatments, and bisphosphonate use may make the infection more aggressive in adhering to the jaw, Sedghizadeh said. The danger is especially pronounced with procedures that directly expose the jaw bone, such as tooth extractions and other oral surgery. After her extractions, two of the three extraction sites had difficulty healing due to infection, Macwilliams said. Luckily, with treatment as well as the rigorous oral hygiene regimen USC dentists developed especially for patients with a history of bisphosphonate usage, the remaining sites slowly but fully healed. “It took about a year to heal,” she said, “but it’s doing just fine now.”
Sedghizadeh hopes to have other researchers confirm his findings and thus encourage more doctors and dentists to talk with patients about the oral health risks associated with the widely used drugs. The results confirm the suspicions of many in the oral health field, he said. “Here at the School of Dentistry we’re getting two or three new patients a week that have bisphosphonate-related ONJ,” he said, “and I know we’re not the only ones seeing it.”
University of Southern California
3375 S Hoover St.
Los Angeles
CA 90089
United States
http://www.usc.edu
Popular New Year’s Resolutions Also Promote Urologic/Sexual Health
Already having a hard time sticking to your New Year’s resolutions? The American Urological Association (AUA) can provide some much-needed motivation: many popular New Year’s resolutions can actually improve your urologic or sexual health.
Resolution #1: Lose Weight
Losing weight may help resolve erectile dysfunction in obese men, according to research presented at the 2008 Annual Scientific Meeting of the AUA. Morbid obesity as well as other conditions such as diabetes, hypertension and smoking can impact sexual dysfunction. In this study from researchers in Boston and Philadelphia, sexual function was restored in men who underwent gastric bypass surgery for weight loss.
“This study showed that weight loss and other risk factors for ED that are alleviated by weight loss may be keys to restoring sexual function,” said Anthony Y. Smith, MD. “These results give men another reason to improve their health by losing weight.”
Resolution #2: Quit Smoking
Smoking causes bladder cancer. But, only about 33 percent of people know that smoking is a leading risk factor for the disease, according to a study recently published in The Journal of Urology®, the official journal of the AUA.
Bladder cancer is the fourth most common type of cancer in men, and the eighth most common in women. About 53,000 men and woman are diagnosed with bladder cancer each year, and about 14,000 die annually of the disease. The American Cancer Society estimates that smokers are twice as likely to get bladder cancer as nonsmokers. Quit smoking to decrease your risk for bladder cancer.
Resolution #3: Lower Cholesterol
High cholesterol is a leading cause of heart disease the number one killer of both men and women. For men, managing your cholesterol may also help you manage your prostate-specific antigen (PSA) level. A study of 1,214 men without prostate cancer at the Durham Veterans Affairs Medical Center in North Carolina shows that PSA levels were lower among men with lower total and LDL cholesterol levels. Moreover, among men with prostate cancer, poor cholesterol management was associated with increased risk of biochemical recurrence after prostatectomy, according to new data from the Duke Prostate Center at Duke University.
“We don’t understand exactly how cholesterol affects prostate health,” said Stephen J. Freedland, MD. “But, we are finding that that there is an important link. Thus, managing your cholesterol level may not only reduce the risk of heart disease, but improve prostate health.”
Resolution #4: Reduce Stress
Stress can contribute to erectile dysfunction (ED), the inability to achieve or maintain an erection. While an occasional problem isn’t necessarily a cause for alarm, experts caution that men should see a doctor if the problem persists. Studies show that about one half of American men over age 50 have some degree of ED.
Most cases of ED (about 75 percent) have an underlying physical cause, including serious medical conditions such as heart disease, high blood pressure, diabetes mellitus or high cholesterol levels. ED can be an early warning sign of one of these more serious diseases. Diagnosing and treating the condition that is causing your ED, whether it is stress or a more serious physical cause, can improve your overall well being, as well as help restore your sexual health.
It’s clear that improving your overall health will lead to improved sexual and urologic health. In fact, urologic health conditions often indicate the presence of other health problems, including cardiovascular disease and metabolic syndrome. If you are experiencing a urologic health condition, put “visiting the doctor” at the top of your list of New Year’s resolutions. Or, if you are looking for another resolution, add “getting a prostate exam” to your list.
About the American Urological Association: Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is the pre-eminent professional organization for urologists, with more than 16,000 members throughout the world. An educational nonprofit organization, the AUA pursues its mission of fostering the highest standards of urologic care by carrying out a wide variety of programs for members and their patients.
American Urological Association (AUA)
1000 Corporate Blvd.
Linthicum
MD 21040
United States
http:// www.auanet.org
Physicians Key In Helping People Quit Smoking – But Most People Don’t Ask Their Physician
Montana physicians play a key role in helping people quit using tobacco products. However, a Montana Tobacco Use Prevention Program (MTUPP) survey shows most people don’t often ask their physician to help them quit smoking.
Consequently, MTUPP sent 2,500 letters to Montana physicians urging them to take the initiative with their patients. The letter offers recommendations physicians can take to help patients who use tobacco products quit and the resources that are available, said Stacy Campbell, MTUPP cessation specialist for the Department of Public Health and Human Services.
“We know that physicians can be essential in helping patients quit smoking, yet only 27 percent of smokers we surveyed who were planning to quit asked their doctor for help,” Campbell said. “The decision to quit smoking is one that ultimately may save their lives.”
Campbell is referring to the annual Adult Tobacco Survey, a survey of more than 2,500 Montana adults regarding their knowledge and attitudes about and their use of tobacco.
Campbell also pointed toward the U.S. Public Health Service’s recently updated ‘Clinical Practice Guideline Treating Tobacco Use and Dependence,’ which recommends physicians proactively speak with patients and, when possible, offer to develop a personalized quit plan. “When patients try to quit without treatment or counseling, only 3 to 5 percent are successful,” Campbell said.
The Adult Tobacco Survey reveals that 72 percent of Montana smokers plan to quit in the next six months, and 73 percent of those who use smokeless tobacco want to quit.
MTUPP’s letter also urges Montana physicians to ask patients who use tobacco if they want to quit. For patients who do, MTUPP encourages physicians to refer them to the Montana Tobacco Quit Line. The mailing includes a reference card explaining how physicians can help patients receive free nicotine replacement therapy (gum, patch or lozenges) or discounted Chantix, a new tobacco cessation drug, by accessing Quit Line services. Nearly one-third of Quit Line participants successfully end their addiction to tobacco products, Campbell says.
“We know that smokefree laws like the Montana Clean Indoor Air Act result in more people attempting to quit,” Campbell said. “With the law requiring Montana bars, taverns and casinos to be smokefree by October 1, 2009 there is no better time to quit than now. People are even encouraged to make it a New Year’s resolution.”
The Montana Tobacco Quit Line, funded by MTUPP, offers free assistance to tobacco users, including free telephone counseling, help developing a quit plan, up to four weeks of free nicotine replacement therapy and reduced cost Chantix. Calls are toll-free at 1-800-QUIT-NOW (784-8669). For more information about MTUPP and the Montana Tobacco Quit Line, visit http://tobaccofree.mt.gov.
Source
Montana Dept. of Health and Human Services
http://www.dphhs.mt.gov
It’s A GO! New Jersey State Combines Medicaid Waivers For Seniors & Adults With Physical Disabilities
Department of Health and Senior Services (DHSS) Commissioner Heather Howard announced today the State has received approval from the U.S. Centers for Medicare and Medicaid Services to consolidate three Medicaid-supported home and community-based service programs currently operated by DHSS into a single program known as Global Options (GO) for Long Term Care.
The consolidation, effective January 1, 2009, improves access to a wider range of in-home long-term supportive services for a greater number of seniors and adults with physical disabilities who meet the income, asset and nursing facility level of care requirements established by Medicaid. GO participants will have the options to hire and direct their own service providers.
The move to GO gives care managers greater flexibility in modifying individual care plans as needs and preferences change over time. It also simplifies administrative processes for federal, state and local officials.
“This approval is good news for New Jersey seniors, adults with disabilities and family caregivers who provide countless hours of care and comfort but sometimes need help to keep their loved ones at home,” said Governor Jon S. Corzine. “Through GO, these individuals will have easier access to important home and community-based services.”
DHSS has mailed letters to everyone enrolled in the current programs – including Assisted Living/Adult Family Care (AL/AFC), Caregiver Assistance Program (CAP) and Community Care Program for the Elderly and Disabled (CCPED) – explaining that the switch to GO will be automatic and seamless. These individuals do not need to complete new applications and the services they are currently receiving will continue. Nearly 10,200 people are currently receiving services through these programs.
Commissioner Howard called the approval “an important milestone in our drive to rebalance New Jersey’s long-term care system so that low-income seniors, adults with physical disabilities, and their caregivers have more options and more control over the services they need to remain safely in the community.”
“The move to GO is good for consumers and fiscally responsible for the State,” added Human Services Commissioner Velez, whose department oversees the Medicaid Program. “This change will allow more individuals to receive care in the community, an option that is more desirable for the consumer and less costly for the State than institutional care.”
Federal approval of GO furthers efforts initiated by Governor Corzine to make the state’s long-term care system more flexible and consumer-friendly. In 2006, he signed into law the Independence, Dignity and Choice in Long-Term Care Act that required, among other provisions, the rebalancing of Medicaid long-term care funding to improve support for in-home services.
GO is designed to supplement – not replace – the assistance already being provided by family, friends and neighbors. By providing a flexible package of services and supports, the new program strengthens the ability of caregivers to continue in their vital role as primary support providers.
GO participants work with a care manager to create an individualized plan of care based on a comprehensive assessment of the participant’s healthcare needs. Once the plan of care is approved, community-based services are put in place and monitored to ensure quality and effectiveness.
Seniors, adults with physical disabilities and their caregivers seeking information and access to GO, as well as other state-funded or private pay home and community-based long-term care services, can do so by calling their local Area Agency on Aging toll-free at 1-877-222-3737, or by visiting the Division of Aging and Community Services’ website at http://nj.gov/health/senior.
State of New Jersey Department of Health and Senior Services
http://www.state.nj.us
Department Of Health Surveys New Mexicans To Improve Their Health
Starting at the beginning of January, the New Mexico Department of Health will call New Mexicans to survey them about their health behaviors for the Department’s annual survey, Behavioral Risk Factor Surveillance System. The survey is designed to provide information on behaviors and risk factors for chronic and infectious diseases and other health conditions among adults in New Mexico.
The Department’s survey unit in the Epidemiology and Response Division will call about 9,000 individuals during days, nights and weekends over the next year. Staff conduct surveys in English and Spanish. The phone numbers are randomly generated, and staff does not know or collect the person’s name or address that they are calling.
“We want to assure you that all information you give us is protected and confidential,” said Health Secretary Dr. Alfredo Vigil. “We value your privacy and the data you provide us, which helps us design effective prevention programs to improve the health of New Mexicans.”
The national survey asks for demographic information and covers such topics as health care access, exercise, diabetes, oral health, disability, tobacco use, falls, seatbelt use, anxiety and depression, and cancer screening. For example, 26.4 percent of adults in New Mexico reported in 2007 not having health-care coverage compared to 16.6 percent of adults in the United States.
In the past, New Mexico’s survey has asked about gambling, suicide, bankruptcy, children’s health care access, emergency contraceptives and asthma in the work place. New topics this year include Native American health issues, race and ethnicity. Staff will also call 250 cell phone users for the first time.
The survey has been done in New Mexico since 1986 and by the Department of Health since 1997. The U.S. Centers for Disease Control and Prevention funds the survey, which is conducted in every state.
For more information about the survey, call the Department toll-free at 877-325-8226.
To view New Mexico’s most recent report, click here. For more information about the Behavioral Risk Factor Surveillance System, look up www.cdc.gov/brfss.
New Mexico Dept. of Health
http://www.nmhealth.org
Cold Weather Brings Hypothermia Threat – Oregon Department Of Health
Low winter temperatures have brought warnings from experts in the Oregon Department of Human Services State Public Health Division. Exposure to cold can lead to hypothermia, so it is important to protect yourself against it.
Hypothermia occurs when heat escapes from your body faster than it can warm itself and you body’s core body temperature falls lower than 95 degrees F. Severe hypothermia can lead to death.
Symptoms of mild hypothermia include uncontrollable shivering and numbness of the hands.
This often happens in temperatures below 50 degrees F., wind, wet clothing and fatigue.
The poor, the elderly, people who have hypothyroidism, those who take sedative-hypnotics, and drug and alcohol abusers are prone to chronic hypothermia. People who abuse drugs or alcohol can fail to recognize hypothermia symptoms. They can have serious problems during a cold wave when the power goes out, if there is a problem with the heating system or they cannot afford to pay heating bills.
Hypothermia is preventable. Be aware of the risk factors and early warning signs. Dress appropriately both indoors and when you are outside during this cold weather.
Dr. Mel Kohn, acting director of the State Public Health Division, said that every year about 8 to 10 people die from hypothermia in Oregon.
“There are things that individuals and communities can do to help prevent these deaths,” Kohn said.
Children should be monitored in cold weather and should be checked every hour to make sure their clothes are dry.
Older adults can die of hypothermia if their homes have inadequate heat. Check in with older neighbors and relatives and those with disabilities during cold weather. Offer to shovel walks, go shopping for them and take out trash. Check on friends and family members who abuse drugs or alcohol.
If your heat goes out, or you cannot afford to keep your home warm, contact the Red Cross to find the warming station nearest to you, on the Web at www.oregonredcross.org.
The Centers for Disease Control and Prevention hypothermia Website.
Oregon Department of Human Services
http://www.oregon.gov
Osteoporosis Drug Linked To Bone Death In Jaw
A new US study found that even short term use of oral bisphosphonates like Fosomax (alendronate), commonly used to treat osteoporosis, may
leave the jaw vulnerable to devastating necrosis (death of bone tissue).
The study was the work of principal investigator Dr Parish Sedghizadeh, assistant professor of clinical dentistry with the University of Southern
California (USC) School of Dentistry, and colleagues, and is published in the 1 January 2009 issue of the Journal of the American Dental
Association (JADA).
Previous studies had already suggested that patients taking bisphosphonates like Fosomax orally were at higher risk of developing osteonecrosis (death
of bone tissue) of the jaw, but this study shows the side effect may be more common than had previously been suggested.
For the study, Sedghizadeh and colleagues looked at the electronic medical records of patients attending USC’s School of Dentistry to find out who
had ever used alendronate (Fosomax) and of those who was also having treatment for osteonecrosis of the jaw.
After controlling for referral bias, they found that of 208 patients with a history of alendronate (Fosomax) use, nine were being treated for
osteonecrosis of the jaw. This is about 4 per cent of the patient population (or 1 in 23 patients).
The researchers concluded that this was “the first large institutional study in the United States with respect to the epidemiology of ONJ [osteonecrosis
of the jaw] and oral bisphosphonate use”.
They wrote that more studies were now needed to “help delineate more clearly the relationship between oral BP [bisphosphonate] use and
ONJ”.
In a separate press statement, Sedghizadeh commented on the contrast between this study’s findings and the drug maker’s assertions that
bisphosphonate-related ONJ risk is only noticeable with intravenous use of the drugs:
“We’ve been told that the risk with oral bisphosphonates is negligible, but four percent is not negligible,” said Sedghizadeh.
The USC statement said that most doctors who have prescribed bisphosphonates have not told their patients about the potential risks, even from
short term use, due to the drug taking a long time to leave bone tissue (after stopping use it takes 10 years for the drug’s level to halve).
The statement related how Lydia Macwilliams of Los Angeles said no one had told her about the risk of Fosomax. She was on it for three years before
she became Sedghizadeh’s patient of at the USC School of Dentistry. She said she was “surprised” that her doctor who prescribed Fosomax “didn’t tell
me about any possible problems with my teeth.”
Macwilliams was especially at risk for because she was to have three teeth removed, said Sedghizadeh, explaining that bisphosphonate use makes
mouth and jaw tissue bacterial infection more aggressive because it sticks more firmly to the jaw. The type of infection that occurs here is often
resistant to many antibiotic treatments because it is a “biofilm bacterial process” where the germs live in a slimy protective matrix. Procedures like
tooth extractions that directly expose the jaw bone, raise the danger under these circumstances.
Two of Macwilliams’ three tooth extractions had difficulty healing due to infection. But she said luckily they healed slowly but
completely because of the treatment and USC’s rigorous oral hygiene routine for patients with a history of bisphosphonate use.
“It took about a year to heal,” said Macwilliams, “but it’s doing just fine now.”
Sedghizadeh said he hoped more studies would confirm their findings so that more doctors and dentists are encouraged to talk to their patients about
the oral health risks of these widely used drugs.
“Here at the School of Dentistry we’re getting two or three new patients a week that have bisphosphonate-related ONJ,” said Sedghizadeh.
“I know we’re not the only ones seeing it,” he added.
Today, osteoporosis affects about 10 million people in the US and according to a 2007 report from IMS Health, Fosomax is the most widely
prescribed oral bisphosphonate and ranks as the 21st most prescribed drug on the market since 2006.
“Oral bisphosphonate use and the prevalence of osteonecrosis of the jaw: An institutional inquiry.”
Parish P. Sedghizadeh, Kyle Stanley, Matthew Caligiuri, Shawn Hofkes, Brad Lowry, and Charles F. Shuler.
J Am Dent Assoc 1 January 2009, Volume 140, Issue 1, pages 61-66.
Click here for Abstract.
Sources: Journal abstract, University of Southern California.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
Debunking The Detox Myth
A group of over 300 young UK scientists and engineers who investigated the evidence behind claims made for products and diets, have started a
public awareness campaing by publishing a dossier that shows the word “detox” has no meaning outside of the clinical treatment of drug addiction and
poisoning.
Called the “Deteox Dossier”, the report describes the findings of the investigation by the Voice of Young Science (VoYS) network of over 300 early
career researchers. They reviewed about 15 products, ranging from bottled water to face scrub, and found that many detox claims were
“meaningless”, said a BBC report.
It follows an earlier report titled “There Goes The Science Bit…” published with the charity Sense About Science about a year ago, where the authors
exposed “dodgy” science claims by phoning manufacturers and asking questions about their products. After the first report was published the authors
received offers of help and lots of examples where the word “detox” was used, and this led to the latest investigation.
According to a BBC report, the advertising regulators said they would look at such issues on a case by case basis. The Advertising Standards
Authority said:
“If a product is making claims not substantiated by the evidence submitted by the company we would challenge that.”
The Detox Dossier investigators found that:
- No two companies had the same definition for “detox”.
- The word “detox” was used to promote a range of things from foot patches to hair straighteners, without consistent explanations of what the word
means.
- In most cases no evidence was presented to back up the “detox” claims on products.
- In most cases, producers and retailers who the young scientists got in touch with were forced to admit that they were using the word “detox”
instead of mundane things like “cleaning” or “brushing”.
- The prices ranged from about 2 pounds for a detox drink to over 36 pounds for detox bath products.
The scientists involved in the research include physiologists, biochemists, doctors and pharmacists and they will be launching their own leaflet titled
“Debunking Detox” outside high street shops in central London.
The leaflet explains how the human body already has a fantastic detox system, called the liver and the kidneys, and that there is no need to spend money
on expensive treatments and products. Eating healthily and getting plenty of sleep is a better investment.
Tom Wells, a chemist and one of the investigators, told the BBC that:
“The minimum sellers of detox products should be able to offer is a clear understanding of what detox is and proof that their product actually
works.”
“The people we contacted could do neither,” he said.
Another researcher who investigated a Garnier face wash that claimed to remove toxins from the skin said that the “toxins” were no more than the
normal dirt, make up and skin oils that one might expect any face cleansing product to remove, reported the BBC.
Garnier said that all their products underwent “rigorous testing and evaluation to ensure that our claims are accurate and noticeable by our
consumers.”
On the leaflet they will be handing out to shoppers in London, the detox investigators said that shampoos, cleansers and moisturizers “can’t help your
body remove excess substances and are no better than any other other shampoos/cleansers/moisturizers” although they may be more
expensive.
Putting a detox patch on your skin may make the area sweat more, and while very small amounts of chemicals may come out in the sweat, the effect is
very small and makes little difference to the overall amount of chemicals in your body, they said.
The investigators also said that detox tonics can’t improve your liver or kidney function, and if you have too high a dose of some of the detox
supplements you could become very ill and even die. They could also interact with other drugs like the contraceptive pill and reduce their
effectiveness.
And, said the investigators, although detox diets are often recommended after periods of excess, such as Christmas and New Year, the “best diet you
can have at anytime is a normal, balanced diet”.
One of the detox diet plans investigated was a five day plan from Boots, which according to the BBC claimed to detoxify the body and flush away
toxins. One of the investigators, Evelyn Harvey, said that consumers would benefit just from following the healthy diet that was recommended with the product, they
wouldn’t need the product itself.
A spokeswoman from Boots told the BBC that their five day detox plan encouraged consumers to drink water and the product contained natural
ingredients that fought against toxins and helped “protect from the dangers of free radicals”.
Click here for more information about
the Detox Dossier (Sense about Science).
Sources: Sense About Science, BBC News.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
