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Makena Advertising in Obstetrics & Gynecology
Thursday, March 31, 2011
Makena Advertising in Obstetrics & Gynecology
To our readers:
Thank you for expressing your concern about the recent Makena ad in Obstetrics & Gynecology. The American College of Obstetricians and Gynecologists is also concerned about Makena and the implications of its pricing on women's health (please see the College's response, available online). The pricing structure for Makena had not come to light before the advertisement was approved to run in Obstetrics & Gynecology. At this time, the journal has taken the appropriate steps to remove all other scheduled Makena ads.
The Editors of Obstetrics & Gynecology
$70M to Be Paid in Corruption Probe by J & J
J&J has agreed to terms with the U.S. government again; not about recalled drugs this time, but overseas corruption. After several years of investigation by the Securities and Exchange Commission and regulators in the U.K., J&J has agreed to pay $70 million to settle allegations that it bribed doctors in Europe and paid kickbacks to win contracts in Iraq. The deal includes a $21.4 million criminal fine.
J&J ran afoul of the Foreign Corrupt Practices Act in several countries, according to their government. They paid doctors in Greece to use its orthopedic devices, while doctors and hospital administrators in Poland got bribes in exchange for contracts. In Romania, doctors were bribed to prescribe J&J meds and paid kickbacks to Iraq to get contracts under the U.N. Oil for Food program.
http://www.fiercepharma.com/story/jj-agrees-pay-70m-corruption-probe/2011-04-11?utm_medium=nl&utm_source=internal
Pfizer and Medivation Announce Results from Phase 3 Trial of Dimebon in Huntington Disease
Pfizer and Medivation announced results from the Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. Dimebon did not achieve statistical significance for either of the endpoints using the Mini-Mental State Examination (MMSE), which measures cognition, and the Clinician's Interview-Based Impression of Change, or caregiver input (CIBIC-plus), which measures global function. The companies will continue their ongoing 12-month Phase 3 trial of dimebon and its open-label extension in patients with mild-to-moderate Alzheimer's disease.
http://pharmalive.com/news/index.cfm?articleID=773692&categoryid=9&newsletter=1
Benzocaine Warning from FDA Associated with the Use of Benzocaine
A drug safety communications about a serious adverse effect associated with the use of over-the-counter (OTC) benzocaine gels, sprays, and liquids applied to the throat and gums to reduce pain has been issued by the FDA.
The warning involves the use of benzocaine which is associated with methemoglobinemia, and in the most severe cases, can result in death. Methemoglobinemia has been reported with the use of all strengths of benzocaine gels and liquids, including concentrations as low as 7.5%. The cases reported occurred mainly in children aged 2 years or younger who were treated with benzocaine gel for teething.
The recommendations are that parents and caregivers should not use OTC benzocaine products on children under 2 years of age, except under the advice and supervision of a healthcare professional. If benzocaine products are used, it should be used sparingly and only when needed, but not more than 4 times a day.
FDA issued a public health advisory warning in 2006 about methemoglobinemia with the use of benzocaine sprays during medical procedures. FDA has reportedly received notice of 72 new cases of methemoglobinemia, including 3 resulting in death, associated with the use of benzocaine sprays, bringing the total to 319 cases.
"While FDA's announcement notes very rare but serious instances of methemoglobinemia . . . these products are safe when used as directed for the large majority of consumers," according to a statement prepared by the Consumer Healthcare Products Association, in Washington, DC.
http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-warns-about-a-serious-adverse-effect-associate/ArticleStandard/Article/detail/715831?contextCategoryId=40137
Patients are Denied High-Cost Drugs by NHS Trusts
Family doctors are being prevented from prescribing drugs for conditions such as diabetes, heart disease, and osteoporosis as NHS managers attempt to make drastic budget cuts, an investigation has found.
More drugs are being added by the Primary Care Trusts to their so-called "red lists" which means they can only be prescribed by a hospital consultant and not a GP. In this system, drugs are prescribed using a "traffic lights" system. If a medication is classified "green" then GPs are free to prescribe it; if it is "amber" they have to discuss prescription with a specialist; if it is "red" then only a specialist can do so.
This process is designed to save money by restricting access to more expensive drugs. Associated with this is that many patients find it more difficult to obtain the most effective drugs free on the NHS, even though they have been approved by the medicines rationing watchdog Nice. Patients' groups have described the disclosure as "outrageous" and "extremely worrying."
Examples of drugs moved to red lists include the gliptins for diabetes, treatments for Parkinson's disease, osteoporosis drugs, and certain types of statins. One health authority added 32 drugs to its red list in the past year, while another said it intended to fine doctors who wrote letters requesting that such medicines be prescribed.
The chairman of the British Medical Association's clinical and prescribing committee said the status of drugs should be based solely on clinical grounds. However, he added that there are lots of people who try to put drugs on these red lists on the basis of cost.
http://www.telegraph.co.uk/health/healthnews/8446782/Patients-are-denied-high-cost-drugs-by-NHS-trusts.html
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