Pediatric Drug Researcher to Cut Ties with Pharmaceutical Companies

Massachusetts General Hospital’s Dr. Joseph Biederman has agreed to curb his interaction with pharmaceutical companies while the hospital investigates charges that Biederman’s dealings with the drug firms may be a conflict of interest. Biederman, known for his aggressive endorsement of Johnson & Johnson’s Risperdal and his $1.6 million undisclosed salary from drug companies, agreed to curb his involvement in drug trials and other entanglements with the pharmaceutical industry.
Late last year, a US Senate review of the pharmaceutical industry’s ties to doctors and researchers discovered the payments to Biederman and questioned his objectivity in promoting certain drugs for children. Embarrassed by the public disclosure, Mass General quickly took steps to begin an investigation of its own. Officials at the highly regarded New England hospital questioned Biederman’s objectivity in his research and openly criticized the financial arrangements. According to hospital officials, there are concerns that Biederman was more interested in promoting Risperdal on behalf of his benefactor than objective scientific research.
According to an article in the Wall St. Journal, “In its statement, Massachusetts General said Dr. Biederman would stop industry-funded activities at the hospital until its review was completed. Hospital spokeswoman Peggy Slasman said that would mean Dr. Biederman would discontinue his participation in several industry-funded clinical trials there. The hospital declined to describe the studies, which it said would continue under a different doctor.
Dr. Biederman also agreed not to participate in “any outside activities that are paid for or sponsored by industry, such as consulting activities or speaking engagements,” the hospital said.”
US Senator Charles Grassley has been particularly vigilant in investigating drug industry and medical device industry ties to researchers and doctors whose research the public and other physicians rely for prescribing medicines and medical devices for their patients. Senator Grassley correctly grasps that the integrity of the healthcare system is at stake when conflictual relationships exist between researchers and medical industries.

FDA Recalls Chemical Agent Used in Eye Surgeries

Citing dozens of eye problems, the FDA has issued a Class I recall of Advanced Medical Optics Inc.’s Healon D which is used in various types of eye surgeries including corneal transplants, cataract removal and other ophthalmic procedures. The FDA recalled the product after receiving numerous complaints and problems associated with the chemical agent.
The recalled product’s lot number is UD30654. The FDA’s determination that the product is Class I underscores the serious nature of the problems associated with Healon D which comes prepackaged in a syringe and is applied using a small tube.
Advanced Medical Optics, Inc. had issued a recall of the product in October but only recovered 964 of the 1,450 units that were distributed on the market.

Coal Ash Spill Huge Environmental Disaster

Health officials are already calling it the worst environmental disaster of its kind in the United States. And that’s before earlier reports underestimated the scope of the spill and its far-reaching effects.
According to the NY Times, “Authority officials initially said that about 1.7 million cubic yards of wet coal ash had spilled when the earthen retaining wall of an ash pond at Kingston Fossil Plant, about 40 miles west of Knoxville, gave way on Monday. But on Thursday they released the results of an aerial survey that showed the actual amount was 5.4 million cubic yards, or enough to flood more than 3,000 acres one foot deep.
The amount now said to have been spilled is larger than the amount the Authority initially said was in the pond, 2.6 million cubic yards.”
The spillage contains such toxins as lead and thallium, known to cause cause birth defects and nervous and reproductive system disorders. The coal ash spill abuts a residential area and the Emory River. The coal ash spill can contain carcinogens and dangerous levels of heavy metals.
According to the Times article, the environmental spill has reawakened old arguments about whether coal ash should be federally regulated as hazardous material.

More Troubles for Osteoporosis Drug Fosamax

A few years ago, Merck’s Fosamax was linked to jaw necrosis. Now, the FDA is looking into Fosamax’s potential link to esophageal cancer. Fosamax has been linked to 23 cases of esophageal cancer since the drug’s inception in 1995. 23 cases is not statistically significant. However, the fact that the FDA is going to investigate the link is noteworthy and is another blow to Merck’s popular osteoporosis pharmaceutical.
Fosamax belongs to a family of drugs known as bisphosphonates. These drugs are known to be associated with esophagitis, which is an inflammation of the lining of the tube carrying food to the stomach.
Diane Wysowski, a member of the FDA’s drug risk assessment division has said that doctors should refrain from using Fosamax and other bisphosphonates in those patients who’ve been diagnosed with Barrett’s esophagus, which is a change in the lining that leads to the stomach. It is often found in people with acid reflux disease and itself increases the risk of cancer.

Diocese of Venice Priest Investigated for Sexual Abuse

The Rev. Jean Ronald Joseph, a priest of the Diocese of Venice (Florida) is being investigated for sexual abuse that occurred 15 years ago when Fr. Joseph was assigned to St. Francis Xavier Catholic Church in Fort Myers. At the time of the abuse, the victim was a minor.
Bishop Dewane asked Joseph to remove himself from ministry and Joseph apparently complied with the Bishop’s request. At the time of the abuse, the Diocese of Venice was run by the Diocese’s first bishop John J. Nevins, a former priest of the Archdiocese of Miami. Nevins retired in 2007 when Bishop Dewane assumed leadership of the southwest Florida diocese.
Since its founding in 1984, bishopaccountability.org, an online database of priests accused of sexual abuse, lists 9 Venice priests accused of sexual misconduct including Edward McLoughlin, Jose Mena, William Romero, Neil Flemming, and Carl Bartholomew. The Diocese of Venice had received reports about McLoughlin for years, including some from doctors who warned Bishop Nevins that McLoughlin should not work around children. In spite of the warnings, McLoughlin continued working as a priest and abusing minors until a lawsuit was brought. Then, the Diocese of Venice arranged and paid for McLoughlin to move to Ireland.
This appears to be the first time Bishop Dewane has had to confront a new allegation of priest sexual abuse. In his news release, the Diocese speaks of the pain of the priest and the Church without acknowledging the pain of the victim, “These are very painful times for Father Joseph, the lay faithful as well as the clergy.”

Abbott’s Humira Marketing Draws FDA Scrutiny

According to the FDA, Abbott Laboratories’ Humira marketing efforts widens the uses for the arthritis drug while downplaying its potential risks. Humira has been approved to treat arthritis, psoriasis, Crohn’s Disease or a form of arthritis called ankylosing spondylitis. However, the federal agency has criticized the pharmaceutical company for a misleading advertisement “because it suggests that Humira is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience,” the FDA wrote in the December 16 letter to the drugmaker. The warning comes after many other drug makers have been criticized for similarly misleading marketing efforts this past year.
Drugs approved by the FDA may be used for so-called off-label uses by doctors who judge it prudent to do so. However, the pharmaceutical companies are not allowed to market the drugs for such off-label uses or uses for which the FDA has not approved the particular drug.

FDA Warns Consumers about Weight Loss Pills

The Food and Drug Administration has released a warning concerning certain diet pills that pose significant health risks because they contain undeclared, active pharmaceutical ingredients. The FDA warning concerns 25 different diet pills that may cause health problems such as high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. The tainted weight loss products are:
Fatloss Slimming
2 Day Diet
3x Slimming Power
Japan Lingzhi 24 Hours Diet
5x Imelda Perfect Slimming
3 Day Diet
7 Day Herbal Slim
8 Factor Diet
7 Diet Day/Night Formula
999 Fitness Essence
Extrim Plus
GMP
Imelda Perfect Slim
Lida DaiDaihua
Miaozi Slim Capsules
Perfect Slim
Perfect Slim 5x
Phyto Shape
ProSlim Plus
Royal Slimming Formula
Slim 3 in 1
Slim Express 360
Slimtech
Somotrim
Superslim
TripleSlim
Zhen de Shou
Venom Hyperdrive 3.0
The products, some of which are marketed as “dietary supplements”, contain sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), and phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent). Some of the amounts of active pharmaceutical ingredients far exceeded the FDA-recommended levels, putting consumers’ health at risk, according to the December 22, 2008 FDA news release. According to the release, “The health risks posed by these products can be serious; for example, sibutramine, which was found in many of the products, can cause high blood pressure, seizures, tachycardia, palpitations, heart attack or stroke. This drug can also interact with other medications that patients may be taking and increase their risk of adverse drug events. The safety of sibutramine has also not been established in pregnant and lactating women, or in children younger than 16 years of age.
Rimonabant, another ingredient found in these products, was evaluated, but not approved by the FDA for marketing in the United States. The drug, which is approved in Europe, has been associated with increased risk of depression and suicidal thoughts and has been linked to five deaths and 720 adverse reactions in Europe over the last two years.
Health care professionals and consumers should report serious adverse events (side effects) or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.”
The diet drug industry has been plagued by health concerns since the infamous fen-phen led to massive lawsuits and years of litigation not to mention untold human suffering and death. These drugs, marketed to consumers desperate to lose weight, are dangerous and need to be more closely regulated. Their promises far outweigh the risks to human health. These drug companies are marketing these products playing upon an age old desire to be thin. It’s unethical and illegal.

Obama Administration Will Get Fresh Start at FDA

Dr. Andrew C. von Eschenbach, the FDA Commissioner has announced that he will resign on Inauguration Day. Many other top FDA officials have either already left the federal agency or plan to do so as President-elect Obama assumes office on January 20, 2009. The resignations are no doubt a consequence of the harsh criticism that the agency has faced during the two terms of the Bush Administration. Critics both within and outside of government have sharply rebuked the Bush policies of politicizing the FDA and its heavy-handed role in scientific research and policy. The criticisms have ranged from food supply safety to protecting pharmaceutical manufacturers whose drugs have been shown to be unsafe or ineffective. Just this year, the heparin contamination, ground beef recalls, and pharmaceutical marketing programs have left the FDA in disarray.
The resignations give the incoming Obama administration an opportunity to instill confidence in consmers who have been awash in stories of drug companies influencing scientific research. This “pay for play” culture may be an early target of the new administration seeking to set a fresh course for the FDA. The New York Times is reporting that Dr. Joshua Sharfstein, a pediatrician and Baltimore health commissioner, is a leading candidate for the FDA post. Sharfstein made headlines earlier this year when he called for a ban on certain pediatric cough and cold medicines.
A fresh start would be good for consumers who must be able to trust the FDA when it comes to the integrity of pharmaceuticals and food stuffs. A new course that doesn’t protect big pharma or the large corporations at the expense of the consumer would be a refreshing change indeed.

FDA Warns About Certain Epilepsy Drugs

The FDA has published a warning concerning certain drugs designed to treat epilepsy and certain psychiatric disorders. The warning coming amidst increasing agency concern that the drugs have shown an increased risk in suicide and suicidal ideation. The drugs include Topamax by Johnson & Johnson, Lamictal by GlaxoSmithKline PLC, Pfizer Inc.’s Lyrica and Neurontin, and Novartis AG’s Tegretol and Trileptal.
While the new warnings will caution consumers and doctors about the harmful side effects, they fall short of the “black box” warning reserved for the FDA’s harshest warning label. The new warning has drawn criticism from the American Epilepsy Association which stated that the FDA’s conclusions were flawed and the warnings raise concern that the new warning will cause patients to cease treatment, exacerbating the epileptic and psychiatric issues.
The pushback from the American Epilepsy Association is symptomatic of the reaction to the FDA’s new emphasis on drug safety. The federal agency must walk a fine line between advocating consumer safety and the risk to benefit analysis drug manufacturers purport in treating patients. It’s an understandable debate. Normally, one could take solace that good science could serve as the final arbiter. Yet, the federal government is probing how scientists and doctors can be influenced by payments from pharmaceutical companies in return for their promotion of a certain drug. This confluence of factors and competing interests makes drug safety and patient care murky at best.

Bed Bugs and Holiday Travel

In spite of the economic downturn, many Americans will travel to visit relatives and friends. Many will stay in hotels and motels across America. Bed bugs can be a problem in even the nicer hotels. The mattresses are used, sometimes overused and if the cleaning crew, isn’t careful these hotel mattresses become breeding grounds for the little nocturnal creatures known as bed bugs. However, there are some simple, quick steps to take so that you and your family remain bed bug free during the holiday season. After you check into your hotel room, take a flashlight, pull back the covers and the sheets and focus the flash light beam on the mattress. If you spot dark brownish or red stains on the mattress, that may be a sign of bed bugs. The headboard and the space between the carpet and the wall should also be inspected. These simple steps can help you avoid the unpleasant experience of bed bug bites. Petra J. Minoff, Vice President of Hospitality for Protect-A-Bed, says, “Visible signs that the room could have a problem include moulted skins, excrement and eggs from the bed bugs.”
Another rule of thumb, according to Minoff, is to never place your luggage on the floor or
the bed.
“Always use the luggage stand and keep your luggage closed at all times.”