Monthly Archives: December 2008

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
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
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.”

Congress Examines Wyeth’s Role in Medical Journal Articles

Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
Congress is investigating huge pharmaceutical company Wyeth, Inc. for its use of ghost writers who prepare scientific articles for doctors’ and/or scientists’ signatures. Additionally, the federal probe includes an investigation into Wyeth’s marketing department role in influencing manuscripts for medical journals.
The Congressional probe is another in a long line of federal examination’s of how big pharma is influencing doctors, science, the marketing of drugs, and the overall approval process of pharmaceutical products. This lates Wyeth investigation concerns payments Senator Charles Grassley said were made to prepare certain articles and for information about how doctors were recruited to place their names on those articles. According to the Wall St. Journal, “The articles, published in peer-reviewed medical journals, involved Prempro and other female-hormone-replacement therapies made by Wyeth.”
Wyeth responded to the inquiry by stating that they do indeed offer professional medical writing services to the scientists however the scientists maintain complete editorial authority and control. Their other response involved a gratuitous swipe at lawyers whom they claim to be recycling old stories. That’s strange, I don’t believe Sen. Grassley consulted lawyers prior to deciding to investigate Wyeth’s practices.

SNAP to Bishop Melczek: Clean Up or Resign

SNAP or Survivors of Those Abused by Priests held a news conference outside the headquarters of the Diocese of Gary today in response to last week’s abuse lawsuit filing in Indiana.
During the news conference, members of SNAP will call on Bishop Dale Melczek to either reform his ways regarding priest sexual abuse or resign. They will also praise the courageous young man who came forward to shed light on his own abuse which happened in 2003.
In their press release, SNAP noted that three dates were key in criticizing Bishop Melczek’s stewardship of the Gary Diocese: 1)1992 Bishop Melczek, in a letter to then Cardinal Ratzinger, admits that he’s been aware of Emerson’s inappropriateness with kids since he came to Gary in 1992.2)2002 represents the year the bishops of the US, including Bishop Melczek promised to begin a new openness about child sex crimes. 3)2006 Bishop Melczek wrote a letter to all his priests in the Diocese telling them to keep silent about Emerson being defrocked by the Vatican.
The sad fact is that the survivor for whom we filed suit last week would not have been abused by Emerson if action had been taken against him a decade ago. If this is about protecting children, this kind of inaction must come to an end.

FDA Issues Warning about Some Asthma Drugs

The FDA has issued a warning that some long-acting asthma drugs actually increase the asthma risks they are designed to lessen. The group includes GlaxoSmithKline PLC’s Serevent and Advair, Novartis AG’s and Schering-Plough Corp.’s Foradil and AstraZeneca PLC’s Symbicort. The group of drugs known as long-acting beta-agonists or LBA’s have been under FDA safety review for quite some time because they may increase asthma related death, hospitilization, and intubation. These risks may actually be higher in children. The class of drugs already carry a black box warning but the FDA is considering a stronger move against them if it turns out their analysis of the drugs warrants such action.
The FDA study included 110 trials and 60,954 patients. Serevent studies alone involved 43,000 trials. According to the Wall St. Journal, “Overall, the agency said its analysis showed “that LABAs were associated with an increased risk of asthma-related events relative to non-LABA treatment as measured by the asthma composite endpoint consisting of asthma-related death, asthma-related intubation and asthma-related hospitalizations.”

Bishop in Charge of Protecting Children Talks a Good Game

Bishop Blase Cupich, head of the Diocese of Rapid City South Dakota, is the new chair of the bishops’ Committee on the Protection of Children and Young People. As the new chair, Cupich has stated the bishops priority must be reaching out to victims. Pope Benedict XVI said the same thing eight months ago and nothing has changed. Bishops are still filing appeals in order to withhold documents and settlement awards. They are still transferring priests and making all sorts of excuses about how they didn’t know, how they couldn’t have known, etc, etc. Words are hollow unless they are supported by clear, transparent action. Since we haven’t witnessed any of the latter, a lot of people have chosen to ignore the former.
Have you noticed that the bishops’ authority in this country seems to be waning? They make individual or collective statements about this or that and the general public yawns. Could it be that the bishops have lost their influence and power among the people because they’ve lost their moral compass? That moral compass was lost during the priest abuse scandal. As a group of religious leaders, they couldn’t have acted worse or fumbled so many things including reaching out to victims.
If Bishop Cupich is serious he has a lot of work to do. Before he tries to reach out to the sex abuse survivors he might want to try and reach out and poke his brother bishops. They need to wake up and treat survivors in a way that befits their Gospel values.

Medical Device Companies Are Marketing on YouTube

In the electronic age more companies are hawking their products over the Internet, using Google and YouTube as venues to sell their products. Now, the medical device industry is joining in. At least three medical device manufacturers including Abbott Laboratories, Medtronic Inc. and Stryker Corp. have placed direct to consumer ads on YouTube. While the marketing plan may be innovative it may not be legal.
According to Prescription Project, a consumer advocacy group, the ads don’t contain the proper disclosures or the warnings that are required in the conventional marketing media such as print, radio, and television. Prescription Project has petitioned the FDA to investigate the ads as well as update their marketing regulations to conform to the electronic medium.
Federal rules require drug companies and medical device manufacturers to clearly provide the consumer with information about potential risks and side effects. In its letter to the FDA, the Prescription Project cited ads for Abbott’s Xience V, a drug-coated stent; Medtronic’s Prestige Cervical Disc, a spinal implant; and Stryker’s Cormet hip-resurfacing system.
According to a Wall St. Journal report, “Stryker said it wouldn’t comment because the issue was before the FDA. Medtronic said it is committed to adhering to FDA guidelines for direct-to-consumer advertising. The company said the video in question had been taken down.
An Abbott spokesman said the company posted a link to Adderall XR’s safety and risk information next to its YouTube video, but will from now on embed safety and risk information in such videos.”