When Hydroxycut was pulled from the market, we blogged about the issues with dietary supplements as far as their labeling of ingredients. Now, we discover that two popular over-the-counter dietary supplements used by high school football players contain banned steroids. Tren Xtreme and Mass Xtreme, both manufactured by American Cellular Labs, are being investigated for containing man-made designer steroids. One of the banned substances is Madol which became notorious during the Bay Area Lab Co-operative investigation.
The investigation has also discovered that Max Muscle, a retail supplement store with over 100 locations nationwide, paid American Cellular Labs to be the exclusive seller of these steroid-containing supplements.
Yesterday, the FDA executed search warrants on a Max Muscle store in San Francisco and another at WVM Global Incorporated in Lake Forest, California. The FDA has jurisdiction over dietary supplements as far as when it identifies a product that is adulterated or harmful and is already on the market.
The dietary supplements indicated in the investigation are highly popular with tenn athletes for their supposed benefits. However, steroids have been shown to be particularly dangerous in pre-teen and teen athletes because steroids can prevent normal bone growth.
As in the Hydroxycut case, these two dietary supplements failed to properly list the active ingredients contained therein. Of course, in this case it’s obvious why the label wouldn’t list steroids as active ingredients since they are illegal. However, this is another instance in which these dietary supplements may cause harm to consumer health. If the consumer is not provided with accurate information regarding the product, how can anyone be certain the product is safe?

Medical device manufacturers have signaled their opposition to the creation of a national medical device registry, at least as proposed in legislation introduced on July 14. The registration requirement is found amoung the proposals outlined in America’s Affordable Health Choices Act of 2009 (H.R. 3200), introduced by Rep. John Dingell, D-Mich., and the chairmen of three House committees with jurisdiction over health policy.
Registry adovcates have noted that creation of such a database would help the Department of Health and Human Services track the safety and effectiveness of medical devices. The registry would classify by type, model, and serial number.
Opponents of the registry have questioned the utility of such a registry asking how it would help the ordinary consumer.
If that’s the opposition argument, it’s a weak one. Such a registry has worked in other countries. It would impact the public’s knowledge of safety data concerning a particular medical device. Such a registry would aid in making the industry more transparent and consumer friendly.
The real question-why does the medical device industry oppose the legislation? Why are they fearful?

Frank McCourt, 78, died of cancer yesterday in New York City. McCourt, whose work Angela’s Ashes plucked him from literary obscurity in 1996, had spent most of his life as a school teacher in NY public schools.
His book, Angela’s Ashes, told the story of a Limerick boy (McCourt himself) caught in the dire grip of poverty. Ironically, McCourt was born in NY and his parents had moved back to Ireland after failing to find work in NY during the Depression.
Angela’s Ashes won the Pulitzer Prize in 1997 and the work spent 117 weeks on the NY Times best-seller list. McCourt’s work was characterized by a sarcastic but insightful glimpse into the influence of Roman Catholicism among the Irish poor, especially in terms of sexual expression. In McCourt’s work, Catholic clerics were portrayed as harsh, sexually repressed, and, at times, sadistic. McCourt’s portrayal of Irish clergy would prove tragic but prophetic when the Irish Abuse Report was finally released earlier this year. The tale of sexual abuse, especially in Irish Catholic orphanages closely mirrored McCourt’s portrayal of the Church and its handling of poor families and children.
Even the sex abuse crisis could be seen as a harbinger in his writings. In McCourt, there was almost an air of inevitability to the advent of the sex abuse crisis. The repression and control demanded by the Church coupled with the poverty and helplessness of the people led to a tragedy that was bound to produce terrible results.

Seven surgical device manufacturers, including Medtronic Inc. and Boston Scientific Corp., have been sued for promoting their surgical devices for unapproved uses. The case has gained notoriety because a former employee of one surgical company has come forward as a whistleblower and revealed the improper marketing and Medicare fraud.
According to the complaint, “Boston Scientific and its Guidant Corp. unit initiated a coordinated nationwide sales campaign (including the use of illegal kickbacks and other improper means) to entice physicians and hospitals to use their products for off-label purposes.”
The suits were filed under the federal False Claims Act alleging the marketing caused excessive Medicare reimbursements.
Unfortunately, these types of lawsuits are not novel in the pharmaceutical and medical device industries. The competition is so intense that some device and drug firms are willing to cross the ethical and legal line concerning how the products and drugs are marketed. Of course, the real loser in these marketing campaigns is the consumer whose doctor may be enticed to choose one of these medical devices or pharmaceuticals based partly on their marketing campaign. The doctor like the patient is assuming in good faith that these companies are complying with the law and their marketing literature is accurate. When this good faith bond is broken, the ultimate loser is the patient. The big pharma companies and medical device manufacturers are undeterred by these nuisance fines and continue to skirt the law.
Until such time as there is real reform in these industries, the companies will continue to act in this fashion. Change will only occur when it is no longer in their financial interest to circumvent the law.

The FDA is probing a possible connection between the asthma drug Xolair and an increased risk of cardiac and cerebrovascular problems. The probe comes as a result of a study submitted to the FDA by Xolair’s manufacturer Genentech that found a disproportionate increase in heart and cerebrovascular events in patients who have taken Xolair.
Xolair is an injectable drug given to patients 12 years or older that present moderate to severe persistent allergic asthma that doesn’t respond to inhalation of corticosteroids.
In its news release, the FDA stated, “”FDA is not recommending any changes to the prescribing information for Xolair and is not advising patients to stop taking Xolair at this time. Until the evaluation of the EXCELS study is completed, healthcare providers and patients should be aware of the risks and benefits described in the prescribing information, as well as the new information from the ongoing EXCELS study that may suggest a risk of cardiovascular and cerebrovascular adverse events.”
The FDA asks health care professionals and patients to report side effects from the use of Xolair to the FDA’s MedWatch Adverse Effects Reporting program. To do so, use any of the following contact information:
Phone: 800-332-1088
Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

According to Washington University officials, Dr. Timothy Kuklo didn’t tell them about Kuklo’s financial ties to Medtronic even though Kuklo was performing research that would benefit Medtronic.
Dr. Kuklo has come under intense scrutiny for medical research conducted at Washington University in St. Louis. The Army has since discredited the study stating that Kuklo falsified information in the study and forged other doctors’ signatures. The study published in a British medical journal has since been retracted.
The latest Kuklo revelations surfaced during a Senate investigation of Kuklo and his failure to disclose his financial relationship with medical device maker Medtronic.
The NY Times quotes a Washington University official, ““Dr. Kuklo’s relationships to Medtronic and the adequacy of his related disclosures to the University are also of great concern to us,” the medical school’s dean, Dr. Larry J. Shapiro, wrote in a letter to Senator Grassley that the senator’s office released Tuesday along with other documents from the university’s investigation.

Acetaminophen is everywhere and enjoys an excellent reputation as a safe, effective, pain reliever. It’s in our over-the-counter drugs that we purchase when we have a cold, the flu, or any type of muscle ache or joint stiffness.
Since the 1980’s Tylenol scare, marketing firms have carefully branded acetaminophen as a safe,effective drug for just about any common ailment.
Yet, there a downside to acetaminophen’s success. The drug is also combined in such narcotic prescription pain medicines as Percocet. When prescribing drugs like Percocet after a procedure or a surgery, doctors often fail to take into account the amount of acetaminophen contained in the Percocet they’re prescribing. The doctor may write a prescription and instruct the patient to “take one every four hours for pain”. Such instructions may exceed the daily limit allowable of acetaminophen (4 grams). The pharmacist in filling such a prescription may also neglect to notice the harmful amounts of acetaminophen prescribed even though that same pharmacist may be liable for such an overdosage.
In these scenarios, which are not uncommon, both the doctor and the pharmacist are legally liable for the acetaminophen overdosage. It’s a dangerous situation for the patient because that very same prescription, legally obtained, may lead to liver damage and/or liver failure.
In cases of acetaminophen overdosage, it’s more than buyer beware. Doctors and pharmacists must pay attention to the amounts of acetaminophen prescribed as well as the over-the-counter acetaminophen the patient may have already ingested. Doctors and pharmacists need to ask what types of over-the-counter medicines are being taken prior to writing and filling potentially lethal prescriptions.

Medtronic Corp. is voluntarily recalling its Lot 8 Quick-set insulin infusion equipment used in conjunction with insulin pumps because it may transmit too much or too little insulin to diabetes patients. Diabetics using the equipment have been warned to immediately stop using such equipment. The affected lots include reference numbers MMT-396, MMT-397, MMT-398 and MMT-399, with lot numbers that begin with 8.
According to Medtronic, the recall affects approximately 60,000 units of the insulin equipment. The infusion set is a thin piece of plastic tubing that is replaced every three days. The tubing connects the insulin pump to the patient. While there are no reports of injuries, the medical device malfunction could lead to serious injury or death.
Medtronic Corporation is no stranger to faulty medical device that require recalls. Just last month, the FDA ordered a Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. A few years ago, Medtronic suspended sales of its Sprint Fidelis defibrillator leads for similar issues.

Since the forced exile of DDT, beg bugs have enjoyed a renaissance in hotels, condos, college dormitories, and other seemingly innocent residential haunts. The problem has become so severe that it’s caught the attention of the EPA which held a seminar this past April on the matter.
According to today’s article in the NY Times, the only sure way to get rid of the pesky critters is exposure to high temperatures. This means put your belongings, at least those that are appropriate and fit, into your dryer. Bed bugs can’t sustain the high temperatures and die as a result. According to the Times article, beg bugs aren’t killed by the regular spray of pesticides that the average bug control company offers.
The Times article offers some helpful tips in ridding yourself of the biting bed bugs-
“ENCASE YOUR MATTRESS All bed bug experts agree that you must encase your mattress and box spring with a durable, leak-proof cover that will trap existing bugs inside the bedding and prevent new bugs from entering. (Even if you don’t currently suspect bed bugs, you might want to do this preventively, if you live in a highly infested area.)
The best covers are made from tightly woven cloth and have enclosed zippers and zipper locks to ensure there are no openings anywhere on the covering. A good cover will cost $70 to $150, depending on the size of your bed. Don’t bother with cheaper covers made of vinyl, which is uncomfortable to sleep on and is likely to crack and tear over time.
BEFORE YOU TOSS … Often, the first response to bed bugs is to throw stuff out. But replacing contaminated furniture, clothes and other possessions can be one of the biggest unnecessary bed bug expenses.
“Nothing kills bed bugs and their eggs better than high temperatures,” said Mr. Bloom, “so the dryer is your new best friend.”
Bedding, clothes, stuffed animals, backpacks and anything else you can fit into the clothes dryer can be decontaminated by 20 minutes on the high setting. Carry the items to the dryer in a cloth laundry bag that you can throw into the machine. If you use a plastic bag, discard it immediately; bed bugs or eggs might be lurking.
For items that can’t go in the dryer, consider packing them in plastic bins or bags and storing them for a year to make sure any hidden insects die.
For furniture and other large items, you may want to consider a professional fumigation service that will decontaminate the items away from your home and return them within a week or so. This can easily add $1,000 to your bed bug bill. But for antiques, heirlooms and other hard-to-replace items, it may well be worth the cost.”

Aggressive marketing efforts have sent sales of bottled water skyrocketing in the last 10 years. Part of the allure is the notion that bottled water is cleaner and purer than tap water.
That’s not necessarily the case according to the Government Accounting Office. The EPA has oversight regarding tap water while the FDA has responsibility for bottled water. It’s an important distinction since the FDA doesn’t have the regulatory authority to demand that bottled water submit to testing and report violations. On the other hand, thanks to the Safe Water Drinking Act, the EPA mandates testing and reporting of water quality results.
Essentially, we know more about the safety of our tap water than we do about the bottled water we purchase and presume to be healthier than the tap water. This discrepancy has caught the attention of Congress. Congressmen Waxman and Stupak have sent letters to 13 companies that sell bottled water asking them for testing and water quality data. “Neither the public nor federal regulators know nearly enough about where bottled water comes and what safeguards are in place to ensure its safety,” Stupak said.
This is somewhat similar to the concerns raised last week about acetaminophen. The general assumption has been that the drug is safe because its ubiquitous. Yet, we probably lack information to make such a judgement.
In the cases of acetaminophen and bottled water, we’ve allowed good marketing to hold sway over science. That’s a dangerous notion.