Monthly Archives: July 2009

FDA Issues Warning on Supplements

The FDA has issued a warning to all consumers to not purchase or use any body building supplements or dietary supplements that may contain steroids due to their association with kidney and liver issues.
While the warning was general in nature, the FDA noted that consumers should be aware of any products that are labeled or advertised as “anabolic” and “tren,” or phrases like “blocks estrogen,” and “minimizes gyno”. According to the FDA, these are code words indicating the possibility that the products contain steroids or other harmful substances.
In the warning letter, the FDA pointed out 8 specific products from American Cellular Labs. The NY Times quoted an official as saying, “We think that there may be a number of firms that are marketing similar products, if not products that are exactly the same,” Michael Levy, director of the Division of New Drugs and Labeling at the agency’s Center for Drug Evaluation and Research, said in a conference call with reporters on Tuesday.
Supplements are a multi-million dollar industry that is not regulated by the FDA in the same fashion as prescription drugs. The FDA has authority to intervene only after there are reports of problems with supplements and can prove the particular product is a health hazard.

Zimmer Attempts to Settle Defective Hip Cases Directly with Patients

Recently, I’ve heard rumors that Zimmer Inc. is attempting to contact patients injured by the defective Zimmer Durom Cup hip implant in order to settle potential legal claims. While some of those injured may be anxious to speak with Zimmer officials about such a settlement, it’s not always in the best interest of those injured to resolve their claims without first speaking to an attorney who’s experienced in handling medical device defect claims. Let me explain why. First, experts are not sure the extent of the Zimmer hip problem. The exact nature and cause of the defect has yet to be determined. Second, a patient is rarely in a position to negotiate a fair resolution for the injuries suffered due to the Zimmer hip. Third, even the injured party may not be aware of future problems the Zimmer hip implant may cause. These are just some of the reasons to consult an attorney who has handled medical device cases.
It’s also important to mention that if you have retained an attorney, Zimmer officials are not allowed to speak with you about your potential case without the consent and advice of your attorney.
Just as I wouldn’t represent myself in a criminal matter, it’s never a good idea to represent yourself in any civil matter. You owe it to yourself and your loved ones to find and retain an attorney so that your rights are protected and your potential claim is investigated thoroughly.

Defective Zimmer Hip Implants

While we’re still not 100% certain the exact cause for the failure of the Zimmer Durom Cup hip implants, one this is for certain, many patients who’ve had the artificial Zimmer hip implanted, have experienced extreme pain and suffering as a result of the hip replacement surgery. It appears that the components of the Zimmer Durom hip don’t experience bone growth so that the implanted medical device loosens and separates at some point after hip surgery.
It’s interesting and ironic to note that the first medical professional to complain about the potential problems with the Zimmer Durom hip was Dr. Lawrence Dorr, a former paid consultant for Zimmer. Upon Dorr’s complaints about the artificial hip, Zimmer officials countered that Dorr was not using the correct procedure in performing the artificial hip implant surgery. Zimmer made this claim in spite of Dr. Dorr’s 30 years of experience in hip implant surgery and his reputation as one of the foremost artificial hip experts in the country. Instead of taking Dorr’s concerns seriously, Zimmer officials waited until 1,300 more patients had Zimmer hip implants before recalling the defective hip implant.
The defective medical device has been recalled in the US but not before approximately 13,000 patients in the US have had Zimmer Durom Cup hips implanted. At this stage, it’s estimated that the failure rate is 5% however it may grow to around a 20% failure rate.

Curbing Drug Ads

The effort is receiving scant attention from the media but it’s a part of the healthcare reform discussion in Washington DC. Proponents of stopping pharmaceutical ads on television note that the marketing campaigns often exaggerate the benefits of the particular drug while downplaying the adverse effects. Other critics point to the ads encourage consumers to self-diagnose ailments and go to their doctors asking to receive certain drugs for previously undiagnosed ailments such as restless leg syndrome, arthritis, and sexual dysfunction.
Pharmaceutical companies spent $4.8 billion last year on direct to consumer advertisements. The companies receive tax deductions for such marketing efforts meaning the consumer is partially paying the bill for these large pharmaceutical companies.
The United States and New Zealand are the only two countries in the world that allow direct to consumer marketing campaigns. We’ve already seen the adverse consequences of some of these efforts. In 2004, Merck removed Vioxx from the market after revelation of safety concerns. However, this happened after Merck had already garnered handsome profits from its aggressive and extensive direct to consumer marketing efforts. In 2008, Pfizer discontinued television commercials for its cholesterol drug after it was discovered that the ad misrepresented the credentials of the doctor pitching the drug. Also last year, Bayer’s popular birth control drug came under FDA scrutiny for downplaying the drug’s side effects. Yasmin and Yaz are both the subject of lawsuits.
In spite of the lawsuits, pharmaceutical companies remain undeterred in their efforts to market their drugs. They stand to make more profits from misleading marketing campaigns than they’ll lose from lawsuits after a drug is found to cause serious injury.
It’s time for direct to consumer drug ads become a central part of the healthcare reform agenda. Consumers will be safer and the doctors who prescribe the drugs will have better, more independent information based on science and not on marketing.

Two Popular Diet Supplements Contain Steroids

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 Oppose Device Registry

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, Popular Irish-American Author, Early Critic of Church, Dies

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.

7 Medical Device Makers Sued

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.

FDA Probing Asthma Drug Xolair for Heart Risk

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

Doc Didn’t Tell Med School Employer about Medtronic Financial Ties

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.

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