Articles Posted in Diet Supplement, OTC, Pharmaceutical Claims

The Texas Attorney General’s office has announced that its litigation against Mannatech has been concluded with a settlement agreement. The agreement mandates that Mannatech return $4m to customers and its founder, Sam Caster, must pay $1m in fines. Caster is also barred from serving as a director, officer, or employee of the company for 5 years, and cannot participate in any multilevel marketing program for 5 years. Caster had been sued twice before by the Texas AG’s office for deceptive marketing of another company he ran, Eagle Shield.

The litigation was filed in 2007, and accused Mannatech of using an illegal marketing scheme to defraud consumers Mannatech markets supplements called “glyconutrients” that supposedly provide the body with “essential sugars” that promote “better communication” between cells and support the immune system. Leading scientists are critical of the company’s theory of “glycobiology,” and one was prompted to characterize the product as literally, a sugar pill (well known in science as a placebo with no active ingredients).

Still pending is the litigation against three other defendants named in the litigation, H. Reginald McDaniel, a Mansfield physician who has been long associated with the company, and two charitable organizations tied to the company, MannaRelief Ministries and Fisher Institute for Medical Research. The litigation accused them of violating the Texas Deceptive Trade Practices Act and the Texas Food, Drug and Cosmetic Act.

The bright spot in today’s news is that the FDA has announced its initiative against “contaminated weight loss products.” One has to applaud the agency’s efforts because diet supplements, in general, and weight loss products, in particular, have been “spiked” with pharmaceutical drugs for some time. The reason diet supplement marketers do this is because: 1.) drugs work, whereas diet supplements rarely do; and 2.) they can get away with it. The agency has been manacled in its enforcement efforts by the restrictions imposed by DSHEA, but it has also been substantially impaired in its efforts because of a lack of political will to regulate this wayward industry where it can. Thus, these kinds of initiatives are a breath of fresh air.

Imagine for a moment that it has been discovered that Pfizer had “spiked” its new blockbuster drug with a different, undisclosed drug, (or for that matter a diet supplement!). The FDA and the industry would be embroiled in immediate inquiries, and heads would roll. On the other hand, the FDA has known for decades about the illegal “spiking” of diet supplements with pharmaceuticals and has simply let the matter fester.

Be that as it may, the FDA has now released warnings as to a number of supplements, and has indicated that it will be seeking recalls of some of them. The supplements were found to contain sibutramine (a controlled substance), rimonabant (a drug not approved for marketing in the United States), phenytoin (an anti-seizure medication), phenolphthalein (a solution used in chemical experiments and a suspected cancer causing agent) or bumetanide (a diuretic). These substances all have pharmaceutical properties that include the laundry list of adverse effects one would expect. We have previously written about the deadly consequences of this type of adulteration here, and here, and we commend the agency for its efforts. Regardless whether the FDA is getting it or just getting around to it, this heightened scrutiny is long overdue.

Judge Jack T. Camp, of the U.S. District Court, has sentenced the CEO of Hi-Tech Phamaceuticals, Jared Wheat, to 50 months in prison for illegally selling knock-off prescription drugs over the internet. He was also fined $50,000, and was required, along with the company and other defendants, to forfeit $3 million in proceeds received in the scheme. In the proceeding, the defendants admitted to operating a facility in Belize that manufactured generic versions of pharmaceutical drugs, such as Xanax, Valium, Ambien, Vioxx, Ambien, Zoloft, Viagra and Cialis, and selling the drugs over the internet without requiring a prescription.

A co-defendant, Sergio Oliveira, a sales associate, was sentenced to 20 months in prison and fined $20,000. The judge had previously sentenced two other Hi-Tech officials, Stephen D. Smith and Tomasz Holda, to 27 months and 16 1/2 months respectively.

Hi-Tech’s supplements include Stamina-Rx, which it claims to be a “maximum sexual stimulant,” Lipodrene, supposedly capable of “advanced appetite control and metabolic stimulation,” and Metanabol, marketed as a “revolutionary catalyst for increasing lean mass and strength.”

The diet supplement industry has used innumerable methods of staying ahead of the posse (the FDA, the FTC, State AGs, and the courts). They have simply outrun regulation, and outfoxed the regulators. The industry has outlobbied the regulators, as well. Despite decades of scientific data and media disclosures, the industry is virtually unregulated, and the consumer still cannot trust that a diet supplement purchased on the open market is safe, effective, or unadulterated. “Caveat emptor, baby, caveat emptor” was also the chant of the Bush Administration in its approach to these issues.

A new report by the FDA asks the simple question whether the FDA is up to the challenge of regulating engineered nanoparticles in diet supplements. Without reading the report, we know the answer to be “no.” The FDA is not set up to litigate, it has not been given a true mandate to regulate this industry, it is underfunded, and its scientists are squelched. But let’s see what they say. “It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up product claims.” We had to pay for a study to get to this conclusion? The industry doesn’t do “rigorous testing”. It doesn’t on anything it sells, because it isn’t legally required to do so. Instead, the industry does “rigorous marketing”.

As for whether the agency is “up to the challenge,” the report concludes: “The short answer is no.” Three reasons are given: 1.) the agency doesn’t have the capacity to identify nano-based supplements; 2.) the agency has little regulatory authority over such supplements; and 3.) the agency lacks the scientific expertise and resources to effectively regulate these supplements. The report recommends what has been obvious for decades now–increase the agency’s regulatory authority, and increase its resources.

Nine scientists at the FDA sent a letter to President Obama on Wednesday to plead for major reform at the agency. Their central concern is with the agency’s scientific review process for medical devices, which they characterize as having beeen “corrupted and distorted by current FDA managers, thereby placing the American people at risk”. The letter detailed their allegations, such as threats of disciplinary action against scientists who dissented from management. It described the atmosphere at the agency as being one where “the honest employee fears the dishonest employee,” and where scientists cannot do their jobs without fear of reprisal. Ultimately, the agency was described as “fundamentally broken”.

The scientists further detailed their efforts to take their concerns to agency leaders, such as Commissioner Andrew Von Eschenbach, and the assistant commissioner for accountability and integrity, attorney Bill McConagha, but no changes have occurred. Worse yet, the problematic managers were not held accountable, but were promoted and rewarded.

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The potential for injury from the antibiotic flouroquinolone (Cipro, Levaquin) has been known for over 20 years, yet it was only recently that the FDA told the drug’s manufacturers to add a black box warning about the increased risk of tendinitis and tendon rupture. The FDA stopped short of requiring the manufacturers to send out a warning letter to doctors.

To date, the FDA has received 2,250 reports of tendon disorders and 775 reports of tendon ruptures. The problems have arisen in the Achilles’ tendon, as well as shoulder, hand, and other tendons. These numbers are only a small percentage of the adverse events that have likely occurred because adverse events are routinely underreported. The risk is higher in patients older than 60, and in those taking corticosteriods.

One concern about the increase in this complication is the increased use of this class of antibiotic, one some refer to as “Vitamin L”. It is apparently widely prescribed because it addresses a wide spectrum of bacteria, but the marketing of the drug characteristically underinforms doctors about this type of complication.

The House of Representatives Committee on Oversight and Government Reform has released its report about the Bush Administration’s imposition of new preemption policies within the FDA. Historically, the FDA viewed litigation brought by those harmed by medical devices or medications as a complement to the agency’s regulatory efforts to protect against the effects of unsafe devices and drugs. The agency recognized that these cases help to uncover the risks that were unknown to the agency (or hidden from the agency by the manufacturer) at the time the product and its labeling were approved, thereby providing another layer of consumer protection against unsafe products. In 1997, former FDA Chief Counsel Margaret Jane Porter stated: “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct layer of consumer protection. FDA regulation of a device cannot anticipate and protect against all safety risks to individual consumers….Preemption of all such claims would result in the loss of a significant layer of consumer protection.” This position was uncategorically reversed in the Bush Administration in favor of overt advocacy by the agency in support of preemption of litigation, effecting essentially a grant of immunity to the manufacturers of medical devices and drugs.

Internal agency documents obtained by the Committee now show that these regulatory changes were made by the FDA over the objections of key career officials who repeatedly warned that the central factual justification offered for the agency’s new directives was false.

For example, the preamble to the 2006 labeling rule asserted that the FDA has the ability to “carefully control” drug labeling and to continuously monitor the safety of pharmaceutical products, incorporating information into the labeling when appropriate. Dr. John Nenkins, the highest official in FDA’s new drug review process, strongly disagreed with these assertions, writing: “[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false….We know that many current approved drug labels are out of date and in many cases contain incorrect information.”