Alaska Injury Law Blog

The Journal of the American College of Cardiology has just published a review of 44 years of research and has concluded that herbal products can contribute to cardiovascular morbidity and mortality. The risks noted include increased bleeding, and reducing or increasing the effect of a patient's cardiovascular medications, Many of the ingredients used (aloe vera, ginkgo biloba, ginseng, and green tea) can interact with a patient's heart medications and lead to serious adverse reactions. For example, some ingredients increase the blood levels of statins, calcium channel antagonists, and several anti-arrhythmic drugs. Another herbal ingredient is known to inhibit platelet aggregation and can lead to increased bleeding risk when the patient is also taking anti-coagulants such as aspirin, Plavix, or Coumadin. Some ingredients (garlic, ginkgo biloba, ginseng, saw palmeto) can have their own cardiovascular effects, and some can induce arrhythmias on their own. The authors, all Mayo Clinic physicians, have called for increased regulation of the products.

Sources:

"Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases," Journal of the American College of Cardiology, 2020; 55:515-525.

Medpage Today, 2/1/10.

Researchers from the UK, Sweden and the US have established that using drugs purchased from the internet can kill and cause patients to bypass health systems that could diagnose life-threatening problems. They estimate that 90% of counterfeit drugs are sold via the internet, which has spawned global sales of over $75 billion, sales which have increased 92% in the last 5 years.

The findings are set out in an article in the International Journal of Clinical Practice. The researchers reviewed over 50 studies published since 1995. The data particularly focused on erectile dysfunction medication, and showed the over 44% of these drugs were fake. The consequences were dire for some, including 150 men admitted to hospitals after taking counterfeit tadalafil and herbal preparations that claimed to cure the dysfunction. Seven were comatose and four subsequently died. Two pregnant women died after being given injections of a counterfeit iron preparation for anemia. Fifty-one children died of kidney failure after taking paracetamol syrup contaminated with glycol, an antifreeze used in cars.

We have previously reported on the problem of herbal preparations being spiked with prescription medications here, here, here, here and here.

Source:

Jackson et al. Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. International Journal of Clinical Practice, 2010

Today's news is that gingko biloba, touted since the 1970's by the diet supplement industry as an herb that would improve memory or forestall cognitive decline in aging or in dementia, has been found to be useless. As routine scientific scrutiny has been applied to the nostrums of the industry in recent years, we see these "ancient healing" claims fall one by one: chondroitin and glucosamine for osteoarthritis, vitamin E and selenium for prostate cancer, or vitamin E and C for prevention of cancer or heart disease. (Indeed, recent studies have shown that the use of vitamin therapies can sometimes increase the risk of disease, as in folic acid increasing the risk for precancerous polyps or higher lung cancer rates for those trusting to beta carotene supplements.) When asked for data in support of their claims of efficacy, the industry simply trots out the claim that the Chinese have used the product for 5,000 years or that sharks never get cancer. By doing so, they seek to avoid the hard work of any scientific endeavor, i.e., proving that their product works.

As for the safety of these products, the industry has repeatedly picked the pockets of consumers with this magical thinking: "it is all-natural, so it has no side-effects but it works better than drugs." Of course, for a compound to work, it must have an effect, which means it is capable of affecting the body and causing side effects. It can't be effective and affect the body positively but never affect the body negatively. If it can affect the body at all, it is capable of having side effects, period. It is as if they were saying, "yes you can have the money and never pay taxes on it." Yet, we know that the IRS always gets its piece. And, herbals and diet supplements will always tax the body--there are always side effects.

We can't blame the industry, because we let them get away with selling billions of dollars of useless or dangerous or tainted products. We let Congress take money from the industry's lobbyists to pass DSHEA and dodge the effective regulation of the marketing and manufacturing of these products. We let the diet supplement industry tell consumers, "Ego exigo, proinde is est bonus,"...."I sell it, therefore it is good." We do not demand that the marketeers prove their case that a product is safe or efficacious, the simple standard the drug and OTC industries must meet.

Today's news comes to us from the Journal of the American Medical Association reporting on a study of over 3,000 people between 72 and 96 who were followed for over 6 years. None had dementia before the study began. Those who took the supplement fared no better than those who took a sugar pill in tests examining memory, language, attention, and other measures of cognitive function.

With annual sales of gingko biloba of over $250 million dollars, the industry could well afford to pay for its own testing for safety and efficacy. But, instead we paid for the testing with public funds. We let that happen, too.

Sources:

Snitz BE, et al "Ginkgo Biloba For Preventing Cognitive Decline In Older Adults" JAMA 2009; 302(24): 2663-70.

Diet Supplement Glucosamine No Better Than Placebo, February 20, 2008

New York Times, Extra Vitamin E: No Benefit, Maybe Harm, March 24, 2009

New York Times, Vitamin Pills: A False Hope?, February 16, 2009

As consumers, we have been repeatedly told that generic drugs are exact copies of their brand-name counterparts. We have been forced by insurers to accept generics over brand-name drugs. This is done by the insurer imposing financial disincentives and refusing to honor our physicians' prescriptions without getting the doctor's office to confirm the prescription. Pharmacies substitute generics for brand-name drugs without asking us first or telling us when they have made the switch. All the while there is an unsettling and nagging question in the back of our brains about whether generics are truly equivalent.

The FDA has taken the position that generics are equivalent, but the public is not informed about the agency's standard of review: a generic is deemed "bioequivalent" if it achieves 80 to 125% of what the brand-name drug provides. This is a huge variance, and one we don't accept in many human endeavors, whether we are talking about a pilot landing a plane or sending in what we owe to the IRS.

Indeed, specialists acknowledge a growing concern that patient experiences on generics are problematic, especially for those patients who have conditions that present significant risk of injury if chronic conditions are not properly treated, as in epilepsy or atrial fibrillation. For example, The American Academy of Neurology has released a position paper on generics, stating that: “The A.A.N. opposes generic substitution of anticonvulsant drugs for the treatment of epilepsy without the attending physician’s approval.”

If you take medications for a condition that has the risk of significant injury or death if your medications are not effective, you should discuss this concern about generics with your prescribing physician. Become an informed consumer about the generic drug you are being asked to take. And regardless what you are told, pay close attention to your symptoms and changes in your condition after taking generics so that you can determine from your own experience whether a generic drug is right for you.

Sources:
New York Times, Dec. 17, 2009

The People's Pharmacy, Dec. 17, 2009

The United States Court of Appeals for the Eighth Circuit, in Mensing v. Wyeth, Inc., has just ruled that generic drug manufacturers cannot use the doctrine of federal preemption as a shield to avoid liability in claims arising out of the manufacturers' failure to warn consumers about their drugs' dangers.

This decision follows on the heels of the United States Supreme Court's ruling in Wyeth, Inc. v. Levine that the FDA's approval of a drug's label does not provide immunity from suit by federal preemption when name-brand drugs cause injury. The Eighth Circuit's decision in Mensing was the first federal appellate decision since Levine to rule that federal preemption does not immunize generic drug manufacturers from liability.

Please see our earlier discussions about the importance of defeating this preemption doctrine.

3/4/09, 12/15/08, 10/20/08, 9/11/08, 8/15/08, and 7/17/08.

Sources:

Mensing v. Wyeth, Inc., (pdf)

The most recent issue of the New England Journal of Medicine has directly called upon Congress to give the FDA the requisite authority and resources to regulate diet supplements. The article is written by Dr. Pieter Cohen, of Cambridge Hospital, and emphasized some alarming statistics:

•More than half of the adult population, about 114 million people, consume dietary supplements.
•The majority of consumers mistakenly believe that dietary supplements are approved by a government agency –- two-thirds of them thought that the government requires that labels on supplements include warnings about their potential side effects or dangers.
•The great majority of the estimated 50,000 adverse events that occur annually remain unreported to the FDA, even though manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA.
•A recent survey of more than 300 physicians who were residents in internal medicine at fifteen different U.S. training programs showed that one-third of them believed that diet supplements require FDA approval – the majority did not know that adverse events suspected to have been caused by supplements must be reported to the FDA.

The Journal emphasized that a wide range of supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Moreover, dozens of supplements have been found to be intentionally contaminated (“spiked”) with prescription medications, controlled substances, experimental compounds, or drugs already rejected by the FDA for safety concerns. As recently as July 2009, the FDA alerted the public to a list of 75 tainted weight loss products that contained undeclared medications, including the stimulant sibutramine, some at levels three times the maximum recommended daily dose. Others contains rimonabant (linked to suicide) and fenproporex (linked to addiction and suicide). Some weight loss pills, many from Brazil, combine multiple medications in a single formula, substantially increasing the risk of adverse events.

The Journal also explained how unscrupulous manufacturers were attempting to fly below the FDA’s radar by using analogues of pharmaceutical compounds. A recent analysis showed that half of 26 supplements marketed for enhancement of sexual function contained analogues of phosphodiesterase Type 5 inhibitors. Reports from three separate countries establish that the analogue of fenfluramine has been linked to liver damage, including fulminant hepatic failure requiring transplantation.

Most recently, tainted products were found being manufactured by a domestic company, American Cellular Labs, which was manufacturing supplements contaminated with anabolic steroids.

The article closed with the admonition that physicians should maintain a high index of suspicion for supplement-induced adverse effects, even when the component stated on the label are not known to cause the symptoms the patient is suffering. After recognizing that DSHEA presents "serious obstacles to the FDA's ability to detect and eliminate contaminated supplements," it called upon Congress to give the FDA the necessary authority and resources to regulate this industry, the author concluded that, until that regulatory authority was given: “Millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.”

Source:

New England Journal of Medicine, Volume 361:1523-1525 October 15, 2009 Number 16

The FDA has recalled 14 Hydroxycut weight loss supplements after receiving reports of severe liver damage that led to the death of a 19-year-old man, and a liver transplant in another supplement user, as well as reports of jaundice and liver enzyme elevation. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite. Other adverse events include seizures, cardiovascular disorders, and rhabdomyolysis, a serious type of muscle damage. The supplement manufacturers, Iovate Health Sciences USA of Blasdell, N.Y., and Iovate Health Sciences of Oakville, Ontario, in Canada, have agreed to voluntarily cooperate with the FDA.

The death occurred in 2007, but the FDA did not learn of it until March, 2009, a delay that is not unusual given that supplement manufacturers are subject only to voluntary, not mandatory, reporting of adverse events. And, unlike drug manufacturers who must follow strict disclosure regulations regarding active ingredients, supplement manufacturers are not required to disclose precise ingredients to the FDA, but can hide behind the "proprietary blend" rubric. This makes it especially difficult for the agency to identify the toxic substances causing the adverse events. The FDA was unable to identify the precise substance believed to be at work here, but the pattern of injury suggests that adverse events may occur regardless of dosage or the length of use of the product.

The surprise here is not that untested diet supplements can cause hepatotoxicity, even at recommended doses, or that there is no free lunch in the world of weight loss supplements. The surprise is that Hydroxycut is still in business. Remember its tattered history of using ephedra in its products, using deceptive before and after photographs, and falsely claiming that it had scientific data of its product's effectiveness (when, in fact, study participants were dropping out due to adverse events and the company replaced them with new study participants). The surprise is that our current regulatory scheme has allowed the company to remain in business at all.

SOURCES:

FDA: News Release--5/1/09

Missouri AG: News Release--3/27/03; News Release--5/4/04

Medical Literature: Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements, World J Gastroenterol 2008 December 7; 14(45): 6999-7004; Hepatotoxicity associated with weight loss supplements: A case for better post-marketing surveillance; World J Gastroenterol 2009 April 14; 15(14): 1786-1787.

New York Times: Studies of Dietary Supplements Come Under Growing Scrutiny, 6/23/03

The FDA has again issued a nationwide alert to consumers about weight loss products that have been "spiked" with undeclared drugs. The FDA identified Herbal Zenicol, Slimbionic, and Xsvelten, bringing its list of adulterated weight loss products to a total of 72 products. The products were spiked with fenproporex (a controlled substance not approved for marketing in the United States), fluoxetine (an antidepressant available by prescription only), furosemide (a potent diuretic available by prescription only), and cetilistat (an experimental obesity drug not approved for marketing in the United States). In the supplements the FDA previously found to be spiked, the supplements contained 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).

The FDA has warned that some of the supplements contained drugs far in excess of the maximum recommended dosage of the drug. The risks posed by these products include high blood pressure, seizures, tachycardia, palpitations, heart attack, or stroke.

Sources:

FDA Press Release, March 20, 2009

FDA Press Release, December 22, 2009

The Bush Administration's attempt to provide complete immunity to the drug industry ended today with a 6-3 vote of the United States Supreme Court. (We previously explored the Bush Administration's attempt to use the preemption doctrine improperly here and here.) The Court has now issued its decision in Wyeth v. Levine, ruling that patients injured by a drug can sue the drug's manufacturer for damages, even if the FDA had approved the drug to be marketed. The decision upholds a $6.7m verdict in favor of a Vermont musician who had her arm amputated when Wyeth's Phenergan, an anti-nausea drug, entered an artery and caused gangrene. The manufacturer claimed that it was entitled to complete immunity from suit based on the FDA's approval, and that any state claims should be preempted.

This opinion completes a trio of Court decisions on the preemption doctrine. The first, Riegel v. Medtronic, Inc. v. Good, established that state products liability suits were preempted by federal medical device regulations unless there were other FDA violations. The second, Altria Group, Inc. v. Good, established that state claims based on unfair trade practices could be asserted against cigarette manufacturers even though cigarette labeling is regulated by the FTC.

Today's decision in Wyeth v. Levine is an essential one because the FDA is not able to ascertain before marketing all the risks of a drug or errors in labeling. When there is negligence by the manufacturers, the safeguard of the courts is needed to protect consumers fully. If the FDA were the only safeguard in the system, and there were no checks-and-balances provided by the courts, consumers would unquestionably be at greater risk. There is no doubt that the Court's decision today was the correct one.

Sources:

Wyeth v. Levine

Reigel v. Medtronic, Inc.

Altria Group, Inc. v. Good

The GAO released a 77-page audit report today critical of the FDA's efforts to protect consumers from dangerous diet supplements. Since manufacturers became required to report adverse events, well-known to be underreported even in the best of circumstances, the FDA has seen a three-fold increase in the number of adverse events reported. Over 948 adverse event reports were received, and 596 of them were mandatory reports submitted by industry. Those included 9 deaths, 64 life-threatening illnesses, and 234 hospitalizations. Once underreporting is accounted for, the FDA estimates that the true number of adverse events exceeds 50,000 adverse events. The audit was conducted at the request of Congressman Henry Waxman, and several other members of Congress.

The GAO ticked off the items we know already: that the FDA should request more power from Congress to regulate the diet supplement industry, that the FDA can't require that a company remove tainted supplements from the marketplace, that the public does not know there has been no testing of the products for safety and efficacy, and that manufacturers should register with the FDA and disclose the specific supplements and ingredients to the agency. We certainly know that "consumers remain vulnerable to risks posed by potentially unsafe products."

Key Events in the Regulation of Dietary Supplements

1990
The Nutrition Labeling and Education Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to require most foods, including dietary supplements, to bear nutrition labeling.

1994
DSHEA amended the Federal Food, Drug, and Cosmetic Act to create a new regulatory category, safety standard, labeling requirements, and other rules for dietary supplements. Under DSHEA, dietary supplements are generally presumed to be safe.

2002
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 amended the Federal Food, Drug, and Cosmetic Act to require all food companies, including dietary supplement companies, to register with FDA no later than December 12, 2003, to provide information on the name and address of the facility and, to some extent, the types of products they manufacture or sell.

2004
FDA was successful in banning ephedra after thousands of adverse events, including a number of deaths, and a lengthy legal process.

2006
The Dietary Supplement and Nonprescription Drug Consumer Protection Act amended the Federal Food, Drug, and Cosmetic Act to require dietary supplement companies that receive a serious adverse event report to submit information about the event to FDA.

2007
FDA finalized its Current Good Manufacturing Practice regulations to establish quality control standards for dietary supplements. The final rule became effective on August 24, 2007, but companies have 10, 22, or 34 months from the effective date of the rule to comply, depending on company size.

2007
Serious adverse event reporting requirements for dietary supplement companies became effective on December 22.

Sources:

GAO Report

We often look to the FDA to regulate this industry, and forget the excellent work done by state agencies. Remember, it was the Texas FDA that began the work against the dangerous marketing of ephedra, which the FDA later took over. In the past, state agencies in California, New York and Florida have also taken strong positions against dangerous or deceptively marketed supplements. The fundamental problem, however, is that we cannot rely on state-by-state regulation; the problem requires a federal solution. Only a few states are large enough to fund their state FDA adequately or support litigation efforts like those of the Texas AG. (And then there is Utah, where the diet supplement industry is treated like a state-sponsored drug cartel.) While we must encourage the efforts of states like Texas, the states should not be left to clean up the industry themselves. The fact that Texas had to bring the litigation at all speaks volumes about the larceny DSHEA permits and the harm that has come from the FDA's inaction. The FDA should be handling these problems with a consistent and unrelenting regulatory effort, and Congress should amend DSHEA to permit the FDA to do its job.

Sources:

Star-Telegram, Feb. 27, 2009

Texas AG's Complaint

Final Judgment against Caster

Final Judgment against Mannatech

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.

Sources:

FDA News, January 8, 2009

FDA News, January 27, 2009

New York Times, February 9, 2009

Minnesota Star Tribune, February 9, 2009

International Herald Tribune, February 10, 2009

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."

Sources:

MSNBC, 2/3/09

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.

The report provides a summary of the regulatory history that brings us to the current DMZ of DSHEA, and it even tackles summarizing the regulatory efforts aimed at corralling ephedra. It provides a disturbing summary of the increased budget and mandate of the agency in inverse proportions to the number of agency employees expected to accomplish the agency's goals.
Ultimately, the report recommends that rational steps be taken, such as product registration, safety standards, market review, pre-market testing, adverse events reporting, and increased resources.

The report's appendix contains a list of over 40 supplements using nanoparticles, but it does not articulate the safety risks the consumer faces. These risks include not only the direct risk to consumers, but also to those manufacturing the products, and the risk to the water supply, the environment, and animals.

One has to appreciate the efforts of the agency to articulate this nano-concern, but the report merely states the obvious as to the flagrant regulatory gaps that have been with us for decades now. The agency has to step up to the plate, as does Congress. The Obama administration's stated goals suggest a new direction for the agency, and a return to science and consumer-based regulatory purposes. This will require that America step back from the gluttony of unbridled capitalism and the ritualistic zeal of woo. Perhaps we can, but I wouldn't bet on it.

Sources:

FDA: A Hard Pill To Swallow

IOM: Risk Assessment of Nanoparticles

Scientific American: Risk of Nanoparticles in Food

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.

Sources:

Dow Jones Newswires, January 8, 2009

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.

This type of adverse event adds to the reasons to question a doctor's prescription of antibiotics, such as toxcity, cost, and creating antibiotic resistant bacteria. If the benefits truly outweigh the risks, the patient should be informed about these potential complications:

Tendon Disorders: Watch for pain, swelling or inflammation.
Heart Problems: Watch for heart rhythm problems.
Dangerous Diarrhea: Watch for persistent or watery diarrhea, sometimes long after use.
Nerve Problems: Watch for numbness, weakness, burning, and tingling.
Others: Seizures, hallucinations, depression, light sensitivity, damage to liver, kidney or bone marrow, and changes in blood sugar.

Sources:

Atlanta Journal-Constitution

FDA

We at the Alaska Personal Injury Law Group have been closely following preemption litigation because the results are so central to consumer-based litigation. Today, we find hope in the news that the United States Supreme Court has rejected the claims by Philip Morris that federal regulation of tobacco companies preempted any state claims from being asserted against the company.

The case arose in Maine and asserted that the company had fraudulently misrepresented that its "light" cigarettes were safer. Essentially, today's ruling refuses to immunize fraudulent statements by corporations and has reaffirmed the presumption in the law against preemption of state laws: "When addressing questions of express or implied preemption, we begin our analysis with the assumption that the historic police powers of the States are not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." "Thus," it continues, "when the text of a pre-emption clause is susceptible of more than one plausible reading, courts ordinarily accept the reading that disfavors preemption."

Sources:

Atria Group v. Good (pdf of opinion)
link

The Alaska Personal Injury Law Group recently posted an article about how the FDA and other federal agencies have systematically attempted to use preemption to make manufacturers immune from suit for injuries caused by their defective products. One point of discussion was how the FDA has weakened regulatory protection of consumers from dangerous, defective drugs. Now, just a few days later, an independent group of objective scientists has issued a new report chastising the FDA for its approval of bisphenol A, commonly referred to as BPA.

The new report was issued by the Science Board, a group of independent scientists that provides advice to the Commissioner of the FDA. The Science Board provided peer review of the FDA’s draft assessment of use of BPA in food contact applications. The Science Board concluded that the FDA position was seriously flawed.

BPA is an industrial chemical used to make polycarbonate plastic and an epoxy resin used in many consumer products. The FDA approved it for use in baby bottles and as a liner in food containers like baby formula cans. It is also used extensively in other food containers, in sport bottles such as Nalgene bottles, and as a liner in soda cans. In mid-2008, the National Toxicology Center issued an extensive report addressing the health risks resulting from exposure to BPA, including effects on brain and behavioral development in infants and small children, and the potential to cause cancer. In response, the FDA steadfastly maintained its position that BPA was safe.

The Science Board has now found multiple flaws in the FDA assessment. First and foremost, the FDA assessment failed to provide ``reasonable and appropriate scientific support'' for its finding that the public wasn't at risk from BPA. Second, the FDA ignored many peer reviewed studies that found BPA presents serious health hazards. Instead, the FDA relied upon two studies funded by the chemical manufacturers’ association, only one of which was peer reviewed. The studies ignored by FDA show multiple risks, including impaired neural development, developmental changes in children, impaired reproductive tract development and diabetes. Third, the FDA assessment improperly analyzed the margin of safety (MOS) provided by the FDA standard for BPA exposure. The Science Board found extensive evidence that the FDA standard for allowable exposure levels was at least an order of magnitude too high, particularly for children.

Continue reading " Independent Scientists Find FDA Report on BPA Defective " »

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."

Remarkably, the preamble to the 2008 labeling rule claims that the preemption revision merely conforms the language of the rule to the agency's settled interpretation, a statement that is manifestly not the case. Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research, advised that, "[t]he rule is not, as it purports to be, consistent with the agency's role in protecting the public health," and was not, in fact, reaffirming the FDA's long-standing interpretation.

Under the Bush Administration, the FDA has been suborned to act in a way designed to protect the manufacturers of medical devices and drugs from potential liability. It has done so by actively ignoring the objections of career FDA officials who understand the vital role the FDA plays in protecting the public in its use of food, drugs, and medical devices. The FDA's mission should be to advance medicine and science, not to serve a political agenda illicitly designed to protect corporate interests over the protection of those they have sworn to protect,

Sources:

House Committee Report, October 2008

FDA Preemption: Another Bush Legacy Wrecking The House

Stealth Tort Reform: AmBush At The FDA

Just because an herbal product is advertised to be "all natural," this does not mean that it is safe. "All natural" is a marketing term used to convince you to buy a product--it is code for "no side effects." In fact, most diet supplements are untested as to both their safety and their effectiveness in treating any particular condition, although most consumers look at the packaging (which is designed to look like pharmaceutical packaging), and assume that someone with a white coat has tested the product. Not so. Moreover, herbal medicines can cause dangerous drug interactions, many of which are unknown to science, when herbals are taken along with prescription medications. If you are taking prescription medications and mixing them with diet supplements, you are taking the risk that your medication's effectiveness may be blunted or substantially increased, either of which can cause significant injury.

The most recent warning is given to us by the Stollery Children's Hospital in a release to the Canadian Cardiovascular Congress. Noting the inherent unpredictability of Warfarin treatment itself, the hospital warned that combining such therapy with herbal remedies increases the risks of clots and bleeding in patients. Remarkably, in a study of children taking Warfarin, researchers found 37% to be taking diet supplements, yet the parents had not informed their physicians about the supplement use.

Set out helow is a list of herbal products known to interact with Warfarin (Coumadin). Be sure to talk with your doctor about combining any of these products with your blood thinning treatment.

Vitamin C--Vitamin E--Vitamin K--Glucosamin/Chonroitin--Coenzyme Q--Agrimony--Dandelion--Pau d’arco--Alfalfa--Fenugreek--Policosanol--Aloe Gel--Feverfew--Poplar
Aniseed Angelica (Dong Quai)--Garlic--Quassia--Arnica--German Sarsaparilla--Red Clover--Asa Foetida--Ginger--Senega--Aspen--Ginkgo Biloba--St. John’s Wort--Bladder Wrack (Fucus) --Goldenseal--Sweet Clover--Black Cohosh--Green Tea--Sweet Woodruff--Black Haw--Horseradish--Tamarind--Bogbean--Licorice--Tonka Beans--Bromelain--Meadowsweet--Wild Carrot--Buchu Boldo--Mistletoe--Wild Lettuce--Capsicum--Nettle--Yarrow--Cassia--Onion--Celery--Parsley--Chamomile (German & Roman)--Passion Flower

Sources:

Heart And Stroke Foundation of Canada

Warfarin Patient Handout

Eli Lilly and Co. has announced that it will now begin disclosing information about the money it pays to individual doctors for advice, speeches, and other services. The company is riding out ahead of legislators at the state and federal levels who have pushed disclosure bills that would impose a legal mandate upon drug manufacturers to make such payments public. Lilly will disclose payments above $500 made in 2009, but will not make disclosure about payments in past years.

A handful of states have legislated disclosure from drug manufacturers: Minnesota, Vermont, West Virginia, and Maine. No disclosure requirements have been imposed on medical device manufacturers, although the obvious ethical concerns apply there as well. ( See our previous posts here, and here.

Source:

AP Wire, September 24, 2008

The Federal Trade Commission announced today 11 law enforcement actions taken against firms deceptively advertising bogus cancer cures. The companies have been charged with making unsupported claims that their products have treated or cured various cancers, and some were charged with falsely stating that they had clinical or scientific proof of their products' efficacy. The FTC's Director of the Bureau of Consumer Protection stated that, "There is no credible scientific evidence that any of the products marketed by these companies can prevent, cure or treat cancer of any kind."

Of the 11 complaints, six were resolved by proposed settlements with the remainder to be litigated by the FTC. The companies will all be required to notify consumers that there is little to no scientific evidence demonstrating the efficacy of the products to treat or cure cancer. The complaints arose out of a year-long effort by the FTC, the FDA, and a corresponding Canadian agency in which 112 websites were targeted. Of those, over 30% responded to the governmental warnings and closed their websites or altered the fraudulent claims. Warning letters were then sent to 23 companies.

To identify the companies and products targeted, follow the links below.

The FTC also announced that it is offering a website to help the public identify bogus cancer cures--www.ftc.gov/curious

There can be little that is lower on the scale of human decency than taking advantage of a person struggling with cancer. The FTC and the FDA should be applauded for their efforts to rein in this industry.

Sources:

FTC Press Release

FDA Press Release

FDA Website Re: Fake Cancer Cures

Fake Cancer Cures FDA Warning Letters

We have learned the lesson repeatedly, with drugs like Fen-Phen, Ephedra (see our litigation here), and similar magic pills, that there is no free lunch when it comes to weight loss. If drugs are being used to amp up the engine of the body's metabolism, something is eventually going to seize up. Yet, the pharmaceutical industry and the unregulated diet supplement industry keep trying.

Here's a case report concerning their latest victim, reported in the September 11, 2008, issue of Clinical Toxicology. A 37-year-old woman suffered a heart attack after using an herbal weight loss product for just 3 days. A urine screen, however, disclosed the presence of sibutramine. (The article doesn't disclose this fact, but one would assume that the herbal product was spiked with sibutramine, and the drug was not listed on the label as an ingredient.) Sibutramine is a serotonin-norephinephrine reuptake inhibitor that is structurally related to amphetamine, although its mechanism of action is distinct. Sibutramine is the active incredient in Abbott Labs' Meridia, a prescription weight loss product. The patient was not obese, did not smoke, and was not known to have hypertension or diabetes. No other stimulants were found in her blood stream. The author reports a similar case involving a young woman in their clinic who had also suffered myocardial infarction after using sibutramine for 30 days.

There have been 397 adverse events reported to the FDA concerning sibutramine between 1998 and 2001. There were 152 hospitalizations. Of the 29 patients who died, 19 suffered cardiac problems that led to their deaths. Sibutramine is one of drugs Dr. David Graham, the FDA whistleblower, and Public Citizen, have warned the public about.

Sources:

Clinical Toxicology, Sept. 11, 2008

Dr. David Graham

Public Citizen's Petition to the FDA to ban sibutramine (Meridia)

According to a recent study presented at the British Pharmaceutical Conference in Manchester, England, 60% of woman may be risking the health of their babies by taking herbal remedies while pregnant. The study was authored by Lone Holst, a researcher in Norway, who studied 578 women giving birth in the UK. In the study population, 49% knew nothing about the safety risks of the products they were taking, and had taken the products on the advice of their family or friends, rather than their healthcare providers. In pregnant women over 40, 72% of women had used herbal preparations during their pregnancy.

The reasons for caution are many. Unlike prescription drugs, herbal preparations are not tested for safety and efficacy. Moreover, the active ingredients often vary from the amounts stated on the label. Manufacturers also fail to test the products to be certain that toxic contaminants are not present, and intentionally "spike" their products with pharmaceuticals to make the concoctions are more potent, without disclosing this to the consumer.

Even in the best of circumstances, it is difficult to test a single active ingredient for safety and efficacy. Diet supplements and herbal preparations are manufactured with a "kitchen sink" approach using the dangerous notion that a combination of ingredients are better for you, than a single, active ingredient. In fact, the interactions between these ingredients, and between the ingredients and other medications that the consumer may be taking, is not known and can be a set up for disaster and cause fetal harm.

Inadvertent toxicities can also occur. For example, warnings have been recently published for women to make certain that no vitamin A toxicity occurs in the fetus from the mother taking excessive doses of vitamin A when using muliple supplements. Vitamin A is a known teratogen capable of causing birth defects.

Some thoughts for you:

Don't take diet supplements or herbal preparations during pregnancy unless you have discussed the product you are using with your health care provider.

If you do intend to take such products, investigate the company making the products by seeing if their products have any safety testing or the company uses "good manufacturing practices." Check the product and company out by googling them, or researching them on websites offered by Consumer Labs, the FDA, or the FTC.

Make certain that your health care provider knows what you are taking and how much. Be certain to have this discussion if you are otherwise already on medications to avoid dangerous interactions.

Don't assume that, because it is supposedly "all natural", that it is safe for your unborn child.

Sources:

Presentation to the British Pharmaceutical Conference, September 7, 2008

Toxic Metals in Ayurvedic Supplements

Spiked Supplements

Vitamin A Toxcity

The FDA has issued its first public disclosure of 20 drugs it is now investigating for safety concerns. The disclosure is the result of the 2007 Food and Drug Administration Amendments Act that mandated that the agency post on a quarterly basis information about drugs it is investigating based on adverse events reported by doctors. The information does not disclose the nature of the adverse events or the extent of the problem. The fact that a drug is listed is not intended to suggest that the agency has, in fact, concluded that the risk exists. The posting does not include all of the drugs currently being subjected to a further safety investigation.

The consumer now has more information at hand to make an informed decision about drugs a doctor prescribes. Hopefully, these disclosures will prevent unnecessary injury when the FDA and the manufacturer are aware of potential risks, and the unsuspecting patient is not. That is a gap that should, and must, be closed. Here is the list:

Arginine Hydrochloride Injection (R-Gene 10): Pediatric overdose due to labeling / packaging confusion
Desflurane (Suprane): Cardiac arrest
Duloxetine (Cymbalta): Urinary retention
Etravirine (Intelence): Hemarthrosis
Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric): Adverse events due to name confusion
Heparin: Anaphylactic-type reactions
Icodextrin (Extraneal): Hypoglycemia
Insulin U-500 (Humulin R): Dosing confusion
Ivermectin (Stromectol) and Warfarin: Drug interaction
Lapatinib (Tykerb): Hepatotoxicity
Lenalidomide (Revlimid): Stevens Johnson Syndrome
Natalizumab (Tysabri): Skin melanomas
Nitroglycerin (Nitrostat) Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR): Ileus
Oxycodone Hydrochloride Controlled-Release (Oxycontin): Drug misuse, abuse and overdose
Perflutren Lipid Microsphere (Definity): Cardiopulmonary reactions
Phenytoin Injection (Dilantin): Purple Glove Syndrome
Quetiapine (Seroquel): Overdose due to sample pack labeling confusion
Telbivudine (Tyzeka): Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers: Cancers in children and young adults

Sources:

FDA FAQs

FDA's Report, January to March, 2008

U.S. District Court Judge Arthur Spiegel sentenced the remaining employees of Berkeley Premium Nutraceuticals this week, each receiving prison sentences. The Berkeley executives, Greg Cossman (former President), Susan Cossman (Warshak's sister), Shelly Kinmon (Sales Director), James Teegarden (Chief Operating Officer), Michael Wagner (Financial Officer), and Steven Pugh (Warehouse Manager) received sentences ranging from 12 to 13 months. Berkeley's accountant, William Bertemes, and its bookkeeper, Sam Grote, cooperated with authorities and drew the lightest sentences of one month in prison.

Berkeley's in-house counsel, Paul Kellogg, was the last of those convicted to be sentenced. He also received a sentence of a year and a day. Despite his professional training, Kellogg claimed that he was following the orders of Steve Warshak, Berkeley's President, and did not realize what he was doing was wrong. (Surely he couldn't have been clueless when he told a night manager to hide potentially damning evidence from FDA inspectors and had it returned to the warehouse when they left.)

All told, 11 Berkeley executives and employees were convicted on fraud, money laundering, and conspiracy charges.

One might ask why the authorities didn't just shut Berkeley down. Well, they can't. Berkeley is not a pharmaceutical company, and the fake sexual enhancement supplement was not a drug, so the FDA has a more limited reach. Instead, the company, (like other diet supplement companies falsifying clinical research, spiking supplements with pharmaceuticals, selling supplements containing toxic contaminants, or mislabeling the amounts of active ingredients) is regulated under DSHEA, the Dietary Supplement Health And Education Act, which is toothless and requires that the FDA prove that the product is harmful before a supplement can be taken off the market (whereas drug companies must first prove to the FDA a product is safe and efficacious before it can be placed on the market).

While the regulatory authorities must be applauded here, this company is not a remarkable exception in the diet supplement industry. This industry is riding out well in front of the posse, and this won't change unless DSHEA is changed.

Sources:

Cincinnati.com

Cincinnati.com

Brandweek.com

DSHEA

Alaska Injury Law Blog, August 28, 2008

Alaska Injury Law Blog, February 22, 2008

Steve Warshak, the founder of Berkeley Premium Nutraceuticals, has been sentenced to 25 years in prison and ordered to pay $93,000 in fines. He had been convicted in February on 93 counts of conspiracy, fraud and money laundering. His mother, Harriet Warshak, was sentenced to 2 years in prison arising from her conviction for conspiracy, bank fraud and money laundering. U.S. District Court Judge S. Arthur Spiegel, also ordered Warshak, his mother, and the company to forfeit more than $500 million in ill-gotten gains. Several other employees will be sentenced this week.

Most of the charges relate to the sale of Enzyte, a supplement supposedly capable of boosting male sexual performance. The company, however, falsified medical studies, used fraudulent bank documents, and ran up charges on the credit cards of customers, while refusing to give refunds or stop serial transactions on the cards.

The company's logo included the Latin phrase suffragium asotas, which Warshak claimed translates to English as "enhanced sexuality". He may have meant to use the phrase suffragor asotis, an awkward way of saying, "refuge for the dissipated". Perhaps that is what the Big House will be for him.

We applaud the prosecutors in this case as these kinds of prosecutions are long overdue in this industry.

And we're relatively certain Smilin' Bob ain't smilin' no more.

Sources:

Alaska Injury Law Blog, February 22, 2008

Cincinnati.com, August 27, 2008

Cincinnati FBI

Wikipedia

The Jounal of the American Medical Association reported today that the toxic metals lead, mercury, and arsenic have been detected in traditional Ayurvedic medicines being sold in the United States. Of the 230 products evaluated by x-ray spectroscopy, detectable levels of the toxic metals were found in 20.7% of the products. The contaminants were found in products manufactured in India and in the United States, but 95% of the contaminated products were being sold by US websites. Most troubling, 75% of the manufacturers claimed to be using Good Manufacturing Practices.

Source:

JAMA, August 27, 2008

With increased attention being put on improper financial influences in medicine, by both the lay and professional press, you may be wondering how you can find out if your doctor is getting brown paper bags of cash from Big Pharma or a medical device manufacturer. The next time a doctor recommends a drug or a medical device, check with the Association for Medical Ethics to see if your doctor has improper financial ties with the manufacturer. As a result of a U.S. Department of Justice settlement with four medical device companies, Zimmer, Inc., DePuy Orthopaedics, Inc., Biomet, Inc., and Smith & Nephew, Inc., these back door consulting agreements must now be made public. (See our earlier post about this: Financial Ties) The Association for Medical Ethics maintains a searchable database that will tell you if your doctor is on the payroll of the company whose product he has just recommended: www.ethicaldoctor.org. Some of the information is shocking: two physicians listed made more than $8 million each from Dupuy Orthopaedics.

Now that's a fact you would want to know before the doctor operated, isn't it?

Sources:

New York Times, March 22, 2008

CNN: August 21, 2008

Association For Medical Ethics

Three executives of Hi-Tech Pharmaceuticals, Inc. of Norcross, Georgia have pleaded guilty to conspiracy and fraud charges for illegally selling prescription drugs. President and CEO, Jared Wheat, Vice President, Stephen D. Smith, and company co-founder Tomasz Holda admitted to conspiring to import and distribute adulterated, mislabeled and unapproved new drugs, and to commit mail and wire fraud. The company was selling via the internet generic forms of Xanax, Valium, Ambien, Vioxx, Zoloft, Viagra and Cialis manufactured in their lab in Belize without requiring a prescription.

As a result of the plea bargain, the government dropped assertions that the company was spiking its diet supplements with ephedrine alkaloids after the FDA's 2004 ban on the marketing of ephedra products. See Alaska Personal Injury Law Group's litigation over this practice of illegal spiking of diet supplements, Talbert v. E'ola Products, Inc.. Also absent were the earlier assertions that the executives had conspired to murder an FDA agent and blackmail a former US attorney general. (Holda also pled guilty to ordering a silencer over the internet.) They face prison terms up to 5 years each, with fines of as much as $250,000, and the company itself faces fines as much $500,000. In June, a different federal court issued a preliminary order against the company for FTC violations for deceptive advertisements of weight loss and sexual performance products. Among the company's diet supplement products is Lipodrene, a weight loss product, and Stamina-Rx, a sexual stimulant.

Wheat had previously been arrested for selling ecstasy, and Holda had been convicted of steroid possession with intent to distribute. The FTC had also previously accused the company of falsifying medical research regarding sexual impotent products.

This conviction follows on the heels of two recent convictions of other diet supplement executives involving the President of Metabolife, Michael Ellis, and the President of Berkeley Nutraceuticals, Steve Warshak, Metabolife CEO Headed To Prison; Smilin' Bob Ain't Smilin' No More: Herbal Company President Convicted

Sentencing is scheduled for October 21, 2008.

Sources:

Four "Hi-Tech Pharmaceuticals" Case Defendants Plead Guilty to Importing and Distributing "Knock-Off" Prescription Drugs

Norcross Company President Pleads Guilty To Conspiracy

From Diet Supplements To Illegal Internet Pharmacy

Online Pharmacy Ordered To Pay FTC $15.8 Million

Another reason to question what your doctor and the FDA tell you about the safety and efficacy of any drug has now come to light. The Annals of Internal Medicine has just reported that Merck used the unsavory tactic of a "seeding trial" in its development of Vioxx. (This has come to light as a result of Vioxx litigation, and is not data the public would know if only the FDA, rather that the courts, were looking over Merck's shoulder.) A seeding trial is carried out by a drug manufacturer just prior to or shortly after FDA approval of a new drug. Ostensibly, such a clinical trial is completed for the obvious medical research benefits, for example post-approval surveillance for safety and efficacy. In reality, there is an unspoken agenda: to get the drug in as many physicians' hands as possible, enlisting them as investigators while picking up the support for monitoring and paperwork. The physicians receive the prestige of participating in a drug trial as clinical investigators and are financially reimbursed, and the drug manufacturer is familiarizing physicians with the drugs, thereby shortening the path to profitability, or "accelerating uptake" in the parlance. Such trials should be initiated for a legitimate research purpose, not as a pretext for profit.

The guidelines imposed by science, the FDA and institutional review boards are there for a purpose--to be sure that evidence-based science guides critical decisionmaking. When medical journals, the FDA, and the public are deceived with these kinds of tactics, the credibility of the system is corroded. Such deception cannot be permitted to stand without penalty by the FDA, and Merck should be subjected to professional and public scorn.

It is a difficult enough proposition for science to drive decisionmaking in America today. Too often, politics and the mythical thinking justifying the herbal phenomenon win the day. When money corrupts the scientific process, its credibility is undermined and the public increases its distrust of conventional medicine. Simply put: seeding trials are a pernicious practice that should never be permitted.

If you can't trust the guys in the white coats, who can you trust?

Source:

Seeding Trials: Just Say "No"

The ADVANTAGE Seeding Trial: A Review of Internal Documents

The Bush Administration has consistently sought to undermine consumer-oriented regulatory practices in favor of corporate interests. If it could also take a shot at plaintiffs and their demon trial lawyers, all the better. One of its more spectacular successes was the Supreme Court's recent decision in a medical devices case, Riegel v. Medtronic, which stands for the proposition that the FDA's approval of a medical device should preempt any litigation against the manufacturer in state claims by someone the product injures. As expected, every defendant with any conceivable preemption argument is now injecting that defense into products liability and negligence claims all across the country. FDA and Mercury Regulation;FAA Regulation. The Alaska Personal Injury Law Group just defeated a similar move by a defendant arguing that the FAA's regulation of aircraft should preempt state claims against an air carrier.

The Supreme Court will next consider the application of the preemption doctrine in an injury claim against Wyeth by a Vermont guitarist who lost her arm below the elbow after she was injected with Phenergan, a nausea medicine. Wyeth v. Levine, Docket No. 06-1249. At issue is Wyeth's claim that it should be immune from suit because of the FDA's approval of Phenergan's label. It reasons that the FDA's regulatory approval should be enough to preempt the plaintiff's claim that the manufacturer failed to warn about the dangers of IV injection of the drug. Remarkably, The New England Journal of Medicine has joined 47 state attorneys general and two past FDA commissioners in submitting amicus briefs to the Supreme Court warning that the FDA lacks the ability to serve "as the sole guarantor of product safety".

It is well known that the FDA simply cannot know all the risks of a product or warning label it approves. This is especially true when the manufacturer intentionally skews clinical trial results, Newsday, Annals of Internal Medicine or otherwise keeps product risks from the FDA to achieve the lucrative benefits that come with the approval of a new drug or device, NEJM, Synthes Story. The FDA is not constituted to truly regulate this industry, and it cannot get to bedrock truth the way litigation can. Often, the FDA does not act until litigation proves the product's dangers and makes public the evidence the manufacturer kept from the FDA when the drug or device was approved. Talbert v. E'ola Products, Inc.. If Big Pharma succeeds in the Wyeth matter, millions of Americans will be at risk from dangerous drugs. Without the protections of the legal system, their claims will be unrepresented, and corporate interests will run roughshod over the FDA. At this juncture, Congress will likely have to act to restore the balance of regulatory and legal interests the courts previously forged in protecting the rights of individuals to pursue state claims when injured by dangerous products approved by the FDA.

It is an extraordinary testament to how far off course the Bush Administration has taken American administrative agencies that a national medical journal must file an amicus brief in the highest court in the land to state the obvious. (Remember, "Well, Mr. President, torture is illegal...) Up has become down in American jurisprudence courtesy of the Bush Legacy. Hopefully, legal analysis and not political agendas will guide the Court when it decides Wyeth.

Oral argument before the Court is to be held on November 3, 2008.

At the Alaska Personal Injury Law Group, we commonly face the unpleasant task of explaining to prospective clients the way in which “tort reform” has dramatically taken away the legal rights they thought they possessed. One of the recent unsung accomplishments of the Bush Administration is the silent destruction of the legal rights of those hurt by the malfeasance of corporations--stealth tort reform at the FDA.

Utterly unnoticed by the American public was an unheralded aboutface at the FDA. Although it had been silent on the issue before, the FDA began taking an active role in pending private litigation espousing the proposition that, if the FDA had approved a drug or medical device, then that approval should shield the manufacturer from any liability if the product were to injure or kill. In legal terms, that shield is called “preemption, “ the argument being that the federal government, by regulating the industry, has preempted state regulation and state tort claims. Manufacturers have long sought this shield, but the courts recognized the argument for the folly that it is, and commonly rejected it. Not surprisingly, this policy reversal by the White House was implemented by Dan Troy, one of 100’s of industry lobbyists President Bush put to work in positions responsible for public advocacy. Before his appointment, Troy’s practice was based on representing drug and tobacco companies in challenging FDA regulations. It was under Troy’s guidance that the FDA flip-flopped its position on preemption, much to the delight of the industry the FDA was supposed to be regulating.

The United States Surpeme Court, its makeup another Bush Legacy, has recently breathed life into the preemption defense, with its ruling in Riegel v. Medtronic. The ruling effectively wipes out all pending medical device litigation, from faulty pacemakers to defective insulin pumps. The natural extension of the legal argument will be to apply this ruling to preemption arguments in drug claims. And from there the erosion of legal rights will spread to every area of American society touched by the FDA (and by logical extension, any federal agency), whether the injury comes from a toxic chemical exposure or tainted hamburger.

Most remarkably, these changes come at a time when the FDA has had to explain one shocking lapse after another. Why shouldn’t the FDA’s approval of a medical device or drug preempt a state tort action? Consider this:

1.) The FDA’s approval of a medical device or drug is based on only partial data, usually the limited and sometimes biased clinical studies of the manufacturer itself. It is not until a product is in wide release and used by patients with many different kinds of health histories and conditions that the product’s true clinical liabilities are disclosed.

2.) The FDA’s approval is sometimes based on bad data provided by the manufacturer seeking product approval. We’ve previously written about this. Because there are often billions at stake, the manufacturers shade what is told to the FDA, so its garbage in, garbage out.

3.) The FDA is an agency subject to political pressures, just like every other federal agency. When the message from the White House is “hands off,” then the agency is less vigilant in its oversight. Lax oversight that is the result of political pressures applied to the FDA should not be transposed by a court into a conclusion that a product is safe.

4.) The FDA approval process is rife with conflicts of interests. Medical device and medication approvals are thus not being made by those who are truly independent and objective. The clinical studies submitted to the FDA are based on research done by those who are, literally, investors in the company seeking the approval. The leadership at the FDA is often drawn from the very industry the agency is supposed to regulate. And the agency’s advisory boards should represent physicians, researchers and patient advocates—not stockholders—but a 2006 study by the Journal of the American Medical Association showed that 22% of the advisory board meetings were completed with over half of the members having direct financial interests in the products being regulated. Nowhere is the problem more clear than President Bush’s appointment of Dan Troy.

5.) Because the FDA is subject to political pressures, the work of experts within the agency is often muzzled. Dr. Lori Love’s work to make public the dangers of ephedra was stifled at the agency. Dr. Andy Mosholder was banned by the FDA from attending a public Advisory Committee meeting to make final recommendations about Paxil, but the agency later relented if he answered only from an agency approved script about the suicide danger the drug posed to teens. Dr. David Graham's work on the dangers of Vioxx was repeatedly suppressed by the agency. In his public warnings about the FDA's botch of that drug's safety evaluation, he identified five other suspect drugs: Accutane, Bextra, Crestor, Meridia and Serevent. Dr. Rosemary Johann-Liang suggested two years ago that the diabetes drug Avandia carry black box warnings about the drug’s cardiac risks, but her supervisors reprimanded her and deep-sixed her report. In a 2006 poll by the Union of Concerned Scientists, 40% of the 1,000 FDA scientists said that they could not publicly express concerns about public health “without fear of retaliation.” Remarkably, 20% disclosed theat the agency decisionmakers had asked them explicitly “to provide incomplete, inaccurate or misleading information” to the public.

6.) The fact that a product has been approved does not mean that it has been inspected. Even when a product is effective, it must still be properly manufactured. The responsibility of the FDA is enormous—it simply can’t be everywhere. It is unable to stop the illegal spiking of diet supplement products with pharmaceutical drugs. It is unable to be sure that contaminated toothpaste and Heparin from China are safe.

7.) The FDA is a lumbering beast. It cannot move quickly. The two decades it took to get ephedra off the market is one example. The FDA didn’t warn the public about the risks of high estrogen releases from the Ortho Evra birth control patch until November 2005, even though there had been 50 deaths associated with the drug beginning in 2002. Bayer knew in 1993 that Trasylol was toxic to the kidneys, but the FDA approved the drug. It wasn't until an independent research published a journal article in the NEJM in 2006 that the FDA issued a health advisory. It was not until the fall of 2007 that independent Canadian study results prompted the suspension of the drug, 14 years after the first red flags went up.

8.) The FDA does not know how to litigate. Its power over those entities it regulates is its control over whether a product can be sold in the American marketplace. It is this threat to billions in potential future profits that keeps a manufacturer in line when the FDA does seek to regulate a product already on the market that is found to be unsafe. Yet, it is with the tools of litigation that bedrock truth is most often obtained about the risks of the product and what the manufacturer knew when. The FDA cannot get this information because it is not built to do so. To think that, despite this, a manufacturer will voluntarily disclose that which is most in its economic advantage to hide, is utter naivete.

The plain fact is that the courts are part of the system needed to protect the public from the avarice of corporations. If these companies can manipulate the FDA to approve their products in the first place, and then use that manipulated approval as a shield against later liability, there will be no redress when the products we most want and need to trust instead maim and kill those we love.

Sources:

Alaska Injury Law Blog, January 17, 2008 and February 15, 2008:
http://www.alaskainjurylawblog.com/2008/01/nejm_another_reason_why_transp.html;
http://www.alaskainjurylawblog.com/2008/02/medical_research_how_can_you_t.html

New York Times April 6, 2008:
http://www.nytimes.com/2008/04/06/washington/06patch.html?_r=1&oref=slogin

The Washington Times, March 31, 2008:
http://www.washingtontimes.com/article/20080331/BUSINESS/161599575/1006;

The Heparin Problem:
http://www.newsinferno.com/archives/2891;

The Journal of the American Medical Association, April 26, 2006:
http://jama.ama-assn.org/cgi/content/abstract/295/16/1921?ijkey=45a6def36d07e306a6b24988b61f91d6393407da&keytype2=tf_ipsecsha

The Journal of the American Medical Association, May 21, 2008:
http://jama.ama-assn.org/cgi/content/extract/299/19/2313

New England Journal of Medicine, April 24, 2008:
http://content.nejm.org/cgi/content/full/358/17/1773

http://content.nejm.org/cgi/content/full/358/17/1774

Abuses of Science at the FDA, Union of Concerned Scientists:
http://www.ucsusa.org/assets/documents/scientific_integrity/Scientific-Integrity-at-Risk-FDA.pdf;

http://www.ucsusa.org/scientific_integrity/interference/fda-scientists-survey-summary.html;

Dan Troy: Bush Administration's Preemption Gang:
http://www.lawyersandsettlements.com/articles/10029/bush-preemption.html

http://www.lawyersandsettlements.com/articles/10030/bush-preemption-troy.html

FDA Is Placing Corporations Above Public:
http://www.house.gov/hinchey/issues/fda.shtml

Dan Troy's Poison Pill:
http://www.motherjones.com/washington_dispatch/2008/03/daniel-troy-fda-preemption.html

When Advocates Become Regulators:
http://www.commondreams.org/headlines04/0523-02.htm

FDA Scientist Says She Was Reprimanded For Warning:
http://www.usatoday.com/news/health/2007-06-10-fda-insider_N.htm

Government Accountability Project: Dr. David Graham:
http://www.whistleblower.org/template/page.cfm?page_id=144

Protect Consumers' Right To Sue Drugmaker:
http://www.philly.com/inquirer/opinion/16670451.html?imageId=7120686

Strong Medicine: What's Ailing The FDA?
http://www.rd.com/your-america-inspiring-people-and-stories/problems-in-the-fda/article55513.html

Bush Administration Rules Limit Lawsuits:
http://www.usatoday.com/money/economy/2008-05-13-536172364_x.htm

The Alaska Personal Injury Law Group has long been involved in the analysis of defective products sold by the diet supplement industry. Talbert v. E'ola Products, Inc. We have watched this industry repeatedly use unqualified personnel to design and sell products that are, in a word, dangerous. The industry has run amuck with virturally no regulatory oversight, and the consumer is repeatedly defrauded or hurt by exposure to the rapacious and dangerous practices of this industry.

It is thus with some appreciation of the legal and karmic forces at work in the universe to read today's news that Michael Ellis, former CEO of Metabolife, was sentenced to prison for 6 months based on pleading guilty to a single count of lying to the FDA about the effects of Metabolife 356 and its notorious ingredient, ephedra. Despite the millions the company relieved consumers of, he was fined just $20,000. In 2005, William Bradley, who was Ellis’ partner in Metabolife, pleaded guilty to seven felonies, including tax evasion, and sentenced the following year to six months in custody.

Metabolife and Ellis had sent letters to the FDA stating that they had “never received a notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356.” Metabolife's own documents, however, showed that it had received many reports from consumers of strokes, heart attacks, seizures, and other serious illnesses. The company ultimately turned over the reports of 14,000 ephedra-related adverse events that the company had previously not disclosed to the FDA, which ultimately was a key factor in the FDA's ban on ephedra imposed on the industry in 2004.

Metabolife became the target of hundreds of lawsuits, and to outrun the posse, went into Chapter 11 bankruptcy in 2005. We have seen this bankruptcy ploy used by a number of diet supplement companies wanting to "hide out while on the lam."

Source:

www.usdoj.gov/usao/cas//press/cas71105-Metabolife.pdf

http://www.signonsandiego.com/news/business/20080610-9999-1b10metabo.html

A federal jury today convicted the president of Berkeley Nutraceuticals, Steve Warshak, on charges of conspiracy to commit mail fraud, bank fraud, and money laundering. Warshak’s mother, Harriett Warshak, was also convicted. They now face more than 20 years in prison, and the company could be forced to forfeit tens of millions of dollars. Seven former company officials pled guilty to conspiracy charges before the trial began.

The company bilked thousands of customers out of millions of dollars using fake product warranties, fake medical spokesmen, and fake credit card transactions. The company's main product, Enzyte, was advertised as a "natural male enhancement" and was hawked on TV ads by a constantly grinning character nicknamed Smiling Bob.

We suspect that Bob isn't smiling anymore.

Source: AP Wire, February 22, 2008:
http://ap.google.com/article/ALeqM5gk4wBhEIdtWWF7hvr9C3Jl7pZ1XQD8UVNMKG0

Under the dubiously named Dietary Supplement Health and Education Act (DSHEA), diet supplements and herbal preparations are not approved by the Food and Drug Administration for medical use in humans. Thus, safety and formulation are solely the responsibility of the manufacturer; evidence of safety and efficacy is not required as long as they are not advertised as a treatment for a medical condition. As we have seen in diet supplement litigation (Talbert v. E'ola Products, Inc.), diet supplement manufacturers often promise the moon in selling their products to the consumer, while having little other than anecdotes to show when it comes to providing data for the safety or effectiveness of their products. Even assuming that the products are not adulterated (because of shoddy manufacturing protocols), have not been spiked (pharmaceutical drugs intentionally put into the supplement), and actually contain the ingredient at the levels claimed (often the “active” ingredient is missing or varies wildly), it is the exception, not the rule, that the manufacturer will have evidence that the supplement is safe for human consumption and actually works. With pharmaceutical drugs, the manufacturer foots the bill for such research. In the world of diet supplements, however, it is often independent researchers or the government (read: the taxpayer) that is burdened with the duty and cost of proving the safety and efficacy of a particular diet supplement.

At the Alaska Personal Injury Law Group, we are frequently asked to help those with serious orthopedic injuries. And our clients commonly face the debilitating consequences of arthritic changes that come from these injuries. So a discussion about glucosamine is in order. Luckily, unlike ephedra and other more dangerous diet supplements, glucosamine has not had a string of serious adverse events (it is not without side effects, however, so you need to read carefully before using glucosamine). But does it work?

Glucosamine is a natural compound that is found in healthy cartilage. Glucosamine sulfate is a normal constituent of glycoaminoglycans in cartilage matrix and synovial fluid (this is the “hydraulic” fluid in your joints). It is believed that the sulfate moiety provides clinical benefit in the synovial fluid by strengthening cartilage and aiding glycosaminoglycan synthesis. The question is, if you take the supplements, will the body put the critical compounds into your blood stream and use them where the arthritis lies? There have been multiple clinical trials of glucosamine as a medical therapy for osteoarthritis, but the results have been conflicting. Early clinical trials sponsored by a European patentholder, as expected, demonstrated a benefit from glucosamine. However, these studies were of poor quality due to shortcomings in their methods, including small size, short duration, poor analysis of drop-outs, and unclear procedures for blinding. Subsequent independent studies did not detect any benefit of glucosamine. This situation led the National Institutes of Health (yes, you the taxpayer) to fund a large, multicenter clinical trial studying reported pain in osteoarthritis of the knee, comparing groups treated with chondroitin sulfate, glucosamine, and the combination, as well as both placebo and celecoxib (Celebrex). The results of this 6-month trial found that patients taking glucosamine HCl, chondroitin sulfate, or a combination of the two had no statistically significant improvement in their symptoms compared to patients taking a placebo.

Today’s news is that the Annals of Internal Medicine has just published a study concerning the effect of glucosamine sulfate on the symptoms and structural progression of hip arthritis. Following 222 patients over a 2-year period, the researchers evaluated the patients’ pain, function and stiffness at regular intervals in the 2-year period. They concluded that “glucosamine sulfate was no better than placebo in reducing symptoms and progression of hip osteoarthritis.” Translation: glucosamine supplements will do nothing for the pain in your hip—the pain is likely coming from what the cost of the supplements did to your wallet.

Source: Annals of Internal Medicine, Effect of Glucosamine Sulfate On Hip Osteoarthritis, 19 February 2008, Volume 148 Issue 4, at 268-277, >http://www.annals.org/cgi/content/abstract/148/4/268.

Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), http://www.clinicaltrials.gov/show/NCT00032890; AND http://www.ncbi.nlm.nih.gov/pubmed/16495392.

Testimony offered in a federal trial in Ohio against Berkeley Nutriceuticals has disclosed that the company faked data regarding the effectiveness of its sexual enhancement product, Enzyte. When I previously wrote about this trial, www.alaskainjurylawblog.com/2008/01/dietary_supplement_company_fac.html, I fully expected to hear that such evidence had been uncovered. The diet supplement industry is virtually unregulated, and manufacturers are not required to provide scientific data or obtain pre-market approval for their products before they are placed on the market. Borrowing a page from the playbook of ephedra manufacturers, supplement manufacturers like Berkeley often go even further to make up data to show that their products are safe and supposedly work. Such faked data can be very effective in bilking consumers out of millions. I encountered this unfortunate fact in the litigation the Alaska Injury Law Group brought in Talbert v. E’ola Products, Inc., the first successful jury trial brought against an ephedra manufacturer.

James Teagarden, VP of Operations at Berkeley, testified that the company created fictitious doctors to endorse the pills, faked a customer satisfaction survey, and made up data to back up claims about Enzyte’s effectiveness. He also testified that the company’s president, Steve Warshak, was intimately involved in the fraud.

In addition to the fraudulent data, the company’s first-time customers were automatically enrolled in a “continuity program” that sent them Enzyte every month and charged their credit cards without authorization. If customers complained, employees were instructed to “make it as difficult as possible” for them to get their money back.

Source:
http://news.enquirer.com/apps/pbcs.dll/article?AID=/20080115/NEWS01/301150105

The coming issue of Clinical Cancer Research will publish two case reports concerning the progression of prostate cancer believed to have been caused by a dietary supplement "spiked" with pharmaceutical compounds. "Spiking" is, unfortunately, an all too common practice in that industry. While claiming to sell "all natural" products, and taking advantage of the regulatory limitations imposed on the FDA under the Dietary Supplement Heath and Education Act (DSHEA), www.fda.gov/opacom/laws/dshea.html , diet supplement manufacturers put consumers at risk by "spiking" their products with pharmaceutical compounds they know to work, when the herbal compounds do not. Unlike prescription and over-the-counter drugs, current law does not require nutritional supplements to undergo pre-market testing or approval for safety and efficacy.

This was a key issue in the first jury verdict in the nation against an ephedra manufacturer, a case the Alaska Personal Injury Group brought: Talbert v. E'ola Products, Inc., www.cfsan.fda.gov/~dms/ds-ephed.html . There, the manufacturer, whose product has since been confiscated by the FDA, "spiked" its ephedra product with the pharmaceutical drug, ephedrine hydrochloride. www.fda.gov/bbs/topics/ANSWERS/2001/ANS01114.html . In that instance, it caused a healthy young woman to suffer a cerebellar stroke.

The product analyzed by the researchers at University of Texas Southwestern Medical Center has led to an equally horrific outcome--virulent prostate cancer. The researchers report in the journal that the diet supplement, which they have declined to identify by name, contained the sex hormones testosterone and estradiol. Laboratory tests of the product on human prostate cancer cells found it to be a more potent stimulator of cancer cell growth than testosterone alone. Such compounds cannot be sold except by prescription. The spiked hormones are believed to have caused the two men to develop rapidly advancing prostate cancer within months of using the dietary supplement. Both men, before using the product, had low levels of prostate-specific antigen (PSA), a signal for prostate cancer and then presented with widespread cancer within six months, which is unusual. One of the men has died; the other is in the final stages of the disease and is expected to die within months. Notified of these findings, the FDA sent a warning letter to the manufacturer, and the supplement has now been removed from the market.

In addition to failing to list all the steroid hormones contained in the product, the researchers also found that the product’s label stated ingredients that were not present, and it also misrepresented the concentrations of the ingredients present. These kinds of failings are very common in this industry, and arise because of the lack of regulation over the industry's manufacturing processes. This type of misrepresentation and mislabeling is not just blatant consumer fraud, it can be dangerous when the concentration of an ingredient is too high.

Continue reading " Diet Supplement Found To Exacerbate Prostate Cancer--Another Spiked Product " »

On January 17, 2008, the New England Journal of Medicine released a study that put numbers to what we already knew to be true: drug manufacturers have more data, particularly negative findings, that they are not making public. Examining the literature concerning antidepressants, the study showed that 94% of the studies published by drug manufacturers discussed only the positive effects of the medication being studied. Drug manufacturers must report the results of all clinical trials to the FDA. When the entirety of the data submitted to the FDA from the manufacturers’ trials was examined, however, efficacy was shown in only 51% of the studies.

Why would this be the case? One could suppose that journals are more interested in publishing data establishing efficacy, as it may be deemed more “exciting,” perhaps medicine’s version of the newspaper adage, “if it bleeds, it leads.” But the more likely reason is what is found in most drug and products liability litigation: it is not in the corporation’s economic interests to release negative information about a product. This is the prime motivator behind the drug manufacturers’ decisions to focus its publication efforts on only those studies that show efficacy, which would, of course, encourage physicians to prescribe and consumers to use the medications, thereby increasing sales.

The FDA Amendment Act of 2007 passed by Congress last September offers a partial solution to the dilemma. It requires that the data from all the clinical trials performed by the manufacturer and submitted to the FDA be made available to the public. The NIH and FDA will be responsible for maintaining a database of the clinical trials completed by manufacturers. The public will have access, however, only to data on drugs the FDA has approved for sale.

We have seen stunning and regressive changes during the Bush administration concerning information such as this, where scientific data and thought were suppressed for political purposes. Allowing researchers, clinicians, and the public access to this type of scientific data is the only responsible thing to do, and it should have happened long ago. Let the sun shine in.

Source: New England Journal of Medicine, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, Volume 358:252-260 January 17, 2008 Number 3 ; www.fda.gov

The federal government has brought fraud charges against a dietary supplement company, Berkeley Premium Nutraceuticals, claiming the company bilked consumers out of $100 million using unauthorized credit card charges. Berkeley Nutraceuticals marketed a number of products it said would help in weight control, memory loss and clear skin, but its main business was sexual enhancement products such as Enzyte "male enhancement" pills. According to the indictment, consumers were put into an automatic shipping program, through which their credit cards were billed without authorization. The company also offered full refunds, "double your money back," and "triple your money back" guarantees that were false. It also is accused of referring complaints to a director of customer care who did not exist. Defendants include Berkeley, its president Steve Warshak, his mother, an in-house lawyer, a computer expert and a warehouse manager. They are accused of fraud, conspiracy to commit money laundering, and of obstructing two federal agencies in their investigations. Last year, Berkeley agreed to pay $2.5 million to settle allegations by attorneys general in Ohio and other states that the company engaged in deceptive practices in the sale of its products. The safety and efficacy of the products were not on trial.

Source: AP Wire, January 9, 2008.

On January 9, the FDA warned seven compounding pharmacies to cease marketing estrogen/progestin products containing estriol. The FDA also warned the pharmacies to stop making claims that the compounded products could be used to treat Alzheimer's disease, breast cancer, depression, and colon cancer. The FDA also demanded that the pharmacies stop using the non-scientific term "bio-identical", which the FDA concluded made the products “misbranded” drugs.

The seven pharmacies were targeted after an FDA review of their websites revealed that they were marketing products with estriol. Estriol is an estrogen produced during pregnancy that has not been FDA approved for clinical use. The FDA review identified what it considered to be “patently false” claims. The FDA also questioned the manner in which the products were marketed to suggest to the consumer that the products were “natural” and therefore safer than FDA approved hormone replacements.

Source: FDA--http://www.fda.gov/bbs/topics/NEWS/2007/NEW01766.html