New FDA Supplement Regulations Proposed

Sen. Dick Durbin (D-IL) plans to introduce legislation to regulate dietary supplements more strictly. Seems the Senate has been unable to do much of anything. Maybe they can agree on some supplement bashing?

Food and drug attorney Justin Prochnow (Greenberg Traurig, Denver) comments on the issue:

Once again, Senator Durbin has taken a run at introducing legislation designed to restrict dietary supplements. The amount of inaccuracies and lack of knowledge in the press release is shocking. Durbin lumps 2 oz energy shots, which are clearly supplements, with other products. Does he really think 2 oz replaces a normal serving? He indicates that dietary supplements contain potentially unsafe additives right next to beverages that have undergone FDA approval. FDA approval? Is that a new regulation I am unaware of? While additives in foods and beverages must be approved food additives or GRAS [generally recognized as safe], there is no requirement for FDA approval and many ingredients are self-affirmed GRAS without specifically FDA approval.

As I see it, the issue is not the need for more regulations — the FDA just needs to enforce the regulations that are already on the books.

I would like to believe Durbin really has public health and safety in mind, but frankly, I don’t. The press release (as usual) says the bill is “Designed to Protect Consumers of Dietary Supplements.” FYI, Senator, proper use of pharmaceutical drugs kills around 300,000 Americans each year and injures two million more. (“proper use” meaning this doesn’t include the additional numerous cases of overdose, suicides and accidents such as pharmacy or physician error). By comparison, supplements are responsible for fewer deaths, meaning ZERO, Senator. Of course, the Senator should know this. It’s hardly new. In 1971 (!) the cost of caring for victims of drug toxicity accounted for 1/7 of hospital stays at a cost of $300 million a year. In 1998 the Journal of the AMA reported that over 2 million patients had a serious adverse drug reaction (ADR) and the 106,000 deaths put drug reactions between the 4th and 6th leading causes of death among all Americans. It seems obvious that drug toxicity, not supplement labeling, is a serious problem we need to address. Instead, Durbin is again demonizing supplements, especially “energy drinks” and “shots.”

Ironically, the specific supplements he takes aim at are energy products, which owe their activity to the most often-consumed and most socially sanctioned drug in the world — caffeine.

Durbin’s press release is HERE

Science in the Profit Interest

Another black eye for the so-called “ethical pharmaceutical” business. In what is being called “the biggest research fraud in medical history,” a member of Pfizer’s “speaker bureau” has pled guilty to fabricating dozens of drug studies. Dr. Scott Reuben, working on a $75,000 grant from Pfizer produced a research study on their drug Celebrex. Naturally, the drug was found to be remarkably effective against pain. Well, except there were no patients in the study. It was completely fabricated.

This isn’t a first for the good (for business) doctor. The peer-reviewed (and shame on the reviewers) journal Anesthesia and Analesia had to retract 10 papers authored by Reuben. Another 21 Reuben articles were apparently also fabricated according to London’s The Day. Reuben received nearly a half million from Pfizer, which I guess he has to give back, and possibly pay a $250,000 fine on top of that. Maybe even jail time.

But for Pfizer and the other companies that got rave reviews from “ethical research,” nothing. Bextra and Vioxx were also beneficiaries of Reuben’s fairy tale “research.” But these drug companies are not treated as conspirators. They’re “victims” of this fraud. Coverage in The Day fills in the details.

Reuben’s studies, five of which were funded by Pfizer, had bolstered claims about the post-surgery effectiveness of such painkillers as Pfizer’s Celebrex and Merck’s Vioxx.

Reuben’s attorneys said a bipolar disorder with “alternating periods of mania and depression fueled his misconduct.”

Oh poor guy. I’m sure we can all understand how depression could make someone want to fake dozens of scientific articles. No, we can’t. That’s a BS defense.

Meanwhile, these bogus “research studies” have been used to bolster claims of effectiveness for Celebrex and other drugs, as the public is fed the fiction that we have the best research in the world and the safest and most effective drugs. Yes, we have the best research results money can buy, and the best “approving for dollars” system too.

This corporate medical/scientific corruption hurts us all, and the media is only too happy to trot out the results of these “studies” while lapping up billions in pharma advertising.

And it’s not like this is new. Before this “biggest drug research fraud case in history,” there was the former biggest in 1989 when NJ physician Robert Fogari pled guilty to taking $2 million from drug companies for investigational new drug research that he never conducted. Fogari “investigated” new drugs for nine drug companies including Ciba-Geigy, Johnson & Johnson, Warner-Lambert, Pfizer, Upjohn, Syntex, and Merck, Sharp & Dohme. Fogari had his employees list persons who were not in the study and make up patients. He failed to do the urine, stool and blood tests and forged signatures of radiologists and others. The doctor also failed to report the deaths of two
patients in the “study” in order to “maintain a favorable impression” with the drug companies who hired him. At least the deaths were presumably not caused by the drugs they didn’t take as a part of the study they weren’t in that never took place.

Fogari admits he did not conduct any legitimate research during the whole eight year period.

A year earlier, Constantine Kostas admitted that of the 85 subjects in his clinical trial of Cipro, only 15 had actually been given Cipro. I suppose it hardly matters, since Kostas also faked the results of lab tests and examinations that never took place.

All of this is especially irksome to those of us who have endured Big Pharma’s war on herbs and supplements. How many of the so-called “research studies” on herbs funded by big pharma are also bogus? It’s easy to find such “studies” in which the patients chosen were inappropriate, or the protocol designed in ways that appear destined to fail. Indeed, “failure” of an alternative medicine is exactly what the drug companies want to see.

et tu Prince Charles? “Herbal medicine must be regulated”

In a recent BBC article (hat tip to Ed Smith of Herb Pharm for noting this) Prince Charles is quoted as saying “herbal medicine must be regulated.” Here in the United States, we often hear legislators and especially FDA officials calling for stricter regulation of herbal products and other dietary supplements. So my first reaction to the BBC article was “oh, no! The orthodox medical establishment has gotten to Prince Charles.” I even wondered if his opinion was colored by the fact that he is now in the herbal medicine business with his own herbal product line.

Prince Charles has been a consistent supporter of alternative medicine, and made a special appearance by video at the Columbia medical school course on botanical medicine. The Prince has been a consistent supporter of homeopathy and traditional herbal remedies. So this seemed like a bit of a betrayal of his former position.

On further thought, though, I had to reflect on the drama surrounding regulation of herbal products and nutritional products by the European Union. The “drama” featured a clash of different regulatory approaches employed by Great Britain and Germany. In Germany, nutritional and herbal products are regulated as drugs, and the German position has been adamantly in support of the entire world treating these products as such. Read more

USP Investigates Safety Of Green Tea Extracts

Green tea is the fourth most commonly used dietary supplement in the United States. After the publication of adverse event case reports involving green tea products and potential liver toxicity, the US Pharmacopeia reviewed safety information for green tea products. 216 case reports on green tea products were analyzed including 34 reports concerning liver damage. 27 reports pertaining to liver damage were categorized as possible causality and seven as probable causality. Pharmacokinetic and animal toxicological studies indicate that consumption of green tea concentrated extracts on an empty stomach is more likely to lead to adverse effects than consumption in the fed state. USP concluded “when dietary supplement products containing green tea extracts are used in formulated appropriately the Committee is unaware of significant safety issues that would prohibit monograph development, provided that caution statement is included in the labeling section.” Read more

GUYANA SEEKS TO REGULATE HERBAL MEDICINE

the health minister of the South American nation of Guyana is becoming concerned about the “growing power and influence of alternative medical practitioners” and is seeking to rein in some of the “more exaggerated claims.” The Guyana Association of Alternative Medicine shares some of those concerns, and official medical institutions have they “uneasy coexistence with this relatively new branch.”

Health Minister Leslie Ramsammy said the time has come not only
to sit down with the subsector and look at it holistically, but
also to draft modern laws to ensure that it operates in the
public’s interest. That is not exactly the case right now.
“Some of the herbalists have invoked a divine right to practice
and heal people. Others have had two weeks’ training or have read
some literature and started to practice, but it is obvious that we
have to do better than that,” he said.

[J]oint teams from the association and the ministry are
working on draft laws to go before parliament. One requirement
would stipulate that herbalists selling medicine must clearly list
the ingredients in much the same way that conventional
pharmaceutical firms are mandated to do.

A framework for self-regulation is also being worked out and a
lobby is emerging from the health faculty of the University of
Guyana to design courses that would properly train and certify
alternative practitioners, mostly to satisfy the anxieties of the
public.

GMP Gems

from the U.S. cGMPs for Dietary Supplements
by James Prochnow

The CGMPs for dietary supplements do not apply to dietary ingredient manufacturers, labelers, packers and those who hold dietary ingredients unless and only if a dietary ingredient is sold in bulk and then repackaged and, without further processing, is sold as a single component dietary supplement. Read more

Proposed Supplement Good Manufacturing Practices

Final Rule on Dietary Supplement cGMP Released
from AHPA

(June 22, 2007) — The U.S. Food and Drug Administration (FDA) has posted its final rule on current good manufacturing practice (cGMP) for dietary supplements at its website and will soon publish the rule in the Federal Register. The agency has simultaneously posted a related interim final rule that allows for submission to, and review by, FDA of an alternative to required 100-percent identity testing of dietary ingredient, as discussed within the cGMP itself, provided certain conditions are met. These documents are on the FDA’s website HERE and HERE

Additional information is at FDA’s home page. Read more

Adverse Event Reporting

Industry experts are proclaiming victory in getting a law passed that requires dietary supplement (and OTC drug) manufacturers to report all serious “adverse events” to their products to the FDA, which will, of course, make those reports public. The idea is that this will be seen as a “responsible” act by industry and help stem the tide of negative publicity about supplements. Oh really? With the obvious bias in the media against supplements, each reported (but not proven) “reaction” will likely be used to hammer dietary supplements. Does anyone think that reports of OTC “adverse events” will get the same exposure? Face it, another aspirin overdose or a liver destroyed by Tylenol is simply not news. Especially to media outlets heavily sponsored by drug companies.

Besides, a supplement manufacturer has no right to ask for a customer’s medical records, to see if she already had a health condition or risk factor that might explain the apparent reaction to a supplement. Marketers of supplements simply can’t fully investigate complaints, which may or may not be related in any way to the supplement. I’m reminded of the infamous case of a fatality attributed by the Texas Health Department to an ephedra supplement. Yes, the ephedra supplement user died, but the coroner blamed the knife wound. In another “ephedra fatality” it was probably the extreme blood alcohol coupled with the head on auto collision. Chaparral was said to be so dangerous it had caused a rash of liver failures. There have been none before or since. Same with kava. And scullcap, that turned out to be germander, itself probably innocent. Again, no problems before or since.

Maury Silverman, a literature researcher and staunch supporter of supplements argued unsuccessfully to have the language of the new law require the disclosure of simultaneous drug use, which may better explain the “adverse event”. For example, if someone takes an herbal supplement and a Tylenol, seriously, which one is more likely to have caused that liver toxicity?

Who Are These Guys?