FOOD FIGHT

Who doesn’t love a good food fight?

Every kid remembers the fantasy of smothering Uncle Elmer’s face in a
banana cream pie. I’ll never forget the battle of the sloppy joes when there was a power failure at the dining hall my freshman college year.

And who could forget the cinematic food fights in Animal House, The Great Race, and Blazing Saddles?

But now the comp world has its own food fight.

Not an actual gooey slinging fest, mind you. But “food” is at the heart of the struggle. This time the struggle over “medical foods”.

Here’s the background of the controversy:

Recently RAND researchers have produced a study for CHSWC (California Commission on Safety, Health and Workers’ Compensation) on compound drugs and medical foods.

Written by Barbara O. Wynn, the study is titled “Use of Compound Drugs, Medical Foods, and Co-Packs in California’s Workers’ Compensation Program”. You can find a pdf of the study here:
http://www.dir.ca.gov/chswc/Reports/201 … -Packs.pdf

Public comment on the paper is requested by March 1, 2011:
http://www.dir.ca.gov/chswc/info_bullet … tin08.html

It’s likely that the eventual CHSWC report on the issue will be a basis for legislative action.

The RAND study notes that “the issues surrounding compound drugs, medical foods, and co-packs rest on uncertainties regarding whether the products are medically appropriate…”. RAND recommends that “The MTUS should be updated and expanded to address compound drugs as a product class” as well as “the medical appropriateness of medical foods”.

Moreover, the RAND study concludes that “physician-dispensing creates financial incentives that affect use of compound drugs, medical foods, and co-packs”and suggests various legislative or regulatory fixes to control abuse.

But the purveyors of “medical foods” are fighting back.

A recent article by reporter Greg Jones in workcompcentral.com
quotes extensively from comments by Dr. William Shell, CEO of Physician Therapeutics, a Los Angeles pharmaceutical company, a subsidiary of Targeted Medical Pharma Inc. (kudos to workcompcentral.com as usual for its excellent day in and day out coverage of the California workers’ comp scene)

It appears that Physician Therapeutics has been awarded a $750,000 National Institutes of Health grant from the U.S. government to study medical foods and co-packs as alternatives to some of the side effects of opioids and non-steroidal anti-inflammatories. Apparently the study will focus on medical foods for Gulf war syndrome victims and elderly with sleep disorders.

Wasted money or visionary use of funds by your government under the Patient Protection and Affordable Care Act?

Time will tell whether the research is meritorious or bogus, but the suppliers and providers of medical foods and co-packs appear ready to fight back in the comp system.

The Physician Therapeutics website claims that “all medical food products use “Targeted Cellular Technology” (trademark), “a patented process that allows very small quantities of neurotransmitter precursors to enter the cells and produce specific neurotransmitters”.

Physician Therapeutics further claims that:

“This five component system includes:

A neurotransmitter precursor supplied as an amino acid
A neuronal uptake stimulator
A neuron activator
An adenosine antagonist, such to disinhibit the neuron
An attenuation inhibitor of the precursor response a well known precursor phenomena
This proprietary application of neurotransmitter science is designed to promote the production and release of the neurotransmitters norepinephrine, epinephrine, dopamine, serotonin, acetylcholine, histamine, glutamine and nitric oxide.

Medical food formulas synchronize the fluctuating demand for neurotransmitters with the availability of the precursor supply, which is especially important for processes that are controlled by circadian rhythms, such as utilization of arginine for the production of nitric oxide. It is important to note that maintaining adequate neurotransmitter levels in disease states is not a pharmaceutical mechanism of action (MOA), but is achieved via a dietary management mechanism, the nutritional ingestion of the required distinctive nutrients in the specific quantities needed to modulate cellular responses.”

However, in 2010 Physician Therapeutics received a warning letter from the FDA. The FDA letter addressed to CEO William Shell, stated:

“Dear Dr. Shell:

On (b)(4), FDA issued a warning letter to (b)(4), (copy attached). As explained more fully in that warning letter, certain drug products that (b)(4) has manufactured are new drugs that lack approved applications as required under the Federal Food, Drug, and Cosmetic Act (the Act). Based on information obtained during FDA’s inspection of from (b)(4), your firm contracted or otherwise arranged with (b)(4) manufacture one or more drug products that your firm distributes. These drug products include, but are not necessarily limited to:

• Theracodophen-650 Convenience Pack (Hydrocodone 10 mg, Acetaminophen 650 mg, and Theramine);

• Strazepam Convenience Pack (Temazepam 15 mg and Sentra PM);

• Gabazolamine-0.5 Convenience Pack (Alprazolam 0.5 mg and GABAdone);

• Gaboxetine Convenience Pack (Fluoxetine 10 mg and GABAdone);

• Trazamine Convenience Pack (Tradazone 50 mg and Sentra PM);

• Senophylline Convenience Pack (Theophylline 100 mg and Sentra PM);

• Therapentin-60 (Gabapentin 200 mg and Theramine);

• Prazolamine (Carisoprodol 350 mg and Theramine);

• Sentradine (Ranitidine 150 mg and Sentra PM);

• Therafeldamine (Piroxicam 20 mg and Theramine)

The above products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are “new drugs” within the meaning of section 201(P) of the Act [21 U.S.C. § 321(P)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301 (a) and (d) and 505(a) of the Act [21 U.S.C. §§ 331(a), (d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an FDA approved application is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for these drug products.

Additionally, because the above prescription drug products are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses, as described in 21 C.F.R. § 201.5. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(1)(1) of the Act [21 U.S.C. § 352(1)(1)]. Because the products lack required approved applications, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(1)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].

Further, as explained in the warning letter dated (b)(4) to (b)(4) the above drug products are adulterated under 21 U.S.C. § 351(a)(2)(B), and thus your firm may not introduce or deliver them for introduction into interstate commerce, 21 U.S.C. § 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. In particular, violations cited in this letter are not necessarily limited to drug products manufactured by (b)(4) and may apply to all drug products that you market and distribute without FDA-approved applications. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your film complies with all requirements of federal law and FDA regulations.

You should take prompt action to Correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, and,’ injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you no longer market the above products, your response should so indicate, including the reasons that, and the date on which, you ceased production.

Your reply should be sent to:

Daniel Cline, Acting Director
Los Angeles District Domestic Compliance Branch
U.S. Food & Drug Administration
19701 Fairchild
Irvine, CA 92612

If you have any questions regarding this letter, please contact John J. Stamp, Compliance Officer, at (949) 608-4464.”

See:
http://www.fda.gov/ICECI/EnforcementAct … 208680.htm

Shell was quoted in workcompcentral.com as saying that “our response to the warning letter took the position that our medical foods are both safe and effective for their intended use, which is as precursors to neurotransmitters and therefore the definition of a drug is “safe and effective for their intended use”.

Further, Shell was quoted as saying that “the issue is whether these are new drugs or old drugs, and since they were grandfathered in in 1962, amino-acid preparations are not a new drug”.

In fairness to both Shell and the FDA, I’ve not seen followup correspondence that my have been generated by the company or regulators. Physician Therapeutics’ website does not provide those details.

When a new AD of the Division of Workers’ Compensation is appointed, the efficacy of “medical foods” and the scientific data thereon can be hashed out as part of an amended MTUS. As part of such a process, medical foods manufacturers may be able to produce their data, presumably data on which the NIH relied in providing significant public research funding.

All of this is a “food fight” that needs to take place in the sunshine of scientific peer review and open public policy analysis.

But Shell did make one point in comments to workcompcentral that may be worth noting. Shell apparently claims that his company was not contacted by the RAND authors of the study performed for CHSWC.

Going forward on these types of studies, it would probably serve the comp community (and CHSWC) well for RAND or other CHSWC study contractors to contact subject “stakeholders” for their input and comment, even if only to “solicit their side of the story” and create an extra appearance of fairness. This has been a problem with a recent study on liens, where many providers claimed that they were not consulted about their perspective on the widely perceived lien problem before a report was generated.

For more on Physician Therapeutics, you can see their website:
http://www.ptlcentral.com/

And you can find this statement from Dr Shell, who has a resume that features a long association with Cedars-Sinai Hospital in Los Angeles as well as a stint as an associate professor at UCLA School of Medicine:
http://www.ptlcentral.com/message-from-ceo.php

Stay tuned.

Julius Young
www.boxerlaw.com
www.thecompguys.org

Category: Medical treatment under WC