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Pa. joint marijuana hearing: Doctors vs. lawmakers, science vs. stories

Eager lawmakers push pot on cautious docs, with Zippy to guide us

The Joint Hearing on Medical Marijuana (yes, they called it that) at Pennsylvania Hospital on Tuesday attracted 20 state legislators and leaders of the Health and Judiciary committees. That's 1/10 of the state House of Representatives. Most were from the ruling Republicans.

Most of the elected officials who spoke -- the people's reps -- said they are inclined to favor pot legalization because they have constituents who say pot has helped them, or hope it would. 

Against them, doctors who lead U.S. and Pennsylvania medical societies -- the men of science -- said they oppose state reps' sweeping proposals to let people try to medicate many painful conditions with marijuana, because there is so little measurable proof the weed is good, and not bad, for humans, even for sick people.

I sat with two legal-pot supporters who hope to gain from legalization -- Scot "Zippy" Ziskind, owner of Camden-based Zipco Wine Cellars, which builds climate-controlled alcohol storage for wine drinkers and drinking establishments nationwide, and has met with clients who want him to build marijuana grow rooms in pot-legal Colorado; and Main Line property appraiser Brian Smith, who has been asked by clients to review pot growing and storage facilities.

Zippy and Brian provided partisan color commentary, which can make the most arcane government hearings bearable. Legislators present are listed the end of the item. -- Highlights from the medical-society part of the hearing, from my notes, expanded from transcripts provided by some of the speakers:

REP. MARSICO: This is the first of three hearings these committees will hold on the topic of medical marijuana... They are not about a specific bill; they are fact-finding hearings, to educate the public concerning medical marijuana.

(Two additional hearings in April) will examine law enforcement and regulatory concerns, and other states' experiences implementing medical marijuana.

DR. BRUST: (Testimony from John C.M. Brust, Professor of Neurology at Columbia University College of Physicians and Surgeons in New York and co-author of this Systematic review: Efficacy and safety of medical marijuana in selected neurologic disorders for the American Academy of Neurology:)

The Pennsylvania Neurological Society, whose board voted to oppose (provisions of Pennsylvania Senate Bill 3,  for the medical use of cannabis), asked me to testify because I coauthored a systematic review (of research on the safety and effect of marijuana on brain disorders.)

Of 1,729 abstracts we reviewed in scientific journals, only 34 full-text articles met (scientific) inclusion criteria. On the basis of this review, our committee concluded that certain compounds present in cannabis plants are probably effective in relieving certain symptoms in multiple sclerosis (including muscular pain; but also) ineffective in treating tremor in multiple sclerosis or abnormal movements in Parkinson disease....

There is no scientific evidence that cannabinoid compounds, alone or in combination, are of benefit (in treating) epilepsy and seizures, amyotrophic lateral sclerosis, Parkinson disease, traumatic brain injury, post-concussion syndrome, spinocerebellar ataxia, post-tramatic stress disorder, severe fibromyalgia (all of which are included as treatments that would be legalized by Bill 3. Marijuana is also not proven or disproven for) Huntingdon disease, Tourette syndrome, cervical dystonia...

The only cannabinol agents ... established as effective, are marketed as oral cannabolid extracts (containing tetrahydrocannabinol (THC) and cannabidiol (CBD), which under current law) are not available in the US (except FDA-approved THC and nabilone), for wasting in AIDS and chemotherapy-induced nausea.

SB 3 is long on bureaucratic structure and short on pharmacology... Who among the 65 authorized processors (allowed to distribute marijuana by the bill) will determine the proportion of THC, CBD or other cannabinoid compounds in treating  each of the bill's 'qualified medical conditions' for which there is no evidence of benefit?...

There are 60 cannabinoid compounds, there are hundreds of non cannabinoid compounds (in marijuana). Which will be present (in state-authorized marijuana medicines?) What about side effects?... The bill fails to mention that the efficacy but also the safety of cannabinoids are unknown... The bill exempts board supervisors from liability...

Acute intoxication from cannabis can last more than 24 hours, resulting in a state of continuous cognitive impairment in daily users. Chronic cannabis use can cause lasting cognitive impariment and altered brain structure, documented in both animal and human studies... (Marijuana compounds) are addictive -- chronic use induces craving.

There is a reason the U.S. has charged the Food and Drug Adminstration with verifying the safety and efficacy of pharmacological producrts. The FDA was created to protect the public from purveyors of snake oil. SB 3 is an attempt to do an end run around that protection, relying on anecdotal testimonials and political pressure rather than evidence.

I also participated in drafting a statement for the 27,000-member American Academy of Neurology, a legislative position statement... (which) declared, 'The Academy does Not advocate for the legalization of marijiuana based products for use in neurological disorders at this time, as further research is needed' (to see if it is effective and safe).

SMITH (to me): I don't think he's in favor.
ZIPPY (also aside): They said the same thing about penicillin.

REP. MARSICO: I appreciate your testimony. Again, we are not here about SB 3.

DR. BRUST: I have given you considerable testimony independent of this bill about the non-efficacy of this stuff and about the danger of this stuff. As we become increasingly permissive about the medical use of marijuana we're finding that it's not good for you.

POT SUPPORTERS: (Scattered derisive laughter)

WHITNEY KRAUSE, legislative aide: Have there been studies... in the UK of (marijuana) spray?

DR. BRUST: There are studies that show those oral extracts are effective in the handful of MS symptoms I listed for you. They were (allowed) in the UK for that reason. Such medicines are not available in the United States... It's been around for many many years.

REP. ROZZI: Israelis have been doing research on medical marijuana afor almost 50 years and they have had great results. They are putting it in pill form, they are putting it in inhalers... Can you put it in some kind of context why are your results so different from what Israel is doing and they are having such great results in treating so many different diseases that you said are not being possibly affected? They use it to treat Krohns diseases, basal cell carcinoma pain of cancer patients, the elderly. What is so different from what their research is saying to the results you are coming up with?

DR. BRUST: Our committee reviewed the scientific literature, boiling it down to hundreds of text studies. There have been only a handful of Class A randomized prospective controlled studies.

Show me a randomized prospective controlled study that shows marijuana is good for basal cell carcinoma and I'll read it. Our commitee didn't find it.

REP. ROZZI: It seems they have been doing research for 50 years and it's working.

DR. BRUST: ... Anecdote and testimonial is not research.

SMITH (to me): (The medical societies Brust represents) did nothing of their own. They didn't do that study.

DR. LEE HARRIS (neurologist in private practice, chief of neurology Abington Memorial Hospital, medical director of the multiple sclerosis center there): I'd like to thank the committees for inviting me today on behalf of our patients in the Commonwealth.

A recent survey of neurologists of the state reflected general support for the idea of legalizing medical marijuana for the treatment of neurological disorders. However, the Board of the Pennsylvania Neurological Society has concerns with some of the specific provisions contained in Senate Bill Number 3, and does not endorse the bill as currently written.

Marijuana is currently classified by the Drug Enforcement Agency as a Schedule 1 (controlled subtance) that has no recognized meidcal value and a high potential for abuse. However, contrary to that contention, a number of recent studies demonstrate that marijuana is effective at alleviating chronic pain and relieving painful muscle spasms in patients with multiple sclerosis...  Based on that it can really no longer be considered to have no medical value. That is factually inacurate, as far as its Schedule 1 classification.

As you have heard, as the the American Academy of Neurology published last year, (the panel Dr. Brust served on) identified Class I evidence, the highest level of evidence-based medicine, that  certain oral but not smoked formulations of marjiuana provide relief of muscle stiffness and pain in patients with multiple sclerosis, as well as hleping to improve bladder control. (But for other neurological conditions) they found no clear benefit...

Based on that, the American Academy of Neurology issued the potential statement stating there may be benefit for some disorders. They did not advocate the legalization of marijuana for the treatment of neurological disorders at that time. (Instead they called for) more research...

A recent survey (corrected) by the Pennsylvania Neurology Society survey, to which 220 responded, 58 percent felt marijuana should be available for research and clinical purposes. 25 percent (favored making it available) for research alone. 4 percent (for) clinical alone. 14 percent felt it should not be available (for any purpose)...

Apart from multiple sclerosis, there's anecdotes of young children with Dravet syndrome -- epilepsy with intractable seizures -- anecdotal information suggesting cannabinoids can be highly effective in treating these patients....

Nonetheless, while the American Epilepsy Society published this anecdotal information, and it gives us some hope, more studies need to be done, the same as any other epileptic drug. They felt it is important to prove efficacy and safety. And not just (go by) anecdote...

At a time when unintentional deaths from prescription opioid use... when there have been 27,000 deaths (in 2007 alone), exceeding heroin and cocaine deaths combined, (from abuse of) narcotic analgesics prescriptions (which have increased rapidly) based on the increased importance of recognizing chronic pain (as the '15th vital sign'): in contrast to tens of thousands of opiate prescription deaths, there have been no known deaths from marijuana. There is no known (fatal) dose...

We are prescribing a potentially fatal drug (narcotics) for relieving chronic pain...

Many of the proposed conditions (for which medical marijuana is listed in the bill, have not been subjected to scientific study.)

The bill proposes to make marijuana available to treat some patients based on anecdote rather than scientific evidence...

It would be wonderful if the FDA could reclassify marijuana away from Schedule 1. because it has been found to have medical benefit. (Then we could run extensive studies.)

Reclassification could take years.

This committee has been charged to come up with evidence today, not years down the road. It's extraordinarly difficult to conduct studies (because illegal. Marijuana was listed as) Schedule 1 many many years ago... when it may not have been known to have medical value... That has since changed. (Marijuana) has clinical value for treating, at the very least, chronic pain and muscle spasms for patients with MS, and relieving nausea and pain for chemotherapy patients. It has been shown to have medical value.

REP. COX:  I'm an advocate for medical cannabis, medical marijuana, being taken to the next level. About supplements, I've talked to a few doctors in my area, are there doctors who might recommend over the counter suppements (that you might get at) GNC?

DR. HARRIS: Supplements are not evaluated or controlled by FDA. Certainly patients use these supplements. Some report they have value. That is likely based on anecdote.

Some of the reluctance of phsyicians to favor medical marijuana is that it has not been subject to those rigid clinical trials.

Someone whose back is aching may have a glass of wine with dinner and achieve benefit. A physician would not prescribe (wine) without knowing (if the patient can safely drink).

REP. COX: In my discussions with medical professionals, things like St. John's Wort and fish oil are prescribed for joint pain. Doctors do fairly frequently recommend. many of them and feel there is enough information about those things...

In 2013, in the New England Journal of Medicine, 2/3 of physicians said, given the right set of conditions, if given the opportunity, they would in fact recommend it. They all fall back on reclassification to Schedule 2.

Anecdotal evidence for marijuana is stronger than for these over-the-counter supplements. Medical marijuana has never killed anyone.

Yet documented deaths for prescribed medications is increasing rapidly. Offspins from oxycodone into heroin is taking the nation by storm.... Physicians I've talked to have said they feel the legalization of medical marjiuana, it's time to take a look at it. The societies aren't going to come and say it. (But) individual doctors ... want to help people. Doctors in Pennsylvania, not all of them, but quite a few are saying, 'We want to be able to help our patients. they are crossing the state line into New Jersey. They are making friends."

ZIPPY (aside): Ha. Yes, People are getting things sent in from Colorado (where many marijuana products are legal).

REP. COX: There's a lot of momentum on Senate Bill 3. How do we proceed, absent federal government leading on this? If they are not going to recalssify it as Schedule 2, why not follow at least some of the paths of the 23 states that have said, "We are going to make this available to some of our citizens?"

DR. HARRIS: Physicians have the relieve pain... First, do no harm... The American Academy and the Pennsylvania Medical Society agreed to (review) a group of specific conditions. Many of theose conditions have not been specifically studied to offer evidence it is either safe or effective... My speciality (multiple sclerosis) it is helpful to treating those symptoms... We don't know the side effects. We don't know the long term effects. We don't know it works for some of the conditions for which it's being recommended by the bill. There is reluctance to authorize use for (these) conditions without evidence that it works.

REP. COX: Are you familiar with Marinol?
DR. HARRIS: I've heard of it. I haven't prescribed it.
REP. COX: I'm curious as to the difference between marinol and medical-grade marijuana. Can you speak to that? My understanding is this is THC in a pill form used to treat chemotherapy-induced nausea. They are looking at it for multiple scleroisis symptoms. Why one is approved, and another is not, I'm not able to say.

REP. COX: CBD and (cannabinoid) oils has been the fallback. Even those who have said they are not comfortable with vaporization tinctures say CBD oils appear useful for seizures associated with intractable epilepsy...

DR. HARRIS: Cannabinoids (may have) no psychoactive properties. They are anecdotes these are useful in treating (certain epilepsy conditions) but there have not been controlled clinical trials. The epilepsy specialists say there may be a reason for hope, but more studies need to be done. Particularly when you are talking about treating children...

DR. CHARLES CUTLER (vice president, Pennsylvania Medical Society; internist): Thank you. This is obviously a very controversial topic and one that is nationwide... A crucial topic for people suffering from illnesses for which there is not a simple treatment.

We are also aware there is a push by the business community to legalize medical marijuana. Many of the advocates will testify before you.

We are here to tell you there is no compelling reason at this time to legalize medical marijuana. The physician leaders of the Pennsylvania Medical Society discussed it. The board is composed of 38 physicians from all over Pennsylvania, of various specialities.

It was unanimous among the board members that the board would like all of you to advocatge more funds for research for medical marijuana and allow scientists and researchers like the ones here at Penn to study this product and establish both the safety and the efficacy of medical marijuana before it is legalized.

Our position is neither pro nor con. It is a position of 'Let's learn more about how and why this product works, for whom it would benefit and what the risks are.'

We simply need more medical research done before legitimizing medical marijuana use. We'd like the members to work with federal authorities to change the classification of medical marijuana, so research is easier to do. And, of course, we need more funds to study.

Medical marijuana is purported to help glaucoma. But the American Academy of Opthamology, representing 32,000 physicians, has recently stated their position that before legalizing medical marijuana we need to study it more. The American Glaucoma Society has asked for more study before legitimizing this for medical use.

(About the use of) Cannabinoid oil to treat seizures: On the surface, in Decmeber 2014, there was a promising article on parents of children with seizure disorders. Parents reported positive effects at the American Epilepsy Society annual meeting report.

Unfortunately, as you read further, you saw that these reports were too good to be true, and there was bias introduced into the studies. Many parent responders had moved into the statistics and created a possible bias. People were looking for a benefit, and not seeing it. Parents were saying children were fine -- seizure-free -- when the EKG was showing they were suffering seizures. In one case a parent was reporting their child was seizure free, as the child was seizing, in the doctor's office.

If medical marijuana was as good as these anecdotal reports claim, the American Academy of Pediatrics would be clamoring for legalizaiton. But the Ameican Academy of Pediatrics has instead repeated its position: that more study is needed.

The mainstream medical associations, the American Medical Association, the American Academy of Pediatrics, the Psychiatric... Neurologic... Family Phisicians...

ZIPPY (to me) Because they're all going to lose money...

DR. CUTLER: Not one state medical society has endorsed (medical marijuana)

ZIPPY: They're afraid to lose their licenses.

DR. CUTLER: You can read our white paper, "Is Marijuana Medicine?

If you do move forward with a bill, here are four isues we'd like you to think about:

(Bill 3 as drafted would) provide protection for the Commonwealth, so the (people supervising the medical marijuana program) are not liable for deleterious outcomes. We would ask you to consider that the physicians of Pennsylvania have similar liability. No doctor should be criticized because he or she provides medical marijuana, when it's been legitimized, and there is an adverse effect. If a physican decides in his or her good judgement (not to prescribe), he or she should not sustain criticism.

Second, we hope you would provide for a robust registry (of marijuana patients and the symptoms they hope to address). We simply need to understand which patients are benefiting from this product, and the downside. A registry would address the scientific needs.

Thirdly, a bill could create a bureacuracy...

ZIPPY: Yeah! They'd be employing people! And paying tax dollars!

Finally, using nurse practicioners (and other) medical providers with limited understanding of pharmacology to recommend this product, would be short sighted.

These are not just rhetorical questions. We simply don't know the proper combination of THC and cannabidiol. How important are the trace elements in the marjiuana plant? What's the appropriate dosage, administration, side effects, longterm effects? Contraindications? We don't know.

ZIPPY (aside): Yes we do!

DR. CUTLER: The Pennsylvania Medical Society believes there's a compelling case (for studying more) before moving ahead with an actual bill.

We want to make sure we are opening a hope chest, not a Pandora's box.

MR. PETRARCA: When I talk to constituents whose children are having 50 to 100 seizures a day, I think they would disagree with what you have to say.

(It's like) in the 1980s, when President Reagan said we should study acid rain? Sometimes, you have to act.

My question is: Do you deny the successes that we are seeing around the country and in other states? And, as Rep. Rossi said, in Israel? To me, that seems compelling reason we should move ahead. And... sometimes, you have to act

DR. CUTLER: Unfortuantely, the research we have is anecdotal. It's simply case reports.

Driving, in, I reminded myself of the father of American medicine, Dr. Benjamin Rush.

ZIPPY (aside): He grew hemp! [Note: A quick Internet search found pro-marijuana folklore making this claim, but no historic account. Anyone with information showing Rush grew or prescribed hemp or cannabis indica or sativa, please post a source in the Comment section.]

DR. CUTLER: During the outbreak of yellow fever, as brilliant as he was, Dr. Rush's treatment was draining people. Yellow feaver was infectious. What he did was wrong. He had anecdotal experience. But he was making patients sicker.

That's the problem we face. If we don't follow the science, if we don't have randomized control trials, placebos, measuring the benefit and the downside risk, we run the risk of making the same mistake that Dr. Rush did, 250 years ago.

SMITH (aside) But this wouldn't be a fatal mistake.

REP. LAWRENCE: Big Pharma is in the business of making big money.

ZIPPY (aside) This will cripple them!

REP. LAWRENCE: Why haven't we seen (foreign development of marijuana drugs?

DR. CUTLER: Great question. I wonder if it's because they know something we don't? The pharma industry in Europe is not willing to do the research when the reward is not there.

REP. LAWRENCE: ...There has been a movement forward in two dozen states to legalize marijuana in some way, shape or form. I wonder if you could comment on precedent for non medical professionals making decisions on what should be permitted, as opposed to the FDA.

DR. CUTLER: I'm glad I'm a doctor and not sitting up where you are. It is difficult. There is an enormous public pressure to move forward with this. When almost two dozen other states have moved forward to legalize marijuna it creates a wave,  it creates momentum, for other states to follow suit.

It's hard (for you) to push back against that momentum. We would urge the Pennsylvania legislature to do that, and push back.

It would be an enormous profile in courage to do that (and resist.)

ZIPPY (aside): It's like an abortion: if you don't like it, don't have one.

REP. REGAN: We had an interesting presentation by the CEO of Penn Health Systems. He showed us a video of a doctor who works at Penn, who came up with a way to fight leukemia in children by injecting AIDS virus in children, in 100 people.

I couldn't come away without thinking, wouldn't it be horrible to be the parent of a child who couldn't get in the study, when you are having this success rate?

How long would it take, how much study, how many children will die, before they get access to this revolutionary drug that could cure them?

As state representatives we are often confronted by constituents who are experts.

(He told of a friend, a former law enforcement officer) who goes to Colorado to bootleg (marijuana) oil (for a sick child.) I can't think why someone would go through the expense and drama to get the drug.

You are proposing (leaving) years and years of children to suffering in order that we can study it ad nausuem.

Marjijuana has been used for a generation. As a doctor, do you see people who have been habitual users of marijuana over a period of 20, 30, 40, 50 years, who have any adverse problems healthwise directly related to use of marijuana?

Cutler: I want to avoid anecdotes, even personal ones, because I'm not sure they move the conversation forward.

There is research that points out dangers of smoked marijuana over a long period of time. It burns the lungs. There are agents in it similar to tar in cigarettes. Emphysema. Bronchitis. The products are not safe over a long period of time. There are studies, fairly good ones, that show aging effects on the brain through a long period of time.

I think we have to have caution.

REP. REGAN: We're not talking about smoked marijuana.

DR. CUTLER: There is a study (we mention) in the white paper that should be done relatively soon that would answer the question whether or not the oil helps children with seizures. There may be wisdom in waiting for that study to make a determination.

The Senate Bill does something unusual: it proposes that the product is beneficial in a wide variety of very divergent diseases.... glaucoma to PTSD.

ZIPPY: Mmm hmm.

DR. CUTLER: That's not common in medicine.

ZIPPY (aside): In homeopathy it is. (Laughter, from ME).

REP. REGAN: It doesn't make sense, much as it doesn't make sense that the AIDS virus kills cancer cells.

REP. TOPER: Is there a state doing research right into marijuana?

DR. CUTLER: It's very cumbersome. We need a reclassification.

REP. COX (asks for research about) longterm effects?

ZIPPY: I like this guy!

DR. CUTLER: Marijuana has a psychotropic effect. wer you to drive or do any kind of manual labor that required very keen intellectual fundctionthose functionsmay be dulled.

REP. COX (asks for proof of) lung damage.

DR. CUTLER: We're really on soft ground here because we havent had this studied in the United States in well over 40 years. You can take a product in year 1 and the impact may not show up til year 25. We're going back to the 1950s.

SMITH: It's no different, in what it does, then or now.

DR. CUTLER: The more I dig in, I'm finding there's a lack of continuity to the research.

REP. COX: Ibuprofen (causes) major stomach bleeding. (Holds up a box.) A few days ago I got a free sample of something, it says here, if I take it, it can cause severe stomach bleeding. (Laughter in audience)

Do you see where I'm going? It sounds likewe know the longterm effects of something like this. Yet doctor after doctor after doctor prescribes it. (There may be side effects to some vaccines,) yet doctors say, 'Vaccinate your child!' Why the digging in of the heels on marijuana?

ZIPPY (aside) Cause I can grow it in my house.

DR. CUTLER: Because we have a broken liability system (General laughter.) That's why an ad for Advil takes three seconds, and to list the side effects takes 45 seconds. The benefit far outweighs the side effects. The problem is -- you may not want to hear it -- our liability system in this country does not work.

REP. COX: ...Damage to the brain?

DR. CUTLER: That's a possiblity.

REP. COX: I wear a 'Legalize for Lorelei' bracelet. It's for a little girl in my district who takes this for seizures. What is the damage of 50 seizures a day from a condition like that?

DR. CUTLER: It's huge.

REP. COX: If we have something. people are going through illegal channels to get, because there is not just a glimmer of hope, there's personal stories, there's family members. And they are finding results. It's not just some ray of hope coming through the window. There's a significant amount of light being shown on the subject.

If I were a parent (of a kid in pain that pot might alleviate) I'd be finding a way to make sure my child got it. To me, the risk of obtaining an illegal substance -- marijuana -- would be worth the benefit.

The potential risks and harms, unknown as they may be, are better than the alternative of my child seizing over and over again. The known side effects and detrimental effects of medical marijuana still outweigh the alternative.

DR. CUTLER: Suppose the product doesn't work. And the parents imagine it helps. But it does not.

REP. COX: I can't imagine that.

DR. CUTLER: In the white paper we report a case where the parents reported the child was not seizing. And he was seizing. In the (doctor's) office. Parents report theri children are doing better. These observations are helpful. But they are not foolproof.

You are proposing giving a product to someone, which may not work. If the illness is ongoing, not only are the parents being fooled, but the children are suffering.

The Medical Society is not pro or con. We are urging that there is study before there is legislation. So we know if these products work.

If they work we are going to be back here begging this comte to legalize marijuana.

REP. COX: 23 states have moved to legalize marijuana. Wisconsin and many others. I hope this is not one of those situations where Pennsylvania will be dead last.

DR. CUTLER: I think we are all on the same page (that we don't want to be last.)

REP. COX: It truly is a difficult situation. You can't study it. But other states haven't hidden behind that. They are moving forward. Compared to most pharmaceuticals, it's not that toxic. And won't have the downside effects.

Florindo J Fabrizio (D-Erie)
Jesse Topper (R-Bedford-Franklin-Fulton)
Joseph Petrarca (D-Armstrong-Indiana-Westmoreland)
Jim Cox (R-Berks-Lancaster)
John Lawrence (R-Chester-Lancaster)
Ron Marsico (R-Dauphin)
Barry Jozwiak (R-Berks)
Todd Stephens (R-Montgomery)
Mark Keller (R-Cumberland-Perry)
Cheryl Delozier (R-Cumberland)
Mike Regan (R-Cumberland-York)
Marcia Hahn (R-Northampton)
Marcy Toepel (R-Montgomery)
Becky Corbin (R-Chester)
Dom Costa (D-Allegheney)
Joe Hackett (R-Delaware)
Mark Rozzi (D-Berks)
Tedd Nesbit (R-Mercer-Butler)
Gary Day (R-Berks-Lehigh)
Garth Everett (R-Lycoming-Union)