SIGN ON PETITION: ads for prescription and over the counter drugs should include a toll-free number and a website to report side effects

IMPORTANT: If you’re interested in signing onto the attached petition, please contact Consumers Union directly (Bill Vaughan at wvaughan@consumer.org or Susan Herold at herosu@consumer.org)



December 31, 2007





Divison of Dockets Management

Food and Drug Administration

Department of Health and Human Services

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852



Citizen Petition



Consumers Union, the independent, non-profit publisher of Consumer Reports[1]

submits this petition pursuant to 4(d) pf the Administrative Procedure Act, 5 USC 553(e), 21 CFR 10.25 & 10.30, and PL 110-85, section 906.



Section 906 of the FDA Amendments Act of 2007 provides that the



Secretary of Health and Human Services shall conduct a study to determine if the [following] statement [“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088”] required with respect to published direct-to-consumer advertisements is appropriate for inclusion in…television advertisements.



Action Requested



Consumers Union (CU) requests the Food and Drug Administration require that all television advertisements for prescription drugs and over the counter drugs include a toll-free number and a website address for the public to report side effects to the agency. All television advertisements for prescription drugs should include the following, “You are encouraged to report adverse effects of prescription drug medication. Log onto www.fda.gov/Medwatch or call 1-800-FDA-1088.”



The FDAAA (P.L. 110-85) requires all print advertisements to include this statement, but this should be expanded to include TV advertisements.







Statement of Grounds





All too often, drug advertisements fail to present the benefits and risks of using prescription drugs in an accurate and balanced way. It is often the newest drugs that are the most heavily advertised, and it is these drugs whose side effects we know the least about. Two-thirds of all drug withdrawals occur within the first three years of release and it estimated that only half of all label changes occur in the first seven years that a drug is on the market.[2] The recent action by the FDA on the use of over-the-counter cold remedies on young children is a clear example of why the public should be encouraged to report adverse events from not just prescription drugs but from over the counter products, even those long considered safe. Therefore, it is important to have information on TV advertisements where consumers can report side effects.



Currently, it is estimated that adverse drug event reporting system catches only a small fraction of all adverse incidents of drugs.[3] Adverse drug reactions are responsible for as many as 700,000 emergency room visits annually.[4] Including a toll-free number and a website to report side effects will increase the information the FDA has on drug risks and would also increase awareness to consumers.



And television drug ads run far more frequently than print ads. Consumers are repeatedly faced with TV ads, with their pictorial power, compared to what is generally a one time scan in the print media. Including this number and website in TV ads would reach far more Americans than through print ads.





The FDA has stated about MedWatch:



“The MedWatch program has four goals:

To clarify what should and should not be reported to FDA.
To increase awareness of serious reactions caused by drugs or medical devices.
To make the reporting process easy.
To give the health community regular feedback about product safety issues.
While participation in MedWatch is voluntary, FDA encourages anyone aware of a serious adverse reaction, including consumers, to make a MedWatch report.”[5]

Including a toll-free number and a website to report side effects would certainly help the FDA achieve the above goals and it would help encourage many more consumers to report adverse reactions with medications.

Increased reporting and use of MedWatch would help in the earlier detection and better analysis of problems. All television ads should contain information on how patients should report unusual side effects to the FDA.



Environmental Impact



We believe that pursuant to section 21 CFR 25.30(a), this petition is excluded from the requirement for an environmental impact statement.



Certification



The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.



Sincerely,



Kim Witczak

2414 West 54th St

Minneapolis, Minnesota 55410



Elizabeth Foley

Consumers Union

Grassroots Coordinator

101 Truman Ave

Yonkers, NY 10703

914-378-2421



--------------------------------------------------------------------------------

[1] Consumers Union is a nonprofit membership organization chartered in 1936 under the

laws of the State of New York to provide consumers with information, education and

counsel about goods, services, health, and personal finance. Consumers Union's income

is solely derived from the sale of Consumer Reports and ConsumerReports.org, its other publications and from noncommercial contributions, grants and fees. In addition to reports on Consumers Union's own product testing, Consumer Reports and ConsumerReports.org, with approximately 6.5 million combined paid circulation, regularly carry articles on health, product safety, marketplace economics and legislative, judicial and regulatory actions that affect consumer welfare. Consumers Union's publications carry no advertising and receive no commercial support. EXPERT • INDEPENDENT • NONPROFIT®



[2] Matthew F. Hollon, MD., “Direct-to-Consumer Advertising: A Haphazard Approach to Health Promotion,” JAMA, April 27, 2005. Vol. 293, No. 16, p. 2032.



[3] Institute of Medicine, “The Future of Drug Safety, 2006, p.53

[4] Daniel S. Budnitz, MD., “National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events,” JAMA, October 18,2006. Vol. 296, No. 15 p.1863

[5] John Henkel., “Medwatch: FDA’s Heads Up on Medical Product Safety,” FDA Consumer Magazine, November-December 1998.

Insulin, Leptin, Diabetes, and Aging: Not So Strange Bedfellows

As we know from several studies, insulin levels seem to be higher in HIV positives than negatives. We also have more problems with increased triglycerides, low HDL, lower bone density, increased visceral fat, and glucose intolerance/insulin resistance.

You will read some radical statements in the link below, among which this is one:

"Incidentally, two of the most popular diabetic medications today, Actos and Avandia, wrongly claimed by their manufactures as being insulin sensitizers, actually work by multiplying fat cells, thereby creating more wastebaskets in which to store sugar as fat. They actually make you fatter and more leptin resistant, and they accelerate your rate of aging"


"Elevated insulin plays an important role in osteoporosis. Insulin promotes the excretion of calcium in the urine...This is a major source of osteoporosis and far exceeds in importance a lack of calcium in the vast majority of people. There is a high correlation between osteoporosis and calcification of arteries. In other words, most people with osteoporosis have the calcium - it's just in the wrong places."

http://www.diabeteshealth.com/read/2008/01/13/5617.html

What is the best delivery method for testosterone in men?

Dear Nelson:

I was wondering what your opinion, Nelson, is self
injecting testosterone a better way to administer
testosterone, or do you recommend the gels? I also see
where you have mentioned appliedpharmacyrx. Would they
also be able to supply Deca (Nandrolone)? I feel like
I can bulk up better when I am a taking this as well.
What are your thoughts about this? Thanks for all the
good work that you do for the HIV community.

*****************************
The choice of testosterone delivery methods depends on: 1- How disciplined one may be for daily application, 2- How well and how sustained the method takes you above 500 nanograms per deciliter of total testosterone in your blood, 3- How much testosterone gets aromatized to estrogen in your body (estrogen can cause water retention and increased breast size), 4- How much testosterone is metabolized into DHT (dehydrotestosterone, the culprit for acne, hair loss).


Some guys like injections of 100 mg a week or 200 mg every two weeks. I have used this method for years with good results, but the ups and down are a lot more noticeable than using more sustained daily methods. Some love the "peak" caused by the injections.

I have tried Androgel and Testim (both 1% testosterone gels) in the past and they have been OK for me. Testim has a smell that many dislike, but the company claims 30% better absorption than Androgel. Androgel came up with a cool pump that you can use to increase the daily dose if needed. The folks from Androgel are coming up with a 2.5% testosterone version soon. Some guys never reach levels above 500 nanograms with either gel and get better results with a more concentrated gel from compounding pharmacies (you can order 5 or 10% gels at a cheap cost from them). I think Androgel and Testim are a rip off when it comes to price, though, and their patient assistance programs do not seem to be working that well.

2007 was an interesting year for me when it comes to testosterone. I tried Nebido, a 1000 mg shot of testosterone undecanoate (not yet approved in the US) that keeps your testosterone above 500 nanograms for 3 months. It worked beautifully for me. I did not need naps, my sex drive was pretty good and constant for weeks, my appetite was great, and my mood was excellent. After that I tried Testopel pellets and got 12 pellets inserted under the skin of my left gluteous maximus. After a month, my testosterone has gone up from 300 to 800 nanograms and I feel great. I am watching to see if 12 pellets will take me to 120 days of good testosterone levels, as claimed by the maker. So far, they are not noticeable to the naked eye and I am very happy with them. The key will be if it gets insurance and Medicare reimbursement.


Before you start testosterone, make sure your doctor tests your blood for prostatic specific antigen (PSA), gives you a digital rectal exam, he/she measures your hemoglobin/hematocrit, and your total and free testosterone along with thyroid and estradiol levels. Some check sex hormone binding globulin, a protein that seems high in many HIVers that binds testosterone and does not allow it to do its job. This is one of the reasons some people do not feel much after testosterone supplementation.

Have your doctor check your testosterone and estradiol again 3 weeks after you start to see where you are. You may have to increase your dose if your free testosterone is not above 35 picograms per mL . I like to at least be mid range since the free testosterone range is 35- 155 pg/mL. But at the end, what really matters is how you feel. Have her/him also check your hemoglobin/hematocrit after a month to see if you are not one of those unlucky people whose red blood cells increase so dramatically which makes your blood gets too thick to be pumped by your heart. This is called polycethymia and it can be a huge problem. People with this problem have to get phlebotomized ( give blood) or stop testosterone all together.


On the subject of nandrolone, I have very strong biases for that drug, as you guys know. I think nandrolone decanoate is one of the best drugs to be used for improved quality of life, body composition, bone strength, energy, and improved body image. It has helped many HIVers "balance out" thin extremities that were afected by years of lipoatrophy. It has a lot of good data in HIV for men and women, and you can ready more in medibolics.com or our book "Built to Survive". My doctor once joked that "Nelson Vergel wants nandrolone in the drinking water" LOL

Watson pharmaceuticals, the makers of nandrolone stopped maufacturing it without telling the comunity Nandrolone is available through several compounders. We posted a list here

http://archive.constantcontact.com/fs020/1101823881298/archive/1101825972178.html

I am writing a book about all my experiments with my health in the past 22 years to disclose practical tips that do not require too much reading and medical knowledge. I hope this information helped you!

HIV/AIDS Experts, Doctors Voice Concerns About Health Problems Seen Among Long-Term HIV/AIDS Survivors

I am so glad people are taking about this now. We are living longer and aging-related problems seems to show up earlier in long term survivors. As more and more doctos leave HIV practices for other fields that offer better reimbursement, or due to retirement, we need more doctors who can deal with the increasing needs of the long term survivor population.
**********************************

Kaiser Daily HIV/AIDS Report



Public Health & Education | HIV/AIDS Experts, Doctors Voice Concerns About Health Problems Seen Among Long-Term HIV/AIDS Survivors
[Jan 07, 2008]
Some experts and doctors recently have voiced concerns that people who were diagnosed with HIV/AIDS in the early years of the epidemic are experiencing "prematur[e]" or "disproportionate numbers" of ailments associated with aging, the New York Times reports. CDC estimates show that the number of people ages 50 and older living with HIV increased by 77% between 2001 and 2005 and that this population now represents more than 25% of all HIV/AIDS cases in the U.S. The "graying of the AIDS epidemic" has raised interest in the link between AIDS and cardiovascular disease, certain cancers, diabetes, osteoporosis and depression, the Times reports.

Cardiovascular disease and diabetes are associated with lipodystrophy, which results in fat redistribution that can leave the face and lower limbs gaunt, the stomach swollen and the back humped. Lipodystrophy also raises cholesterol levels and causes glucose intolerance, which could be particularly harmful to black people, who are predisposed to heart disease and diabetes. According to the Times, there are no data that compare the incidence, age of onset and cause of aging-related diseases in the general population with long-term survivors of HIV. However, experts say they do not see HIV-negative people in their mid-50s with hip replacements associated with vascular necrosis, heart disease or diabetes related to lipodystrophy, or osteoporosis without the usual risk factors.

The most comprehensive research has come from the AIDS Community Research Initiative of America, which has studied 1,000 long-term survivors in New York City. The ACRIA study, published in 2006, found unusual rates of depression and isolation among older people living with HIV.

The NIH-funded Multi-Site AIDS Cohort Study -- which has followed 2,000 subjects nationwide for the past 25 years -- will examine the effects of HIV/AIDS and aging over the next five years. MACS investigators and other researchers say the slow pace of research on HIV/AIDS and aging is a result of numbers. They note that the first generation of people diagnosed with HIV/AIDS in the mid-1980s had no effective treatments for 10 years and died in large numbers, leaving few people to participate in studies.

Charles Emlet -- an associate professor at the University of Washington-Tacoma and a leading HIV and aging researcher -- said HIV/AIDS and aging research has been slow to start because of "the rapid increase in numbers." CDC's most recent data, from 33 states that meet certain reporting criteria, showed that the number of people age 50 and older with HIV or AIDS was 115,871 in 2005, compared with 64,445 in 2001. In addition, the "routine exclusion" of older people from drug trials by large pharmaceutical companies has undermined such research, the Times reports. The studies are designed to measure safety and efficacy but not long-term side effects of drugs. The lack of research also limits a patient's care, the Times reports.

"AIDS is a very serious disease, but longtime survivors have come to grips with it," Emlet said, noting that although some patients experience unpleasant side effects from the antiretroviral drugs, a vast majority find a regimen they can tolerate. "Then all of a sudden they are bombarded with a whole new round of insults, which complicate their medical regime and have the potential of being life threatening. That undermines their sense of stability and makes it much more difficult to adjust," he added (Gross, New York Times, 1/6).

The Battle to Decrease Visceral Fat: Leptin vs Serostim (growth hormone) vs TH9507 (growth hormone releasing factor)

http://www.natap.org/2007/CROI/croi_80.htm

Leptin Reduced VAT by 30%/Improved Metabolics in Pilot Study
CROI, Feb 2007, Los Angeles
"Improvements in Hepatic and Adipocyte Insulin Sensitivity, Dyslipidemia, and Visceral Fat during Leptin Treatment in HIV-infected Men with Lipoatrophy and Hypoleptinemia"
Kathleen Mulligan

Comments:
When it comes to visceral fat reduction in 6 months, this product looks as good as Serostim (human growth hormone) at 3 mg/day and better than the Theratecnologies' growth hormone releasing factor TH9507 . The dose used in this tiny pilot was 0.01 mg/kg twice daily for 3 months, followed by 0.03 mg/kg twice daily for 3 months. I wonder how the cost of leptin would compare with the unknown price of TH9507 (which will up for FDA approval in the coming months.) We know that the cost of 3 mg a day of Serostim ( the lipodystrophy dose they tried to get approved unsuccessfully) cost $12,000 for 6 months of use and that 20% of people who wanted to enroll in the Serostim HARS study were rejected due to impaired baseline glucose tolerance.

Unlike Serostim, leptin does not seem to have side effects in this study ( although the abstract below mentions high blood pressure) and no negative effects on glucose tolerance. Not sure if we really know what the side effects of TH9507 are, although I have heard that mild edema and joint aches are caused by this product, but at a much lesser degree than Serostim.


***********************

About Leptin:

Leptin, a hormone discovered in 1994, is produced by fat cells. In general, leptin levels in the blood are proportional to an individual's level of body fat. At work in the hypothalamus, the part of the brain that controls appetite and other basic functions, high levels of leptin generally suppress the appetite and stimulate fat-burning. This function of leptin may be less effective in people who gain weight easily. When caloric intake is reduced, leptin levels decrease and signal the hypothalamus to produce NPY which stimulates appetite and lowers the body's metabolism.
High leptin levels may provide one mechanism to explain the link between obesity and hypertension. Overton theorizes that leptin may contribute to hypertension because of its role in stimulating the body to burn fat.
"The way it does that," he says, "is by increasing the "fight or flight" nervous system-the sympathetic nervous system. The activation of the sympathetic nervous system may also increase blood pressure and lead to hypertension."

From http://www.rinr.fsu.edu/springsummer98/departments/abstracts.html

Best Erectile Dysfunction Options in the US

QUESTION AND COMMENTS FROM MY POZHEALT LIST:

Regardelss of its pathogenisis, ED can be a problem for many of
us....wether the etiology is urological, medication induced, r/t
psychiatric problems, other comorbidities or idiosyncratic, most men,
not all, like to do something about this "floppy" situation (so to
speak)....
I tried Viagara about 10 years ago but had no remarkable
results, I tried it at the suggestion of my ID MD at the time
although the ED was not really an issue for me psychologically, you
see I am one of the "sicker ones" here as far as battling many
debilitating IO's over the years, so at the time I tried the Viagara
I was more focused on my overall wellness that a hot romp in the
sack, so the fact the Viagara didn't work was moot for me as other
concerns tokk a higher priority....
Move forward 10 or so years & I am beginning to have the same
problems again, although my IO's area under control, the ED is
popping back into my life it was however a thing of the past for the
past 2 years, but his ugly head has reared again (or should I
say "not reared"....LOL)....now I am more concerned & woulde like a
good stiff woody to keep my boyfrind & I happily entertained....
My bf takes Cialis & beleive you me it works WONDERFULLY & keeps
me smiling & both of us entertained, I look at it & it stands
straight up, he is also HIV-.....so now since I am beginning to feel
a little "inadequate" at this point when I am with him I have
approached Dr. Slim about my longing for some nice "stiffies"....he
would not prescribe me the Cialis as his rationalization was since I
take 100 mg Norvir BID it would increase it's half lfe & he didn't
want to take that approach, we bypassed the whole Viagara idea as my
history with that was less than "so-so"....he did however, prescribe
the Levitra which is patiently waiting to be cracked-open this
upcoming Tesday 1/8 to be welcomed for our planned party (we don't
live together)....
My question to all of you is, what other approaches have any of
you taken in the past?, have any of you taken Levitra, Cialis or
Viagra & can you share your experiences with us all?....
Feedback please....Michael RN, Montclair, NJ

********************************

Dear Michael:


Levitra is all right. It works a lot like Viagra. Cialis works for 2-3 days in some guys. But some still preferred good ol' Viagra since it seems to give them better and faster erections.

I hate all three. They give me headaches, a flushed face, heart burn, diarrhea...yeah I may get hard but who wants to have sex with all these side effects? These side effects were worse when I was on Norvir, even at a lower dose for all three. Al Benson suggested that I used Zyrtec or Claritin plus Advil plus limotyl to counter the three side effects. It seems to work but I hate the pill burden. I prefer to use TRIMIX injections when I am very horny and want to go for a long time (sorry but it is "hard" not to "share" too much when speaking about hard ons). Some guys are still victim of bad doctors and get prescriptions for Caverjet, which is a horrible product in my opinion. One warning: you cannot use "combination Therapy" with TRIMIX or Caverjet plus oral agents like Viagra, Cialis or Levitra. This will send you to the emergency room with an erection that lasts over 12 hours (priaprism) and your penis has to be drained to prevent it from coagulating and causing cangrene.

For a long weekend of fun, Cialis plus my side effect prevention regimen works wonders, but I have to plan ahead for that. I also find that these drugs work better when your testosterone is high-normal. DHEA supplements at 25 mg a day seem to also give me an extra "motivation". It also seems that women I talk to love DHEA at 10-20 mg a day to get their sex drive up.

I remember when all we had was a cock ring to deal with ED. It is so good that in 2008 we have so many options to have good sex even as we age with HIV. I tell people to get over the shame of admitting they have ED and try one of these options. Life is too short for hang ups about performance anxiety.

I find that when my sex drive is the highest, I also feel the healthiest and more connected with people and my partner. It is not all about 'sex" but also feeling passion for others. I am not sure if anyone has done a study about this. Of course, a high sex drive can make some of us compulsive, so we have to be highly aware of that!

I hope this helped some. You should talk to your doctor or an urologist about all of these options.


Nelson

What is the least toxic HIV medicine regimen (HAART)?

Question: what is the least toxic HAART combo?
I've heard that the NNRT/NRTI combo is better than the PI
is that true for first line combo?
I want the least toxic long term combo.
Also want the least side effects long term.
I'm staying away from Sustiva because of the psychological effects.
My. Doc recommends Viramune + Truvada to start.
I'm not resistant to any of the meds.
I'm concerned about the high liver toxicity in Viramune is anyone
taking this?
What about Epivir?
Is there one called Emtriva I can't seem to find it on the net?
Thanks.
J.T.

*****************

Dear JT:


If you do not have liver or rash problems, Viramune plus Truvada may be Ok for naives, except for men with over 450 CD4 cells or women with over 250 CD4 cells. It is too bad that this combo has not been studied much, believe it or not.

Emtriva and Epivir are pretty friendly drugs. Emtriva is part of Truvada along with Viread.

Another extremely friendly combo is Raltegravir plus Truvada. No Norvir, no nightmares or depression. Just a little bloating for a few weeks for a few patients. No increases in bad cholesterol or triglyecerides either, and probably not a bad regimen when it comes to lipoatrophy. It is NOT part of the guidelines for naives yet, but data looks encouraging.


Atripla is good for most people but some never get over the bad dreams, and some may have long term depression due to sleep problems. One of the active medicines in Atripla, Sustiva, can cause increases in LDL and triglycerides in some people.

Reyataz plus Norvir plus Truvada is also not a bad combo at all. Once a day and no bad lipid problems or CNS related side effects. But some people are very sensitive to Norvir, and some have extreme sensitivity to Reyataz when it comes to increases in bilirubin. Saquinavir plus Norvir plus Truvada seems to be ok on triglicerides and does not increase bilirubin, but can increase LDL. Lexiva plus Norvir plus Truvada may be ok also but not as friendly on lipids, and it may also shut down your options down the road since resistance to Lexiva may impair efficacy of Prezista, a second generation protease inhibotor.


Of course, your doctor is always the best source of information.

Congress to reclassify growth hormone and DHEA- Should we be concerned in the HIV field?

Should we be concerned in the world of HIV?

Human Growth Hormone (Serostim) is currently approved for HIV wasting. DHEA is a supplement sold over the counter.

Currently, growth hormone is a class IV drug ( no triplicate or DEA number required for prescribing it). DHEA is an over the counter supplement not shown to increase testosterone at all in men, but they will try to stop its sale over the counter...

http://news.yahoo.com/s/ap/20071218/ap_on_go_co/congress_steroids

"The bill by Sen. Charles Schumer, D-N.Y., would classify HGH as a "Schedule III" substance, equating it legally with anabolic steroids and bringing it under the watch of the Drug Enforcement Administration.
A second proposal by Sen. Charles Grassley, R-Iowa, would make it illegal to sell dehydroepiandrosterone (DHEA) to anyone under 18. DHEA is a naturally occurring precursor to testosterone and a dietary supplement that some athletes are using as an alternative to illegal anabolic steroids, Grassley said."

Testosterone Pellets for More Sustained and Longer Term Blood Testosterone Levels

I just got back from seeing Dr Richard Cavender in New Albany, OH (ammedicalcenter.com) which is close to Columbus. This man has a full wellness clinic like I have always envisioned with exercise equipment that collects your progress data and feeds it wirelessly to a computer for tracking purposes. He also provides hormone replacement and nutritional support. He has a doctor in exercise physiology, physical therapists, registered dietitians, and a psychologist. He has a very charming personality and treats his patients like equals. Great concept and ahead of his time.

He inserted 12 75- mg testosterone pellets (Testopel) under my skin in the upper gluts area. No discomfort and no pain. He has been using them for years and he says most people can sustain proper testosterone levels for 4-6 months. We took baseline blood work and I will do them again in a month and then 3 months after that to see how I respond.

I have been using testosterone for 15 years now without any side effects. However, my busy travel schedule sometimes gets in the way of perfect adherence to gels or shots, so I decided I would give this a try. Bad adherence to testosterone delivery methods can cause swings in mood and energy levels, so I definitely want more constant testosterone levels!


I will let you know when I get my next testosterone level results.