Halloween Safety Tips

Dr. Steven Horvitz- Reading between the Lines:

Bringing you healthcare information you can trust!

Halloween Safety Tips- from keepkidshealthy.com

Halloween is a fun time for kids, but it is also an important time to be extra vigilant for possible safety hazards so that your children have a fun and safe Halloween.

Some tips to make Halloween safe include:

Costume safety

• choose a costume made of flame retardant material
• costumes should be short enough so that they don't cause your child to trip and fall,
• for good visibility, add some reflective tape to the costume or bag he is using to carry candy or make/choose a costume made of bright material that is visible in the dark
• masks should fit securely and allow your child to see well and not hinder visibility
• if using face paint, make sure it is nontoxic and hypoallergenic
• knives, swords and other props should be made of a flexible material, so that they don't pose a hazard if fallen on

Trick-or-Treating safety

• children should be well supervised by an adult when trick-or-treating. Older children should trick-or-treat in large groups in well known neighborhoods.
• carry a flashlight
• stick to well lit houses in familiar neighborhoods only
• follow traffic signals and rules of the road
• drive slowly
• avoid taking shortcuts across backyards or alleys. Stick to the sidewalks of well lit streets

Candy safety:

• instruct your children to bring all candy home before eating it so that you can carefully inspect it for tampering. Children shouldn't snack while they're out trick-or-treating, before parents have a chance to inspect the goodies. To help prevent children from munching, give them a snack or light meal before they go -- don't send them out on an empty stomach.
• Tell children not to accept -- and, especially, not to eat--anything that isn't commercially wrapped.
• Throw out candy or treats that are homemade, unwrapped or if they appear to have been tampered with (pinholes in wrappers, torn wrappers, etc.)
• Parents of young children should remove any choking hazards such as gum, peanuts, hard candies or small toys.
• Wash all fresh fruit thoroughly, inspect it for holes, including small punctures, and cut it open before allowing children to eat it.

General safety tips

• homeowners should prepare their home for trick-or-treaters by removing obstacles from the front yard, restraining dogs and other animals, and lighting the house well
• provide treats that are individually wrapped candy or offer kids nonfood treats, such as stickers and erasers.
• artificial lights and candles are a safer alternative to real candles with a flame that can pose a fire hazard
• if going to an adult Halloween party, make sure that you don't drink and drive. Use a designated driver if alcohol is being consumed.

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Halloween can be a fun time for kids.

But as parents, we are responsible for their:

Safety, Health and Happiness.

So let us review the above safety tips, so our children will not only stay safe, but will stay healthy and have a very enjoyable and Happy Halloween!!

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Aspirin Does Not Prevent Heart Attacks in High-Risk Patients

SOURCE: University of Dundee

DUNDEE, United Kingdom -- October 17, 2008 -- Taking regular aspirin and antioxidant supplements does not prevent heart attacks in high-risk groups with diabetes and asymptomatic arterial disease, according to a study published today in the online issue of the [BMJ].

Although there is considerable evidence showing no protective benefit of aspirin in high-risk patients without heart disease, guidelines are inconsistent and aspirin is commonly prescribed for the primary prevention of heart disease in patients with diabetes and with peripheral arterial disease.

Jill Belch, University of Dundee, Dundee, United Kingdom, and colleagues investigated whether aspirin and antioxidants given together or separately can reduce heart attacks and death in patients with diabetes and arterial disease.

The study included 1,276 patients aged over 40 years with diabetes and evidence of artery disease. Patients were randomized to receive either aspirin or placebo, an antioxidant or placebo, aspirin and antioxidant, or double placebo. Patients were followed over 8 years.

Overall, the researchers found no benefit from either aspirin or antioxidant treatment in the prevention of heart attacks or death. Patients in the aspirin groups had 116 primary events compared with 117 in the placebo group. No significant difference in events was seen between the antioxidant group and the placebo group.

The authors concluded by voicing their concern at the widespread prescribing of aspirin despite the lack of evidence to support its use in the primary prevention of heart attacks and death in people with diabetes and in view of its possible side effects.

In an accompanying editorial, William Hiatt, Colorado Prevention Center, Denver, Colorado, said: "These findings show that unlike statins and drugs for reducing hypertension, which have a benefit in all risk groups including those with and without heart disease, only patients with a history of clinical or symptomatic heart disease or stroke disease benefit from taking aspirin."

SOURCE: University of Dundee

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Interesting study! We have long thought that aspirin was beneficial for prevention of first and future heart attacks, especially for diabetics who have a higher risk of heart and vascular disease. The question is now:

But why not take an aspirin a day? It can't hurt me, can it ???

All medicines may cause side effects, even aspirin. The most common side effects from aspirin include heartburn, nausea and upset stomach. However other reactions can occur and you should seek medical attention right away if any of these SEVERE side effects occur when using aspirin, including:

• rashes
• hives
• itching
• difficulty breathing
• tightness in the chest
• swelling of the mouth, face, lips, or tongue
• black or bloody stools
• confusion
• diarrhea
• dizziness
• drowsiness
• hearing loss and/or ringing in the ears
• severe or persistent stomach pain
• unusual bruising
• vomiting.

This study concludes that "only patients with a history of clinical or symptomatic heart disease or stroke disease benefit from taking aspirin." In other words, regular use of aspirin for prevention of heart disease or stroke in low risk individuals is not helpful and could actually be harmful.

The study also suggests that the use of the cholesterol lowering drugs known as statins benefits all risk groups. I have disagreed with this notion for many years. More info on the cholesterol issue can be found in these past newsletters:

• The side effects of statins: Heart healthy and head harmful?
  
• Cholesterol may help build muscle

Bottom Line:

If you have diabetes and presently have a low risk of vascular disease, and take aspirin only for prevention, you may consider stopping. Whether this advice holds up for individuals without diabetes will hopefully be in a future study.

We all try to do what is healthy. However what we hear is healthy today, we may hear to be harmful tomorrow. That is why you need a doctor who will take the time keep up with the latest medical information, and weed out the truth from the fiction.

To get a truer overall picture of your health, including reviewing and modifying your individual risk factors, you should schedule a yearly preventive physical.

As Benjamin Franklin once said:

"An ounce of prevention is worth a pound of cure"

Eating to Feel Great in the Season of Joy and Feasting

Thanksgiving is the start of the holiday season.

We start thinking of New Years Resolutions to make, many of them ways to take off the excess pounds we gained from Thanksgiving thru New Year.

In the spirit of good health and wellness, let's try something new this year.

With some tasty and real life tips on how to accomplish this monumental task, Dr Jennifer Phillips, an affiliate of the Institute for Medical Wellness has prepared the following:

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Eating to Feel Great in the Season of Joy and Feasting

Starting next week, what gathering will not feature rich deserts to be enjoyed (never passed over) after a rich meal? It wouldn’t be a holiday season without plenty of opportunities to overindulge and to eat what we consider fattening foods. This is the nature of Thanksgiving (proceeded of course by Halloween- we need not forget) and followed closely by Hanukah, Christmas, and New Year’s Eve! And along with this comes all the reasons that we may over-indulge during the holiday season; if not for the sake of tradition, we eat due to stress and fatigue of all the busy-ness and demands that come with the season. But most of all, it’s just fun to eat, and eating is part of the Joy of the season.

I know why I love the holidays- nostalgia. And for me it’s all about the tradition, smells, and joy of preparing delicious foods as the focus of gatherings and gifts. However, not long ago I decided that I was all done with baking 300 cookies to give as gifts to friends and relatives that were already inundated with sweets and treats of the season. No one seemed to miss it! It was a much less stressful season for me. This decision came at the start of my career as a naturopathic doctor and was just one way that I began to slowly change the nature of the feasting season so that it didn’t pack on 5 lbs and a load of unnecessary stress.

The following is not a list of ways to make your holiday stuffing “low fat” or your Christmas cookies “sugar free”. I am a good cook and know that butter and sugar are a necessary part of delicious holiday food!

The key is, as always, moderation and balance. Here are 5 easy suggestions to make a difference in your feasting season:

1. Eat Healthy for 5 out of 7 Days. If your holiday gatherings are on weekends, you have the other 4- 6 days each week to eat as healthy as possible with 1 serving leafy greens, 2 servings of other vegetables (broccoli, carrots, beets, among the best), and 3 servings of whole fruits daily. On non-feast days, (weekdays for example) avoid sugar & white flour, and eat fewer than 3 servings of grains/pasta/potato each day.

2. Eat Healthy the Day of the Event. In anticipation of a holiday feast eat moderately for the meals that proceed it. You can still get in your one serving of leafy greens, two servings of colored vegetables, and 2-3 fresh fruits during the day if you know that it won’t be possible at the evening meal.

3. Bring a Healthy Dish. If you are going to attend a pot luck, bring something healthy but tasty, such as mixed green salad topped with cranberries, pecans and mandarin oranges to make it special. You can fill your plate with this if there are few other vegetable options at the event. I guarantee that you will have complements from others if you make the effort to bring this type of dish instead of a plate of cookies or pumpkin pie.

4. Send Your Guests Packing. If you are the host of a holiday feast, send your guests home with food! Your guests will be glad to go home with a foil-covered plate full of your delicious dinner or dessert. Don’t even ask them before you make a plate for them to take home. Less left-over in your house means less that you’ll be feasting on for the days after your event.

5. Just say NO to the holiday candy jar or “goodie” table at work. Eating sugar at work will lead to cravings that eventually get you many more calories and much less energy to get through your work-day.

Implementing these suggestions will help to keep weight off and will keep you feeling better throughout the holidays.

Enjoy a healthy and happy holiday season!

Jennifer Phillips, ND

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Dr Phillips is a Naturopathic physician and sees patients at my office on Thursday afternoons.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

For past issues of the newsletter, please click here.

Shingles Vaccine- Is it worth getting?

Lately, I have been asked many questions about the Shingles Vaccine or as I will refer to it as Zostavax.

Shingles is caused by the reactivation of the Varicella zoster virus, the same virus that caused you to contract Chicken Pox infection as a child. Some of the causes of this reactivation include increasing age, weakened or altered immune system, physical stress and psychological trauma. Post-Herpetic Neuralgia is a painful condition affecting your nerve fibers and skin that may occur in 1 out of 8 individuals following a Shingles infection. While Shingles may last up to 3 weeks, Post Herpetic Neuralgia can last for many months or more. Luckily, developing Shingles or Post-Herpetic Neuralgia more than once is rare.

A picture of a Shingles rash is included below.

Shingles is not a communicable disease and if you receive the vaccine you have a chance of protecting yourself, but this will not transfer protection to your family, neighbors or community. In contrast, the full series of childhood measles vaccines will protect 99 of 100 children from measles and also will prevent the spread of measles to unvaccinated people in your community. Thus a big difference is that the Measles vaccine prevents initial infection and spread, while Zostavax tries to prevent the reoccurence of Chicken Pox as Shingles.

In the Shingles Prevention Study, Zostavax was found to decrease the annual incidence of Shingles by about 50% in individuals between the ages of 60-80, although the vaccine's long-term protective effects remains unknown. It is also believed that a booster would be necessary at 5-10 years post-vaccination. The vaccine was found to be much less effective in individuals 80 years of age and over and is not recommended for this age group. The side effects of the vaccine are mild and I will refer you back to the Zostavax web site for more information.

Insurance Coverage is also an issue with this vaccine as it is not cheap. The cost varies based on availability and has ranged from $200-300. As of October 2008, all Medicare Part D plans cover Zostavax. However, the amount of cost-sharing (money you have to pay) for the vaccination varies. Medicare Part B does not cover Zostavax. If you have private insurance, your plan may or may not cover the vaccine Please contact your insurer to find out.

If we accept the information contained in the population based Shingles Prevention Study, then if everyone between the ages of 60-80 received the vaccine, it would decrease the annual incidence of Shingles by 50%, or it would seem to protect 50 of 100 people, and it would also seem to reduce Post-Herpetic Neuralgia by about 66%, or 66 of 100 people.

Now let us look at Zostavax from an individual perspective. Shingles occurs in only about 1 out of every 100 individuals per year. So if we vaccinated everyone, the incidence of Shingles would drop by 50%, to about 1 out of every 200 individuals per year. So to prevent one Shingles case per year, we need to vaccinate 200 people. Sounds good for that one person, but how about the other 199? By using the same logic, we would need to vaccinate 7,500 people to prevent one case of Post-Herpetic Neuralgia per year.

Conclusion:

If you are between the ages of 60 and 80 and receive Zostavax, your absolute risk of developing Shingles will be reduced from 1% per year to 1/2 of 1%. Your chance of developing Post-Herpetic Neuralgia will be reduced from 0.13% to 0.08%.

So the choice is yours, and there is no right or wrong choice, just an informed choice!

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Jupiter Study- What does it really mean??

Dr. Steven Horvitz- Reading between the Lines:

Bringing you healthcare information you can trust!

The following is part of the abstract from the New England Journal of Medicine.

You will be hearing alot of information in the press about the benefits of cholesterol drugs, otherwise known as statins, especially Crestor, which was the drug used in this study.

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From the New England Journal Of Medicine:

n engl j med 359;21 www.nejm.org november 20, 2008

Rosuvastatin to Prevent Vascular Events in Men and Women
with Elevated C-Reactive Protein

Background
Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein
predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment.

Methods
We randomly assigned 17,802 apparently healthy men and women with low-density
lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per
liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to
rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the
combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.

Conclusions
In this trial of apparently healthy persons without hyperlipidemia but with elevated
high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)

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ANALYSIS

The Jupiter (Justification for the Use of Statins in Prevention) study, another multimillion dollar study paid for by a pharmaceutical company, this time AstraZenaca.

AstraZeneca wants to justify that Crestor, a statin cholesterol lowering drug, be used in people with normal cholesterol as well as high cholesterol by the outcomes data in the Jupiter study.

Let's take a closer look.

The Jupiter study focused more on testing for inflammation in arteries, via high-sensitivity C-reactive protein as a criteria for inclusion. They want to prove that Crestor would lower inflammation in the arteries and thereby lower major cardiovascular events.

For each year of treatment out of 100 people, 0.17 in the Crestor group versus 0.37 in the placebo group had a heart attack, or an absolute difference of 0.2%. So it would take 500 people a year to take the drug to prevent one heart attack each year. Yet, up to 3% of people may get muscle or liver damage from the drug. That is 1 out of every 33 people.

So every year, 1 in 500 benefit, and 1 in 33 get side effects.

I would also like to follow the money trail and find out who is paying for the interpretations of the study. Below is the long list of consulting agreements to the pharmaceutical industry engaged in by the authors of the study and the funding by AstraZeneca below. This can also be found at the end of study. I have highlighted and underlined pertinent areas for emphasis.

Dr. Ridker reports receiving grant support from AstraZeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; consulting fees or lecture fees or both from AstraZeneca, Novartis, Merck, Merck–Schering-Plough, Sanofi-Aventis, Isis, Dade Behring, and Vascular Biogenics; and is listed as a coinventor on patents held by Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease, including the use of high-sensitivity C-reactive protein in the evaluation of patients’ risk of cardiovascular disease. These patents have been licensed to Dade Behring and AstraZeneca.

Dr. Fonseca reports receiving research grants, lecture fees, and consulting fees from AstraZeneca, Pfizer, Schering-Plough, Sanofi-Aventis, and Merck;

Dr. Genest, lecture fees from AstraZeneca, Schering-Plough, Merck–Schering-Plough, Pfizer, Novartis, and Sanofi-Aventis and consulting fees from AstraZeneca, Merck, Merck Frosst, Schering- Plough, Pfizer, Novartis, Resverlogix, and Sanofi-Aventis.

Dr.Gotto reports receiving consulting fees from Dupont, Novartis, Aegerion, Arisaph, Kowa, Merck, Merck–Schering-Plough, Pfizer, Genentech, Martek, and Reliant; serving as an expert witness; and receiving publication royalties.

Dr. Kastelein reports receiving grant support from AstraZeneca, Pfizer, Roche, Novartis,
Merck, Merck–Schering-Plough, Isis, Genzyme, and Sanofi-Aventis; lecture fees from AstraZeneca, GlaxoSmithKline, Pfizer, Novartis, Merck–Schering-Plough, Roche, Isis, and Boehringer Ingelheim; and consulting fees from AstraZeneca, Abbott, Pfizer, Isis, Genzyme, Roche, Novartis, Merck, Merck–Schering-Plough, and Sanofi-Aventis.

Dr. Koenig reports receiving grant support from AstraZeneca, Roche, Anthera, Dade Behring and GlaxoSmithKline; lecture fees from AstraZeneca, Pfizer, Novartis, GlaxoSmithKline, DiaDexus, Roche, and Boehringer Ingelheim; and consulting fees from GlaxoSmithKline, Medlogix, Anthera, and Roche.

Dr. Libby reports receiving lecture fees from Pfizer and lecture or consulting fees from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, Sanofi-Aventis, VIA
Pharmaceuticals, Interleukin Genetics, Kowa Research Institute, Novartis, and Merck–Schering-Plough.

Dr. Lorenzatti reports receiving grant support, lecture fees, and consulting fees from Astra-Zeneca, Takeda, and Novartis;

Dr. Nordestgaard, lecture fees from AstraZeneca, Sanofi-Aventis, Pfizer, Boehringer Ingelheim, and Merck and consulting fees from AstraZeneca and BG Medicine;

Dr. Shepherd, lecture fees from AstraZeneca, Pfizer, and Merck and consulting fees from AstraZeneca, Merck, Roche, GlaxoSmithKline, Pfizer, Nicox, and Oxford Biosciences; and

Dr. Glynn, grant support from AstraZeneca and Bristol-Myers Squibb.

So do you think there may be a potential conflict of interest relevant to the Jupiter study?

There is more to heart disease than cholesterol and inflammation. While they may be useful markers for potential disease, they do not necessarily become the main cause of disease. If they were, then you would expect much better outcomes.

An analogy I use is that cholesterol is like smoke, and heart disease is like the fire. Cholesterol, like smoke is a warning sign we can spot easily. Using Crestor and other statin drugs can lower cholesterol, or "blow away the smoke". But it does very little to put out the fire or reduce heart disease. When I see alot of smoke, I try to find natural lifestyle changes in diet and exercise to put out the fire. When that occurs the smoke goes away!!

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Experts Conclude Pfizer Manipulated Studies:

New York Times - 8-Oct-2008

The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.

Summary:

• The drug maker Pfizer earlier this decade manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses, according to experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company.
  
• Pfizer's tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, ''spinning'' negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs' lawyers.
• One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out ''a publication strategy meant to convince physicians of Neurontin's effectiveness and misrepresent or suppress negative findings.''
• Pfizer issued a statement Tuesday denying that it had manipulated Neurontin data, saying ''study results are reported by Pfizer in an objective, accurate, balanced and complete manner, with a discussion of the strengths and limitations of the study, and are reported regardless of the outcome of the study or the country in which the study was conducted.''
• The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.
• In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors.
• Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.
• Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries.

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Here we go yet again.

The story above concerns Pfizer, but they are not alone. Many pharmaceutical companies employ the same strategies, and you need to be aware, especially when watching their well produced television commercials.

For physicians to utilize medications properly, we need to have access to good information. This should include not only positive results, but also the negative results of testing and trials. Physicians need to use their own brains to pore through all the information, and use their instincts to distinguish truthful information from what I will now dub, pharminformation.

In today's health insurance dominated system, patient's are often rushed through their doctor's evaluation quickly. It is easier for a doctor to hand you a prescription and move on to their next patient. It would only take a few more minutes to get to the root cause of your illness, and to formulate other options or treatments, instead of relying on just a prescription. And the more rushed doctor's are, the less time they have to think through the pharminformation. The healthcare system has changed the way doctor's practice, and it has changed the trusting relationship the pharmaceutical industry once had with the public.

Treating the individual and their illness, instead of only their symptom has been my focus since I started my practice. I do not rush through patient visits. You are given the time needed to discuss your issues and to answer follow up questions appropriately. Sometimes that puts me a few minutes behind schedule, and I apologize. But be certain that I will always give you the time you need. A few extra minutes of conversation goes a long way in preventing pharminformation from affecting your health.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

State sues Merck for deceptive marketing of Vioxx

South Florida Business Journal- Wednesday, October 1, 2008 - 11:49 AM EDT

Florida Attorney General Bill McCollum has filed suit again Merck & Co. for alleged deceptive marketing and promotion of the prescription drug Vioxx.

The lawsuit claims that Merck repeatedly failed to disclose the drug’s adverse effects while offering it to the state’s Medicaid program as a safe painkiller, in direct violation of Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx was used to treat joint pain until it was removed from the market in 2004 after studies suggested those taking it had an increased risk of heart attack and stroke associated with long-term use.

The lawsuit follows a three-year investigation of Merck’s promotional practices and alleges that, due to the company’s marketing practices, numerous state agencies approved the inclusion of Vioxx as a covered or approved drug, and agreed to pay for the prescription or reimburse its expense.

In a prepared statement, Merck said it acted responsibly and intends to defend the complaint, which is similar to those filed by eight other states and pending in federal and state courts.

“The medicine was labeled appropriately under the direction of the FDA according to evolving science available at the time it was on the market,” the company stated in a news release.

Vioxx purchases by the Florida Medicaid program alone exceeded $80 million between 1999 and 2004.

The suit also alleges that Merck tried to intimidate physicians and researchers who questioned the safety of Vioxx, and may have misrepresented or concealed published evidence, including its own, showing possible harmful effects.

The lawsuit demands restitution to the state plus interest, for all state program payments – including Medicaid reimbursements – made for Vioxx prescriptions. It also seeks civil penalties of up to $10,000 per violation.

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Well, Don't say I didn't tell you so!

In one of my recent newsletters from September 21, 2008, Top-Selling Prescription Drug Mismarketed to Women?, I wrote , "I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor."

Fortunately or unfortunately it seems that the state of Florida is making my prediction ring true by filing suit against Merck Pharmaceuticals Vioxx medication. Vioxx is in a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Vioxx worked by reducing substances that cause inflammation, pain, and fever in the body. The manufacturer of Vioxx, in 2004, announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal was due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

What the true risks of Vioxx were will probably never be known. In my practice, Vioxx worked very well and caused very few and minor side effects. It was removed from the market not due to lack of efficacy, but due to the economic potential of future lawsuits. It was a sad day for the 99%+ of patients who used the drug safely and effectively. But it was a sadder day for the patients who were potentially injured by the drug.

This all could have been avoided if Merck marketed the medication properly and did not allegedly attempt to hide data that showed possible complications from using the drug. If Merck had been prudent and shared this knowledge beforehand, Vioxx would still be on the market, helping millions of patients with Arthritis and other inflammatory conditions. It would have a big black-box warning attached to it warning of the dangers in a select population, but it would still be in use today.

Motto of the story: Big Pharma needs to work on their business and marketing practices and once again put patients health and well being ahead of profits. Until that time, do not expect the pharmaceutical industry to be trusted or respected as it had in the past.

If you have any questions on your medical care and the medications you take, call the office, make an appointment and discuss your options. My motto has always been to use the least amount of medication possible and only when necessary.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Top-Selling Prescription Drug Mismarketed to Women?

From the PharmaLive.com News Archive - Sep. 17, 2008

ITHACA, N.Y. – September 17, 2008 – Lipitor has been the top-selling drug in the world and has accounted for over $12 billion in annual sales. It has been prescribed to both men and women to lower cholesterol and reduce the risk of heart attack and stroke in patients with common risk factors for heart disease. However, a new study appearing in the Journal of Empirical Legal Studies was unable to find high quality clinical evidence documenting reduced heart attack risk for women in a primary prevention context. Furthermore, advertising omits label information relevant to women.

Theodore Eisenberg of Cornell Law School and Martin T. Wells of Cornell University assembled studies for a meta analysis of drugs’ effects on cardiovascular risk, taking into account all relevant studies reporting risks for both men and women.

Not one of the studies that included women with a mixture of risk factors for heart attacks provided statistically significant support for prescribing Lipitor or other statins to protect against cardiovascular problems. Pfizer’s claims of clinical proof that Lipitor reduces risk of heart attack in patients with multiple risk factors for heart disease does not appear to be scientifically supported for large segments of the female population.

In addition, Lipitor’s advertising repeatedly fails to report that clinical trials were statistically significant for men but not for women. Unqualified advertising claims of protection against heart attacks may therefore be misleading. Pfizer’s advertising also does not disclose critical portions of the Lipitor FDA-approved label, which acknowledges the absence of evidence with respect to women.

“Our findings indicate that each year, reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist,” the authors conclude.

This study is published in the September 2008 issue of the Journal of Empirical Legal Studies.

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This article shows the increased scrutiny of the pharmaceutical industries medical studies, medical claims and marketing practices.

As many of you already know, I am not a big fan of Lipitor or other statins, such as Crestor, Pravachol, Zocor, Mevacor and Lescol. Their use in prevention of heart disease leaves a lot to be desired. While not being a fan of statin drugs, I still am a fan of the pharmaceutical industry, just as I am a fan of the vitamin and neutraceutical industries, as long as their claims are valid and marketed truthfully.

I hope I am wrong, but this article from the Journal of Empirical Legal Studies may be a trial balloon for legal trouble for the pharmaceutical industry. We may soon see health insurers, Medicare and State Medicaid filing lawsuits worth billions of dollars to recover money spent on alleged false claims for Lipitor.

There are other methods of reducing heart disease risk, that do not rely on drugs. Eating and exercising properly. quitting tobacco, and reducing alcohol intake are just a few. The goal is not to lower your cholesterol number to the lowest it can go, but to increase your age to the highest it can go, but in a safe, effective and healthy manner that increases your quality of life. That is the goal of my practice, and I hope it is yours as well.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Battle Plan to Quit Cigarette Smoking

As we know smoking is a leading contributor to heart disease, high blood pressure, emphysema and many different forms of cancer. Quitting smoking can decrease these risks dramatically.

Many patients come into my office asking for the latest fad or the latest pill to quit smoking. Usually the request will come at the end of the patient visit as, " By the way doc, Can you give me a prescription for that new pill that will stop me from smoking? " To my patient's surprise, my answer is almost always "No, not right now." I usually get a quizzical look and then a "Why not doc? Don't you want to help me quit smoking?"

Let me explain:

It is not that I want you to continue smoking. I just want you to fully prepare for the battle that lies ahead of you. I want to help you to succeed, not set you up to fail. There is no pill or patch that alone, will stop you from smoking. To quit smoking you need to set up a battle plan as if you are in a war.

Here are a few questions you must ask yourself when you decide to try to quit smoking:

· Do I enjoy smoking?

· Why do I smoke?

· Where do I smoke?

· When do I smoke?

· Who do I smoke with?

· How much do I smoke?

· How much do I spend on cigarettes per day, per week, per month and per year?

· Do I get sick more often due to smoking?

· Do I miss work or school due to smoking?

I always ask my patients to think about these questions, devise answers to each, and then develop a plan of attack to combat them. Once the plan is set, I ask my patients to come in to my office to review their plan. If the plan sounds reasonable we then review the different pharmaceutical and non-pharmaceutical options available that might help. But please let me repeat myself. I have never seen a patient quit smoking just by taking a pill. Every patient who has been successful at quitting smoking first devised a plan of attack and also had the courage, motivation and true desire to quit.

I encourage all my patients who smoke to please utilize all resources available in your effort to quit. When you feel you have developed a plan and need my help, the chances that you will succeed will be much greater!

Below are some resources that you may utilize to develop your battle plan:

www.NJQuitNet.org
www.Chantix.com
http://www.gsk-scrc.com/ (Smoking cessation resource center)
www.quit.com

Good Luck and I hope to see you in my office with a well developed battle plan soon!!

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

Pharmaceutical Advertising- Good or Bad?

Pfizer Resuming Ads for Lipitor After Controversy

From The Associated Press WorldStream - Sep. 02, 2008

TRENTON, N.J._Television ads for the world's top-selling drug, cholesterol fighter Lipitor, are back, six months after Pfizer Inc. pulled them amid charges its use of a celebrity doctor endorser who's never practiced medicine misled the public.

This time, Pfizer is leaving out the celebrity.

In the new ads, the endorser is a talent agent from the San Francisco Bay area who tells viewers he started taking Pfizer's Lipitor after surviving a heart attack last year.

The ads began running Tuesday and will be part of an open-ended national campaign that also includes print ads in newspapers and magazines, said John Sage, head of Pfizer's marketing team for Lipitor.

Lipitor generates more than $12 billion a year in revenue for New York-based Pfizer.

Pfizer had run frequent TV ads from late 2006 until then in which artificial heart inventor Dr. Robert Jarvik endorsed Lipitor, appearing to be giving medical advice. While he holds a medical degree, Jarvik never completed licensing requirements to practice medicine.

Pfizer, the world's biggest drugmaker, pulled the ads in February as members of Congress were investigating and media outlets were reporting on that conflict and Pfizer's use of a stunt double in an ad that showed Jarvik rowing.

"Although it wasn't clearly our intent, the ads created misimpressions and distractions around what we were trying to do," Sage said late last week.

He said the man in the new ad, John Erlendson, is "a real Lipitor patient, who is very representative of people with" cholesterol problems.

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Growing up in my father's family practice office, I saw the interaction between doctors and pharmaceutical sales reps. I have seen the interaction change very little over the past 20 years, but what has changed is the public perception of Big Pharma.

Big Pharma used to be adored by patients and by Wall Street.

But No Longer!

Why???

Just look at the a few items.

1) Direct to Consumer Advertising for medications that may cost the same as a car payment with very little if any benefit over much more affordable generic medications.

2) Putting profits ahead of patient care. I have analyzed many of the big medical studies that are marketed to doctors, and much of the statistics are achieved with smoke and mirrors. Profits to improve their stock prices has more influence than patient health and safety.

3) The most telling point comes from my discussions with many of the pharma reps. Ten years ago, the reps were usually 10-20 year veterans in their fields and hoped to remain until retirement. Today , many of the reps are much younger, and are keeping their eyes and ears open for other employment. They see the future of their industry and at present it does not look so good.

Pearl of the day.

Never believe the pharmaceutical marketing and propaganda on television or print advertisements. Their goal is to sell you something that most likely you do not need.

If you have any questions on your medical care and the medications you take, call the office, make an appointment and discuss your options. My motto has always been to use the least amount of medication possible and only when necessary.

Steven Horvitz, D.O.

Board Certified Family Medicine

Founder of The Institute for Medical Wellness

For past issues of the newsletter please click here.
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Addendum: 9-9-2008 taken from a pharmaceutical website:

Published on FiercePharma (http://www.fiercepharma.com)

Pharma drops again in public opinion

By tracy

Created Jun 30 2008 - 10:01am

It's not pleasant company at the bottom of this list. According to a new Harris Interactive poll, only 26 percent of Americans have a favorable view of the drug industry--a record that's even worse than Big Oil, and better only than tobacco companies. It's a low point, following a slow-but-steady decline in consumer opinion.

Fair? That's not the point. The question is, do drugmakers intend to do whatever it takes to reverse the trend? Or should they just accept the dubious honor? Given the challenges pharma faces these days, improving public opinion may not be number one on the priority list.
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Published on FiercePharma (http://www.fiercepharma.com)

Survey: Pharma not a good info source

By tracy

Created May 29 2008 - 10:35am

Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit [0]?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Nearly half of the responders said pharma has too many conflicts of interest to be appropriate sources of general information on medications.

Some of the responses, however, indicated that if drug companies provided a clear distinction between ads and information, they could be valuable repositories because of their intimate knowledge of their products.

The opinions will be factored into decisions about a proposed code of conduct governing the release of info about pharmaceuticals in the E.U.
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Pharma CEOs mull industry "trust deficit'

By admin

Created Apr 24 2008 - 6:59am

We love it when pharma CEOs depart from their usual talking points about financial results and restructurings and pipelines, to wax philosophical on their place in the word. This week, we heard an entire trio musing on the state of the industry: Merck chief Richard Clark, GlaxoSmithKline's putative chief Andrew Witty (photo [1]), and Pfizer's Jeff Kindler (photo [2]). Some choice bits:

• Pharma's equilibrium is "shattered," Witty told the Academy of Medical Sciences this week. To fix it, drug makers need to listen more--and talk more--particularly with drug buyers (about the true value of new meds) and with government. Pharma and regulators are "like two ships missing in the night," he said.
  
• "There is a trust deficit we have to fix," Merck's Clark told The Star Ledger, when asked about lessons learned from the Vytorin controversy. "I think everyone has a lesson to be learned from this. Drug makers "may have to become more transparent" about their spending and their relationships with docs, he said.
  
• "There's a lot of public concern about the pharmaceutical industry," Kindler told the Wall Street Journal. "But...everybody recognizes that you can't solve the healthcare reform problem without an innovative, healthy pharmaceutical industry. We have to be a part of the solution." He went on to talk about truth-telling: "It's important for the industry to communicate with integrity and to do everything it can do to insure the integrity of the data and the science."

Sounds like these guys are all picking up on the same vibe: communication, transparency, telling the truth. And that they recognize that the "shattered equilibrium" and "truth deficit" need to be fixed. What will they do to make that happen, that's the question.
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Published on FierceBiotech (http://www.fiercebiotech.com)

10 reforms for drug advertising

By maureen

Created Aug 2 2007 - 2:06pm

At BrandweekRx, Jim Edwards outlines 10 direct-to-consumer advertising reforms he says are urgently needed to protect consumers from unscrupulous drug advertising. Edwards' recommendations include banning product-placement ads and forcing drug companies to disclose to the SEC how much money they're spending on advertising (companies don't have to say how much is spent promoting a drug, but it's about double the cost of R&D). He also recommends an FDA requirement for head-to-head studies between competing drugs so that doctors can make educated decisions when prescribing medications. Finally, Edwards argues in favor of total transparency of the amount and usage of drug company dollars spent on Continuing Medical Education, along with full disclosure of payments and gifts to doctors.