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Hospitalizations from prescription drugs increase 98% in 5 years!

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Below is an article on prescription abuse and misuse in the U.S.  The numbers are startling.  If we want to begin to cut health care costs we need to reign in the pharmaceutical industry and their aggressive marketing.  See my comments at the end of the article.

NY Times Article

By ABBY GOODNOUGH
Published: January 5, 2011

The number of emergency room visits resulting from misuse or abuse of prescription drugs has nearly doubled over the last five years, according to new federal data, even as the number of visits because of illicit drugs like cocaine and heroin has barely changed.

The Substance Abuse and Mental Health Services Administration found there were about 1.2 million visits to emergency rooms involving pharmaceutical drugs in 2009, compared with 627,000 in 2004. The agency did not include visits due to adverse reactions to drugs taken as prescribed.

Emergency room visits resulting from prescription drugs have exceeded those related to illicit drugs for three consecutive years, said R. Gil Kerlikowske, President Obama’s top drug policy adviser.

“I would say that when you see a 98 percent increase,” Mr. Kerlikowske said, “and you think about the cost involved in lives and families, not to mention dollars, it’s pretty startling.”

In 2010, the Substance Abuse and Mental Health Services Administration reported that the number of people seeking treatment for addiction to painkillers jumped 400 percent from 1998 to 2008. And in a growing number of states, deaths from prescription drugs now exceed those from motor vehicle accidents, with opiate painkillers like Vicodin, Percocet and OxyContin playing a leading role.

In September, the Drug Enforcement Administration organized the first national prescription drug take-back program, and thousands of people dropped off old or unused drugs at designated locations around the country. While the effort captured but a tiny fraction of the addictive drugs in the nation’s medicine cabinets, law enforcement officials said it helped people understand how deadly such drugs can be. Another collection day is being planned for April, Mr. Kerlikowske said.

“The most important thing that actually seems to be gaining a lot of traction,” he said, “is the recognition that the prescription drugs sitting in your medicine cabinet can be dangerous. That’s huge.”

Dr. Court’s Comments

In a time when health care costs are through the roof and insurance premiums continue to rise this story explains a lot.

Since 2004 the number of emergency room visits has almost doubled because of complications from pharmaceutical agents that were misused or abused.  This does not take into account the number of people who are hospitalized because of adverse reactions or complications from taking their medications as prescribed.

There is a major war going on against illicit drugs like cocaine and heroin and rightfully so.  But according to this research hospitalizations for prescription drugs exceed those of the illegal drugs.  Why are we not fighting back against this problem?

In my opinion, the aggressive marketing of pharmaceutical drugs is partly to blame.  Just watch the nightly news.  You will see ad after ad for drugs. This leads people to believe that these drugs are basically harmless because of the happy and joyous people you see living their wonderful lives on these drugs.  It desensitizes people to their dangerous side effects.

Don’t believe me?  How much attention do you think the average American pays to the list of side effects that each company is required to state in their commercials?  The level of attention is directly related to how many times to you hear something.  The more you hear it, the less you pay attention to it.  And you hear it all the time!  You can’t get away from it on television.

Prescription drugs have their place, but that place should be as a last resort.  If all other methods have failed, perhaps  a drug will work. Tell me if this sounds familiar:

“If diet and exercise alone are not enough to control your cholesterol, adding Lipitor may help.”

You know what the problem with that statement is?  Diet and exercise are never given a chance.  The first thing that happens when someone is diagnosed with high cholesterol is a prescription is written.  No advice about diet or exercise is given.  Over prescribing has become a habit in the medical community and because of this, we pay the price.

If we want to reduce the number of hospitalizations from prescription drugs we need to reduce the number of prescriptions that are written in this country by using safe and effective alternatives and we need to stop the aggressive marketing of pharmaceutical agents to the general public.

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Solving Childhood Obesity Part IV – Food Marketing

The marketers that come up with advertising campaigns for the food industry are pure genius.  They can take a food that is completely unhealthy and spin the commercial so that it appears as if the food is as good (if not better) than any health food available.  My rant on Tostitos is a good example. (Click here to read the post.) Some excerpts and statistics from this blog were taken directly from the Let’s Move Report to the President available at www.letsmove.gov.

Honey Nut And Chocolate Cheerios are Health Foods!

I recently saw another good example.  This was a Honey Nut Cheerios commercial.  It started about by talking about cholesterol and how high levels of the stuff can be bad for you.  Then it mentions how whole grains can improve cholesterol numbers.  I have issues with that statement as well but that’s a whole different post.  The commercial continues and states that Honey Nut Cheerios is made from whole grains and in a “study” was shown to reduce cholesterol.  We are of course provided no information on this so called study, but it sounds official so it’s included in the commercial.  They also put a big read heart on the box to suggest that eating Honey Nut Cheerios is heart healthy.  At the end of the commercial they also introduce Chocolate Cheerios and it too has a big red heart on the box!  It’s heart healthy too!  The problem?  Honey Nut Cheerios and Chocolate Cheerios are not heart healthy!  In fact, they are the opposite.  They are loaded with sugar and are not a good way for children to start the day.

Both Honey Nut Cheerios and Chocolate Cheerios provides a child with the equivalent of more than 4 teaspoons of sugar to start the day.  That’s equal to half a soda for breakfast.  Would you let your child drink half a soda for breakfast?  Probably not.  But wait, Cheerios does provide vitamins and minerals, right?  Yes, they do but what if Coca Cola decided to fortify its soda with vitamins and minerals?  Does it make soda healthy?  Certainly not.  I have provided the nutrition information and packaging of both Cheerios below for your viewing pleasure.

As you can see, both boxes have the big red heart on them.  The marketers know that the vast majority of people that see this box with assume that means Cheerios is healthy and that’s a major problem because it’s cereals like this that are contributing to childhood obesity is a big way.

The Marketing Billions

Food marketing to children and adolescents is a big business. The Federal Trade Commission (FTC) estimates
that, in 2006, food, beverage, and quick-serve restaurant companies spent more than $1.6 billion to promote their products to young people. Children and adolescents are an important demographic for marketers for several reasons: (1) they are customers themselves; (2) they influence purchases made by parents and caregivers; and (3) they are the future adult market.  The last reason is of particular importance to marketers.  Just like the cigarette companies of the 50’s and 60’s, the food industry knows that if it can get you hooked on their products as a child, you are unlikely to change as an adult.  Habits are hard to break.

Food and beverage companies utilize a full range of marketing techniques including print, internet advertising (such as advergames), product packaging, in-school marketing, cross-promotions, prizes and contests, and the use of popular licensed characters that appeal to children and adolescents.

Marketing Works (Unfortunately)

Research conducted by the Sesame Street Workshop in 2005 found a strong influence of popular licensed characters on preschoolers’ food preferences. When preschoolers were asked if they would rather eat broccoli or a Hershey’s chocolate bar, 78% of the children chose the chocolate bar and only 22% chose broccoli. When an Elmo sticker was placed on the broccoli, however, 50% of the children chose broccoli.  This shows that children are extremely impressionable and will likely always want to eat the foods that have the marketing behind them.  Unfortunately, this is almost always foods that are nutrient empty.

Can Big Business Police Itself?

The food industry claims it is concerned with the health of children.  In 2006 the Council of Better Business Bureaus established the Children’s Food and Beverage Advertising Initiative (CFBAI).  CFBAI was intended to change the ratio of food and beverage advertising messages directed to children under the age of 12 to encourage healthier eating and lifestyles. It has 16 current member companies – Burger King, Cadbury Adams, Campbell Soup, Coca-Cola, ConAgra Foods, Dannon, General Mills, Hershey, Kellogg, Kraft, Mars, McDonald’s, Nestle, PepsiCo, Post Foods, and Unilever.

These companies are doing this on a voluntary basis and have set guidelines for themselves:

  1. 100% of child-directed television, print, radio, and internet advertising must promote “healthier dietary choices” or “better-for-you” products.
  2. Products depicted in child-directed interactive games must be “better-for-you” foods or the games must incorporate healthy lifestyle messages.
  3. Companies must reduce their use of third-party licensed characters in advertising that does not promote healthy dietary choices or healthy lifestyles.
  4. Companies must not pay for or actively seek placement of their products in entertainment directed at children.
  5. Companies must not advertise food or beverage products in elementary schools.

While these guidelines sound noble, it’s like asking the wolves to guard the sheep. A recent examination of the CFBAI has showed that it really is nothing more than a thinly veiled attempt to appease the public while continuing to do what they have always done.

The Federal Trade Commission’s 2008 report on the CFBAI noted that the participating companies’ nutritional standards, as well as their definitions of “child-directed,” vary by company. Within certain guidelines, each company developed its own nutritional standards for what constitutes a “better for you” food or a “healthy dietary choice.” Moreover, the FTC criticized the program for applying these standards only to certain forms of advertising.

A recent study analyzed the effectiveness of the CFBAI and found that it had not substantially shifted advertising for children toward healthier products. Using one measure of nutritional quality, the study determined that, in 2009, advertisements for healthy products accounted for a very small fraction of all advertising by participating companies, while most advertising promoted foods of low nutritional value. The study also found that companies participating in the CFBAI nearly doubled the use of licensed characters over the past four years, increasing from use in 8.8% of advertisements in 2005 to 15.2% in 2009. Roughly half of all advertisements with these characters are for foods in the lowest nutritional category.

This clearly shows that while the guidelines have been set, they are not abiding by them at all.  And why would they?  There is no actual power in this CFBAI.  It’s a voluntary group that is regulating itself.  The food industry is not going to do anything that may cost them any profit.  The sad fact is though that it is costing the youth of America their health.

The Solution

There has got to be tighter regulation on what is termed health food.  Just because it contains whole grains does not make it a health food.  Industry wide changes need to be made.  Official guidelines need to be set that categorize foods into good and bad (easier said than done, I might add) and these big companies need to be forced to adhere to them.  The consequences of not doing so need to be severe as well.

Another big part of the problem is the lack of education in the general public.  I see these ads and brush them off as ridiculous.  I can do this because I’ve had years of nutritional training.  While it does not take years to train someone how to eat and evaluate food properly, the food industry knows that most people don’t know the difference between good and bad foods.  They also know that people trust what they see on television.  If they are told that Chocolate Cheerios are heart healthy then it  must be true.

Education is the only real solution to this problem.  Children need to be taught from a young age what foods are good for you and what foods should be viewed as treats and eaten sparingly.  My advice to my patients is always the same – if it comes in a box and is processed, don’t eat it. Those are the most likely culprits to destroy your health.  Shop around the edges of the grocery store.  Skip those middle aisles with all the cookies, snacks and cereals.  Most of the cereals on the market today are no better than a box of cookies anyway.  If you do this, you’ll live a healthier and happier life.

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Take Our Quiz – 10 questions to find out what you know about the latest health news!

Take our quiz and let us know how many you were able to answer correctly.  If you don’t know the answer, search our blog for it!

1. Q: Discount brands of fish oil were recently found to contain what carcinogenic chemical?

2. Q: A recent study confirmed what treatment was beneficial for depression relief?

A. Massage
B. Chiropractic Adjustments
C. Acupuncture
D. Yoga

3. Q: What genetic disease was recently demonstrated to cause infertility in women?

A. Rheumatoid Arthritis
B. Celiac Disease
C. Cystic Fibrosis
D. Diabetes

4. Q: If you want to improve your brain function, what activity should you participate in?

5. Q: Drinking more than two sodas per week increases the risk of cancer of the…?

A. Pancreas
B. Colon
C. Breast
D. Skin

6. Q: Low levels of what neurotransmitter were found in babies who died of SIDS?

A. Dopamine
B. Glutamate
C. GABA
D. Serotonin

7. Q: Which nutrient was recently shown to be linked to Autism?

A. Vitamin C
B. Vitamin E
C. Vitamin D
D. Vitamin A

8. Q: A new field of study has showed that our genetic make up does not necessarily control our entire health picture.  What is the name of this field of study?

A. Genetics
B. Epigenetics
C. Hypogenetics
D. Engineered genetics

9. Q: Recent epidemiological studies show that the US currently ranks ____ in terms of obesity rates in the world.

A. 1st
B. 2nd
C. 3rd
D. 4th

10. Q: What type of diet is most favorable for reducing inflammation and losing weight?

A. Low fat
B. Low carb
C. Combo of low fat and low carb
D. Low protein

The answers to all of these questions are listed below.  You can find the articles from which they came here on our blog.  Search our tag cloud on our home page for the key words if you want!

ANSWERS: 1. PCBs, 2. C, 3. B, 4. Napping, 5. A, 6. D, 7. C, 8. B, 9. C, 10. B

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Like Smoking, Soda Needs to be Taxed

Sugar intake, especially in children, is a major US health problem.  It is a major contributor to obesity and is creating an epidemic of diabetes in children, a disease once considered an adult problem.  The soda industry, much like the tobacco industry in the 80’s, markets heavily to children knowing that if they can form the habits of soda drinking young, they will most likely have a life long costumer.

While soda is not chemically addictive, although some would argue that point, it certainly creates dependency.  It does so by setting up a dangerous process within the body by which a person can become dependent on the sugary surge they get from a soda to feel normal.  Also consider that many sodas contain caffeine.  This caffeine also have a profound affect on a person and can actually cause withdrawal symptoms just like a drug.  The withdrawal symptoms can be very uncomfortable and include  headache, fatigue, sleepiness, inability to focus and concentrate. Others report experiencing flu- like symptoms, irritability, depression and anxiety.

The real problem of soda, however, is the sugar in soda.  It forces the body to release a hormone called insulin in such large quantities that children quickly become insulin resistant and soon thereafter are diabetic.  Soda creates a disease in children that used to take decades to develop in adults.  These children are also overweight increasing their risk for just about every chronic disease ranging from heart disease to cancer.  This places a huge financial burned on our health care system, driving cost up higher and higher.  The way to off set this?  Perhaps a soda tax is the answer.

The Joint Committee on Taxation calculated that a 3-cent tax on each 12-ounce sugared soda would raise $51.6 billion over a decade.  This is quite a lot of money.  A 12 pack of Coke costs about $2.99 so that would up the price to $3.35.  It certainly isn’t enough to stop people from buying their sodas, but it would provide some income to help fight the health problems it is causing.  Proponents of the tax say the money would be used to fund a health marketing campaign to teach people how to eat healthy.  This is a good idea only if they teach it correctly and disregard the whole low fat paradigm.  Studies show that sugared beverages are the No. 1 source of calories in the American diet, representing 7 percent of the average person’s caloric intake and up to 10 percent for children and teenagers.  You will notice sugared beverages are fat free!  Maybe the beverage industry should start advertising that.  The problem in this country is the carbohydrate consumption is through the roof.  Teaching people about eating fat free is a terrible idea because it will only push people towards things high in sugar like soda.  They are fat free after all!

The marketing campaign needs to focus on low glycemic, low carbohydrate options.  This is the only way to change the health picture in the US.  We need to shift our paradigm and consider that fat is not the enemy.  Carbohydrate is.  Simple and refined carbohydrates cause disease and keeping them out of the diet is the single most important factor in long term health.

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Learning to Read Labels

When I put patients on a diet, I routinely ask them to look at the labels when they’re buying various products.  It is not uncommon, however, that people aren’t very efficient readers of food labels.  You know, that small black and white box of letters and numbers on the sides of food containers?  The reason I ask patients to read these is because it contains valuable information on it.  I like people to look at the carbohydrate content because this will be most reflective of whether it is a healthy food or not.  Foods with high carbohydrate content and high amounts of sugar are obviously not healthful.  After several months of reading labels it becomes very natural and you can actually begin to guess what the contents of certain foods are without even looking at the label.

The problem though is that the current food labeling system can be quite confusing.  There are a lot of people that don’t know what a calorie is.  There are a lot of people that don’t know the difference between fat, carbohydrate and protein.  There are a lot of people that don’t know that all three have profoundly different affects in the body when consumed.  Learning these are of utmost importance for being able to understand the nutrition label.

What is a calorie?

The definition of a calorie is a unit of heat equal to the amount of heat required to raise the temperature of one kilogram of water by one degree at one atmosphere pressure.  Not helpful?  Didn’t think so, but that’s the definition.  Basically a food’s caloric content is measured using this definition and chemical process.  When speaking of food calories we are actually talking about kilocalories because there are other caloric measurements.  The basis of caloric measurements is based on gram calories or 1/1000 of a kilocalorie.  If we used gram calories as the standard, food would contain hundred of thousands of “calories” and would difficult to calculate caloric content.  So, kilocalories are used to measure food and the term -kilo is dropped from the word to give us simply a calorie.  Calories are measured in a ‘calorimeter.’ A substance can be combusted (literally burned) in the presence of oxygen, to measure the amount of heat generated per gram. From such basic measurements, and by extrapolation to mixtures of different ingredients, the ‘calorie count’ can be applied as a measure of the energy derivable from a food source.

Basically, what you need to remember is that a calorie is energy.  We use the energy, or calories, from our food to survive.  They allow us to pump blood, breath, think, etc.  Without calories we cannot survive.

What is Fat, Protein and Carbohydrate?

These are considered the macronutrients and they contain different amounts of calories.  Protein and carbohydrates both contain 4 calories per gram.  Fat contains 9 calories per gram.  Basically what this means is that any amount of fat contains a little more than twice the energy that the same amount of protein and carbohydrates does.  

Protein

Protein is used to do a lot of things in the body.  It is used for cell signaling, cell structure, enzymes, neurotransmitters, muscle function and many other things.  It supplies a small amount of energy when needed.  It is very important.

Fat

Fats play a vital role in maintaining healthy skin and hair, insulating body organs against shock, maintaining body temperature, and promoting healthy cell function.  It is also a great energy source.  They are also important in that they must be present to absorb the fat soluble vitamins which are vitamin A, D, E and K.

Carbohydrates

Carbohydrates are the most common source of energy in living things.  Just because they are common, does not mean they are necessary for survival.  There is no such thing as an “essential” carbohydrate.  You can obtain all the energy you need from fats and proteins.  There are, however, essential proteins and fats.

So What’s Wrong with the Current Food Label?

The current food label is confusing and should be set up a little differently.  To see a great example of what it should look like click here and scroll to page 6.  This is from the Center for Science in the Public Interest.  There are some things that I agree with on this “new” label and some I do not.

I agree that there needs to be clarification with regards to the amount of calorie in each serving.  People often see 350 calories listed and can’t figure out how much food they can have for their 350 calories.  On the new label clearly stating that there are 350 calories in one serving makes that a little easier.  Secondly, the larger typing on the whole label makes it a lot easier to read.  Thirdly, there are a lot of foods that claim they have whole grain content.  At the top of this new label, companies would be required to tell you how much is whole grain.  In this case, it’s a lowly 2%.  I think that is a great idea because the food industry is getting away with marketing their products a whole grain when it fact they contain very little of it.  I also like the red numbering and lettering letting you know that you should pay attention to what’s been highlighted.  Although I believe they should highlight the total carbohydrate content rather than just the added sugar, it’s a good start.  It’s lets people know they need to pay attention to these things because they are important.  I also like how the major and minor ingredients have been broken down so you can see clearly what this food is actually made up of.  Separating the ingredients by bullets and taking out all the capital letters is also very helpful.  I have many patients with allergies and the allergy information at the bottom would be a life saver for these people.  It’s a great idea to have it listed on every package.

People need to take their own health into their hands and not rely on others to do it for them, but this is a great step in the right direction.  Making the food labels easier to understand would probably help a lot of people manage their diets more effectively.

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Coca-Cola and Heart Health? Precisely why America is the least healthy industrialized country.

Coca-Cola has partnered with The National Heart, Lung and Blood Institute to sponsor a heart health awareness program.  The main sponsor happens to be Diet Coke which on the surface looks to make sense.  Most people know that regular Coke is loaded with sugar and contributes significantly to heart disease.  The fact that the sponsor is Diet Coke is irrelevant.  This is a marketing stunt by Coke designed to get more press for the entire Coca-Cola brand.  When people leave an event sponsored by Coca-Cola they hope you leave, go to the store and remember the name Coca-Cola.  There won’t be a Coca-Cola representative with you to make sure you buy the “heart healthy” Diet Coke.  And Diet Coke is hardly healthy by the way.  It is loaded with an artificial sweetener called aspartame which has serious health consequences by itself.  Read below for information about aspartame.

Aspartame is the technical name for the brand names NutraSweet, Equal, Spoonful, and Equal-Measure. It was discovered by accident in 1965 when James Schlatter, a chemist of G.D. Searle Company, was testing an anti-ulcer drug.

Aspartame was approved for dry goods in 1981 and for carbonated beverages in 1983. It was originally approved for dry goods on July 26, 1974, but objections filed by neuroscience researcher Dr John W. Olney and Consumer attorney James Turner in August 1974 as well as investigations of G.D. Searle’s research practices caused the U.S. Food and Drug Administration (FDA) to put approval of aspartame on hold (December 5, 1974). In 1985, Monsanto purchased G.D. Searle and made Searle Pharmaceuticals and The NutraSweet Company separate subsidiaries.

Aspartame accounts for over 75 percent of the adverse reactions to food additives reported to the FDA. Many of these reactions are very serious including seizures and death. A few of the 90 different documented symptoms listed in the report as being caused by aspartame include: Headaches/migraines, dizziness, seizures, nausea, numbness, muscle spasms, weight gain, rashes, depression, fatigue, irritability, tachycardia, insomnia, vision problems, hearing loss, heart palpitations, breathing difficulties, anxiety attacks, slurred speech, loss of taste, tinnitus, vertigo, memory loss, and joint pain. (From http://www.mercola.com/articles/aspartame)

I have highlighted several side effects which are clearly not heart healthy
that are associated with aspartame, the main sweetener in Diet Coke.

Coca-Cola is a major reason there is an obesity epidemic in this country.  They have partnered with this health initiative to position themselves as health conscious and that hopefully the public will view soda, not just Diet Coke, as “not that bad.”  This is, of course, designed to sell more soda which will continue to contribute to the poor health of America.  Think about this; there are 39 grams of sugar in one 12 oz. Coke.  That’s equal to 8 teaspoons of sugar! And this brand is promoting heart health?  It makes absolutely no sense.

If Coca-Cola were truly concerned about health, they wouldn’t make their product.  Now I am not so naive that I believe Coca-Cola will just stop making soda.  My fundamental problem is that they align themselves with health initiatives in the hopes that people will view their products more favorably.  Many people can see through the smoke screen, but there are people who don’t.  These are the people that Coke is trying to reach in the hopes that it will create bigger sales.  However, the bigger sales are at the expense of their health.

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Big Pharma and Politics

Do me a favor.  Just read this quote below and think about what it says.  It is from a story published in the New York Times on February 11th, 2010.

Billy Tauzin, one of the highest paid lobbyists in Washington, is resigning as president of the pharmaceutical industry’s trade group amid internal disputes over its pact with the White House to trade political support for favorable terms in the proposed health care overhaul.

This is the first paragraph of the story and I could not believe it when I read it.  It basically says that our laws, in this case health care reform, are completely controlled by large companies.  It is not that surprising, I guess.  It has been known for a long time that most laws in this country are implemented for powerful special interest groups, and “the people” have little to say about it.

My problem with the pharmaceutical industry providing “political” support for favorable terms is that they are the largest reason that health care in this country is so expensive.  A simple example is the $175 prescription fish oil they market when high quality fish oil is available for $25-$40 through qualified health care professionals.  “Political” support is generally monetary support.  Check out the ridiculous numbers spent by the pharmaceutical industry.

  • Drug companies and their trade groups spent $155 million, lobbying on a variety of issues ranging from protecting lucrative drug patents to keeping lower-priced Canadian drugs from being imported to the United States Drug interests employed about 1,100 lobbyists to do their bidding in each of the past two years.

That is a lot of money.  Pharmaceutical Research and Manufacturers of America (PhRMA), the industry’s main trade group, has 1,100 lobbyists to do its bidding.  That’s 22 lobbyists per senator. Think about if the nutrition industry had that kind of lobby.  Don’t you think the view of health care in this country would be different?  People who turn a blind eye to this kind of thing are kidding themselves.  It is not a conspiracy and I am not a conspiracy theorist.  This is fact and available in the public domain.  Below I have posted a list of laws passed and moves made by the pharmaceutical industry from 1980 to 2008 starting with the most recent events.  This is just a small sampling of how the pharmaceutical industry controls the laws that are supposed to govern them.  They write the rules to their own game.

2008

On Jan. 1, the administration of vaccines (in addition to the cost of the vaccine itself) is included in the coverage of Medicare Part D drugs.

In June, House Democrats announce plans to introduce legislation preventing FDA regulation from trumping medical device patients’ ability to seek damages under state law.

2007

On Jan. 3, Speaker of the House Nancy Pelosi and House Democrats release their agenda for the first 100 hours of the legislative session, planning to enact a bill that will allow the Secretary of Health and Human Services to negotiate directly with pharmaceutical companies to negotiate lower prescription drug prices for Medicare beneficiaries. The Senate has not acted on the measure.

In mid-January, a bipartisan Congressional contingent announces plans for legislation to allow importation of prescription drugs from Canada and other foreign countries, estimating that consumers could save $50 billion over the next ten years if the measure is passed.

In April, patent reform legislation is introduced in the Senate to improve the U.S. patent system. Despite support from high-tech and communications companies, the measure is opposed by the pharmaceutical industry because of the possibility that it would weaken patent protections by reducing infringement penalties. The bill was reported out of committee but has not made it to the Senate floor.

In May, a drug-import plan that would have eased the process of importing cheaper prescription drugs into the country from Canada and other foreign countries is defeated during Senate debate on a bill designed to strengthen the FDA.

In late September, President George W. Bush signs into law the Food and Drug Administration Amendments Act (FDAAA) of 2007. The bill revises and extends the user-fee programs for prescription drugs and medical devices, enhances the postmarket authorities of the FDA with respect to the safety of drugs, requires clinical trials and research for pediatric medications, and reauthorizes multiple bills, including the Orphan Drug Act relating to medications for rare diseases, the Best Pharmaceuticals for Children Act, and the Public Health Service Act.

In November, legislation that would have prevented reverse payment, or the practice of brand-name drug companies paying generic drug manufacturers to delay market entry of generic medications, stalls in Congress.

On Dec. 21, President George W. Bush signs into law an extension of the State Children’s Health Insurance Program (SCHIP) to provide funds to states to grant health insurance to children in families with incomes that are modest but too high to qualify for Medicaid. Amidst a bitter partisan battle between Congress and the White House, the bill extends funding for eighteen months so that a compromise can be reached.

2006

On Jan. 1, the Medicare Modernization Act of 2003 goes into effect. It gets off to a shaky start, with many consumers unable to utilize the benefit because of administrative problems. Within the first month at least half the states are forced to bypass the system, pay the bills themselves and seek federal reimbursement later.

The FDA unveils new rules that force drug makers to simplify informational inserts that come with prescriptions in an effort to make medications safer for consumers. The move comes amidst heavily publicized safety concerns from painkillers Vioxx and Bextra, both of which were removed from the market in 2005.

2005

The pharmaceutical industry mounts a successful $83 million effort to defeat Proposition 79 in California’s November special election. The initiative would have cost drug companies millions of dollars in mandatory discounts and could have set a precedent, opening the door to such action in other states.

In August, a federal judge in Minnesota dismisses claims that several drug giants violated antitrust law by taking steps to block the importation of prescription drugs from Canada.

Thirty-three of the 40 countries that PhRMA requested be put in the U.S. Trade Representative’s Special 301 Report appear on the list. Inclusion establishes intellectual property issues — such as drug patents — as a priority in bilateral discussions between the United States and the designated countries.

2004

American Jobs Creation Act is signed into law. The act repeals the Extraterritorial Income Act tax regime and provides for $137 billion in new corporate tax incentives over the next decade. Taking advantage of a provision in the law, Pfizer, the world’s largest drug company, is expected to repatriate nearly $17 billion it earned in profits abroad.

BioShield Act passes, providing $5.6 billion over 10 years for biodefense products.

CREATE Act passes unanimously in both houses of Congress. Allows patents for inventions researched jointly by public institutions and private entrepreneurs.

Thirty-three of the 38 countries cited in a PhRMA petition to the United States Trade Representative’s Office appear on the USTR watch list.

2003

The Medicare Modernization Act of 2003 provides for a prescription drug benefit for Medicare recipients but prevents price negotiations with drug companies. The act partially reverses cuts in reimbursements to pharmaceutical companies.

2002

The Best Pharmaceuticals for Children Act is signed into law. It extends “pediatric exclusivity” provision of the FDA Modernization Act of 1997 that gives prescription drug makers an additional six months of patent protection during which generic drugs cannot be sold, in exchange for the manufacturer conducting studies of the drug’s effects in children. The Congressional Budget Office estimates that, in the long run, prices for prescription drugs will increase as a result of the bill.

Trade Act of 2002 (H.R.3009) passed. The Act makes intellectual property rights and the elimination of regulatory practices (such as price controls) negotiating objectives in trade agreements.

Prescription Drug Users Fee Act renewed. Included in the legislation are industry requests to speed up product reviews and use third-party advisors recommended by the companies to assess products.

Greater Access to Affordable Pharmaceuticals Act is defeated. The Act would have weakened patent restrictions on pharmaceuticals, making way for more generic drugs.

A policy is enacted that requires warning letters sent to drug companies to first be cleared by the FDA counsel’s office. The number of warning letters sent by the FDA dramatically decreases.

The Department of Health and Human Services proposes new privacy regulations that could give FDA-regulated entities, including drug companies, access to medical records without notice to patients.

The FDA approves rule change allowing some drugs, such as vaccines against biowarfare agents, to be approved after testing in animals.

A provision to protect companies from lawsuits regarding thimerosal contained in their vaccines is a last-minute addition to the bill that created the Department of Homeland Security. In the face of popular outrage, the provision is repealed a few months later.

1997

FDA Modernization Act is signed into law. Allows medical device makers to hire for-profit companies to review their products and promote them to the FDA. Codifies previous reforms. Allows manufacturers to disseminate journal articles describing the results of trials for unapproved uses of drugs. Reauthorizes the Prescription Drug User Fee Act. Authorizes six-month “pediatric exclusivity” patent extensions.

The FDA eases restrictions on direct-to-consumer advertising of prescription drugs, allowing ads to refer consumers elsewhere to find risk information instead of including it in the ads themselves.

The Orphan Drug Act tax credit is made permanent.

1996

Congress reauthorizes the Orphan Drug Tax Credit for one year. The credit covers 50 percent of the cost of clinical trials for orphan drugs. Companies not yet profitable enough to pay taxes are allowed to take the tax credit at a later date.

1995

The FDA relaxes regulations, eliminating the establishment licensing application, which required a separate application to approve the manufacturing sites of new drugs. Lot-lease approvals, a continuous review of manufacturing sites after initial approval, also end.

The US Patent Office allows companies to show potential usefulness by submitting preclinical trial data rather than data from clinical trials.

The Patent Office relaxes its criteria on awarding patents for genes.

1994

After heavy lobbying by the industry, price control proposals that were part of the Clinton health care plan are abandoned.

1992

Prescription Drug User Fees Act passes. Allows companies to pay a fee to the FDA in return for a faster review period.

1991

The FDA accelerates the review of drugs for life-threatening diseases.

1987

The Prescription Drug Marketing Act passed. (Requires distribution of samples and safeguards against the sale of substandard or counterfeit drugs.)

1984

Hatch-Waxman Act (The Drug Price Competition and Patent Term Restoration Act of 1984) passes. One of the major loopholes in the act allows brand-name drug companies a 30 month patent extension on a drug by suing a generic manufacturer.

1983

Orphan Drug Act passes. The law encourages development of drugs to treat rare diseases affecting fewer than 200,000 by giving incentives to companies.

1980

Bayh-Dole Act passes. The Act promotes university-industry partnerships and allows the industry to tap research conducted at taxpayer-subsidized facilities.

Source: The Center For Public Integrity.

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