All posts by Zarina Memon

Editorial: Black Air Pollution Needs More Attention

New research shows that air pollution due to Black Carbon (BC, not to be confused with the commercial/industrial pollutant Carbon Black) produced form the burning of biofuels and biomass for cooking and heating in the underdeveloped world has a great impact on the future as the population increases. This biofuels/biomass burning will increase global morbidity and mortality due to contributing to respiratory infections and other ailments its decomposition materials Black Carbon cause. We cannot solve this air pollution problem medically because respiratory microbials alter their antigens and are becoming less susceptible to combating with the current arsenal of antibiotic regimen. This is an environmental issue that is only to get larger in the current political climate.

According to the World Health Organization (WHO) press release on September 27, 2016, the estimates are that there are 6.5 million premature deaths (11.6% of all global deaths) related to exposure to air pollution. These killings were related to exposure to indoor and outdoor air pollution. Indoor air pollution causes 2.8 million deaths annually, and outdoor pollution takes a toll on 3 million people a year. Nearly 90% of air-pollution-related deaths occur in low- and middle income countries, with nearly 2 out of 3 occurring in South-East Asia and Western Pacific regions. Almost all (94%) of these deaths are due to noncommunicable diseases such as cardiovascular diseases, strokes, chronic obstructive pulmonary diseases and lung cancers. Air pollution also increases the risks of acute respiratory infections. These take a toll most heavily on the health of the most vulnerable populations such as women, children and elderly.

With these staggering numbers, the burden of costs to society financially and morally is enormous. Unfortunately, in our imbalanced world, many developing nation population rely on open fires or stoves using solid fuels (i.e. wood, charcoal, coal, dung, crop wastes) to heat their homes and to cook their meals. Incomplete combustion of these matters produces BC that ranges from fine particle to carbon monoxide especially in poorly ventilated dwellings that the inhabitants end up inhaling. Due to the economics of life that allow many women and children to spend much of their time around the domestic hearth and leads to their premature deaths.

BC particles are heterogeneous in chemical and physical properties, including higher organic contaminants (OC) content and levels of polyaromatic hydrocarbon (PAHs). Global Black Carbon emissions are approximately 7600 Gg total (a 2000 estimate), while US black carbon emissions are 581 Gg total (a 2005 estimate). BC is a form of ultra-fine particulate matter and even relatively low exposure concentrations of Black Carbon have an inflammatory effect on the respiratory system of children. Researchers of the Flemish Institute for Technological Research note that BC exposure (on children) on the morning of sampling was associated with airway oxidative stress while 24-h and weekly exposures were linked with airway inflammation.

The Recent study released by the Department of Genetics of the University of Leicester of England have brought together their expertise in genetics, microbiology, and air pollution chemistry to show the impacts of air pollution on the bacteria of the respiratory tract. They note that air pollution may alter the healthy bacteria that line the nose, throat, and lungs by making them antibiotic resistant, and the researchers are concerned about the increased risks for respiratory infections. These researchers showed that BC changes the way that bacteria grow and form “communities.” Interestingly, the researchers note that these bacteria change by hiding the immune system and thus increasing their survival.

Researcher Julie Morrissey from Leicester University states that this shows us how the bacteria that causes respiratory infections are affected by air pollution, possibly increasing the risk of infection from Staphylococcus aureus and Streptococcus pneumonia, and the effectiveness of penicillin used to treat these ailments. Researchers found that with exposure to Black Carbon, these Streptococcus pneumonias move from the nose to the lower respiratory tract along with the resistance of these bacteria increasing.

In 2009, the International Network for Environmental Compliance & Enforcement (INECE), the only global network of environmental compliance and enforcement practitioners, set goals to raise awareness of the importance of environmental compliance and enforcement and strengthen capacity throughout the regulatory cycle to limit Black Carbon particulate emissions.

This knowledge and research has significant potential to initiate a global research effort to understand a hitherto unknown effect of air pollution and provide significant additional impetus to the control of contamination.

To eat healthy or not to eat healthy, the choice is yours

“You are what you eat,” is a simple statement, but it is packed with great insight. This saying implies that a saturated fats loaded diet leads us to a fat-laden body. And if you snarf on beer and chips, you doom yourself a beer belly and chip hips.

So, give yourselves the luxury to reflect on what you eat every day, and why you choose the foods that you eat. I am sure your body will appreciate this in the long run. I have reflected on my diet many times, and I have found a few things that work for me. Maybe some of these tips will work for you. I want to share my top tips with you today.

Tip #1: Break the morning fast.
a. Many of you know that breakfast is the most important meal of the day, so don’t skip it.
b. Breakfasts nourish our mind and body with energy
c. A healthy nourishing breakfast is an essential step to every healthy diet.
d. So fill up on a breakfast loaded with cereals, whole grains, nuts, fruits, and vegetables
e. I find my breakfasts immensely satisfying to the point where I have limited cravings for sweets throughout the day and even desserts after the evening

Tip #2: Don’t skip meals
a. A regularly scheduled meal helps us refueling our bodies constantly during the day
b. Eat three healthy meals and two small snacks – portion controlled, and packed with protein.
c. By eating regular meals and snacks, we regulate our blood sugar throughout the day, which in turn helps us maintain our productivity and reduce fatigue.
d. Studies have noted that fatigue can cause us to make poor eating decisions, causing us to have a negative feedback loop that destroys our health.

Tip #3: Cook your meals.
a. These meals do not have to be anything fancy, just something simple and fresh
b. Make a big batch and save some for later
c. Cooking makes us appreciate food more, makes us aware of what we are eating, and forces us to shop for wholesome grains, whole fruits, and whole vegetables.
d. By eating whole produce and grains, we get the proper nutrients and fiber our bodies need for good health.
e. Also, the fiber in these whole products helps us regulate our metabolism throughout the day.
f. Satisfy your cravings with a leafy green salad loaded with crunchy, orange carrots, green bell peppers, and grilled cauliflower.
g. Also, experiment with foods and add a variety of colors and textures to meals. Add some herbs and spices to stimulate our senses.
h. Use frozen vegetables to limit the prep time

Tip #4: Don’t forget the drink –
a. Yes, a good drink is key, but keep it simple, stick with cold, clear, clean, hydrating pure water.
b. Not only will water quench your thirst, but it will also hydrate your body for optimal function.
c. So, keep the water bottle handy, put a note in the kitchen to sip water every hour, and have some with our meals.

Tip #5: Eat with others
a. Not only is it enjoyable to eat with other, but you will eat fewer calories, and end up nourishing your spirits at the same time. What a delightful treat!

Tip #6: Analyze for your foods triggers
a. Food triggers cause us to eat impulsively so learn what they are to keep these foods outside of our homes and to avoid these when we eat out, or shop.

Tip #7: Keep it slow and steady
a. After all, we, humans, are hardwired. So to make real changes, we must do them very slowly.
b. Make only one small change at a time, and once you have mastered this one change, add another one the following week.
c. For examples: add an extra glass of water daily in week one.
d. Once mastered, replace the crunchy chip habit with a crunchy apple.
e. And continue to add changes gradually. If we fail at our changes, just recognize this and start again. After all, if we fail occasionally, these are onetime events and do not constitute a real habit. Just being aware of our diet is a big win for us!

Tip #8: BE GRATEFUL
a. We should be grateful for being able to enjoy such amazing nourishments. Since most of us are privileged to have such blessings.

So in conclusion, I hope that my tips will help you as much as they have helped me.
a. After all diets and healthy eating are difficult tasks to manage.
b. But you have at least five chances a day to choose foods wisely.
c. I wish you the best in making the right choices for a healthy body and a healthy mind.

Women Health 101

HEALTH:  Hardiness, Energy, Ability, Live/Life, Together, Happy

Synonyms: fitness, strength, well-being, bloom, complexion, constitution, euphoria, spirit, state of mind, form, shape, state, stamina, tone, vigor, wholeness, condition

Antonyms: lethargy, weakness, disease, illness, infirmity, sickness

There are eight areas of interest in women’s health:  Physical, Psychological, Social, Sexual, Spiritual, Emotional, Safety, and Financial.  Balance in these regions lead to a sound body and mind (physical and mental).

Stages of Women Health:

  1. PREGNANCY (12 to 50+ yr.; menses to post menopause)

 Physical

  • Body changes during the pregnancy with weight gain, nausea/vomiting, back pain, cravings, hemorrhoids.
  • Get prenatal care and vitamins (Fe, Ca, Folic acid).
  • May develop co-condition: gestational diabetes (pregnancy-related diabetes), hypertension, and edema; must follow the obstetrician’s advice carefully.
  • Nutrition: eat well-balanced, healthy foods.  Mya is best to prepare for the pregnancy by using multivitamins before conception.  Talk to you doctor.  Avoid fish high in mercury such as shark, swordfish, tilefish and mackerel; avoid coffee/caffeine and alcohol (and tobacco).
  • Make sure the medication you are on is safe for pregnancy.  If already on baseline medications then it is good to know ahead of the conception of what medications that you are on and their consequences to the unborn.  Avoid cats during pregnancy (toxoplasmosis).
  • Maintain exercise to ensure excess weight gain and to keep weight post-delivery.
  • Educate yourself about pregnancy and mothering.
  • Epidural/Spinal – consider for a more pain controlled delivery.
  • Reduce infections; your doctor will test for hepatitis, bacteriuria, Rh compatibility
  • Psychological & Emotional
  • Exciting time in a woman’s life, but can be scary too.  Many emotions can run wild.
  • Due to hormones depression may present (especially postpartum); Watch for symptoms and use depression reduction techniques to maintain moods as needed. Symptoms include: feel down, sad, hopeless, have felt little interest, or pleasure in doing things; worrisome if these last more than two weeks.  Depression reduction techniques include finding reasons to get up in the morning such as work, community, volunteering, love, pets (avoid cats during preg), volunteering.

Social

  • isolation, lack of support or criticism from parents/in-laws, stigma in culture, unplanned pregnancy, the division of labor, breastfeeding, balancing life/schedule, achieving pre-pregnancy weight.

Sexual

  • Hormones change the urges (mostly increased).
  • Sexually transmitted diseases: chlamydia, gonorrhea, syphilis. If present then makes it hard to achieve pregnancy, effects on baby (gonorrhea may cause eye problems and syphilis may cause nerve damage).

Spiritual

  • May become more religious.

Safety

  • Unfortunately, pregnancy may be the start of intimate partner violence.

Financial

  • Plan savings/spending wisely and know what your insurance policy covers.

2. CHILDHOOD – Overall, the young and the old are the most vulnerable to infections!

Physical

  • Growth so needs plenty of exercises and a proper balanced diet.  Limit candy and sugars, fats and salt.  Get plenty of variety of fruits and vegetables.
  • Develop good hygiene habits- brushing teeth, bathing, cleanliness, combing hair, lice checks.
  • Get chicken pox.  Get the flu shot and the required immunizations before teenage years are reached: varicella (if not exposed to chickenpox), measles, mumps, rubella, Hepatitis B and A series, meningococcal meningitis, human papilloma vaccine, diphtheria, tetanus and acellular pertussis booster
  • May develop childhood diseases so watch health carefully with regular checkups and preventions.  Some chronic illnesses of children include asthma, diabetes, cerebral palsy, sickle cell anemia, cystic fibrosis, cancer, AIDS, epilepsy, spina bifida, and congenital heart problems.

Psychological/Social/Emotional

  • A women’s health begins with a healthy childhood where the girl child is raised by the values of her society.
  • Encourage curiosity and development of the mind and body.

Sexual/Safety

  • Hopefully none, but beware of predators for abduction, abuse.

Spiritual/Financial

  • Hopefully, no issues but best to start to talk about these early on both.

3. TEENAGE (Thirteen to Nineteen)

Physical

  • Many changes; braces, menses, bra, makeup.
  • Hygiene musts: floss teeth daily; exfoliate skin; wash hair (every 2-3 days is best) and condition (it is best to leave conditioner in for about 3 minutes before rinsing); shave underarm and leg hair (shave in direction of hair growth to avoid ingrown hairs and apply hair conditioner just before shaving to reduce shaving cuts/nicks); and sanitize.
  • Exercise routinely.
  • Peak time for accidents.  Reduce risks and know your blood type.
  • Health checkups: blood pressure screens start at age 18 and recheck every two years. High blood pressure is 140/80 or greater. Untreated high blood pressure can cause stroke, heart attack/failure, kidney, and eye problems.

Psychological

  • Notice the opposite sex; start dating.
  • There may be social competition.

Social

  • Family expectations/responsibilities.
  • Pressures to learn to cook, be a homemaker, and look and act in a certain way.

Sexual

  • Menses, sexual curiosity, cervical checks for cancer, sexually transmitted diseases (STD) and human papillomavirus (HPV); May opt for cervical cancer vaccines; abstinence, and safe sex.  Be educated to reduce STD/HIV; start cervical screens with sexual activity. Use pain controls with menses.

Spiritual

  • There may be religious responsibilities.

Emotional

  • Trying time for many, develop friendships (Saheli’s -female friends), start a diary, engage in physical activity.

Safety

  • The risk of rape, abduction, abuse.

Financial

  • Start work – save the cash!

3. WOMANHOOD: (20’s to mid-40’s)

Physical

  • Most Productive period: career, get married, have children.
  • Stress and workload increases.
  • Need to maintain or learn about proper nutrition: plenty of water, fruits, vegetables and protein in a diet.  For healthy eating and reduce constipation and other problems.
  • Start calcium supplements at age 30 because our bodies start using calcium from bones if not present enough (which leaches out of bones to form osteoporosis later in life).
  • May gain weight at this time due to lack of exercise and self-care.
  • Safe medication issues (too much acetaminophen may lead to liver damage and too much ibuprofen to kidney damage).
  • May develop migraine headaches.
  • Urinary tract infections may occur.
  • Still have menses which may cause food cravings and sexual urges; pain is stronger as you age (until menopause when menses have ended).
  • Maintain a healthy weight with enough exercise.
  • High heel shoes may lead to foot damage later in life.
  • Health Screening: Pap smears, blood pressure, cholesterol checks (begin at age 20), self-breast exam (start at age 20 and perform monthly); mammograms (usually start at age 40 then repeat every two years- parameters change so what for new guidelines); eye exams to rule out glaucoma (another silent disease).

Psychological

  • Due to increased demands of life, the woman may ignore self and not sufficiently use stress relievers.  Can quickly develop depression.

Social & Emotional

  • Need a support system, friends, hobbies, and career.

Sexual

  • Use birth control as required for proper family planning.
  • Know about STDs (be aware that your partner may be fooling around, and you may be still susceptible to these diseases).

Spiritual

  • May become more or less engaged in one’s religion.

Safety

  • Domestic disputes, violence, rape concerns

Financial

  • Unless some source savings or money, women are limited in discretionary spending.

4. MIDDLE-AGE (mid 40’s to early 60’s – Happiest time)

Physical

  • Gravity takes effect along with weight gain.
  • May start aches of arthritis or osteoporosis.
  • Consider adding more medicines such as glucosamine sulfate, multivitamins, baby aspirin, vitamin D and B12, Magnesium and other medications as needed.
  • Diabetes signs may be seen with loss of estrogen, which may lead to muscle mass loss.
  • Nutrition needs need to be adjusted with a higher protein breakfast.
  • Add exercises if not already.  Exercise strengthens bones.
  • Hair loss may start (decrease this loss with regular hair washing, not handling wet hair, and sleeping on satin pillow case).
  • Wrinkles –avoid the sun, use sunblock.
  • Drink plenty of water – may need up to or more than 2 liters of water per day.
  • Sleep patterns change with insomnia or increased requirements for sleep.
  • May develop hot flashes.
  • May go through stages of insomnia.
  • May develop headaches irritable bowel syndrome, gallstones, multiple sclerosis.
  • Start colorectal cancer screens at age 50 then repeat every ten years or as recommended by your doctor.

Psychological

  1. Depression due to lack of a career; empty nester.

Social/Spiritual/Emotional-

  • Could be problematic.  Adjust as needed.  Look for support in the community.

Safety

  • Domestic violence and other security issues still a concern.

Financial

  • A huge concern if no income is coming in.

Sexual

  • Many concerns: menopause, vaginal dryness, urinary incontinence (start Kegel exercises, gels for sex/estrogen supplement: Menopause increases heart attack risks, cancers.

5.  ELDERLY   (Age when you feel it the most, around mid-60’s and onward). Again, the young and the old are the most vulnerable to diseases/infections!

Physical

  • May develop osteoarthritis, osteoporosis.  Check bone density test and get plenty of sunlight (a vitamin D source) and vitamin D.
  • May develop dementia, heart-lung disorders, diabetes, visual changes, cataracts, urinary incontinence, may need dentures and muscle loss.
  • Medication sensitivity, watch carefully for side effects.
  • Get the flu shot YEARLY and a  pneumonia shot when over age 65 years old.

Psychological/Emotional

  • May develop depression from isolation.  Also increased the risk for anxiety, sleep disturbance, insomnia.

Social

  • Lack of support system, not get enough social activities.

Sexual

  • Pain with sex due to vaginal dryness.

Spiritual

  • May become more religious.

Safety

  • Watch for falling issues.  Maybe robbed easily.

Financial

  • Limited resources or savings lead to limited discretionary spending.

KNOW AND CARE FOR YOUR BODY BEFORE IT STARTS GOING DOWNHILL!!!!!!!

Essential medicines as per World Health Organization

 

The American healthcare offers 24,000 medicines for the patients in this country.  According to the World Health Organization, only 350 or so are essential, and this is the number a majority of the world uses to provide health care for their citizens.  Why is there such an enormous disparity?  There are several reasons.  First, the uses of prescription or over-the-counter medicines are not a trend in the developing world.  Second, there are alternatives such as natural remedies available them that are not harvested yet by the American health care industry.  Third, there is a different lifestyle in the developing worlds that is not driven to produce to live.  This lifestyle is not to say that that they do not work hard, but they are more forgiving to customs of productions that drives the developed world.  Lastly, there are balanced approaches to healthcare that Americans are beginning to understand and appreciate.  These balanced approaches involve the mind-body-soul balance. 

The FDA’s report on the FY 2011 Innovative Drug Approvals states that there were 35 innovative drugs approved for the year 2011.  This report breaks down the types of medicines approved.  It is evident from the reports that of these approvals, approximately half were innovative therapies and half was modified available therapies.  American pharmaceuticals offer the state-of-art medicines for cancer, hepatitis C, lupus, heart attacks and strokes, MRSA infections, kidney transplant rejection, hereditary angioedema, clotting disorder, and scorpion stings. 

The world is a wrong place with no uniformity.  However, this does not mean that we cannot improve the advanced systems.  Coming from an American clinical medicine background, I can appreciate the offerings of the modern pharmaceutical world.  However, I found it daunting to understand the nuances of each available therapy and all the additional knowledge that is constantly produced in the U.S.A at times.  This information is invaluable but can be overburdening.  It is there I will review some to the essential medicines approved by the WHO.  Using the following links, I will summarize the types of drugs essential medicines recommended by the WHO.  The link for essential adult medicines is: http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  The connection to essential medicinal products for Children is : http://whqlibdoc.who.int/hq/2011/a95054_eng.pdf.

In American medicine there are 24 medical specialties.  I will go over some familiar to me.  There are over 90 anesthetics medicines available in the USA (http://www.drugs.com/condition/anesthesia.html).  The developing world has 13. 

The number of NSAID analgesics offered in the USA are 20 (verses 3 in the world) http://www.uptodate.com/contents/patient-information-nonsteroidal-antiinflammatory-drugs-nsaids-beyond-the-basics.    The numbers of opioid analgesics offered in the USA are 9 for severe pain and 15 for moderate to mild pain.  In contrast, the developing world has 2 (only morphine and codeine) for only severe pain.  Not only is there greater availability, but more considerable discretion of prescription in the developed world.  This leads to a higher number of poisonous deaths related to these agents (http://www.cdc.gov/nchs/data/databriefs/db22.htm).

The point of this article is not to indicate a fault to the system that produces abundance but asks if we produce more types of medicines just to medicate our population versus to help them.    This matter is for American community to address.  It is not an easy discussion, but it must be had to improve our quality of life.

Protecting America’s Health

The American pharmaceutical and food industries and the U.S. Food and Drug Administration (FDA) are critical allies in the advancement of the health of Americans. These groups work together in concert—sometimes synergistic, but usually antagonistic—to advance the general welfare of the population. This advancement is not an easy undertaking, involving the creation of laws based on business and consumer needs, rooted in scientific study. Published almost ten years ago (2003) by writer Philip J. Hilts, “Protecting America’s Health” [1], lays out the history behind the challenges in creating regulations for the pharmaceutical and food industries.

Protecting America’s Health starts off describing the agrarian lifestyle and medicines of the 1800’s. 1800’s were the beginning of the industrialization of America. In 1883, the U.S. Department of Agriculture hired a brilliant chemist, Dr. Harvey Washington Wiley, to study the chemical nature of sugars from various substances such as sugarcane, honey, and sorghum. Wiley’s findings showed that there was a common practice of deception by manufacturers in the quality of honey, sugar, and syrup sold. These results were the first of a kind and aroused the interests of leaders in Washington.

Wiley hypothesized foods and drugs were being adulterated. He set up experiments to study the effects of products sold in the market on healthy young men. A strict diet of the products suspected of causing illnesses was to these volunteers. During the experiments, many of the men fell ill. Newspaper reporters called these the “poison squad” studies. In fact, because industry advertising heavily invested in the newspapers, many newspapers would not publish Wiley’s findings. The experiments, while not entirely scientific, helped to identify toxic and dangerous preservatives that were in common in use.

Wiley was a devout Christian, Republican, and honest man. He believed in science and free-enterprise. However, through his studies, Wiley concluded that industry could not self-regulate.

These practices continued until muckraking writers emerged. The book, The Jungle, by Upton Sinclair, described the unsanitary conditions of meat packers. Articles in the Ladies’ Home Journal and Collier’s by Samuel Hopkins Adams described the toxic ingredients used in medicines. Through these publications and nearly a quarter century of Wiley’s work, Wiley’s data finally resulted in proposed regulations for the industry.

These proposed regulations were challenged. Industries and their political proxies insisted that these provisions were unnecessary and unconstitutional. President Theodore Roosevelt was also skeptical of Wiley’s findings. He asked for an independent evaluation of the industry practices, but the conclusions were the same: industry cannot self-regulate.

The passage of the Pure Food and Drug Act of 1906 (also known as the “Wiley Act,” and the “Pure Food Law”) enacted legislative action This Act mandated independent inspections for the meat industry and accurate drug labels for the pharmaceutical industry. The Act required the Bureau of Chemistry to perform sampling and testing of food and drugs to ensure purity. The aim of the Act was to eliminate practices of adulterated and misbranded food and drugs.

After the passage of the 1906 Act, Wiley enforced the law with some success. However, more often than not, Wiley was hindered. Impure, adulterated, and misleading products were still being sold. Wiley tried to seize grain tainted with sulfur (done to hide the decomposition). Wiley was prevented by Secretary Wilson and President Taft from prosecuting a company under the Act. Wiley submitted his resignation in disgust. He then went on to head the Good Housekeeping Research Institute to further testing of foods.

Additionally, the 1906 Act could be easily sidestepped. In one case, Dr. Johnson of Kansas City claimed to cure cancer with his concoction, which had accurate labeling of content, but no evidence of healing. The Bureau of Chemistry tried to prosecute him but lost the case in the Supreme Court. The judges decided that the defendant was following the law: the law did not restrict drug producers from making false and misleading claims.

The Sherley Amendment of 1912 tried to prohibit manufacturers from labeling their products with false therapeutic claims. However, this 1912 Amendment and the 1906 Act were still insufficient to stop the problems that consumers and regulators faced. Since these Acts did not require proof that products were safe, there were no controls over false advertising. There were no food standards defined. The meaning of “adulterated” was vague. Anecdotal evidence and authoritative opinions were acceptable. The government had to show the intent of producer to adulterate or mislead, which could not be proven. Enforcement was minimal because it was not budgeted. And injuries from cosmetics could not be addressed. Further amendments passed could not address all of these problems.

In the 1920’s, little was done by the Republican Congress and Presidents. But, with the Great Depression, public sentiment paved the way for the election of Franklin D. Roosevelt (FDR). In his first hundred days in office, the FDR administration established laws and regulations to stabilize the economy.

FDR’s transition team included many intellectual leaders, including Rexford Tugwell. Previously a professor of Economics at Columbia University, Tugwell became second in command to the Agriculture Department. He felt strongly that the welfare of the citizens was directly connected to food and drugs and took an interest in learning all he could about the deficiencies of the FDA.

Initially, Tugwell felt that the problems with the agency were due to internal issues but soon realized that this was not the case. Pressures from industry and political opponents and simply outdated laws were controlling the effectiveness of government mandates. Tugwell reasoned that the only way to tackle these problems was through new legislation that addressed the deficiencies of the current law.

There was resistance to this new law, and Tugwell’s bill ended up undergoing several revisions aimed at weakening it. The Department of Agriculture tried to raise public awareness of the problems with the infamous “Chamber of Horrors” exhibit, but the conservatives stopped this information from being spread to the people.

Five years later, the bill was approval after a tragedy involving children surfaced. Almost 100 children lost their lives when they were prescribed an antibiotic, Elixir Sulfanilamide, for streptococcal throat infections. Unfortunately, this medicine contained diethylene glycol, a poisonous solvent. The outcry from the public led to the introduction and approval of the Federal Food, Drug, and Cosmetic Act in 1938, which was stronger than Tugwell’s initial version of the law proposed.

The 1938 Act replaced the 1906 Act, requiring drugs sold must be proven scientifically to be safe. The 1938 Act also required inspection of factories that manufacture the product. Enactment of this law was a pivotal step in American and Internationals pharmaceutical industries and modern medicine. For the first time, the law also regulated medical devices, cosmetics, bottled water, and pesticide residues on food. Civil and criminal penalties were enhanced.

Through this law, the U.S. government hoped to integrate scientists and doctors in pharmaceutical companies to help the industry evaluate their medicine before selling. However, this collaboration did not occur.

After World War II, drug manufacturing evolved into huge rackets, operating in a machine-like fashion, with a philosophy of purchasing, patenting, and promotion. The pharmaceutical companies purchased their products and manufacturing processes from universities and governments. With little or no modifications, the company patented the products and processes. As far as safety, the company would just refer to papers written by university professors, which were typically small studies that would usually show only a slight advantage of the new drug over existing old drugs. Heavy promotion of the drug would then follow.

At first, marketing was targeted toward consumers. But later, companies found it more useful to target doctors instead. Companies would promote and sell the new drug as new curative wonders. Additionally, companies would make small modifications to the drug, and then repeat the process of patent and promotion to stretch out the money-making venture. In the end, it only confused professionals. If this was not enough, companies succeeded in getting laws passed that made it illegal for a pharmacist to substitute a generic drug for the brand-name drugs they offered.

But, the biggest problem was that companies would not disclose side-effects. FDA would approve the drug without proof of safety; the drug would be approved automatically if the FDA did not respond to an application within 60 days. Due to inadequate scientific data of safety and heavy promotion, dozens of drugs were recalled. At this time, no data on the effectiveness of a drug was needed. The Supreme Court ruled that companies could deny FDA inspectors from inspection of their unsafe and unsanitary manufacturing processes.

Resistance to change was fierce from drug companies. Unfortunately, again it took another tragedy to force changes into laws: Thalidomide.

Thalidomide was a drug for morning sickness and insomnia. Thalidomide was already approved in the less-regulated European market when the FDA was reviewing the application for its approval in the U.S. Unfortunately, the drug caused deformities in babies born to pregnant women taking the drug. (The manufacturer incorrectly assumed that the drug would not cross the placental barrier.) In spite of heavy pressure from manufacturer Richardson-Merrell, FDA reviewer Frances Oldham Kelsey [2] refused to approve the drug without further information. In the few months that followed, it was discovered that over 10,000 babies would be born with deformities, causing a huge public uproar.

Due to the tragedies, in October 1962, John F. Kennedy (JFK) administration introduced the Drug Amendments Act called the Kefauver-Harris Amendment. This amendment was to ensure that medicines sold were safe. JFK administration felt that drugs must show minimal side effects and more benefit over risk. Efforts by the JFK administration and the Congress insisted that drug developed had clinical studies to demonstrate safety and benefit with minimal risks.

The 1938 Law and the 1962 Kefauver-Harris Amendment aimed to make the American public safe with the products aimed at them. Public health triumphed over health care product businesses. Experiments on people could not be carried out without prior approval from the FDA, and proper record keeping had to be taken. Well-designed scientific studies transferred evidence of drug safety and efficacy from the “expert” opinions on data.

With the passage of the Kefauver-Harris Amendment, all medicinal products in the market at that time underwent an examination of safety and efficacy with the Drug Efficacy Study of the National Academy of Sciences, National Research Council. Of the 5,000 drugs evaluated, 300 drugs were eliminated and banned. The author describes in detail the story of Panalba, a combination antibiotic manufactured by Upjohn. Despite repeated FDA warnings that the drug was both ineffective and unsafe, Upjohn would not stop production of the drug. The company ended up exporting the drug to maintain the multimillion dollar profits it was collecting for this dangerous medicine.

In the years after the Kefauver-Harris Amendment, the industry has continued its onslaught aimed at chipping away authority from the FDA. During the Nixon administration, Republicans were appointed in both the FDA and lower-level technocrat positions. These conservatives were more lenient is approving drugs. During the Reagan administration, funding was cut, and improvements in laws delayed, including mandatory label inserts for patients taking drugs, and the ban on raw milk. Not all changes proposed by Republicans were for the worse: the Waxman-Hatch Act of 1984 was instrumental in expanding the availability of generics.

But, in the early 1990’s, Congress was considering strengthening food and drug laws, which made the health-food industry nervous and it pushed for a law which banned FDA regulation in dietary supplements. The health-food industry won and in 1994, the Dietary Supplement Health and Education Act passed. This law was bad. Because it allowed untested and ineffective dietary supplements to be sold, the New York Times labeled this Act as the “Snake Oil Protection Act.” Additionally, the FDA could take action against a dietary supplement company only if the FDA was able to prove that the supplement was harmful.

Conservative-advocacy non-profit corporations have tried to limit FDA regulations. The Washington Legal Foundation sued the FDA for allowing drug manufacturers to distribute information to physicians regarding off-label uses of their drug in the name of “free speech,” and thankfully it won.

Because conservatives insisted that the FDA approval process was too slow, in 1996, organized by Gingrich and other ultra-conservative Republicans, Congressional hearings were held to determine if the FDA should be abolished, or completely side-stepped with an own approval process. David Kessler, director of the FDA, testified that this was in error and that the approval process was faster in the US than most countries.

Ironically, Kessler was appointed by George Herbert Walker Bush, a Republican. Kessler is a modern day Wiley and was trained both in medicine and law. He worked actively to foster science standards expected of the agency under the legislations of America and honest trade practices. Kessler encouraged companies’ incentives to innovate safe products of high standards. He also enforced rules to discourage and eliminate dishonest, fraudulent promotional practices. Kessler worked to contain the acquired immune deficiency syndrome (AIDS) epidemic, ban silicone breast implants, regulate tobacco, and improve x-ray mammography standards. Kessler was also momentous in introducing and setting up proper food labels that include nutritional information on packaged foods.

The best part of Protecting America’s Health is the epilog, on “greed and goodness”. The book tells a story of J. Scott Armstrong, a professor at the Wharton School of the University of Pennsylvania. During class, he presented the problem of Panalba to students and asked students to play the role of Upjohn executives. Would students continue to sell a drug that was shown to be both ineffective and unsafe? To his dismay, the students made the same wrong decisions: roles dominate behavior [3]. Time and again, for-profit corporations cannot be trusted to make decisions that the benefit the public.

In conclusion, despite the age of Protecting America’s Health, I urge those interested to read this book. As George Santayana said, “Those who cannot remember the past are condemned to repeat it.”

  1. Hilts PJ. Protecting America’s health: The FDA, Business, and One Hundred Years of Regulation. The University of North Carolina Press. 2004
  2. Harris G. The Public’s Quiet Savior from Harmful Medicines. New York Times, Sept 14, 2010. http://www.nytimes.com/2010/09/14/health/14kelsey.html.

3. Armstrong JS. The Panalba role-playing case. University of Pennsylvania Scholarly Common. August 1, 1976. (see http://marketing.wharton.upenn.edu/ideas/pdf/Armstrong/Instructors_Notes_Panalba_Case_.pdffor additional instructions

The Basics Behind Off-Label Use of Medicines in Clinical Care

Both medical providers and medical patients find medical care in the United States complicated. Both want optimal care with the least complications. Therefore, product makers, such as the pharmaceutical businesses, seek approval from the Food and Drug Administration (FDA) to market their products that help patients. The FDA has the responsibility to make sure that the pharmaceuticals, biologicals, and medical devices are safe and effective. Unfortunately, the drug development (DD) process is time-consuming and costly. Many times, DD can be more than 13 years, from the bench to the patient, and more than half of this period involves clinical studies.1 Even with these ardent requirements, doctors have the qualifications to access medicines not approved for specific conditions. If the drug has an approved use, the practitioner can legally prescribe this to a patient for other purposes. This type of access is called off-label use (OLU). OLU involves the use of an FDA-approved medicine for anything other than that for what it is approved. Unapproved therapy or unproven therapy are alternate names for OLU. OLU can involve an alternative route, dose, or a different disease than that its approved application. The objective of this paper is to review the fundamentals, benefits, and problems of OLU medicines.

Overview of OLU

The first purpose of OLU is for practitioners to get a treatment specific for the patient. The Physician Desk Reference (PDR) lists more than 24,000 prescriptions and over-the-counter FDA-approved medicines.2 The World Health Organization (WHO) lists roughly 12,000 diseases under 22 categories.3 Even with this favorable ratio, clinicians can have a difficult time getting the right medicine for the individual patient. Patients themselves may also use medicines off-label.

The second purpose of OLU is to compensate for the particular processes utilized in the for drug approval. At present, drug approvals are validated on data collected from a small population, under controlled conditions. Clinical trials in DD are set up to study the product in less than 5,000 people over a year or two. The remainder of the population (300 million people) use this extrapolated clinical data for their safety, and this translates to the medicine or the product only examined in only less than two-one thousands percentage of the population. Additionally, the average patient ends up taking the medication for a much longer time than that spent on studying the medicine.

The last purpose of OLU is to advance medical knowledge. OLU is used routinely in certain challenging conditions or understudied specialties, such as orphan diseases,4 cancer treatments,5 chronic pain, or psychiatric conditions. When OLU works, not only may it treat the patient, it may help to identify the mechanisms of the disease.

In the past, all clinical studies excluded certain groups such as pregnant women and children. As a result, OLU efficacy is justified by anecdotal evidence in this population.6

Who can prescribe OLU medicines? Because of the licensing regimen, practitioners are not bound to use OLU medicines as indicated by FDA. Medical professionals can use a drug in any manner as long as the drug is FDA approved. If a drug is not effective, the practitioner can try an alternative. In this manner, OLU may be considered personalized medicine. OLU is acceptable as long as the practitioner prescribes drugs from the drugs that are already approved by the FDA.

OLU Statistics in the U.S.

Between 2005 and 2008, 48% of office visits resulted in at least one prescription drug, which amounts to 2.3 billion prescriptions in the U.S. per year. A separate study found that OLU involves 21% of all prescribed medicines.4 Most of these treatments are for the management of pain, elevated cholesterol, and depression.

Unfortunately, three-quarters of OLU are ineffective,4 and 29% of OLU medicines cause adverse drug reactions (ADR).5 OLU medicines often result in black box warnings, but typically only after ten years on the market.5 Therefore, both the ineffectiveness of OLU and its complications may contribute to the high cost of health care.

In 2010, 10% of all U.S. healthcare costs were prescription drugs and amounted to $260 billion.7 Even though OLU accounts for 21% of all prescription drugs, OLU costs $55 billion of 2010 healthcare costs.5

One of the highest rates (>50%) of OLU medicine is biologics.4,8,9 Biologics include agents such as recombinant enzymes, cytokines, and monoclonal antibodies, which are used to treat cancers and diabetes.10,11 Biologics have been growing 20% per year and account for more than $40 billion in sales.12 Unfortunately, they are usually the most expensive, often costing more than $1,000 per month and are potentially risky.13 Due to past court cases and the Omnibus Budget Reconciliation Act of 1993, Medicare and third-party payers must cover OLU of biologics for cancers.5

Controversies of OLU

If OLU costs much with little assurance of effectiveness and safety, who should pay for OLU medicines? Patients, doctors, manufacturers, insurance carriers, or government?5 Most of the time, insurance carriers will not pay for a treatment that is not proven. However, biologics for treating cancer are covered by Medicare and insurance carriers. Some people wonder why the costs of cancer are covered while costs of many other diseases are not. Also, if a generic is available, then who pays for the off-label drug, and how much more should be allowed over the cost of the generic?

Should OLU be regulated? The biggest problem with off-labels is the lack of clinical evidence of efficacy and safety. Even with the lack of proof of the effectiveness of OLU, there is little the FDA can do to regulate this practice. The only authority the FDA has for regulating OLU is for misbranding violation, for inappropriate use, or for misleading advertisement/promotion.14 While some prefer the freedom of regulation, others want laws to prevent practitioners from practicing non-evidence-based medicine.15

When patients are subjected of OLU, should patients be informed? Currently, practitioners are not required to inform patients that the drug being used is off-label. Malpractice laws and the courts often favor OLU in medical practices because medical practices are considered honorable. Some people support general disclosure on whether the drug is approved for a condition because they believe a revelation gives the patients enough information to evaluate their treatment options (similar to that in a research study). Nearly all specialties practice uninformed OLU. Only the American Academy of Pediatrics (AAP) believes in full disclosure of OLU. Therefore, in a pediatric setting, the providers inform the legal guardians of the off-label use of medical products utilized in individual patient care.6

Recommendations

While OLU medicine has value, there should be a greater role of institutions and government in identifying best practices and regulation of OLU.15. Several suggestions for improving OLU include: restricting prescriptions to be utilized only evidence supported medications; obtaining informed consents for OLU drugs; setting up a database or registry to collect ongoing research of OLU medicines regarding safety and effectiveness; and, considering sanctions for doctors who violation measures to study OLU medicines more effectively.15 Clearly, there is a lot that could be done.

Conclusion

OLU is useful and sometimes necessary alternative, but can be risky and costly. Nevertheless, OLU in America continues to grow. It is unclear when the value of OLU outweighs the risks, and additional studies are needed. The primary cause of OLU is that the lack of understanding of the diseases involved, and the dearth of FDA-approved medicines to treat the disease. Practitioners must demand more fundamental research and further studies of products currently in use for a wider set of people and illnesses.

References

  1. Kaitin K. Deconstructing the drug development process: the new face of innovation. Clinical Pharmacology & Therapeutics. 2010; 87(3):356-361.
  2. Barnhart ER. Physicians’ Desk Reference: PDR: Medical Economics Company. 1986.
  3. World Health Organization. International Statistical Classification of Diseases and Related Health Problems 10th Revision. http://apps.who.int/classifications/icd10/browse/2010/en. Accessed July 6, 2012.
  4. Stafford RS. Regulating off-label drug use—rethinking the role of the FDA. New England Journal of Medicine. 2008; 358(14):1427-1429.
  5. Gillick MR. Controlling off-label medication use. Annals of internal medicine. 2009; 150(5):344-347.
  6. Dresser R, Frader J. Off‐Label Prescribing: A Call for Heightened Professional and Government Oversight. The Journal of Law, Medicine & Ethics. 2009; 37(3):476-486.
  7. Martin AB, Lassman D, Washington B, Catlin A. Growth in US Health Spending Remained Slow in 2010; Health Share Of Gross Domestic Product Was Unchanged From 2009. Health Affairs. 2012; 31(1):208-219.
  8. Graves JE, Nunley K, Heffernan MP. Off-label uses of biologics in dermatology: rituximab, omalizumab, infliximab, etanercept, adalimumab, efalizumab, and alefacept (part 2 of 2).Journal of the American Academy of Dermatology. 2007; 56(1):e55-e79.
  9. Patkara A, Holdford D, Brophy DF, Pyles M. Off-label prescribing of erythropoiesis-stimulating proteins in US hospitals. Drug information journal. 2007; 41(4):431-440.
  10. Domingo-Espín J, Unzueta U, Saccardo P, et al. Engineered biological entities for drug delivery and gene therapy protein nanoparticles. Progress in molecular biology and translational science. 2011; 104:247.
  11. Lacana E, Amur S, Mummanneni P, Zhao H, Frueh F. The emerging role of pharmacogenomics in biologics. Clinical Pharmacology & Therapeutics. 2007; 82(4):466-471.
  12. Hillner BE, Smith TJ. Efficacy does not necessarily translate to cost effectiveness: a case study in the challenges associated with 21st-century cancer drug pricing. Journal of Clinical Oncology. 2009; 27(13):2111-2113.
  13. Baumann A. Early development of therapeutic biologics-pharmacokinetics. Current drug metabolism. 2006; 7(1):15-21.
  14. Craft Jr GS. Promoting Off-Label in Pursuit of Profit: An Examination of Fraudulent Business Model. Hous. J. Health L. & Pol’y. 2007; 8:103.

15. Rosoff PM, Coleman DL. The case for legal regulation of physician’s Off-Label prescribing. Notre Dame L. Re

Medical marijuana regulation in the United States: past, present, and future

Psychotropic drugs are dangerous and should be under lock and key.  At least, this is what many believe [1].  Of course, applying that logic, all Starbucks would have to be shutdown because coffee contains caffeine, a psychotropic drug.  Prejudice thwarts the uninformed from understanding the benefits of many drugs.

Continue reading Medical marijuana regulation in the United States: past, present, and future

An interesting book to read

I just read an excellent book, The Innovator’s Prescription by Clayton Christensen, Jerome Grossman, M.D. and Jason Hwang, M.D.   This book is fascinating, going into details of how to improve our health care system here in the U.S. based on what has worked in other businesses such as the automobile industry.  It shows what can happen when different solutions from other areas can be applied to the medical industry.

The authors discuss the disruptive business model to improve the quality, accessibility, and affordability.  It presents excellent ideas on how to change the way the players in the health care operate the business of medical care.  It also covers topics including regulatory reform, the future of medical education, the future of the medical device and pharmaceutical industries and much more.

This book is not like anything else I have read, and I appreciate the work that went into creating and writing this book.  I understand that this book took ten years to research and write.

If you get a chance, please check this book out from your local library or purchase it through your favorite bookstore.  You will gain so much more than you would have thought.

Zarina Memon, MD, MS

Will the Patient Protection and Affordable Care Act stifle medical innovations?

In March 2010, the United States Congress and President Obama passed the Patient Protection and Affordable Care Act (PPACA) [1] to contain America’s medical costs [2].  Although this law passed, it was not by a bipartisan measure [3], and many Republicans believed that the American healthcare care should have been left unaltered.4  However, most understood that the status quo was not a viable option.  American health care costs were over 16% of GDP in 2010 and expected to be over 20% by 2020 [4].  The PPACA puts costs on a more sustainable trajectory.

Continue reading Will the Patient Protection and Affordable Care Act stifle medical innovations?