FDA and tainted PR Deal

publicrelationsFDA Tackles Image Problem With Tainted PR Deal

FDA Will Rewrite Rules For Marketing for Children

The Food and Drug Administration will rewrite decades-old federal regulations governing how over-the-counter cold and cough medicines are marketed to children amid concerns over whether the products are safe and effective.

[FDA to Rewrite Marketing Rules] 

The FDA is revisiting marketing rules.

As part of that effort the agency held a daylong hearing Thursday to solicit views about how the rules should be changed. While the effort is expected to take years, the end result could be a tougher regulatory environment for many over-the-counter cold and cough products — such as requiring drug makers to seek approval for their products in a manner similar to that for prescription drugs.

An estimated 95 million packages of children’s over-the-counter cold and cough medicines are sold each year in the U.S. under a range of brand names, including Johnson & Johnson‘s Tylenol Plus Cold, Novartis AG’s Triaminic and Wyeth’s Robitussin, according to industry estimates.

John Jenkins, the FDA’s office of new drugs director, said the system that currently governs over-the-counter cold and cough products was really designed to grandfather the over-the-counter medicines that were on the market in the 1960s. The system allowed certain active ingredients (such as those in decongestants) to be legally marketed without obtaining prior FDA approval for each individual product. The studies used to establish the safety of those ingredients were mostly done in adults; current dosing recommendations for kids are simply reduced from adult doses.


Vit D and Flu

Something that can explain why flu epidemics also occur both in warm and cold climates is this: During a flu epidemic, wherever it may be, the atmosphere blocks ultraviolet B (UVB) radiation from the Sun. In the temperate zones above latitude 35 degrees North and South, the sun is at a low enough angle in the winter that the ozone layer in the atmosphere absorbs and blocks the short-wavelength (280–315 nanometers) UVB rays. In the tropics during the wet season, thick rain clouds block UVB rays.

Skin contains a cholesterol derivative, 7-dehydrocholesterol. UVB radiation on skin breaks open one of the carbon rings in this molecule to form vitamin D. The activated form of vitamin D (1,25-dihydroxyvitamin D) attaches to receptors on genes that control their expression, which turn protein production on or off. Vitamin D regulates the expression of more than 1,000 genes throughout the body. They include ones in macrophages, cells in the immune system that, among other things, attack and destroy viruses. Vitamin D switches on genes in macrophages that make antimicrobial peptides, antibiotics the body produces. Like antibiotics, these peptides attack and destroy bacteria; but unlike antibiotics, they also attack and destroy viruses.

Vitamin D also expresses genes that stop macrophages from overreacting to an infection and releasing too many inflammatory agents – cytokines – that can damage infected tissue. Vitamin D, for example, down regulates genes that produce interleukin-2 and interferon gamma, two cytokines that prime macrophages and cytotoxic T cells to attack the body’s tissues. In the 1918–19 Spanish flu pandemic that killed 500,000 Americans, young healthy adults would wake up in the morning feeling well, start drowning in their own inflammation as the day wore on, and be dead by midnight, as happened to my 22-year-old grandmother and my wife’s 24-year-old grandmother. Autopsies showed complete destruction of the epithelial cells lining the respiratory tract resulting, researchers now know, from a macrophage-induced severe inflammatory reaction to the virus. In a terribly misguided way, these victims’ own immune system attacked and killed them, not the virus, something in future pandemics vitamin D, in appropriate doses, can prevent.

A creditable hypothesis that explains the seasonal nature of flu is that influenza is a vitamin D deficiency disease. Cannell and colleagues offer this hypothesis in “Epidemic Influenza and Vitamin D” (Epidemiol Infect 2006;134:1129–40). They quote Hippocrates (circa 400 B.C.), who said, “Whoever wishes to investigate medicine properly should proceed thus: in the first place to consider the seasons of the year.” Vitamin D levels in the blood fall to their lowest point during flu seasons. Unable to be protected by the body’s own antibiotics (antimicrobial peptides) that this gene-expresser engineers, a person with a low vitamin D blood level is more vulnerable to contracting colds, influenza, and other respiratory infections (e.g., respiratory syncytial virus).

Studies show that children with rickets, a vitamin D-deficient skeletal disorder, suffer from frequent respiratory infections; and children exposed to sunlight are less likely to get a cold. Given vitamin D’s wide-ranging effects on gene expression, other studies, for example, show that people diagnosed with cancer in the summer have an improved survival compared with those diagnosed in the winter (Int J Cancer 2006;119:1530–36).

A growing body of evidence indicates that rickets in children and osteomalacia in adults (both a softening of bones due to defective bone mineralization) are just the tip of a vitamin D-deficiency iceberg. Tuberculosis and various autoimmune diseases, such as multiple sclerosis, lupus, and type I diabetes have a causal association with low vitamin D blood levels. Vitamin D deficiency plays a causal role in hypertension, coronary artery disease, congestive heart failure, peripheral vascular disease, and stroke. It is also a risk factor for metabolic syndrome and type II diabetes, chronic fatigue, seasonal affective disorder, depression, cataracts, infertility, and osteoporosis. At the bottom of the vitamin D iceberg lies cancer. There is good evidence that vitamin D deficiency is a causal factor in some 15 different common cancers. (NEJM 2007;357:266–81.)

The increased number of deaths that occur in winter, largely from pneumonia and cardiovascular diseases, are much more likely due to vitamin D deficiency than to an increased prevalence of serologically-positive influenza virus (which also results from vitamin D deficiency).

Experts reckon that an optimum blood level of vitamin D (25-hydroxyvitamin D) is 50–99 ng/ml. (Children need a blood level >8 ng/ml to prevent rickets. It takes a concentration >20 to maintain parathyroid hormone levels in a normal range. A level >34 is needed for peak intestinal calcium absorption. And in elderly people neuromuscular performance steadily improves as vitamin D blood levels rise to 50 ng/ml.) The government’s recommended daily allowance (RDA) for vitamin D is 400 IU (international units) a day, an amount sufficient to prevent rickets and osteomalacia but not vitamin D’s other gene-regulating benefits. To achieve all of vitamin D’s benefits one has to take an amount ten times the government’s RDA – 4,000 to 5,000 IU a day.

A light-skinned person will synthesize 20,000 IU of vitamin D in 20 minutes sunbathing on a tropical beach, at which point vitamin D synthesis shuts down for the day (it takes a dark-skinned person 6 to 10 times longer to make this amount). Human breast milk does not contain vitamin D, since, from an evolutionary standpoint, our African ancestors’ infants, reared near the equator, could readily synthesize this gene regulator from sunlight in their skin. Food contains very little vitamin D. (The highest concentrations are in wild salmon, mackerel, sardines, and cod liver oil.) Federal regulations now require that some foods, like milk, be fortified with vitamin D. But one would have to drink 200 glasses of milk to obtain the amount of vitamin D a light-skinned person can make in 20 minutes sunbathing.

The majority of Americans are vitamin D deficient, with a 25-hydroxy D blood level <20 ng/ml, or insufficient, with a level of 20–<30 ng/ml. Cheap vitamin D supplements (D3, not D2) provide the only way most of us can maintain a year-round vitamin D blood levels greater than 50 ng/ml. That requires taking 4–5,000 IU of vitamin D a day (50,000 IU every ten days or 150,000 IU a month).

Taking vitamin D in these doses is safe, far safer than a flu shot with all the bad chemicals it contains. Concerns about vitamin D toxicity are overblown. One can take a 10,000 IU vitamin D supplement on a daily basis without any adverse effects. In healthy persons, long-term consumption of more than 40,000 IU a day is necessary to cause an elevation in the blood calcium level (hypercalcemia), the first manifestation of vitamin D toxicity (Am J Clin Nutr 2006;84:694–97). Check your vitamin D (25-hydroxy D) blood level. People with granulomatous diseases like sarcoidosis should also check their blood level of 1,25-dihydroxyvitamin D, the active form.

Can a shot (or tablets) of vitamin D prevent influenza better than a flu shot? There is good reason to believe that it can.

Doctors in India and Canada give people a once-yearly injection of 600,000 IU of vitamin D (MJA 2005;183:10–12). That would be better, and safer, than having a flu shot. Daily, weekly, or monthly vitamin D tablets work just as well. For more on this subject see my article “Vitamin D in a New Light” and visit Dr. Cannell’s Vitamin D Council website.

Investigators have completed one double-blind, randomized, placebo-controlled trial that shows vitamin D prevents colds and influenza significantly better (P <0.002) than a placebo pill (Epidemiol Infection 2007;135:1095–6). A large multi-center randomized trial conducted over multiple flu seasons comparing vitamin D to a flu shot can show conclusively which is better, and safer. But given the financial stakes underpinning flu shots, and unpatentable vitamin D, who will fund it?


Officials suspended for ‘detecting polio cases’

October 05, 2008
By Amer Malik


THE fate of 117 School Health and Nutrition Supervisors, Sargodha district, hangs in the balance as Health Department suspended them after one year of their service on basis of not filling recruitment rules.

However, the affected officials alleged that they had been penalised for detecting polio cases during their health and nutrition campaign in schools in Sargodha district. The issue has raised warning that polio cases in Punjab may have been under-reported to hide failure to control the alarming spread of polio virus in Punjab this year….

They further said that they had been made a scapegoat for detecting some polio cases in schools in Sargodha, which caused their own suspension. “The District Health Department, Sargodha, had warned us against making polio cases public, which ultimately became reason of their suspension,” they added.

The medical experts and officials of Health Department that Punjab’s health authorities were facing a challenge to control the spread of polio virus, which had emerged like an epidemic in different districts of Punjab during this year. Presently, there are 16 reported polio cases in Punjab out of total of 65 cases across Pakistan. Out of total of 65 polio cases, 50 cases are of P-I strain of polio and 15 cases of P-III strain of polio virus. All 16 cases in Punjab are detected as attacked with P-I strain of polio virus.

However, medical experts and officials of Health Department said there might have been many more cases of polio as against moderately reported 16 cases in Punjab, as reporting of greater number of polio cases reflected failure of Health Department’s anti-polio drives through low coverage of immunization of each and every child below five years of age or raised questions about the substandard or expired vaccines being used during the vaccination campaigns under Expanded Programme of Immunization or special three-day anti-polio campaigns under National Immunization Days (NIDs). “It has prompted health authorities to under-report polio cases to conceal their own failure to control the spread of crippling polio disease among the children in the province,” they added….



Anti-U.S. views fuel polio growth in Pakistan  

To date, Farah is the lone case of polio in this city of 10 million inhabitants. But health officials fear the polio virus is re-emerging across Pakistan. It is especially serious, they say, in the lawless tribal North West Frontier Province along the border with Afghanistan where the Islamic fundamentalist Taliban rule and many families have refused vaccinations on religious grounds…

In 2007, the World Health Organization recorded 32 cases of polio in Pakistan, up from 28 in 2005. Between January and August, 31 more cases have been recorded, with one-third in the tribal areas.

Since a door-to-door immunization program began in 2001, tens of millions of children have been vaccinated or given polio drops, according to health authorities. But in tribal areas, radical Islamic clerics such as Maulana Fazlullah have convinced residents that U.S.-manufactured polio drops are designed to sterilize Pakistanis and reduce the Muslim population.

Health authorities say polio vaccines used in Pakistan are produced in WHO-accredited laboratories not only in the United States but in Japan, Belgium and India. Pakistan has no such laboratory.

Kahn says recent air strikes in tribal areas have also contributed to residents refusing to allow vaccinations for their children. Since Aug. 13, there have been at least seven reported U.S. missile strikes, as well as a ground force operation, in tribal territories.

“Due to the security situation in these areas there is a lot of resentment against America,” said Kahn. “The perception that this vaccine is a U.S. product holds strong in these areas, leading to refusals” to accept vaccinations.

Khan also noted that Fazlullah’s sermons have stressed that those who become crippled or die from polio are martyrs. The vaccine is considered haram, or that which is forbidden for Muslims.

“There are other diseases also – like hepatitis, typhoid, etc. Why is everyone concentrating on polio?” asked Kahn. “See, this is an American conspiracy.”…

Khilji says that aside from conspiracy theories, religious beliefs can also play a role in keeping children from being vaccinated. “Some parents say it’s un-Islamic to vaccinate their children because it’s akin to tampering with the will of Allah,” said Wahaeed Khan, a former EPI official…



I think their views and feelings are justified. Who is to say vaccines aren’t contaminated? In fact, we know right here in the U.S. and Canada it happens. Air strikes? What type of toxins and pollutants are being distributed in their region which could lead to higher polio cases?  Religious beliefs are always valid and should be upheld.