Editorial: Are we really where we want to be?

Do consumers (including patients) really "save" money by America's pharmaceutical companies outsourcing manufacturing to other countries? Possibly not! There are many other costs that enter into the equation that result in the final cost of a product, including pharmaceuticals. True, the large corporations may save costs and increase their bottom line, but that is not the entire story. Let's look at the situation.

1. A company decides that it is no longer cost-effective to meet the government EPA and OSHA standards, pay the high salaries for employees, and maintain the manufacturing facilities to FDA standards in order to produce active pharmaceutical ingredients (API).
2. The pharmaceutical company then must purchase the API from another country where the government standards are not as strict, employee costs are less, etc.
3. The pharmaceutical company receives the API and produces the finished product here in the U.S.

In this scenario, the company receives the API, does the required testing, and then produces the finished pharmaceutical product and sells it at a certain price.

However, there are other costs involved that must be considered that are not a direct cost of the product but must be paid by the consumer. Additional costs include:

1. FDA establishing offices and facilities in the other countries at taxpayers' expense.
2. Lost jobs in an era of about 9.5% unemployment in the U.S. increasing unemployment benefits that we must also pay.
3. Impact on the environment of the fuel required for transportation of the API from other countries to the U.S.
4. Impact on the environment of the manufacturing facilities in other countries that produce the API without any environmental standards.
5. Impact on the health of the employees and population in cities where the manufacturing facilities are located in the other countries.
6. Slow responses by these companies when there are problems, as demonstrated the past couple of years with the situation involving contaminated heparin, melamine-tainted milk products, and diethylene glycol. We pay for this in different ways.
7. Rejected lots that do not meet U.S. standards. Many of these companies produce different grades of product in the same facility, sometimes resulting in drug shortages and delays.

On June 22, 2010, Margaret A. Hamburg, M.D., Commissioner of Food and Drugs at the Woodrow Wilson International Center for Scholars, made a presentation which included the following statement:

About 70 percent of seafood and 40 percent of fresh fruit and produce on the U.S. market comes from other countries and some 80 percent of active pharmaceutical ingredients in drugs consumed in the U.S. come from outside our borders. So we're definitely talking about real numbers here.

In addition to the sheer volume of imports and foreign facilities, there has been an increase in the variety and complexity of imported products�and a large expansion in the number of countries involved in producing these products�including many with less sophisticated regulatory systems than our own.

This all adds up to an enormous task for the FDA - especially because we've already seen the warning signs.

Obviously, this is an area of great concern�and expense. If the situation continues, we will see a great increase in the size and budget of the FDA to address this situation at the cost of increased taxes to the consumers/patients. Why not consider putting our own people back to work to decrease unemployment and eliminate an increase in the size of the FDA and the taxes we must pay? In summary, we will all pay increased costs; it's just a matter of where the money goes and for what.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

Zinc Nasal Sprays Culprit in Loss of Smell
Zinc nasal sprays used to relieve symptoms of the common cold can cause anosmia, a loss of the sense of smell. This was the conclusion of Terence M. Davidson, MD, and Wendy M. Smith, MD, of the University of California San Diego, when they applied the nine Bradford Hill criteria to the relationship.

Intranasal zinc gluconate is a popular over-the-counter alternative therapy for treatment of the common cold, but it may also be linked to severe or potentially permanent hyposmia and anosmia and its efficacy is questioned.

Bradford Hill criteria have been used to determine causation when an association is observed between exposure to an environmental agent or a drug and a disease and includes strength of the association, consistency, specificity, temporality, dose-response, biological plausibility, biological coherence, experimental evidence, and analogy.

The investigators applied the criteria to the cases of 25 patients who presented to a nasal dysfunction clinic complaining of anosmia after they used the zinc gel nasal spray as well as assessing the literature on the relationship.

Based on the Bradford Hill criteria, they found that intranasal zinc gluconate therapy causes both hyposmia and anosmia.
http://www.medpagetoday.com/PrimaryCare/AlternativeMedicine/21249

Can Melatonin Help Rebuild Brittle Bones?
Melatonin, a hormone involved in regulating our internal body clock, may also help treat osteoporosis. Melatonin is now being studied in women over 45 as part of a clinical trial to test the benefits.

There are around 300,000 osteoporosis-related fractures each year. The condition affects both women and men of all ages, although it's most commonly associated with postmenopausal women.

Traditional treatment includes bisphosphonates, strontium ranelate, and vitamin D. In the new study at the University of Pittsburgh, researchers are looking at melatonin as an alternative treatment.

Previous studies have pointed to a connection between melatonin and osteoporosis. In one American study, women who worked nightshifts for more than 20 years were more likely to suffer wrist or hip fractures. Meanwhile, animal studies have shown melatonin in bone marrow. Increasing the amount of the hormone in animals with osteoporosis has encouraged bone growth. Melatonin also has a powerful antioxidant effect, so may help to prevent the inflammation and damage that leads to bone breakdown.

This might provide an inexpensive, efficient way to help some of the millions who have osteoporosis. However, much more work is needed before any benefits of melatonin can be assessed.
http://www.dailymail.co.uk/health/article-1296091/Could-sleeping-pill-help-rebuild-brittle-bones.html

House Probe Says China Never Investigated Tainted Heparin
The Chinese government never pursued an investigation into contaminated heparin sent to the U.S. in 2007 and 2008, despite repeated requests from the U.S. Two House Republicans said FDA officials recently told them that the agency has been "severely hampered" by the lack of cooperation from China in finding those responsible. Contamination in the widely used blood-thinner was linked to at least 81 deaths in the U.S. The probe by House Representatives comes as FDA Commissioner Margaret Hamburg prepares for her first trip to China since assuming her post last year.

"It is shocking to find out two years after Chinese-made heparin was killing Americans, the Chinese government still has done no investigating to find out why," said Mr. Barton, the top Republican on the House Energy and Commerce Committee. He has requested that Ms. Hamburg air the issue with Chinese officials, who claim they did do an investigation.

A spokeswoman for the FDA said "There are serious limitations on what the FDA can do to pursue civil and criminal investigations in foreign countries, especially without the cooperation of the foreign government." In a June 16 letter to the congressmen, the FDA wrote that it was "denied full access" to manufacturers of raw heparin in China.
http://online.wsj.com/article/SB10001424052748703954804575381540372921432.html?mod=dist_smartbrief

�that beginning with the September/October 2010 issue of IJPC that each issue will cover a wide variety of compounding topics instead of having a specific "theme"? This will make each issue more applicable to a wider variety of practice sites.

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