Karma Catching Up With Big Pharma?

by Kimberly Ann on November 2, 2007

ejectonolShould US citizens be concerned about pharmaceutical drugs and personal safety? Aside form the litany of side-effects that accompany pharmaceutical drugs, the US’s FDA might be putting patients in harm’s way. Here are the facts, you decide:

An article in the NY Times today announced that 80% of the components comprising the US’s pharmaceutical drugs are made in foreign countries. Foreign drug suppliers do not have to meet the minimum regulatory standards set here in the US, which may result in counterfeit products. When you take a moment to consider all the recent news from China concerning toothpaste ingredients such as diethylene glycol (a poison found in antifreeze) and the lead-based paint used on toys, we may want to reexamine our health care options.

The FDA announced that it is unable to keep regulatory records for the safety of these foreign manufacturers, citing poor data management systems. The result is that the FDA relies on foreign inspectors and volunteers, oftentimes where the manufacturer gets a “heads up” before an inspection or translators are used. Are we receiving an honest picture of what is going on?

Following that same line of thought, recently the FDA recommended NOT to import/buy pharmaceutical drugs from international sources, such as Canada and Mexico, citing caution about unknown ingredients and ineffective doses of active ingredients:

“For public health reasons, FDA remains concerned about the importation of prescription drugs into the U.S. In our experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality. FDA cannot assure the American public that drugs imported from foreign countries are the same as products approved by FDA.” (Source)

Does the new information highlighted today in the New York Times conflict with these precautionary measures? Perhaps so. Clarification from the FDA and US policies for the origins of its pharmaceutical drugs should be reexamined and implemented in a way that protects consumer safety.

Why are the costs for pharmaceutical drug higher in the US than any where else on the globe? 60 Minutes attempted to get to the bottom of this powerful lobbying action with their expose` entitled: “Under the Influence“. You’d be surprised how this got through Congress.

And if that’s not enough questionable karma:

When it comes to pharmaceutical advertisement, the specifics are presented with a slight of hand technique, leading scientists say at the Poynter Institute. An example of a recent NPR interview looks at the drug, Lunesta, a sleep-aid, where the consumer is given the particulars in a manipulative manner. To name a few techniques: benefits are read at a sixth-grade reading level, side effects read at a ninth-grade level; visual imagery was used to detract from a cautionary list of complications; and the only difference between the treatment group (those that received Lunestra) and the control group (those that did not), according to the fine print, was a mere 40 minutes of sleep! Is this a reasonable antidote for sleep considering the list of side effects?

Not convinced of Big Pharma’s karmic debt? Well, unfortunately, you ain’t seen nuthin’ yet: http://www.newstarget.com/Big_Pharma.html

Stay informed, protect your most valuable asset: your health because you’re worth it.

{ 12 comments… read them below or add one }

JeremyS November 5, 2007 at 6:50 pm

Right on. I’m increasingly taken aback by the leap of faith taken by both sides of the equation in the world of pharmaceuticals.

Here’s another interesting article you can add to your collection: WIRED.com: From Benzedrine to Abilify, Chronicling America’s Love of Psychiatric Drugs. Check out how many drugs were created for one ailment and ended up being used for another. Some might think that’s a good thing, but for me it means you can never know what artificial substances will do to the body!

C. Biscuit November 20, 2007 at 10:39 am

Blowing the Whistle, Many Times

An account of Cynthia Fitzgerald’s 20-year occupation as a pharmaceutical representative, how the business has changed, and how one experience with Johnson & Johnson took her deep into the legal system.

http://www.nytimes.com/2007/11/18/business/18whistle.html

C. Biscuit November 27, 2007 at 10:32 am

Dr. Drug Rep

A psychiatrist’s perspective on the selling of pharmaceuticals to other doctors. This is a behind-the-scenes on how doctors can obtain information about the drugs they prescribe for patients in the clinic.

http://www.nytimes.com/2007/11/25/magazine/25memoir-t.html

C. Biscuit December 13, 2007 at 10:29 am

Agreement With China to Regulate Some Drugs

“American and Chinese regulators signed an agreement Tuesday to strengthen regulation of drugs and medical devices exported to the United States. But the accord covers only a tiny fraction of the pharmaceutical ingredients being marketed worldwide by thousands of unlicensed chemical companies….”

http://www.nytimes.com/2007/12/12/business/worldbusiness/12safety.html

C. Biscuit January 18, 2008 at 10:27 am

Researchers Find a Bias Toward Upbeat Findings on Antidepressants

“The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found.

In published trials, about 60 percent of people taking the drugs report significant relief from depression, compared with roughly 40 percent of those on placebo pills. But when the less positive, unpublished trials are included, the advantage shrinks: the drugs outperform placebos, but by a modest margin, concludes the new report, which appears Thursday in The New England Journal of Medicine….”

http://query.nytimes.com/gst/fullpage.html?res=9B0CEFDA163CF934A25752C0A96E9C8B63

C. Biscuit February 4, 2008 at 10:25 am

The F.D.A. in Crisis: Another Danger Made in China

“The F.D.A. — and American consumers — got another warning last week about the need for vigilant monitoring of imported drugs from the developing world, especially from China. The contamination of a drug used to treat Chinese leukemia patients should also raise alarms at multinational pharmaceutical companies that plan to outsource manufacturing to China….”

http://www.nytimes.com/2008/02/03/opinion/03sun2.html

C. Biscuit February 16, 2008 at 11:18 am

Unfortunately, since this publication, there is still much to be done. Here’s an article by the New York Times that reports that US pharmaceuticals are still coming from unchecked, unregulated sources. It’s entitled: “China Didn’t CheckDrug Supplier.”

http://www.nytimes.com/2008/02/16/us/16baxter.html?_r=1&hp=&adxnnl=1&oref=slogin&adxnnlx=1203185338-JqiZy+mFZt5bm8M64H+XuQ

C. Biscuit February 17, 2008 at 10:24 am

China Didn’t Check Drug Supplier, Files Show

“A Chinese factory that supplies much of the active ingredient for a brand of a blood thinner that has been linked to four deaths in the United States is not certified by China’s drug regulators to make pharmaceutical products, according to records and interviews….”

http://www.nytimes.com/2008/02/16/us/16baxter.html

C. Biscuit March 17, 2008 at 10:21 am

Tainted Drugs Put Focus on the F.D.A.

“After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions. The drug was a common antibiotic, and the year was 1999. But in recent weeks, the Food and Drug Administration has faced an almost identical crisis….”

http://www.nytimes.com/2008/03/17/health/policy/17fda.html

C. Biscuit March 31, 2008 at 10:20 am

The Drug Scare That Exposed a World of Hurt

“When cold medicine containing a poison made in China killed nearly 120 Panamanians in 2006 and early 2007, Americans could take some comfort in the belief that a similar epidemic could never happen here, not with one of the best drug regulatory systems in the world….”

http://www.nytimes.com/2008/03/30/weekinreview/30bogdanich.html

C. Biscuit April 6, 2008 at 10:18 am

An article on how the pharmaceutical companies are able to prevent consumers from filing complaints about their products.

Drug Makers Near Old Goal: A Legal Shield
http://www.nytimes.com/2008/04/06/washington/06patch.html

C. Biscuit April 24, 2008 at 10:07 am

Follow up to the FDA progress:

NY TIMES article: “House Panel Criticizes F.D.A. Role in Drug Cases”
It’s worth following the history and how the FDA is handling our pharmaceutical situation.

http://www.nytimes.com/2008/04/23/health/policy/23heparin.html?ref=health

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