Why Big Pharma now outsources its clinical trials overseas

In New Delhi, 49 babies died at the All India Institute of Medical Sciences (a public hospital renowned for providing low-cost treatment to the poor) while they were taking part in pharmaceutical clinical trials over a 30-month period. These babies had been given a variety of new drugs being studied to treat conditions like zinc deficiency, high blood pressure or a brain inflammation called chronic focal encephalitis. The head of the pediatrics department at the All India Institute claimed that “none of the deaths was due to the medication or interventions used in clinical trials.”

The blood-pressure drugs had never before been given to anyone under 18. Yet of the children enrolled in these studies, two-thirds of them were infants less than one year old.

As recently as 1990, only 271 drug trials were being conducted in foreign countries on drugs intended for North American use. But by 2008, that number had risen to 6,485—an increase of more than 2,000%Continue reading

Viagra goes generic: then what?

Jim Edwards asks a question that many Big Pharma watchers are asking, too: “What will happen when Viagra goes generic?”  The BNET pharmaceutical writer and former managing editor of Adweek offers this best guess in an AccessRx column:

“When the drug giant Pfizer loses its patent protection for its erectile dysfunction drug Viagra, any drug company will be able to make and sell a cheap generic version of the blockbuster drug. Doctors and lawyers believe that the expiration of Pfizer’s monopoly on the drug will be good news for patients, as it will force competition between Pfizer’s Viagra and the new generic versions, dramatically driving down the price not only of Viagra but also of Eli Lilly’s Cialis and Bayer’s Levitra.

“However, increased options and cheaper prices for patients will lead to some confusion in the marketplace as Pfizer defends the reputation of its original brand and pharmacies become flooded with copycat pills, many of which may be made in China Continue reading

Is ugliness a disease?

Something strange is happening in medicine, according to physician,  bioethicist and author Dr. Carl Elliott in his landmark article in The Guardian called Is Ugliness a Disease?  No longer, he claims, is medicine being used merely to cure illness. Medicine is now being used in the pursuit of happiness. We take Viagra at bedtime and Ritalin before work. We inject Botox into our wrinkled brows and rub Rogaine on our balding heads. We swallow Paxil for shyness, Prozac for grief, and Buspar for anxiety.

“For stage fright we use beta blockers; for excessive blushing and sweating, we get endoscopic surgery. We ask surgeons to trim down our noses and suck fat from our thighs in the pursuit of what we believe to be our true selves.  Continue reading

Top 10 biggest-selling prescription drugs

The editors of Consumer Reports Health took a very close look at the recently released list of the Top 10 biggest-selling prescription drugs last year. No surprise that most of the drugs to make this list (based on total dollars spent) are expensive and heavily advertised brand name drugs prescribed for common ailments such as heartburn and high cholesterol.

But oddly enough, many would not be the first picks as recommended by the independent medical experts at Consumer Reports Health.  Here’s the list, along with some of their Best Buy Drugs list alternatives:  Continue reading

How to turn a condition into a disease by “selling sickness”

“Selling sickness” means that the line between healthy and sick becomes blurred – and demand for medical treatment increases. If you’re a drug company, it’s a swell way to get consumers to demand treatment that may or may not even be necessary. So says a Dutch study that investigated industry-funded information campaigns around common conditions like restless legs syndrome, overactive bladder and heartburn.

These “ask your doctor” campaigns focused on symptom advertising or disease mongering.

Dutch law, as in Canada (but not, significantly, in only two countries: the U.S. and New Zealand) prohibits “Direct To Consumer” public advertising of prescription drugs. You might well wonder why these two countries are the only ones on earth who still permit this marketing practice. Continue reading

Clinical practice guidelines vs. routine screening mammograms

When you need medical help, your doctor and other health care providers may be faced with difficult decisions and considerable uncertainty. So they rely on the scientific literature in addition to their own knowledge, experience, and patient preferences to inform these decisions.

And they also consider clinical practice guidelines, which are published recommendations intended to optimize patient care. But in a New York Times piece last month, Ronen Avraham, a professor at the University of Texas School of Law, observed that these clinical practice guidelines often conflict with one another.

Recommendations for when and how frequently women need mammograms, for instance, notoriously vary depending on which group is giving them. Continue reading