Female Viagra: The rigged truth

Female Viagra, Pharma, FDA, United States, patients, doctors, CROs, India, Medical

Pharma industry is badly rigged. There is nobody you could trust.

“Female Viagra” and its approval by the US Food and Drugs Administration (FDA) has made screaming headlines. Before you hail it, a few facts on the “rigged” pharma industry deserve your attention:

·          If you were to be told that most clinical trials of drugs are funded by its own manufacturers; negative data is routinely withheld; independent academic papers are ghost-written by pharmaceutical companies or their contractors themselves without disclosures; doctors, patient groups have little basis for the drugs they advocate;

·          That regulators examine the trial data but only at the start of a drug’s life. But they don’t forward this data to doctors or patients or even to other sections of government;

·          That nobody knows what’s the best treatment is because it’s not in anyone’s financial interest to conduct any trials at all

So go on, give a four-letter expletive, warn your near and dear ones, hit the social media and generally increase your exercise regimen for that’s the best guarantee you have on your medical safety. The rest is sheer chance.

“Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients” is a book by British physician and academic Ben Goldacre.  He argues in the book that the “whole edifice of medicine is broken.” In the introduction, he says (a condensed version):

“In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions from sales reps, colleagues or journals. But a number of colleagues or journals are on payrolls of drug companies. So are the patient groups…sometimes the whole academic journals are owned outright by one drug company.”

Glodacre cites the example of oseltamivir (Tamiflu), manufactured by Roche to reduce the complications of bird flu. Billions of dollars were spent by governments to stockpile the medicine, based largely on a meta-analysis, funded by the pharma industry itself. Two tireless independent researchers, Tom Jefferson and Cochrane Collaboration Respirator Group, were able to bring out the real story on this drug out.

Female Sexual Dysfunction was highlighted in 1999 by a study published in the Journal of the American Medical Association which alleged that 43 percent of women were suffering from it. Later, the New York Times wrote that two of its three authors had worked as consultants for Pfizer, which at that time was about to launch “UK 414,495” known as female Viagra. The journal’s editor later admitted their mistake in withholding association with Pfizer.

In clinical trials, participants are usually taken from poorest groups in society. These volunteers are paid (in US, they are paid $200-$400 per day).This has sprouted Contract Research Organizations (CROs) in countries with mass poverty. The rate of growth for clinical trials in India is 20 percent a year. Three of the biggest international CROs in India are Quintiles, PPD and Paraxel. Among the Indian CROs, Siro Clinpharm, GVK Bio, Clininvent, Ecron Acunova and CliniRX are majors.

Similar to India, clinical trials in Argentina have grown by 27 percent and in China by 47 percent. The trials in the UK meanwhile have fallen by 10 percent a year and in the US by six percent.

The shift to outsourcing begs some serious questions. Goldacre asks whether a depressed patient in China is similar to one identified in California? Further, the people of Asian descent metabolize drugs differently from Westerners. Language difficulty, informed consent among poorer people are other issues. A population’s expectations are thus raised with compromised expertise.

Goldacre, throughout the book, offers some interesting suggestions:

·          Doctors, nurses and managers must stop seeing drug reps and ban them from clinics, hospitals and medical schools; to declare online and in waiting rooms all gifts and hospitality received from the industry; to remove all drug company promotional matter from offices and waiting rooms.

·          Regulations must be introduced to prevent pharmacists from sharing prescription records with drug reps

·          Academics must lobby their universities and academic societies to forbid academics from being involved in ghostwriting

·          Full disclosure of all past clinical trial results and list of academic papers “rigged” by the industry

·          Patients must ask their doctors if they accepted drug-company hospitality or sponsorship; and if so to post details in their waiting rooms; and to make it clear whether they want their medical history to be shared with drug reps.

·          Goldacre advised patient groups to write to drug companies with the following: “We are living with this disease; is there anything at all that you’re withholding? If so, tell us today.”

Goldacre was recognized in June 2013 by “Health Service Journal” as having done “more than any other single individual to shine a light on how science and research gets distorted by the media, politicians, quacks, PR and the pharmaceutical industry.”

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