By MARTHA ROSENBERG

Americans are getting used to the withdrawal or severe restriction of drugs "previously thought safe." From last year's Avandia warnings to the withdrawal of Vioxx, Bextra, Baycol, Meridia, Trovan and Fen Phen, "Pill Buyer Beware" seems to be a shrewd stance, especially when a drug is new.

Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.

But this month FDA issued a warning that pregnant women who take the antiepileptic drug Topamax are twenty times as likely to have their babies develop cleft lip and cleft palate as they would otherwise be, says Reuters. Children are three times as likely to develop the facial anomalies as infants exposed to other seizure drugs, adds the Associated Press.

Johnson & Johnson's Topamax is FDA-approved to treat seizures and migraine headache. But like the off-label marketed seizure drugs Neurontin and Lyrica (for which Pfizer paid massive fines), J & J agreed to a $6.1 million fine for illegally marketing Topamax for psychiatric conditions, less than a year ago.

And the marketing worked. Thanks to J & J's subsidiary Ortho-McNeil's "Doctor-for-a-Day" scheme in which it paid outside physicians to call on health care providers along with sales reps and speak at meetings and dinners, according to the AP, Topamax made J & J a cool $2 billion a year by 2006. (A lot less than the $6.1 million it paid in criminal fines for the marketing that made the $2 billion.)

http://counterpunch.org/rosenberg03212011.html

Will read through when I have more time.  This is all always very interesting to be kept posted!

I hade made some research re vaccins - would you by any chance know of any docs. or links related to that subject? 

Again, would you also have any re "where/on whom/how - in which circumanstances" new drugs are tested before being commercialized in the western world?

This is only to broaden my current knowledge - I do not want to enter any monologue with any pharmaceutical employees :), so just want some info! 

 Thanks!

Dear Marieh,

I am by no means an ‘expert’ (whatever that might be) on the pharmaceutical industry but have worked inside it in a number of companies.  Neither am I an expert on vaccines but have read a number of articles on childhood vaccination and the link to autism (http://www.google.com/search?q=vaccine&domains=http%3A%2F%2Fwww.counterpunch.org&sitesearch=http%3A%2F%2Fwww.counterpunch.org) .

 I do believe that drugs including vaccines have made a substantial contribution to human health, but clean water, sanitation and a healthy food chain and environment probably outweighs this benefit many fold.   However if I was to suffer from a heart attack I would be quite willing and happy to receive appropriate medication.  The risk with the drug industry (as with any industry) is that the drive/push/pressure to increase sales and profits sometimes leads to unethical behaviour (including by physicians who speak on behalf of drugs and the supporting companies).  For example if you look at psychiatric drugs, the rise in their use is questionable if not disturbing (http://www.google.com/search?q=psycopharmacology&domains=http%3A%2F%2Fwww.counterpunch.org&sitesearch=http%3A%2F%2Fwww.counterpunch.org).

 I do not believe the ‘truth’ is known about the link (more to non-drug constituents e.g. mercury, rather than the active medicinal ingredient) of vaccines and the various forms of autism.

Drug research before commercialisation is by necessity limited to hundreds or thousands of volunteers and patients and because of the strict inclusion criteria for studies many issues of safety only come to light with commercialisation to the wider public.  This is why the industry is obliged and ethically complies with post-marketing drug surveillance and reports very regularly to government drug approval agencies such as the FDA and EMEA.  The drug industry has made substantial contributions to human health but must be understood to be an industry that seeks profit and sometimes this puts some in a difficult ethical situation when serious health issues surrounding a drug have arisen after so much has been invested.  However some have no problem stretching (breaking) the ethical boundaries.  On the other hand approval agencies for a variety of reasons also fall short of having the appropriate knowledge/understanding to approve certain drugs.  These agencies are under pressure from doctors patients and the industry to do ‘the right thing’.  They are human and subject to all our foibles and errors of judgement and sometimes lack of knowledge.

As a starting point on drug development you can read this from Wikipedia http://en.wikipedia.org/wiki/Drug_development and also the subjects mentioned at the bottom.

http://the-whistleblower-by-peter-rost.blogspot.com/

Prozac, Suicide and Dr. Healy

By Rick Giombetti

Dr. David Healy of the Department of Psychological Medicine at the University of Wales in the UK is hardly a household name in the United States and that is a shame.

One of the world's leading research psychopharmacologists, Healy's expert testimony in last year's Paxil civil trial was one of the deciding factors in the plaintiff's jury victory in that case. Wyoming resident Donald Schell, 60, killed his wife, daughter and granddaughter and then himself with a gun in 1998 after only two days on Paxil. Schell's surviving family members sued Paxil manufacturer UK-based Glaxo-Smith-Kline (GSK), the world's largest pharmaceutical manufacturer, and won. The decisive factor in the case was the company's own internal data demonstrating that they knew Paxil could cause agitation and suicidal ideation in research subjects. A month after the June verdict in the case, GSK caved in to the British Medicines Control Agency's request to put a suicide warning on Paxil.http://www.counterpunch.org/prozacsuicide.html

By EUGENIA TSAO

Eugenia Tsao is a Ph.D. candidate in medical anthropology at the University of Toronto and a CGS Doctoral Fellow of the Social Sciences and Humanities Research Council of Canada (SSHRC). She can be reached at [email protected]. A full list of references, sources for the quotes and figures cited in this article can be obtained by emailing the author.

http://www.counterpunch.org/tsao08202009.html