James O’Keefe— what only “real” bad mainstream journalists can allow

research: evidence-​based medicine and the benefits of generic drugs


New drugs trail many old ones in effec­tive­ness against dis­ease by Sharon Beg­ley at Reuters

Research pub­lished on Mon­day showed that the effec­tive­ness of new drugs, as mea­sured by com­par­ing the response of patients on those treat­ments to those tak­ing a placebo, has plum­meted since the 1970s.

While that is already unwel­come news to drug and biotech com­pa­nies, the con­se­quences for the phar­ma­ceu­ti­cal indus­try could get worse under Pres­i­dent Barack Obama’s health­care law.

The law estab­lished an inde­pen­dent research insti­tute to com­pare the effec­tive­ness of dif­fer­ent treat­ments for the same con­di­tion. That way, patients as well as pri­vate insur­ers and gov­ern­ment pro­grams such as Medicare can stop pay­ing for less effec­tive ther­a­pies. If the new analy­sis is cor­rect, then “com­par­a­tive effec­tive­ness research” could con­clude that older drugs, which are more likely to be gener­ics, are bet­ter than pricey new brand names that deliver the most prof­its for drugmakers.

Nine pharma firms face EU fines over pay-​for-​delay deals at PMLiVE

The poten­tial new fines fol­low an inquiry launched into the prac­tice in 2009 by the EC — the Euro­pean Union’s anti-​trust reg­u­la­tor — in a bid to crack down on the industry’s pay-​for-​delay deals.
It recently found that con­sumers are pay­ing up to 20 per cent more than nec­es­sary for some med­i­cines, had a legit­i­mate generic not been delayed.

In April, Glax­o­SmithK­line was accused by the UK’s Office of Fair Trad­ing of set­ting up delays with sev­eral gener­ics firms in the UK over the sale of copy­cat forms of its drug Seroxat.

If found guilty the firm could be fined 10% of its global rev­enue — a poten­tial loss of over £2.6bn.
The prac­tice has been a par­tic­u­lar prob­lem in the US, where a Fed­eral Trade Commission’s (FTC) staff report found these deals involved 22 brand-​name pharma prod­ucts in 2011, with com­bined annual US sales of about $9.3bn.
Much like the EC, the FTC is now increas­ing its efforts to com­bat these deals, and have even chal­lenged a num­ber of patent set­tle­ment agree­ments in court, con­tend­ing that they are anti-​competitive and vio­late US antitrust laws.

video: David Healy on school shooting and prescription drugs

Are pre­scrip­tion drugs to blame for school shootings?

Meet the Doc­tor Big Pharma Can’t Shut Up at Alter­net

For years, it was fairly easy for peo­ple in the phar­ma­ceu­ti­cal and med­ical indus­tries to label Healy, Kirsch and Breg­gin as alarmists. But two sum­mers ago, one of the most promi­nent mem­bers of U.S. med­ical establish-​ment, Mar­cia Angell, for­mer editor-​in-​chief of New Eng­land Jour­nal of Med­i­cine, pub­lished an arti­cle damn­ing the over-​prescription of psy­choac­tive drugs. In two essays in the June 23, 2011 and July 14, 2011 New York Review of Books, Angell backed argu­ments by the uni­ver­sity clin­i­cian Kirsh, the men­tal heath jour­nal­ist Robert Whitaker, and Boston psy­chi­a­trist Daniel Car­lat that there is some­thing extremely sus­pi­cious about the fol­low­ing trends: the num­ber of peo­ple treated for depres­sion has tripled since the launch of Prozac in 1987; 10 per­cent of Amer­i­cans over age six are tak­ing anti­de­pres­sants; and 30 antipsy­chotics like Risperdal, Zyprexa and Sero­quel are replac­ing cholesterol-​lowering agents as the top-​selling class of drugs in the U.S., largely because they are being pre­scribed to children.

book review: melancholia as a distinct category of endogenous depression


Review of Melan­cho­lia The Diag­no­sis, Patho­phys­i­ol­ogy and Treat­ment of Depres­sive Ill­ness at Metapsy­chol­ogy Online Reviews

Melan­cho­lia is a recur­rent, debil­i­tat­ing, per­va­sive brain dis­or­der that alters mood, motor func­tions, think­ing, cog­ni­tion, per­cep­tion and many basic phys­i­o­logic processes. In this way, patho­log­i­cal mood can be described, in per­va­sive and unremit­ting appre­hen­sion terms, psy­chomo­tor dis­tur­bance is sec­ond char­ac­ter­is­tic, veg­e­ta­tive func­tions are dis­rupted, and psy­chosis is rec­og­nized when the mood is severe in about 30% of patients and is seen as an inte­gral part of melancholia.

These authors are not alone in defin­ing melan­cholic depres­sion either. Prof Gor­don Parker of the Aus­tralian “Beyond Blue” orga­ni­za­tion like­wise regards motor dis­tur­bances as a hall­mark of melan­cho­lia (see www.beyondblue.org.au) as well as psy­chotic melancholia.

Such dis­cus­sions are astound­ing in the envi­ron­ment an advanced sci­ence such as psy­chi­a­try, and are some­what dis­turb­ing evi­dence to be added to a plethora of works that psy­chi­atric noso­log­i­cal cat­e­gories are insuf­fi­cient eco­log­i­cally to sus­tain effi­cient prac­tice. Ele­ments in the FDA report by per­sonal com­mu­ni­ca­tion that even though drug com­pa­nies sub­mit mul­ti­ple com­pounds to the FDA each year, about 50% have insuf­fi­cient data to sup­port their approval and in those that are safe, most sim­ply don’t bet­ter placebo by more than 10%. This is more likely to rep­re­sent the fil­ter­ing effect of using the DSM-​IV cat­e­gories to estab­lish the drug cohorts rather than the drugs: if the tar­get is ill defined, how does one estab­lish which ther­a­peu­tic arrows are likely to strike home? Here, the authors then take their argu­ment to sev­eral related con­di­tions, such as bipo­lar and post par­tum dis­tur­bances, and demon­strates the logic of their tar­geted approach.

They point out that the bound­aries have been blurred between melan­cho­lia and other het­ero­ge­neous or “mixed bag” con­di­tions, such as dys­thymia or pre­men­strual syn­dromes. They con­clude that melan­cho­lia, from the lit­er­a­ture and expe­ri­ence of oth­ers, is a dis­tinct syn­drome, a spe­cific depres­sive dis­or­der, and offers a spe­cific par­a­digm shift in think­ing about mood dis­or­der. This shift allows for lab­o­ra­tory test­ing which lends cre­dence to the idea that this is a ‘real’ rather than tai­lored entity. The diag­no­sis leads to tests for it being spe­cific to the entity, rather than try­ing to find reli­able tests for DSM enti­ties, which so far have proved fruit­less. HPA tests and those of elec­tro­phys­i­ol­ogy are put for­ward for consideration.

Apart from lab­o­ra­tory test­ing the authors needed to describe the exact clin­i­cal approach to exam­in­ing for mood dis­or­ders of this type. This will include exam­in­ing for veg­e­ta­tive signs and psy­chotic fea­tures, sui­ci­dal thoughts, cog­ni­tive falloff, per­son­al­ity dis­or­der and so on. Var­i­ous inven­to­ries are also eval­u­ated, with such stal­warts as the Beck Depres­sion Inven­tory regarded as not being use­ful for assess­ing melan­cho­lia or in assess­ing the sever­ity of depres­sive ill­ness in hos­pi­tal set­tings, although it is held to be use­ful in out­pa­tient set­tings. The dif­fer­en­tial diag­no­sis is also offered, with cri­te­ria against non melan­cholic depres­sion, atyp­i­cal depres­sion, sea­sonal affec­tive dis­or­der, dys­thymia, adjust­ment dis­or­der and pre­men­strual dis­or­der. The con­cept of the con­di­tion in chil­dren and ado­les­cents is dis­cussed, with an indi­ca­tion that inci­dence of comor­bidi­ties may be higher. Also dis­cussed here is autism, the elderly, patients with a psy­chotic dis­or­der, OCD, drug-​related con­di­tions, and other typ­i­cal DSM cat­e­gories such as gen­eral med­ical con­di­tions. Sui­cide is taken seri­ously in melan­cho­lia, and so many aspects of this are dis­cussed, with treat­ment often involv­ing locked ward stays and ECT, as well as medication.

the importance of women mentors for women in the sciences


Becom­ing the Men­tor I Want to Be vs. the Men­tor I Need to Be And how to not ask ques­tions like a girl… by Isis

… there was one female pro­fes­sor in my depart­ment I had been told to avoid. “She’s a bitch,” my male col­leagues told me. “She is unrea­son­able.” “She will bust your nuts about every damned thing.” I avoided her like the plague. Even­tu­ally, I had to take a class with her and couldn’t avoid her any more.

She absolutely changed my life.

I’ve been strug­gling for the last week to think about how to write about her. Any­thing I’ve come up with seems like trite bull­shit­tery, but I truly owe my career to her. My male col­leagues were right. She was really, really hard on me. She busted my nuts for every flaw. Every typo on a slide. Every poorly worded answer. She sought out those imper­fec­tions like a heat-​seeking, estrogen-​tipped mis­sile and blew them the fuck up.

And I resented her for it. I hated her for it. Until I got it.

AWIS cham­pi­ons the inter­ests of women in sci­ence, tech­nol­ogy engi­neer­ing, and math­e­mat­ics across all dis­ci­plines and employ­ment sec­tors. Work­ing for pos­i­tive sys­tem trans­for­ma­tion, AWIS strives to ensure that all women in these fields can achieve their full potential.

Reach­ing Gen­der Equity in Sci­ence: The Impor­tance of Role Mod­els And Men­tors by Laura Bonetta