How drug companies get the clinical trial results they want

Every prescription drug (or over-the-counter medication) in your bathroom cabinet is there because it’s been evaluated in research called a clinical trial. For a basic introduction to clinical trials, let’s turn to former editor-in-chief of the prestigious New England Journal of Medicine, Dr. Marcia Angell, who wrote the following in her frightening landmark piece called “Drug Companies & Doctors: A Story of Corruption” (New York Review of Books, 1/15/2009):

“Before a new drug can enter the market, its manufacturer must sponsor clinical trials to show the Food and Drug Administration that the drug is safe and effective, usually as compared with a placebo or dummy pill.

“The results of all the trials (there may be many) are submitted to the FDA, and if one or two trials are positive – that is, they show effectiveness without serious risk – the drug is usually approved, even if all the other trials are negative.” 

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“I’m not a real doctor – but I play one on drug ads”

You may recall seeing Dr. Robert Jarvik‘s pleasant face on your TV screen a few years ago flogging Lipitor, the biggest-selling drug on the planet at that time, earning well over $12 billion a year for Pfizer – the biggest drug company on the planet.

This partnership emerged just as the company was seeking to protect Lipitor from emerging competition by cheaper generics, and just before a U.S. Congressional investigation started looking into Jarvik’s credentials and his controversial role as paid pitchman for the cholesterol-lowering statin drug. Continue reading

How a new drug gets approved

alarm clock boyPity the poor schmuck who has no trouble falling asleep at bedtime, but is then wide awake in the middle of the night, staring bleakly at those evil green numbers on the clock radio for the next four hours. Have you been there yourself?  What if there were a magical pill we could take in the middle of those nights that would help us drift off to sleep again for just a few more hours until morning?

Enter the drug Intermezzo, a potential treatment for people suffering from this specific form of insomnia that involves difficulty falling asleep after waking up in the middle of the night.  Continue reading

Drug marketing by the numbers

  pills more meds please

  • Volume of annual pharmaceutical drug sales worldwide: $733 billion
  • What drug companies spend annually on full page ads in medical journals: $500 million
  • Amount drug industry spent on marketing directly to doctors last year: $7 billion
  • Amount drug industry spent on Direct To Consumer “Ask Your Doctor” ads: $5 billion
  • Hours spent watching TV drug ads last year per person, on average: 30
  • Number of patients who request drugs by name from their doctors each year: 16 million
  • Drug industry’s research and development budget compared with marketing budget: 1/3 to 1/2
  • Ratio of drug reps to doctors in North America: 1 to 2.5
  • Median annual total cash compensation for a drug rep (2008): $96,700
  • Favourable change in a doctor’s prescribing habits after less than 1 minute with a sales rep:  ↑16%
  • Prescribing change seen after 3 minutes with a sales rep:  ↑52%
  • Number of presentations last year where North American doctors paid by drug companies pitched that company’s drug to peers:  237,000
  • Forest Labs’ average payment per speech to 2,000 doctors lecturing about Lexapro: $17,350
  • Biggest legal penalty in U.S. history against Pfizer for unethical drug promotion: $2.38 billion
  • Merck’s advertising budget to launch sales of its painkiller Vioxx: $300 million
  • Annual sales of Vioxx from 1999 to 2004: $2.5 billion
  • Number of deaths due to heart attack or stroke caused by Vioxx before Merck’s recall:  60,000+
  • Number of years that Merck knew about the deadly risks of Vioxx before pulling the drug, according to the Annals of Internal Medicine, 11/23/09:   four

Find out more about drugs you’re taking from the independent Therapeutics Initiative at the University of British Columbia.

How are hockey-playing goons the same as “puzzled” medical journal editors?

hockey calgary fightI’ve often said to my hockey-mad son Ben that we could end on-ice fighting in hockey (not, incidentally, our national sport, but arguably our Canadian obsession) if only the National Hockey League would put me in charge for just one week. But the folks who do run the NHL clearly have no appetite for banning hockey fighting, or they would have acted to end it by now.

Despite their feeble protests about the unacceptability of fighting and the known dangers of career-ending concussions, team owners tolerate cheap shots by beefy goons who spear, hit, and drop their gloves to fight. The League accepts it, the owners accept it, the players accept it, and the fans apparently love it.

There is, alas, no organizational will to ban violence on the ice.

And much like hockey goons, medical journal editors could end the appallingly unethical and dangerous practice of medical ghostwriting in one week, but these editors clearly have no appetite for banning ghostwriting in their journals, or they would have acted to end it by now.

There is, alas, no organizational will to ban medical ghostwriting. Continue reading

Merck paying off 3,100 families for heart attack/stroke deaths linked to Vioxx painkilling drug

vioxx blueDrug giant Merck & Co. is paying the families of more than 3,100 Vioxx painkiller users who died of heart attacks and strokes that were blamed on the drug. Merck introduced Vioxx in 1999 but withdrew it from the market in 2004 when a study showed the drug doubled the risk of heart attacks and strokes. By 2007, Merck had set up a fund of $4.85 billion (yes, that’s billion with a ‘B’)  to cover claims of death and lesser injuries, after reserving $1.9 billion to fight over 26,600 Vioxx lawsuits in court. Houston attorney Mark Lanier observed at the time:

“We don’t know any drug right now with this number of deaths associated with it. This is a very sad chapter in the tragedy of pharmaceutical companies gone wild.” 

And – quelle surprise! – Vioxx turns out to be one of countless prescription drugs that have been fraudulently promoted in industry-funded ghostwritten articles in medical journals.    Continue reading