Ethicists demand external, independent investigation of Dan Markingson’s death

In November 2003, psychiatrists at the University of Minnesota used the threat of involuntary commitment to force a mentally ill young man named Dan Markingson into a profitable, industry-funded study of antipsychotic drugs. Dan, who was mentally incapable of giving informed consent to participate in this research, was recruited into the study over the objections of his mother, Mary Weiss.

For months Mary tried desperately to get him out of the clinical trials, warning the psychiatrists in writing that Dan’s condition was deteriorating and that he was in danger of killing himself.

The psychiatrists refused to listen to her.

On May 8, 2004, Dan committed suicide, and Mary Weiss lost her only child.  Continue reading

When medical research is funded to favour the drug, not the facts

Here’s a cardiac research story so confusing that the average dull-witted heart attack survivor like me can barely keep up with the plot. So let’s try telling the tale in pared-down plain English to see if we can figure out how two well-respected “experts” can have such viciously opposing interpretations of the same research, and what factors might just be at work to influence those opinions – financial and otherwise.

But before even looking at the story’s details,  let’s do what everybody should do before evaluating any study results: fast-forward to the end of the research report until you find the teeny tiny fine print revealing researchers’ conflict of interest disclosures. And it turns out that each of the opposing researchers in this story has plenty of reason to trash the other’s interpretation.  Continue reading

Why is Big Pharma getting away with paying billions in criminal fines – but avoiding criminal charges?

Drug giant AstraZeneca has been working on a back room legal settlement deal with the U.S. government since last fall. And according to a New York Times investigation, the company has earmarked $520 million for the purpose.

According to the Times, the final arrangement will wrap up two federal investigations: one related to doctors who participated in clinical trials of the drug and another involved the company’s sales organization. The company allegedly misled both doctors and patients about the safety of its atypical anti-psychotic drug Seroquel, downplaying the known risks of weight gain and diabetes.

AstraZeneca has repeatedly denied any wrongdoing.

The drugmaker will pay $520 million in criminal fines and sign a corporate integrity agreement to settle probes into its marketing of the anti-psychotic drug. But the company will not face any criminal charges.   Continue reading

Do you want to take medications made in China?

Let’s say you are a heart attack survivor like me, who must now take a fistful of cardiac drugs every day.  And let’s say one of them is Crestor, a drug manufactured by the U.K – Sweden based pharmaceutical company, AstraZeneca. But today you learn that AstraZeneca plans to move all drug production of its “active pharmaceutical ingredients” from the U.K. to China.

Next, you find out that the world’s biggest drug company, Pfizer – manufacturer of both Norvasc (your calcium channel blocker drug) and Accuretic (your ACE inhibitor) – is doing the same thing.

Pfizer plans to close its Connecticut plant and expand operations in Wuhan, China, where hundreds of new jobs will be added.  Pfizer is also expanding in Shanghai.

The list gets longer. The drugmaker Novartis (creator of many ‘over the counter’ drugs like Maalox, ExLax, Buckley’s, Bufferin, as well as generic prescription drugs like amoxicillin and fentanyl) has just announced a $1 billion investment that will create China’s largest pharmaceutical plant. Eli Lilly (makers of many diabetes drugs, plus Cymbalta, Prozac, Cialis) has just axed 5,500 North American jobs, and is adding 2,000 jobs at its China plants. Contract drug sales rep firms are ramping up in China to serve these companies.

Outsourcing to China is part of a disturbing Big Pharma trend. Drug companies with massive Western operations are shutting them down and moving them to China to reduce costs. The question you should be asking now is: “How will our government regulators monitor drug safety if all the factories are in China?” Continue reading

What drug company sales reps wrote on their BlackBerries

 blackberry office

  • A psychiatrist, originally skeptical about prescribing the powerful anti-psychotic drug Seroquel to his patients, becomes a super-prescriber who is rewarded by the drug’s manufacturer with generous $1,500 speaking engagements.
  • a neurologist jokes that she doles out so much Seroquel for her migraine patients that the drug company probably thinks she’s a psychiatrist;  she is rewarded with free trips to Scotland and Spain by the company.
  • a  busy physician has no problem leaving patients to stew in the waiting room while he listens to a pitch about Seroquel from a drug rep. “Dr had 3 patients waiting but did sit down with me x 25 minutes,” the rep wrote in her daily call notes.  Continue reading