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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Medical journals: “information-laundering for Big Pharma”?

Whenever you read a medical journal article with a title like Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies, you know it’s a bad day for patients.

As a heart attack survivor who spends way too much of my time hanging out with cardiologists, pain specialists and other doctors who read these journals, I especially hate seeing this article written by a person like Dr. Robert Smith, who was himself the editor of the British Medical Journal for 25 years.*

Dr. Smith’s not alone. Consider Dr. Richard Horton of the medical journal, Lancet, who once wrote:

“Journals have devolved into information-laundering operations for the pharmaceutical industry.”

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Drug company uses movie promotion to target your kids

It was Mickey Mouse who started it all. Back in 1934, the iconic cartoon mouse generated $600,000 in merchandise sales for its creator, Walt Disney – a staggering sum for the era.  Although it was during the Great Depression, Disney was able to save his struggling film company and his business partners from bankruptcy – including the Ingersoll-Waterbury Clock Company, maker of the first Mickey Mouse watches.

It wasn’t until 1978, however, that the modern age of movie merchandising really took off. George Lucas cashed in on the trend with $2.6 billion worth of the collectible toys he sold based on his original Star Wars trilogy.

For the first time in history, a movie producer partnered with a toy company (in this case, a young company called Kenner) to create little 3 3/4″ high collectible “action figures” as well as assorted Star Wars toys, books, lunch boxes, backpacks, etc. (My kids’ rooms were filled with these!) Even the popular TV sitcom Modern Family recently featured a discussion between Mitchell and Cam about their favourite Luke Skywalker collectible – “Luke wearing the shorty robe”.

But today, the release of a new movie includes the launch of corporate partnerships that not only sell action figures, but help push over-the-counter drugs for children.   Continue reading

Is your doctor a “thought leader”?

When a drug company’s sales rep needs to get a doctor to write more prescriptions for his company’s drug, there’s one almost foolproof way to get that task accomplished, according to a revealing National Public Radio report called Drug Company Flattery Wins Docs, Influences Prescriptions.

“To get a doctor to write more prescriptions, the drug rep asks the doctor to become a speaker on the company’s Speakers Bureau.”

For example, drug giant GlaxoSmithKline, like most other drug companies, hires doctors to speak to other doctors as part of their Speakers Bureau marketing efforts. The top GSK drug that their paid Speakers Bureau doctors talk about is called Avodart, a drug prescribed to treat enlarged prostates, and which has been locked in a heated sales battle with its main competition, Merck’s Proscar (now available as a generic).

But over the past five years of these Speakers Bureau presentations, Avodart has seen its sales more than quadruple and its market share double. Convincing a doctor to push your drug to his/her peers during a paid Speakers Bureau presentation really does seem to work.

According to this NPR report (in partnership with the Pulitzer prize-winning investigative journalists from ProPublica), drug companies train their sales reps to approach potential Speakers Bureau doctors in a very specific way. Drug reps use language that deliberately fosters the idea that the Speakers Bureau doctors they hire are educators, and not just educators, but the “smartest of the smart”.

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“We never imagined people would think of osteopenia as a disease”

Here’s a drug marketing plan that is dazzling in its brilliant effectiveness. I’m thinking of including it in any future PR workshops I do on marketing communications. It’s a plan to sell pills to treat something called osteopenia, a condition that only recently started to be thought of as a problem that even needs treatment.

It’s a plan to convince consumers and their physicians that these pills should be in the medicine cabinets of millions of women worldwide.

But more broadly, it’s a plan to change the definition of what a disease is, and the role that drug companies can play in that change.  Continue reading

Zetia & Vytorin: how Merck got patients to spend $21 billion on drugs that don’t work

How did drug giants Merck and Schering-Plough persuade patients to spend $21 billion on a cholesterol drug that doesn’t prevent heart attacks? According to a December 14th report in Forbes, the cholesterol-lowering drug Zetia works by a little-understood mode of action, and no research has shown that it prevents heart attacks at all. Physicians have been brutal in their assessment. Zetia’s rise “was the miracle of marketing, not the miracle of medicine,” says cardiologist Dr. Sanjay Kaul of Cedars-Sinai Medical Center. Cleveland Clinic cardiologist Dr. Steven Nissen adds:

“We’ve spent billions on a drug that may turn out to be a placebo.”

Yet Merck’s clever marketers have spun straw into gold. Over the last seven years, they have convinced doctors to prescribe $21 billion worth of Zetia and its sister drug, Vytorin, which combines Zetia with Merck’s old cholesterol drug Zocor. In fact, the drugs are on track to do $4 billion in combined sales this year, despite multiple studies suggesting they fail to prevent clogged arteries. Thanks to an agressive $200 million ad campaign, American sales of Zetia and Vytorin represent 16% of all cholesterol-lowering drug sales, but only a 3% share in Canada, where direct-to-consumer (“Ask your doctor”) advertising is banned.   Continue reading