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Apr13
Merck’s Woes: How Will This Impact Pharmaceutical Communications?
Yesterday, the New York Times reported that a jury in New Jersey awarded $9 million in punitive damages to John McDarby, who suffered from a heart attack in 2004 after taking Vioxx for four years.  According to the Times, this verdict was surprising because:

-The verdict was handed down in a New Jersey courtroom, Merck’s home state.

-New Jersey has a very high standard for awarding punitive damages in lawsuits against pharmaceutical companies.  The jury has to believe that the firm “knowingly misrepresented facts to the F.D.A.” in order to find against the company.
 
-The jury said that Merck did not disclose the risks of the drug to patients, which may lead to a criminal investigation of the company. Beyond Vioxx

On Monday, another lawsuit was filed against the company – but not for Vioxx.  This time the suit focused on Merck’s Fosamax, an osteoporosis medication.  According to the Miami Herald the plaintiffs assert:

“Fosamax is a defective product because it can cause osteonecrosis of the jaw, or a rotting of the jaw bone. The suit, which seeks class-action status, alleges Merck concealed and continues to hide Fosamax's potentially dangerous side effects from patients and doctors.”

(On a side note, Kevin Pho, author of Kevin, MD, observed that: “cases of osteonecrosis of the jaw are associated with cancer patients requiring intravenous bisphosphonates.  Fosamax is generally quite safe - osteonecrosis of the jaw with this medication is a rare, rare occurrence.”)

The Implications

Clearly, the recent jury verdict and the new lawsuit puts additional pressure on the pharmaceutical industry to adjust its marketing practices.  Following are some preliminary thoughts on how these recent developments may impact pharmaceutical communications.

Companies May Try To Communicate Risks More Clearly:  Currently a number of pharmaceutical companies, including Pfizer, have begun initiatives to change the way medical information is presented to patients.  The purpose is to ensure that patients fully understand the risks of the drugs they take.

There is debate going on right now about how best to present information about drug risks to patients.  Should people receive information via a color coded system?  What are the benefits and drawbacks of presenting risk in absolute versus relative terms

No matter how the debate plays out, we may begin to see companies make more effort to ensure that patients fully understand the potential side effects of the medications they take.  This can only be good for patients.  They should be able to make an informed decision about whether taking a medication is worth the risk, as is routinely done in cancer.

More Decoupling:  Currently a few pharmaceutical companies are decoupling their marketing and medical departments.  Will this result in companies giving scientists more power to highlight potential drug side effects more aggressively before a medication is widely marketed? 

Increased Scrutiny:  The Vioxx verdict may cause pharma’s legal and regulatory officials to increase their scrutiny of marketing materials.  This may make it much more difficult for communicators to receive approval for press releases, advertisements, internal announcements and other statements. 

These are just a few of the potential implications of the Merck verdict on healthcare communications.  Let me know if you think of others.

(Via Kevin, MD; Pharma Gossip; Pharma Marketing Blog)

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