Propecia victim Kevin Malley continues hunger strike at Merck’s NJ headquarters

One starving man is continuing his lonely crusade against corporate goliath Merck & Co. outside of the drug giant’s New Jersey headquarters to bring public attention to the severe, life-changing side effects of the company’s hair-growth drug Propecia.

Thirty-year old Las Vegas resident Kevin Malley began his hunger strike at 3 pm on May 13 in protest of Merck’s failure to acknowledge Propecia’s role in causing a battery of persistent side effects, including sexual dysfunction.

“I want Merck to see how their drug is destroying lives — and know that I’m just one of thousands of victims suffering across the globe,” said Malley (702-219-5632) who was prescribed Propecia last year by his doctor.

Since the Examiner first broke the story on March 2 that the FDA was investigating Propecia, Merck has repeatedly ignored questions from the Examiner regarding the drug’s safety.

Meanwhile, others within the industry are speaking out on the drug’s devastating effects on male sexuality.

Recently, AdverseEvents, Inc., the leading resource for information on drug side effects, released a report identifying FDA approved medications that are most associated with causing brain-related side effects.

By a wide margin, the top drug linked to inhibition of libido side effects was Propecia and the second was Proscar. Propecia is the brand name for the drug finasteride when it is prescribed in 1mg doses to treat male pattern baldness. (When prescribed in 5mg doses to treat enlarged prostate it is sold under the brand name Proscar).

P. Murali Doraiswamy, M.D., a professor and leading neuropsychiatric drug safety researcher at Duke University Medical Center, commented, “This is a very timely and insightful report. While the warning signals in this report don’t necessarily prove a causal relationship, they are often the first sign of such a link. Therefore, it is critical for consumers and prescribers to be aware of such potentially adverse effects. Some of these side effects, such as loss of libido or amnesia, can have a devastating impact on a person’s quality of life.”

AdverseEvents used the Proportional Reporting Ratio and the Reporting Odds Ratio calculations to determine the top drugs in each side-effect category. Both are common methods of disproportionality analysis and signal detection used with AERS data. Case reports from 1/1/04 – 9/30/2011 were studied and drugs with limited case reports were excluded from the final list.

Top Three Drugs Linked To Inhibition of Libido:

Suspect Drug    PRR         ROR

PROPECIA      167.29      200.10

PROSCAR         84.01        91.69

AVODART        44.03        45.96

AdverseEvents, Inc. (www.adverseevents.com) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications.

As previously reported by the Examiner, the FDA urges anyone affected by Propecia to “formally document your case via the MedWatch reporting system. The information you provide will be added to FDA’s post-marketing safety database and reviewed by the post marketing safety staff.”

Propecia consumers can find a link to the Internet voluntary reporting form by going to the MedWatch homepage (http://www.fda.gov/Safety/MedWatch/default.htm), click on ‘Reporting Serious Problems to FDA’, then ‘Reporting by Consumers’.

Dr. Tatiana Oussova is responsible for conducting the agency’s ongoing Propecia safety review. Her email address is Tatiana.oussova@fda.hhs.gov.

Dr. Kavita Dada is responsible for interacting with the public regarding the FDA’s current Propecia safety review. Those persons who have been affected by Propecia may either email or call Dr. Dada by phone. It is Dr. Dada’s job to interact with the general public. Her phone number is 301-796-3105 and her email is Kavita.Dada@fda.hhs.gov.

Due to a lack of compressive information on Propecia’s severe and persistent side effects, Ingerman & Horwitz LLC, has published an educational brochure on the drug which is available free of charge on the firm’s website at www.ihlaw.com.

The Examiner will continue to report on this unfolding story and will publish updates on the latest information on the drug’s safety.