EXCLUSIVE: Merck Petitioned FDA for Teen Propecia Study
Pharma Giant Played Cancer Card in Bid to Hook Kids on Controversial Hair-Loss Drug
By Propeciasideeffects.co.uk PUBLISHED: 11:18AM BST 11 Sep 2013
LONDON – As far back as 2000—more than a decade before it finally mandaded a label change on the medication—the U.S. Food and Drug Administration expressed concern that Propecia could be hazardous to the growth, development and sexual function of adolescent boys.
But that didn't stop Merck & Co. from proposing that 15-year-olds be fed its hair-loss pill as part of a pediatric-research program.
In 1999, Merck sought FDA approval to study the effects of its controversial hair-loss drug, Propecia, in boys as young as 15.
Now, through documents obtained by Propecia Side Effects U.K., details behind the pharmaceutical giant’s bid to hook kids on a drug that has since been reported to cause persistent side effects including erectile dysfunction, penile shrinkage, Peyronie's disease, gynecomastia, muscle atrophy and cognitive impairment are being revealed for the first time.
On Dec. 9, 1999, Tamra L. Goodrow, then associate director of regulatory affairs for Merck, sent a “Citizen Petition” on behalf of her employer to the FDA requesting that the agency add finasteride (Propecia's generic name) “to the priority section of the ‘List of Approved Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population’.”
Goodrow went on to write that “No therapy is currently approved for the treatment of androgenic alopecia [aka male pattern baldness] in adolescent males,” and “There are very limited published data on the prevalence of...androgenic alopecia occurring in adolescent men aged 15-17 years.”
She then cited a 1951 study by James B. Hamilton of the Department of Anatomy at the State University Medical Center at New York City.
“In his series, Hamilton reported one case of androgenic alopecia (male pattern Type 4) among eighteen males 15 to 19 years old, but the age distribution of the sample and the age of the affected individual were not reported,” she wrote.
“However, it is widely acknowledged by practicing dermatologists that adolescents with this type of early onset, or premature, androgenic alopecia comprise part of their practice,” Goodrow added.
Leading the dubious charge for pediatric approval of Propecia was Dr. Tamra Goodrow, a Merck regulatory executive. (CREDIT: FDA)
The latter assertion, about dermatologists widely acknowledging that balding teenage boys make up part of their practice, was not backed up with any research.
But Propecia Side Effects U.K. did retrieve the Hamilton study, published 62 years ago in the Annals of the New York Academy of Sciences (“The Growth, Replacement, and Types of Hair,” Volume 53, pages 708-728). In it, the author noted:
"The subjects consisted of 312 males and 214 females who were students or members of the staff of Yale, Missouri and New York State universities or were inmates or members of the staff of Riker's Island Prison, of Fairfield State Hospital in Newton, Connecticut, and of the Jewish Sanatarium in Brooklyn; 83 babies attending the Well-Baby Clinic at the Long Island College Hospital and the State Training School of Winfield Kansas; 77 normal Chinese males in New York; and 62 fetusus and stilborn children at the Carnegie Institute of Embryology in Baltimore."
Goodrow's petition, in which she asked the FDA not to “make its content...public without first obtaining the written permission of Merck & Co.,” further stated that:
“The pediatric population in need of a therapy option is comprised of males in late adolescence, i.e., males between the ages of 15 and 17... Pediatric studies are proposed solely for this pediatric population.”
To bolster her argument, Goodrow played the cancer card, writing:
“It has been demonstrated that some adolescents with cancer who experience hair loss as a result of chemotherapy restrict themselves in social interactions with peers due to the alteration of their self-image.”
Then she added: “Thus, a clear rationale based on patient need, exists to offer therapy for adolescents seeking treatment for early onset androgenic alopecia.”
Goodrow stated that dermatologists regularly treat balding teens—but cited no research to substantiate that claim. (CREDIT: FDA)
Yet the FDA bristled at Goodrow's request. In a letter dated May 16, 2000, Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told the Merck Ph.D., “your petition is denied.”
“Finasteride is indicated for the treatment of male pattern hair loss...in men 18 years or older,” Dr. Woodcock wrote. “As stated in finasteride's labeling, efficacy in bitemporal recession has not been established. Finasteride is also indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostate... FDA has no evidence that these indications occur in the pediatric population.
“You suggest that androgenic alopecia can occur in men younger than 18 years old. However, the references you submitted show only that bitemporal recession, not androgenic alopecia, MAY occur in men younger than 18 years old,” Dr. Woodcock continued.
Finally, Dr. Woodcock told Goodrow: “FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks regarding growth, development and sexual function.”
After a reporter left a message for Goodrow at her home in Willow Grove, Pa., she called to confirm that she “had done some work on Propecia,” but would need to run the interview request by Merck's media-relations department.
A day later, a Merck media-relations staffer called the reporter to inform him that all interview requests need to go through the company’s media-relations department. But beyond that, the staffer declined to comment on Merck’s petition for a pediatric Propecia study.
Goodrow asked the FDA to remain hush on Merck's bid to give teenagers Propecia. (CREDIT: FDA)
Last week, men who took Propecia in their early 20s, only to develop post-finasteride syndrome (PFS)—a condition marked by long-term sexual, neurological, hormonal and psychological side effects—were horrified to learn that Merck attempted to target patients even younger than themselves.
“Since being diagnosed with PFS last year, I’ve spoken to a lot of other victims, and it seems that the younger they are, the worse their side effects are,” said Macy Van Alstyne, 30, of Jacksonville, Fla., who was first prescribed Propecia at age 23. “I shudder to think what would've happened if Merck had been successful in getting approval to sell Propecia to kids.”
“That petition makes Dr. Tamra Goodrow sound more like Dr. Josef Mengele,” said fellow PFS victim Ben Evins, 26, of Austin, Texas, referring to the infamous Nazi physician at the Auschwitz death camp. “Thank god the FDA saw through her BS and tossed her request in the trash.”
The FDA was worried that Propecia might turn teenage boys into stunted, underdeveloped eunuchs. (CREDIT: FDA)
This isn't the first time Goodrow has surfaced in a report about a controversial Merck drug.
In July 2006, the Los Angeles Times ran a 5,200-word story headlined “Drug Trials With a Dose of Doubt: A National Institutes of Health researcher with ties to pharmaceutical firms helped test their new medications.”
Written by Pulitzer Prize-winning investigative reporter David Willman, the story began:
BETHESDA, Md.— On Jan. 10, 2001, pharmaceutical giant Merck & Co. gathered its forces in a hotel conference room here with a clear-cut mission: Win a favorable vote for a new antifungal drug from a federal advisory committee—a victory that would position the product for swift government approval... But after hours of speeches and slides, the committee members, appointed by the U.S. Food and Drug Administration, had yet to vote. The members were focused on the quality of Merck's case for the new drug, which rested on the treatment of only 69 patients.
Merck summoned to the microphone one of its announced consultants, a man whose government job was nearby, at the National Institutes of Health. Dr. Thomas J. Walsh assured the committee that Merck's data describing the patients was "extremely robust and very, very rigorous." He said his government staff had assisted in vetting the company's data. About 30% of the patients were helped by the drug, he said.
The advisory committee voted unanimously to endorse the drug, called Cancidas. Sixteen days later, the FDA approved it... In its first five years on the U.S. market, Cancidas would generate $859 million in sales for Merck.
U.S. law generally prohibits a federal employee from representing an outside party before a government agency.
Later in his report, Willman noted that when Dr. Walsh was asked about his role at the Cancidas presentation to the FDA committee, he replied, “I did not appear as a consultant to Merck.”
However, Willman added, “That is how Merck identified him to the FDA committee, both orally and in a slide. Tamra Goodrow, a Merck regulatory affairs official, said: ‘Merck has brought several consultants to the meeting today so that they are available to facilitate the advisory committee's discussion and deliberations.’ Goodrow then named the consultants, including ‘Dr. Thomas Walsh.’”
The FDA halted Merck's bid to give Propecia to teenagers. (CREDIT: FDA)
Hope for a Change
Meanwhile, the medical and scientific communities are undertaking clinical explorations of PFS, in hopes of identifying the root causes of the condition, and developing effective therapies.
And last year, Dr. Michael Irwig of George Washington University published two studies on the drug's long-terms dangers. The first, featured July 12 in The Journal of Sexual Medicine, showed that 96% of the 54 young, previously healthy Propecia patients examined by Dr. Irwig suffered sexual dysfunction for more than a year after quitting the medication.
The second study, published Aug. 7 in The Journal of Clinical Psychiatry, showed that nearly 44% of the 61 young, previously healthy Propecia patients reported suicidal thoughts, while 36% had symptoms of severe depression.
Meanwhile, social-media efforts to generate awareness of the dangers of Propecia have been gathering steam.
The @RecallPropecia Twitter feed is closing in on 250 followers, including U.S. Senator Al Franken (D-Minn.), the New York Post, CNN medical producer Val Willingham, Associated Press reporter Matt Perrone, HealthRadio.FM, and the International Young Urologists Association.
A MoveOn.org petition asking Merck to fund studies on PFS currently has 151 signatures. And a Change.org petition to “take Propecia off the market” has gathered more than 200 supporters. Among them is Saeed Ali of Ottawa, Canada, who lamented:
"My in-law has suffered severely. He is very weak and cannot work anymore. He has muscle loss, aching joints, dry eyes and very low energy."
On April 11, 2012, the FDA finally ordered Merck to revise the labeling on Propecia to reflect growing evidence that the drug can cause persistent sexual dysfunction. Of the 421 Propecia-related sexual-dysfunction cases reviewed by the agency, 14 percent lasted longer than three months after patients ceased taking the medication.
FDA honcho Dr. Janet Woodcock (above) may have saved untold boys from impotence, penile shrinkage, enlarged breasts and other long-term side effects that can arise in Propecia patients. (CREDIT: FDA)