Some FDA Staff Had Drug Safety Concerns-Survey

[Jacob]

Thursday, December 16, 2004 6:18 p.m. ET

By Lisa Richwine

WASHINGTON (Reuters) - Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.

Also, two-thirds of the scientists questioned by the Department of Health and Human Services' inspector general said they lacked full confidence in the FDA's ability to monitor side effects of prescription drugs after they hit the market.

The survey shows at least some government scientists backed accusations last month by FDA safety officer Dr. David Graham, who told a Senate hearing he had felt pressured to water down safety concerns about Merck & Co. Inc.'s painkiller Vioxx. The drug was pulled from the market Sept. 30 over links to heart attacks and strokes.

Graham, associate director for science in the FDA's Office of Drug Safety, also told Congress he felt the FDA was incapable of protecting the public from other dangerous drugs.

In an interview on Thursday, Graham said the survey "confirms that the FDA is more interested in taking care of business clients than it is in taking care of the American people." Safety "is not given the priority it deserves" while the agency focuses on approving drug company applications to market new medicines, he said.

An FDA spokesman, speaking on condition on anonymity, said the agency "strongly disagreed" with Graham's assessment.

In a written statement, the FDA said it encouraged scientific debate and made decisions based on "the best available, verifiable science."

"As with any institution, sometimes an individual within FDA may ultimately disagree with a consensus scientific judgment," the agency said.

The FDA noted most scientists surveyed gave high marks to the pre-approval process for drugs. Seventy-eight percent felt comfortable with decisions regarding drug effectiveness, while 65 percent were mostly or completely confident about safety assessments of drugs before approval.

The survey of nearly 400 FDA scientists was obtained through the Freedom of Information Act by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two environmental activist groups. Portions of the survey data were made public in March 2003.

"The scientists' concerns warrant further investigation as Congress reviews drug approval practices at FDA," said Kathleen Rest, executive director of the Union of Concerned Scientists, which has Nobel prize-winning researchers as well as activists as members.

Among other findings, 36 percent of the FDA scientists said the were "not at all" or only "somewhat" confident that "final decisions adequately assess the safety of a drug."

Parts of the survey were published in a March 2003 inspector general's report about the FDA's review process. But the negative opinions often were downplayed in favor of a focus on positive findings, Rest said.

A main conclusion in the 2003 report was that "both FDA reviewers and (drug company) sponsors have confidence in the decisions FDA makes."

The inspector general's report did note that many reviewers felt time-pressured. Fifty-eight percent said the six months allotted for a priority drug review was inadequate.

"Our report fully and accurately reports the findings of our survey," said Ben St. John, a spokesman for the inspector general's office.

"It shows some of the issues now being raised were ones that we'd identified last year, and had recommended FDA take appropriate actions," he said.

Copyright 2003 Reuters Limited.

[HairLossFight.com]

Interesting article Jacob. Definitely the FDA has had and is having problems. However, to have a body overlooking drug approvals is better than NOT having one, IMO. You wouldn't have the slightest clue what might work vs. what is useless. The FDA approves certain drugs based on the clinical studies that it requires, then independent research is done in various institutions, primarily universities to either corroborate the data, refute it, or add to it in some fashion.

I think in the cases of the approved hair loss medications we have a significant body of independent research showing them to be effective. Also, some of the research has shown that there are risks associated with using them, as with any medication, case in point being the study that showed that although prostate cancer rates went down in the group of people using finasteride, the percentage of those who DID get the cancer who's cancer was of a particularly aggressive form went up. Despite this, Finasteride has been around for over a decade and is a very commonly prescribed drug and you don't hear of masses of people dying from using it.

I'm quite comfortable with using it myself (although I'll admit that despite all the research showing it to be effective and safe, even I didn't want to take something internal unless I absolutely had to).

Anyway, thanks for the article. I think it serves to show us that we shouldn't just blindly use a medication just because it's FDA approved. Rather, we should use the FDA approval as another factor to consider when doing our own investigating and analysis of the known risk factors before taking something...

There's my schpiel for the day.

Regards,
Sam

[Jacob]

Having a body overlooking drug approvals may be better than having none, but IMO it doesn't have to be the gov't. It sure looks like they can't do any better of a job, anyway. It's obvious the FDA approval and then supposed independant research isn't all that great.


Drugs don't have to kill to be questionable or be something to worry about. . I would be more concerned about the long-term effects of drugs such as Fin(used for hairloss btw..not a life threatening disease/problem) and the messing with our hormones as the article by Partick Arnold discusses: http://www.mesomorphosis.com/articles/arnold/dht.htm

Then there's the side effects that the company doesn't have to point out- the one by Kevin of HLT and then:

Finasteride is linked to mood disturbance, mild to severe depression.
Journal of Drugs in Dermatology

January 01, 2003

finasteride, mood disturbance, treatment, minimal adverse, adrogenetic alopecia, adverse effects, aga, study developed, mg/day orally, severe depression, patients, depression, significatively impaired, impaired sociofamilial, researchers evaluated FINASTERIDE IS USED IN THE TREATMENT OF ADROGENETIC alopecia (AGA) and has been shown to have minimal adverse effects. In this study, researchers evaluated the effect of finasteride on mood disturbance.

23 patients were treated with finasteride, 1 mg/day orally, for AGA. 19/23 patients in this study developed a mood disturbance (moderate to severe depression) during treatment. Depression, which significatively impaired sociofamilial relations, sleep, and eating behavior, was associated to marked anxiety in some cases, developed after 9-19 weeks of treatment with finasteride, and promptly resolved after suspension of the drug. Two patients accepted reintroduction to the drug, and depression relapsed ...

Finasteride: suspected association with depression

A white man in his mid-40s with no prior history of psychiatric problems was treated with finasteride for male-pattern hair loss. Clinical depression developed about 3 months after the onset of therapy. The depression was described as moderately severe but was unresponsive to treatment with various antidepressants. Treatment was maintained for 4 years. Following cessation of the finasteride therapy, the depression resolved in about 2 weeks, and the patient made a complete recovery. A published report has described 19 cases (14 males, 5 females) in whom moderate to severe depression developed during treatment with finasteride (1 mg/d orally) for androgenetic alopecia.1

Reference

1. Altomare G, Capella GL. Depression circumstantially related to the administration of finasteride for androgenetic alopecia. J Dermatol 2002;29(10):665-9.

and

Depression circumstantially related to the administration of finasteride for androgenetic alopecia.

J Dermatol 2002 Oct;29(10):665-9.

In this paper we report 19 patients (14 males, 5 females; mean age 28.16 years +/- 7.68 SD) out of a series of 23 (17 males, 5 females) who developed a mood disturbance (moderate to severe depression) during treatment with finasteride, 1 mg/day orally, for androgenetic alopecia (Hamilton subtypes III-V; Ludwig subtypes I-II). Depression, which significatively impaired sociofamilial relations, sleep and eating behaviour, was associated to marked anxiety in some cases, developed after 9-19 weeks of treatment with finasteride, and promptly resolved after suspension of the drug. Two patients accepted reintroduction of the drug, and depression relapsed within 2 weeks. Depression as an adverse effect of finasteride has been reported only once. Further studies are needed to confirm our circumstantial observations, which are based on a retrospective series of patients.

PMID: 12433001 [PubMed - in process]

_____________

Comments by "thread" at alt.baldspot in a discussion about the above study:

"By the way, everyone mentions the prostate and hair follicles as two important oragns with 5-alpha reductase activity. But almost no one mentions that the brain is also an organ that significantly expresses 5-alpha reductase. So, finasteride (and dutasteride) affects steroid metabolism within the brain itself."

I think the thing that ppl should really think about is that Fin and Dut aren't something you just take for a couple of weeks and see results- and that's it. You have to constantly take it. Even most herbs you shouldn't take constantly and for long periods of time. When someone has high cholestorol, there are other options besides drugs. But if they do take drugs they SHOULD(and this is another problem....the docs.....don't get me started on docs lol) alter their lifestyle and exercise etc so when it does get down they can go off the drug.

Bryan Shelton doesn't take the drug(s).....Kevin of HLT doesn't....they use topicals.

I agree with your last statement about not just going by what the FDA says. I think we should listen to those who do get side effects(someone posted about such side effects which made me look for those "studies" found in the quotes above) as well as keep our eyes on those not using such drugs to see how they're progressing.

BTW..Merry Christmas- in case I don't get back here before then.