The FDA Cracks Down

Cool.

I would love to see an FDA that was actually able to do its job.

may leave you thinking it wouldn’t be such a terrible thing to have this new and improved bad-ass FDA in town.
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Is there anyone who thinks otherwise?
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Thanks for highlighting this story. I had somehow missed that ad during Grey’s Anatomy…

Hmmm. A federal agency protecting the public from fraudulent claims and dangerous behavior (peanut factory).
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What a concept.

Well, I didn’t know about any aspect of this and now I do. Thanks, AS. This is promising news. It’s appalling that the FDA in once again looking into claims of effectiveness is promising news, but still…

I would also like to note that Amy wrote something substantive and correct.
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Must be a brand new day in America.

Well, I take back the I wouldn’t have known abot this thing. The story is on the front page of the NYT business sections. Still, as wvng said.

I much preferred it before prescription medicines were allowed to be advertised on TeeVee at all. Certainly the popularity of ‘male enhancment’ and ‘weight loss’ preparations tell us that humans are notoriously bad at self-diagnosis and horribly susceptible to wishful thinking. My fundemental belief in free speech hits a brick wall when it comes to giving drug companies free rein to lie to the public.

Hey guys, I have magical powers, watch.
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research shows the bill is still effective

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Now even though we have AS on the run and she rarely engages any more watch her rush to change her spelling of pill/bill.
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Cool right?
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/snark

@sg: Good catch! I has mistakenly assumed that the “bill” was the one being crafted in congress which was going to cure the PMS (Post-Meltdown Syndrome) that Wall Street was experiencing…;)

Here’s a concept: No TV ads for prescription medication.

kbang
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I was confused too. But now I have put AS in a conundrum. Does she fix the spelling error thus revealing my “magical” powers. Or does she ignore it so as to make it SEEM like she just isn’t paying attention to the commenters thereby making her look like a bad spelling dumb arse. I can’t wait to see how this plays out lol.

This post kind of reminds me of the press’s role in deception. This from Glenn’s post:
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At one point while making his way through the press questioners, Bush awkwardly referred to a list of reporters whom he was instructed to call on. “This is scripted,” he joked. The press laughed. But Bush meant it was scripted, literally. White House spokesman Ari Fleischer later admitted he compiled Bush’s cheat sheet, which made sure he did not call on reporters from some prominent outlets like Time, Newsweek, USA Today, or the Washington Post. Yet even after Bush announced the event was “scripted,” reporters, either embarrassed for Bush or embarrassed for themselves, continued to play the part of eager participants at a spontaneous news conference, shooting their hands up in the air in hopes of getting Bush’s attention. For TV viewers it certainly looked like an actual press event.
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That was not the night’s only oddly scripted moment. Before the cameras went live, White House handlers, in a highly unusual move, marched veteran reporters to their seats in the East Room, two-by-two, like school children being led onto the stage for the annual holiday pageant. The White House was taking no chances with the choreography. . . .
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The entire press conference performance was a farce — the staging, the seating, the questions, the order, and the answers. Nothing about it was real or truly informative. It was, nonetheless, unintentionally revealing. Not revealing about the war, Bush’s rationale, or about the bloody, sustained conflict that was about to be unleashed inside Iraq. Reporters helped shed virtually no light on those key issues. Instead, the calculated kabuki press conference, stage-managed by the White House employing the nation’s most elite reporters as high-profile extras, did reveal what viewers needed to know about the mind-set of the MSM on the eve of war.
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http://www.salon.com/opinion/greenwald/?source=rss

I’ll be happy to see the FDA and other federal agencies return to doing their jobs. They’ll have a lot of catching up to do — heck, I have friends at the FCC who’ve been reined in since the Clinton years.

Just to add the perspective of a pharmacist to this, I’ve noticed that there has been an increase in frequency of drug recalls as of late – largely due to a failure to meet good manufacturing processes. Of course, it’s possible that investigations were started by the Bush administration and the results were only just made available, but I can’t help but wonder how much the new administration’s attention to detail is impacting this sort of thing. (not that things weren’t recalled before – they certainly were – but within the past week, there’s definitely been a lot more drugs that my pharmacy has had to send back)
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Regardless of the reason for the step up in recalls, I’m grateful for the increase in oversight – both of drug products and of advertisements. (also: fun fact? Yaz is *almost* the same thing as Yasmin … which just went generic over the summer)

gunny, after 8 years of “calculated kabuki press conferences, stage-managed by the White House,” isn’t it interesting to hear reporters complain that President Obama (I still enjoy writing that) gave substantive answers to their questions, and complain that he called on Sam Stein.
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sg, K-bank, give AS a break. It was a good post. Praise her when she does well.
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Speak roughly to your little boy
and beat him when he sneezes
he only does it to annoy
because he knows it teases.
I speak severely to my boy
I beat him when he sneezes
for he can thoroughly enjoy
the pepper when he pleases

@sgw -
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As your digital-universe pastor, I am honestly sorry to have to break it to you . . . no magical powers, dude. I want you to know that we were all pulling for you, and none of us thinks any less of you as a result. Amen.
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As a consolation prize, you have demonstrated pretty categorically that AS is a drive-by blogger.

BTW, wvng, you’re right – this was actually a good post.

While I was reading and my wife was catching up on “Grey’s Anatomy” via TiVo the other night she she said the ads were getting much more careful about what they said and asked if I had heard the FDA was cracking down. I told her I expected it would as it had been a joke for eight years and the new High Sheriff was likely to change that, but I’d be surprised if it happened this quickly. But I was interested to see this and emailed AS’s post to her.
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So here’s the question – was the prior campaign just so outrageous even the out-going Bush hacks couldn’t avoid ordering this, or did the rank-and-file put this front and center for the incoming folks once they were released from Bush bondage? I hope the latter, as that means the FDA as an institution may not be as sick as we feared and change can come quickly.
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Thanks for the tidbit, Amy.

mousebumples — What’s your take on the issue of advertising that sqr1 raises? Teevee ads are expensive, and the idea of advertising prescription drugs to consumers is only a step or two away from advertising sugary cereals to kids and telling them to ask your mom to buy them.

OT, but never really OT in today’s msm world:
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A CONSERVATIVE LIE CASE STUDY…. To paraphrase Twain, a right-wing talking point can travel the media world, while the truth is still getting its pants on. We’ve seen a classic example over the last 48 hours.

I agree that the post is accurate, however there are a couple of things that bother me about it. For one, did AS actually WATCH Grey’s Anatomy as the post infers or did she just read from the NYTimes article that the ads played during that time? Mind you I know thats nitpicking but inquiring minds want to know. The second thing is I think the post is missing a perspective on how punitive this measure is. I will illustrate from the actual article.

Yaz is the best-selling oral contraception pill in the United States, with sales last year of about $616 million or about 18 percent market share

, according to IMS Health, a health care information company.

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snip
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Bruce L. Lambert, a professor of pharmacy administration at the University of Illinois at Chicago, lauded the F.D.A. for insisting this time that Bayer run a corrective advertising campaign. But he referred to the corrective $20 million ad campaign for Yaz as “chump change” and “just the cost of doing business.”
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I always think about the book/movie “The Rainmaker” where the young lawyer discovers that a health insurance company basically factors in lawsuits into their “cost of doing business” and if a lawsuit is lest costly than paying out the claim they just keep denying the claim. It would have been helpful to know that the ad campaign pales in comparison to the amount of sales Yaz pulled in for the company last year. Hell when you think about it $20 million is an acceptable business expense to pull in over $600 million.

Personally, I’m not a fan. I’m also not a fan of drug reps – largely because doctors often prescribe for Brand Name Drug X when there is Older Generic Drug Y that is just about as good and would save patients a lot of money. Do drug reps have a purpose? For new, innovative drugs, absolutely! But there are too many situations where drug reps (and TV ads) are there *just* to milk the American consumers for more money.
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Example: There are (relatively) new ads for Lipitor out, and they specifically say, “Do not let anyone change you to a generic medication because there is no generic for Lipitor.” While that is true, Zocor, Pravachol, and Mevacor have all gone generic and are all very similar. I never try to switch a patient by telling them that the generic is the same thing as Lipitor, but if they have an expensive copay (or if they generally ask me how they can save money), I’ll mention that these other drugs are very similar.
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The one good thing about drug ads might be that it could make patients aware of conditions that they didn’t know they had that should be treated. On the flip side, how many people hear those ads, and go, “Yeah, I’m feeling tired lately. And I’ve been irritable. I must have this dread disease!” (when, actually, they don’t)
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My understanding is that the reason TV ads started was to fully educate consumers about potential drug regimens – so they knew their options. Again, there’s good and bad, and I wouldn’t mind having that sort of thing be addressed at some point by this administration. (also, I can’t help but wonder how much cheaper drugs would get if drug companies didn’t also have to pay for advertising dollars … )

much preferred it before prescription medicines were allowed to be advertised on TeeVee at all.
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It does seem to undermine the whole idea of requiring prescriptions.

Next in the regulatory crosshairs (I hope): the commercials for “supplements” that claim miraculous physiological effects, with a four-point type, white-on-light blue disclaimer that says “We’re making this $#it up. We’ll take your money, but there’s no evidence any of this is true”

I can’t help but wonder how much cheaper drugs would get if drug companies didn’t also have to pay for advertising dollars
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I think you can be sure that the advertising generates net revenue. Production costs are very low, and margins very high for on-patent drugs.
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I know someone who gets migraines. Sumatriptin is effective for him. It just went off-patent (Copay from 25 to 7 dollars for 9 pills). About six months before it went off-patent, he was getting mail from the drug company pitching a new formulation that includes a second, on-patent drug.
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Careful, FlownOver, that would outlaw nearly all political advertising, too! On second thought . . .

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The funny thing is that Amy Sullivan writes well when she’s not writing about religion and politics…Thanks for bringing this to our attention, Amy.

Amy Sullivan:
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This is better…

It was a good post. If the FDA is now going to protect consumers, is it too much to expect the EPA to start protecting the environment now? This whole idea of having grownups in charge is scary. If the State Department starts to talk to other countries instead of having the Pentagon decide policy, I’m going to hide in my basement. I’ll be in the storage room behind the Christmas tree boxes where no one will ever find me.

Good post Amy. Sorry it took so long to compliment you but I am old and it took a while to pick myself up from the floor.

Birth control pills have been prescribed for acne and cramps for years – at least ortho-tri-cyclen. It appears the main difference with YAZ is the the dosing method, not the chemistry. My point being it’s odd that doctors can prescribe these drugs to treat problems that aren’t the drugs primary use but drug companies can’t advertise them to the public that way. Seems deceptive. I hate drug ads as much as the next person, but maybe there is something to the fact that we all know a lot more about which drugs are out there and what they are (potentially) used for.

The FDA has long worked for the interests of big pharmaceutical companies ahead of the interests of the American people. We will have to wait to see whether this case is an anomaly or if it is indeed the new and improved FDA.

Upon further review (of the YAZ website) it appears the dosing method is traditional, and I didn’t see ortho-tri-cyclen as the active ingredient, rather drsp (drospirenone). It’s interesting, however that the site clearly claims what Amy writes the ads are correcting:
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YAZ is the only birth control pill that’s also approved by the FDA to treat emotional and physical symptoms of PMDD (Premenstrual Dysphoric Disorder) that are severe enough to impact your life, for women who choose the Pill as their contraception method.
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Not only is YAZ contraception less likely to upset your skin, it is also proven to help treat moderate acne.1 Nearly all birth control pills are made up of a combination of estrogen and progestin hormones. The progestin in YAZ actually blocks the male sex hormones (androgens) that cause acne.

I always thought David Gregory should get a credit at IMDB for his supporting role in “Pre Invasion Press Conference”.
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Words I never want to hear on my teevee: ‘that certain part of the male anatomy’.

FlownOver
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The FDA doesn’t handle supplements which is why they can say whatever in the hell they want as long as they put the asterick on the bottle that “these claims have not been evaluated by the FDA”