FDA wants to loosen rules on drug marketing

[Lone_Star_Dem]

Source: McClatchy News

WASHINGTON — The Food and Drug Administration is considering whether to loosen rules on how easily drug makers can pass out information that highlight so-called "off label" uses of drugs.

The FDA said the move could allow drug makers to share information about medical treatments that could help doctors better treat patients. Critics of the proposal, however, say it will open the door to allowing drug makers to push their products in ways that have never been approved by the FDA — some of them potentially harmful.

<snip>

After 1997, drug makers could pass out some medical journal articles that highlighted potential new uses for drugs. But that ability was restricted to articles submitted beforehand to the FDA and for uses that the company planned to seek formal approval. The law covering that policy recently expired.

In a new proposal, the FDA said it would allow drug makers to hand out medical journal articles without submitting them beforehand to the FDA. And they no longer would have to promise to seek formal approval for such uses. The articles would have to meet other quality standards.

Read more: http://www.mcclatchydc.com/homepage/story/28213.html

[MannyGoldstein]

1. This Is A Very, Very, Very Bad Idea

I work in the medical-industrial complex, including work on FDA submissions, so I probably have a bit of knowledge on this. It's just bad.

[Lone_Star_Dem]

3. I agree and I'm not in the business

I see false claims being made in attempts to make a buck. "Prometa" is the first thing that came to my mind.

[tom_paine]

2. In Bush -Occupied Amerika, corporations are people, people are peasant scum. n/t

[xxqqqzme]

7. no people are the lab rats to test their drug claims.

If it kills or harms you - whoops, our bad!

[lonestarnot]

4. Ack peeeeu!

[mhatrw]

5. Just what we need. A lot of more drugs being used for unapproved purposes.

Did you know that Prozac can make your hair all shiny?

[Lone_Star_Dem]

6. So long as you call your doctor if you have an erection that last more than 4 hours

What's the harm?

There's profits to be made here, and the American people have a right to shiny hair.

[mhatrw]

8. I called my doctor about that and he advised me to stop

surfing porn.

[Occulus]

15. Is a four-hour erection bad if it's self-induced or,

ah, 'perpetuated' by another?

:silly:

:D

[juno jones]

23. Was reading some comments by prozac users last night

Both good and bad. What was scary was the number of guys who completely and permanebtly lost the ability to have erections. That would make me think twice about SSRI's for anything but profound clinical depression. IMO, they give this shit out like candy and don't monitor side effects as well as they should.

I was also surprised at the number of people taking them for years with side effects and little improvement just because the doctor told them to keep on it.

[NashVegas]

32. I Hope Insurance Companies Fight It Tooth and Nail

For what they're worth.

[Voltaire99]

9. Look at the lawsuits over antipsychotic drugs.

Antipsychotics are being overprescribed for everything from psychosis to a stubbed toe, and the results are hideous.

Making the FDA even more of a rubber stamping mechanism for big pharma is suicidal. Is this the way we really want to go out -- narcotized by capital into the zombified sheep it always wanted us to be?

[cbayer]

18. I am going to have to challenge you on this.

I believe that the number of lawsuits you mention has more to do with lawyers looking for a quick buck than actual damages to patients.

They have been used off-label a lot. And very probably too much.

But Penicillin was probably over-prescribed too. It worked miracles and was probably then tried for everything.

Stubbed toe? No. Dementia, autism, OCD - yes. And these drugs have saved a lot of lives and reduced a lot of misery.

[depakid]

21. I suggest you educate yourself before making such statements

You might begin by looking into what's happened with zyprexa and risperdol, to name but two.

[CheshireCat]

25. Clarification, please!

SSRI's and antipsychotics are two very different classes of drugs.

"Antipsychotics are being overprescribed for everything from psychosis to a stubbed toe, and the results are hideous."

Are you talking about antipsychotics here or talking about SSRI's? Most of the lawsuits have been about SSRI's and SSRI's are the ones that are prescribed for everything.

depakid - I know that the you are talking about antipsychotics since you mention zyprexa and riperdol. I'm not asking for clarification from you.

I doubt that there will ever be widespread use of antipsychotics because the side effects are really hard to live with. While antipsychotics can quiet the voices in the heads of those who are schizophrenic, the side effects can be so terrible that even they have a hard time staying on these meds. Very few people will stay on antipsychotics, even when the drug is necessary for them to function.

SSRI's do not have side effects that are immediately noticable to most people. These drugs are over used and over prescribed. These drugs (SSRI's) can be a miracle and a lifesaver for the clinically depressed, but the long term effects are still unknown. They should be prescribed very carefully.

[cbayer]

26. My credentials would most likely leave you speechless

Google zyprexa risperdal (yes, it's spelled risperdal) lawsuit and you will see link after link to lawyer sites. I am aware that there have been some serious side effects and some legitimate claims. But these drugs are such an improvement over what was available previously and have benefited so many people with serious psychiatric disorders that you really have to look at the risk/benefit ratio.

[CheshireCat]

28. Misunderstanding

I was not putting down the antipsychotics - just pointing out the difference in side effects between SSRI's and antipsychotics. Believe me - I KNOW that these drugs save lives. And some do continue taking them in spite of the side effects.

When I posted, I wanted clarification on whether the post previous to yours was referring to SSRI's or antipsychotics. Since the first part of the thread was about SSRI's, I wasn't sure if the poster really meant to say "antipsychotics".

I was not aware of all the lawsuits targeting antipsychotics. Thanks for telling me about them.

[conflictgirl]

29. But they are also being prescribed as first line treatment for the wrong types of patients

Example: I have recurrent, fairly severe depression and have tried every single SSRI antidepressant and had seriously bad reactions to all. Supposedly such a response to SSRIs can indicate Bipolar II instead. I mentioned this to my doctor and asked about whether trying a mood stabilizer would be appropriate. She said it would - and suggested Zyprexa. I have no symptoms of psychosis whatsoever. I asked why she wasn't suggesting lithium or even an anticonvulsant as a first line treatment for possible bipolar, since I had already researched this and knew that lithium is supposed to be the gold standard treatment - and she said, "well nobody really prescribes that anymore, we're finding more success with medications like Zyprexa." I have a family history of diabetes (which can be caused or aggravated by Zyprexa) which she knew, and again no symptoms of psychosis whatsoever, which would make Zyprexa a completely inappropriate first line treatment for someone like me. I have since found out that I have a lot of company in being prescribed this drug inappropriately; someone else I know was prescribed Seroquel for insomnia! Obviously I didn't take it either. Those drugs may help people with legitimate symptoms of psychosis, but they're also being prescribed to people who don't even *have* psychosis. Such meds have way too many risks to be prescribed to people who might or might not have bipolar illness, based solely on their lack of response to SSRIs, or for people who have standard insomnia.

[cbayer]

30. I absolutely agree with you.

Again, because they are so superior to previous anti-psychotics in both their effectiveness and side effects, they have been grossly over-prescribed without adequate regard to risk.

On the other hand, as you are finding out, it is difficult to put people's psychiatric conditions into neat little boxes. And these meds have been used very effectively to treat some illnesses that are not strictly psychotic.

In the end, it is a decision to made between a patient and their physician. And having both parties well-informed is imperative.

[depakid]

31. Whenever I hear someone net tout "credentials" on the net, it's a red flag

that they have an agenda or don't know what they're talking about.

So called "second generation" or "atypical" anti-psychotics like risperdal AND zyprexa (trade names for risperidone and olanzapine) and have been icreasing touted for off label use- even in children, despite the fact that they have common side effect profiles that include (among other things) extreme weight gain and insulin Resistance that leads to diabetes.

Not only have drug company marketing practices been driving these trends (the ultimate goal of pharmaceutical marketing whether through direct to consumer advertising, sponsoring fancy CME's or other "inducements" to providers is to influence prescribing habits) but "selective publication" and ghostwritten articles intentionally skew the information available in professional journals.

The zyprexa case is both representative and instructive. The evidence shows (through Eli Lilly's own documents) that the company was furthering unsubstantiated claims and withholding information about serious- even lethal adverse events. Yet the FDA turned a blind eye (and in the past, has actively suppressed withheld its own researchers' information, as it did with the Mosholder report on pediatric use of paxil). Without the civil justice system- Lily would have every incentive to continue its unethical and illegal practices, causing untold suffering and needless deaths while driving demand in its 4.2 billion dollar market.

Yep- it's the plaintiffs' lawyers' fault.

That's not to say that the drug doesn't have legitimate evidence based uses. It's perhaps the most efficacious intervention for acute manic episodes- but that's a short term therapy. Unfortunately, more often one sees patients with bipolar disorders ending up on this medication for long term maintenance, which is both dangerous and impacts their quality of life.

Then there's the pediatric misuse- which is rampant, and as often as not based on ambiguous or controversial diagnoses. Foster children in particular have been subjected to this- as are families in distress who lack the sophistication to adequately research or understand the medical risks and purported benefits.

btw: the reason one finds "lawyers sites" proliferating on google is the same reason why it's so difficult to get accurate and objective information about gun control. It's the nature of PageRank (google's algorithm) to bring certain sites to the top, while discounting others. It has little to do with the quality or quantity of the information you find.

Presumably, someone with impressive qualifications has access to more targeted and objective databases, such as Lexis/Nexis and PubMed, where this difficulty should be minimizal.

[Oak2004]

36. Dementia? No, it's been shown to be not only ineffective, it hastens death.

Evidence that it does anything positive with regard to autism is very limited The evidence suggests it's useful to control short- and medium- term aggression in about 50% of autistic persons -- not surprising as the drugs are sedating -- yet this very limited evidence is being used to prescribe antipsychotics to any and all autistic kids, with some ugly long term consequences.

OCD I know nothing about. But antipsychotics should not be prescribed to elderly patients, and rarely are genuinely useful in autism.

[fascisthunter]

10. Get This Administration and Their Corporate Tools Out of the FDA

Jesus, these fascists are sick in the head!

[OhioChick]

11. Not Good. n/t

[mattfromnossa]

12. I am so disgusted

with the FDA. von Eschenbach is a major disappointment.

[sutz12]

13. Every time they deregulate somthing, somethng goes to crap.

S&L
Enron
Telecoms

I think that two of the worst moves made in the last 20 years or so was letting lawyers and drug companies advertise.

[Occulus]

16. I thought 'deregulation' was a bad thing years ago

when I first heard the word, and I am sad to see I was 100% correct in my assessment.

[mzmolly]

14. Well then, let's just abolish the FDA shall we?

We'll have no need for this agency if they keep advocating in this direction. :eyes:

[cbayer]

17. It's really complicated

Physicians use drugs "off-label" all the time because they have to. In order to alleviate pain and treat illness, it is necessary to do this.

But the threat of lawsuits based on the lack FDA approval may inhibit physicians from prescribing "off-label" and patients will suffer.

Handing out studies supporting "off-label" use is not so horrible. I believe that most physicians are able to read this information critically and make their own decisions.

[DCKit]

19. Doctors have enough legitimate material to read already.

This ruling would result in a tidal wave of marketing materials that would overwhelm the best of them.

I'm not saying "off-label" use is wrong or even dangerous, just that direct mailing and marketing is a poor method of educating medical professionals and, given the profit motive, probably a Pandora's box for everyone involved.

[cbayer]

27. That's a thoughtful response

And I tend to agree with you. I think that pharmaceutical representatives are a scourge, for the most part and much of the "literature" they bring around is some of the weakest science I've ever seen. I guess my concern is more about the FDA giving physicians some leeway and, by doing so, some protection for off-label use. I read this as possibly supplying that, but I see your point.

[OneBlueSky]

20. a more accurate headline would read something like . . .

"Big Pharma wants to loosen rules on drug marketing; FDA complies" . . .

[crimsonblue]

22. This is bullshit

I talked to my dad this morning (he's a doctor), and he said that these new rules were completely unneccessary. He said almost every doctor knows the uses for 95% of drugs, and that these articles are targeted directly at consumers. The drug companies have been trying for years to get rid of the FDA. Well, no need to do that when they give you a free pass! Goddamn BushCo...

[NashVegas]

34. That Was My Take On It As Well

Of course they can pass this information to doctors. To consumers? Don't think so.

[rexcat]

24. It could be a good thing or a bad thing...

depending on how the Pharma companies are "allowed" to disseminate the information.

Currently there are many drugs on the market that are used off-label. Some to harm but some have therapeutic benefit. Every time someone takes a medication off-label they are an experiment without the benefit of informed consent and without benefit of oversight by Institutional Review Boards that protect the rights of the patient or study subject as it may be.

There is big debate within pharmaceutical research on what to do about off-label use and the ethical and moral issues of off-label use of approved drugs. What I believe needs to be done is to have the pharma companies do more clinical research for off-label use of their drugs so that the labeling can be changed if there is benefit or if no benefit or harm comes to patients label the drugs as such to prevent the use of the drug if there is no therapeutic benefit. If a physician then uses a drug off-label and it clearly states that the drug does harm or there is no therapeutic benefit they can be taken to task by their patient.

Disclosure: I work in clinical research with Pharma companies. My therapeutic area of expertise is oncology where there is a tremendous use of drugs off-label.

[hunter]

33. I think drug marketing should be a felony.

Throw 'em all in prison with the guys who make and sell methamphetamines.

"Ask your doctor" ads piss me off, and when doctors prescribe expensive drugs that people can't afford in situations where a very inexpensive generic would work better, that pisses me off even more.

The pharmaceutical industry is corrupt, and this will make the problem worse. But apparently the U.S. government exists to protect huge corporate profits rather than people.

[pinniped]

35. Pretty soon, drugs will be railroaded through faster than before.

Tests, we don't need no stinking tests.

These freaks are insane, but we already knew that.