What is your opinion of pharmaceutical companies and research and development?

[Fire_Medic_Dave]

Poll question: What is your opinion of pharmaceutical companies and research and development?

[CAG]

1. It would be nice if they really spent more money on R&D than on marketing

[Jackpine Radical]

2. Drug research is fundamentally corrupt

because the people who stand to make the profits are in charge of reporting the data. They hide adverse results all the time. I can cite examples that were unearthed by FOIA excavations.

[Tartiflette]

20. That's a big brush you're tarring with

one swallow does not a summer make

[Jackpine Radical]

23. Here is a brief sampling on just one class of drugs, the antidepressants:

http://www.drugrecalls.com/antidepressants.html

Lawsuits against pharmaceutical manufacturers for product liability and consumer protection have been traditionally been pursued in lawsuits brought by consumers or consumer groups. Perhaps indicating a trend for the future, the New York Attorney General, Eliot Spitzer, recently brought a lawsuit against drug maker GlaxoSmithKline under consumer protection laws for not disclosing clinical research. The New York lawsuit is seeking disgorgement of profits made by the drug maker for the sale of Paxil to children and adolescents.

The lawsuit accuses pharmaceutical giant GlaxoSmithKline of "repeated and persistent fraud" for concealing problematic issues of safety and efficacy when the company's blockbuster drug, Paxil, is used by children for treating depression. The lawsuit further alleges that Glaxo concealed data showing that in some clinical trials Paxil was less effective in children and adolescents than a placebo, and in some instances the drug could be more likely to cause suicidal feeling.

The lawsuit comes in the wake of reports citing the suppression of negative, unpublished antidepressant studies, and the inefficacy of antidepressant drugs in children and adolescents. In March 2004, the FDA issued a Public Health Advisory urging the manufacturers of antidepressant drugs to place warning on their drugs, cautioning doctors to monitor their patients for worsening signs depression or suicidal thoughts.

http://www.youtube.com/watch?v=OXdVL297wlM

Antidepressant suppression of clinical trial data


http://www.biopsychiatry.com/antidepressants/fda-warning.html

British health authorities sounded the alarm last year, saying long-suppressed research suggests certain antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. Because only one drug, Prozac, has been proven to alleviate pediatric depression, Britain declared others -- drugs called SSRIs and their close relatives -- unsuitable for depressed youth.


http://online.wsj.com/article/SB120051950205895415.html?mod=hps_us_whats_news

The effectiveness of a dozen popular antidepressants has been exaggerated by selective publication of favorable results, according to a review of unpublished data submitted to the Food and Drug Administration.

As a result, doctors and patients are getting a distorted view of how well blockbuster antidepressants like Wyeth's Effexor and Pfizer Inc.'s Zoloft really work, researchers asserted in this week's New England Journal of Medicine.

Since the overwhelming amount of published data on the drugs show they are effective, doctors unaware of the unpublished data are making inappropriate prescribing decisions that aren't in the best interest of their patients, according to researchers led by Erick Turner, a psychiatrist at Oregon Health & Science University. Sales of antidepressants total about $21 billion a year, according to IMS Health.

[Tartiflette]

25. Yes, you're right

Selective publication of data, as it's described here, does lead to distorted impressions. However, even if the companies were to try to publish negative efficacy data - no defense here, note - it might be difficult (it is always more difficult to publish negative data). I definitely take your point though, just making the comment on the way articles are selected for publication. However, do note that when a drug is submitted for application ALL clinical trials are required as part of that documentation, so ultimately, the effectiveness of the drug is determined and adjudicated by the health authorities.

Partly as a result of this discrepancy concerning results and the slant towards positive-only data, there is now a clinical trials website where the FDA publishes ALL clinical trial data reaching a certian stage in development and companies are required to submit their data for this within a defined period after the conclusion of the trial. So, the data will be there for all proscribers and the general public to access.

Oh, and on edit, companies are required to submit applications for running trials well in advance, with detailed information demonstrating how the trial is to be run and analysed, so there is little wiggle room if something negative shoud arise during the trial.

[Jackpine Radical]

26. Here's a little more:

Volume 358:252-260 January 17, 2008 Number 3

Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy
Erick H. Turner, M.D., Annette M. Matthews, M.D., Eftihia Linardatos, B.S., Robert A. Tell, L.C.S.W., and Robert Rosenthal, Ph.D.

ABSTRACT

Background
Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials — and the outcomes within those trials — can lead to unrealistic estimates of drug effectiveness and alter the apparent risk–benefit ratio.

Methods
We obtained reviews from the Food and Drug Administration (FDA) for studies of 12 antidepressant agents involving 12,564 patients. We conducted a systematic literature search to identify matching publications. For trials that were reported in the literature, we compared the published outcomes with the FDA outcomes. We also compared the effect size derived from the published reports with the effect size derived from the entire FDA data set.

Results Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

Conclusions We cannot determine whether the bias observed resulted from a failure to submit manuscripts on the part of authors and sponsors, from decisions by journal editors and reviewers not to publish, or both. Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients.


Source Information

From the Departments of Psychiatry (E.H.T., A.M.M.) and Pharmacology (E.H.T.), Oregon Health and Science University; and the Behavioral Health and Neurosciences Division, Portland Veterans Affairs Medical Center (E.H.T., A.M.M., R.A.T.) — both in Portland, OR; the Department of Psychology, Kent State University, Kent, OH (E.L.); the Department of Psychology, University of California–Riverside, Riverside (R.R.); and Harvard University, Cambridge, MA (R.R.).


BMJ 2008;336:516-517 (8 March), doi:10.1136/bmj.39510.531597.80 (published 4 March 2008)
Editorials
Efficacy of antidepressants

Is not an absolute measure, and it depends on how clinical significance is defined

In February 2008, Kirsch and colleagues reported a meta-analysis of the efficacy of antidepressants using data from clinical trials submitted to the Food and Drug Administration.1 They provocatively concluded, "there seems little evidence to support the prescription of antidepressant medication to any but the most severely depressed patients."

In January this year, we published an article about the selective publication of antidepressant trials and its influence on apparent efficacy,2 in which we also used FDA data. Our main finding was that antidepressant drugs are much less effective than is apparent from journal articles. From the FDA data we derived an overall effect size of 0.31. Kirsch and colleagues used FDA data from four of the 12 drugs we examined and calculated an overall effect size of 0.32.

[Tartiflette]

28. Well, essentially we're in agreement

Current requirements are generally that a drug show acceptable efficacy (compared to placebo or comparator) in at least one trial, and sometimes two. As psychiatric trials are notoriously difficult to show efficacy in there is even a passage in regulatory guidance which comments on this. The publication question affects all people in research - in academia I had difficulty getting published, as my results were negative, and negative results are (or were, I can't speak to the current climate) far more difficult to get into a journal. I tend to think this is self-defeating, as negative results can take people forward.

I wouldn't ascribe this to nefarious behaviour on the part of the companies though - as stated above, the regulatory authorities see all the data, and determine from this data whether the drug should be licensed or not, and the FDA have a team of more than capable statisticians who really do sift through the info looking to see if the conclusions drawn by the company concerning the drug match up to the data.

[Fire_Medic_Dave]

30. There seems to be a little bias in their study.

Otherwise they might have differentiated between negative and questionable results. Say for instance a 1st year grad student was involved in the study and screwed up the pre-study interviews. Any results of that study would be questionable, whether the outcome was positive or negative. So why would a company publish a study in which researcher error led to questionable results?

David

[Tandalayo_Scheisskopf]

3. Simple short-term fix:

Return to the ban on drug marketing to the public.

[Fire_Medic_Dave]

5. How would you let consumers know that a drug for their condition is available?

People are reluctant to discuss certain issues such as erectile dysfunction unless they know a certain treatment or medication is available.

David

[Donnachaidh]

10. uhh, they should find out at the doctor's office, like people used to

Oh come on, you go to your personal physician and you are reluctant to talk about your problems unless you know a drug is available? :eyes:

[Fire_Medic_Dave]

12. I haven't experienced it personally but I've had a ton of patients lie to me.

I would guess that before Viagra was marketed there were tons of men who went to the doctor for years without saying, "doc I can't get it up do you have any suggestions".

David

[napi21]

9. I agree with you on that one! I happen to think most of the ads turn more people off of their drug

than on! Did you ever listen to all the cautions in them? Damn...it sure sounds like the cure is worse than the ailment in most cases!

I still believe your Dr. is best able to judge what meds are best for you. He went toi school for a very long time to learn that, and the pharms already spend a lot of $$ boosting their new discovery to every one of them!

If you have a problem and don't ask if there's a treatment, that's YOUR PROBLEM!

[The_Casual_Observer]

4. Don't they mostly invent boner enhancers & tranquilizers?

The real medicines are discoveries done almost by accident.

[Fire_Medic_Dave]

8. What wrong with discovering those things especially if they work better than what's available?

[Liberal Veteran]

34. Mostly? Not so much.

There were over a hundred new drug approvals since the beginning of 2008 and only 2 of those were tranquilizers and 1 approval of low dose Cialis (the once a day stuff).

Granted, some of them would hardly constitute "new drugs" since some are just approved for a different indication (ie, Finasteride is approved for use as benign prostatic hyperplasia as Proscar, but also marketed as Propecia for hair loss).

If we based the new drugs on the commercials, you'd think that the majority of work was done on anti-depressants, erectile dysfunction drugs, osteoporosis treatments, and heartburn medications, but for every one of those there is usually a dozen to a score of drugs quietly put on the market for use in chemotherapy, prevention of complications in surgery, anti-seizure medications, antibiotics, antivirals, antifungals, hypertension, etc....

[PDJane]

6. The government already subsidizes R & D;

most of it is done in universities with the public purse.

Institute caps on drug prices (the US is the only country NOT to have them), make serious rules and regulations about who tests the new drugs and what standards they use, and cap the profits these companies can make on someone else's misery.

[Booster]

7. As long as you pay researchers to find a cure, they will

never find a cure. We should put a billion dollars in a trust fund and tell them whomever finds a cure for any desease gets the money. Isn't it odd that they can't find any cures (not since polio in the '50's), but they sure can find pills that treat the problem. And isn't it odd that these pills are so costly in the U.S., but not in other countries where they are exported at a cost. Our country is so currupt when it comes to medical problems and solutions.

[Fire_Medic_Dave]

11. Maybe one of the reasons they are so expensive is that other countries control the prices.

I bet if we forced them to sell the drugs for the same cost throughout the world they would be less likely to enter into agreements that force them to sell the drugs so cheaply elsewhere.

[Celebration]

22. Good idea!

There is no reason that American consumers should bear the brunt of the cost of drugs.

[Celebration]

21. Love this idea

Set up a bunch of "cure" funds with piles of money in them.

[LeftishBrit]

24. 'can't find any cures since polio in the 1950s'...

Polio was prevented by vaccines (not cured). And other vaccines have become available to prevent other diseases since then - e.g. measles. Yet vaccines are often regarded as particularly suspect by the very same people who claim that 'doctors only treat and don't cure'.

And there have been cures for many diseases since then. E.g. certain cancers, such as Hodgkin's disease and most forms of childhood leukemia, are nowadays cured in most people (they remain serious, but cure is the most likely outcome).

Knee and hip replacements cure many people with severe pain and disability.

Many congenital heart conditions which would have caused death in infancy in the 1950s are now cured.

Etc. I'm not saying that there shouldn't be more cures, but the idea that there are no new cures is just wrong.

[Liberal Veteran]

35. Leprosy, Hep C, Some forms of cancer. systemic fungal infections,

I won't argue that medications are WAY overpriced. I am in agreement on that.

What is more fascinating to me is that some of our greatest successes have been PREVENTION of disease through vaccination: Smallpox, influenza, diptheria, measles, pertussis, polio, etc.

Of course there is a vocal group that questions the safety and/or the effectiveness of immunization, and often for some very odd reasons.

[Juche]

13. Seperate R&D into a seperate industry, apart from manufacturing & marketing

Right now there is alot more money in making me too drugs that don't work better than off patent drugs already on the market.

Make R&D a seperate industry funded by public funds, philantrophy and the revenue from leasing their ideas to pharm manufacturers. Let them do the R&D, then sell the ideas to the pharma companies.

[Fire_Medic_Dave]

14. That is close to option #4.

[orleans]

15. with all the money big pharma makes from cancer patients, why the hell

would they want to "cure" it??

they don't. it's that simple.

[Tartiflette]

19. It's not that simple

Whether they "want to" or not. First, cancer is not one single disease (although all cancers share the same manifestation of unregulated cell growth), and some "cancers" are in fact, pretty much treatable these days. Others, such a pancreatic cancer, are definitely not so easy to treat, and the prognosis for those poor individuals who develop that is not so good. It's all really very difficult, because to cure a cancer you have to find a way of targeting it, and that has been very difficult to do, hence some of the treatments you're familiar with, such as radiation and chemotherapy, are very general in nature, targeting all growing cells (hence the falling out of hair).

Believe me, a drug company would be happy to find a "cure" for cancer, as it would mean bucketloads of of money for them, and some of the novel treatments being developed are looking at earlier timepoints in the progression of the di ease (vaccines, for example) but as yet, there have been enormous problems with finding treatments that don't have unacceptable side effects. Drug companies wold even be OK with a drug that prevented the disease from starting in the first place; that too, would be a money-spinner.

[uppityperson]

16. Show me your picture and then I can vote.

I lied. I already voted. Based on a picture I haven't seen yet. But then I am a shill and all. Picture?

[Fire_Medic_Dave]

17. People seem to like firefighters.

[Tartiflette]

18. The problem is mostly marketing, IMHO

Contrary to public opinion the pharmaceutical industry is heavily regulated at the R+D level, and companies are required to collect raw data (collected in a blinded fashion, so that the company has had no chance to manipulate it) and provide it for the FDA, so the agency can make independent analyses to check the claims made by the company. To get a drug on the market is a long, difficult process, involving basic research to identify potential drugs, followed by cell work, animal modelling, testing in healthy volunteers under very tightly controlled conditions, and then testing in the disease area of interest against either placebo or a comparator drug. It takes 8-14 years to get a new drug to market, and I think only 1/200 drugs that start on the process make it through, especially since the final step, Phase III clinical trials, often reveals problems that had been hitherto hidden due to the relatively small number of volunteers/patients tested in earlier trials. By the time a drug is approved, there is a fairly clear picture of the short to medium term safety risks a drug might have. However, the effects of the drug over a long period (<2 years) will not become known until some time after the drug is marketed, and the regulatory authorities across the world are demanding ever more stringent monitoring of the drugs post-launch to ensure that any long-term effects are picked up as soon as possible. It is a truism that under modern regulation aspirin would be unlikely to get a licence (it can have side effects, such as intestinal bleeding, that might warrant discontinuation under modern guidelines).

Problems have arisen for a number of reasons, including in some instances, dishonesty on the part of the company. Off-label use, as it is called, whereby a patient is prescribed a drug for something that has not been tested in a clinical trial, is something companies may have turned a blind eye to in the past, as it resulted in more sales, but this too is being looked at more closely by the FDA and the EMEA (the europeans). If there are known safety risks (and there always are) then the company must justify why the potential benefits outweigh those risks, eg why for example one might put on a few pounds of weight, have increased headaches or some such adverse event, as a trade-off for an effective treatment against the illness in question. The "label" should describe the potential side effects, and the relative risk of having such an event.

There are drugs reaching the market that have a good effect on eg cardiovascular disease, but which come at a cost, which might be as serious as (I am making this up) as an increased risk of something like diabetes, but whose immediate benefit (keeping a patient alive) might make the trade-off worth it.

I do have some problems with relatively new developments like giving drugs to healthy people though, as a means to prevent heart disease, as I think this is novel territory that should be part of a public debate before it becomes accepted practice.

[xchrom]

27. i would be happy to let more money than does already

flow to universities for more research than they are currently doing.

[Tartiflette]

29. seconded!

So much promising research that could go somewhere with adequate funding....and so many promising scientists needing to leave basic research for industry or other careers due to a shortage of funds...

[mopinko]

31. ED drugs are not for what you all think. they are extremely important.

take this hypothetical test- you have been diagnosed with a life threatening condition, which you cannot see, feel, or taste. no symptoms that you know of, just the doc says your health is in danger. or maybe there are symptoms, but you don't think they are that bad. there are many simple treatments. the only trouble is, you will be unable to have sex as you know it for the rest of your life.
ask yourself honestly, just how long would you continue to take your prescribed meds?



one week?


one month?




one year???



what is your condition?



high blood pressure. maybe diabetes. maybe depression.

or maybe a lot of things. your eyes would give out reading through the fine print on all the drug warnings of all the drugs that have sexual side effects.

THAT IS WHY ED DRUGS MATTER.

it's your boner or your life for a hell of a lot of people.

[unc70]

33. And don't forget prostate cancer

Even with newer surgery that tries to perserve the nerve bundles, ED is still a problem.

[cosmik debris]

32. Under the current rules

Drug companies are ONLY obligated to their share holders.

Like most people here, I'd like to see the rules changed.

But it really doesn't make any sense at all to expect the drug companies to play by rules we wish for instead of the rules that are written into law.

It seems rather hypocritical to criticize the companies when they ignore the rules for FDA approval and still expect them to ignore the rules on corporate responsibility to their investors.

You can't have it both ways.