Posted on 11/30/2008 12:46:34 AM PST by neverdem
Results of most drug trials are unreported, inaccessible to clinicians and patients, a new study confirms
Patients asking their doctors if a new drug is right for them would do well to also ask for supporting evidence. Conclusions about drug safety and effectiveness in reports submitted to the FDA are sometimes changed to favor the drug in the medical literature, a new analysis finds. And a quarter of submitted drug trials were never published at all, researchers report in the Nov. 25 PLoS Medicine.
Information published in journals is the most accessible to health care professionals and also drives marketing of new drugs. The new study suggests that this information is incomplete and biased, says health policy expert Lisa Bero of the University of California, San Francisco, who led the study.
An-Wen Chan, who wrote an accompanying commentary but was not involved with the work, says he does not think health care providers will be surprised to learn of suppression and inaccurate reporting of new drug information.
“These new findings confirm our previous suspicions that this is happening on a much broader systemic level. It shows that information is unavailable to those who really need it the most — the clinicians and the researchers,” says Chan, of the Mayo Clinic in Rochester, Minn. “If we take the view that research on humans is ethical, is allowed based on an assumption of public good, then all clinical trial information should be publicly available.”
Food and Drug AdministrationDrug manufacturers are required to submit all their studies to the U.S. Food and Drug Administration as part of new drug applications. That’s the last step in drug development, following testing on animals, trials with healthy people, and larger trials with sick and healthy people. Ideally, if the drug receives FDA approval, all the clinical...
(Excerpt) Read more at sciencenews.org ...
Bias, Spin, and Misreporting: Time for Full Access to Trial Protocols and Results
We've seen entire studies where not one single adverse event has been reported during the study and gone in and audited only to find many unreported AE's. This is why you end up with drugs like Avandia killing people.
Another thing to keep in mind is that drug companies have a big incentive to not hide side effects. If their drug is marketed, and then a significant number of patients develop these side effects post-marketing, they will have to pull the drug and face significant lawsuits. For larger companies that already have a repertoire of marketed drugs, the risk is too great to continue development of new drugs that have significant side effects. Actually, some drugs under development with what many would consider acceptable side effect profiles are shelved by the companies because they don't want to take the risks.
Having said that, human beings work at and run companies, and it is certainly conceivable that individuals within those companies hide data. Oversight is key.
It’s because of greed. Drugs like Vioxx were generating billions of dollars in annual sales and were dangerous. But, the doctors that reviewed it got paid, the sales reps that sold it got paid, the ad firms that marketed it got paid, and the pharmacies that gave it to patients got their markup.
There is no incentive along the way to question a new drug.
Another one is Lipitor. There are many reports in patients of rhabodmyolysis yet most doctors never bother to liver enzyme checks in patients reporting leg pain.
I think in the future you will see most statins removed from the market. Yes, some will reduce you total cholesterol level. But there is no correlation in lower cholesterol and reduced morbidity or mortality according to AZ own studies. JMHO.
“perhaps FDA-sponsored journal that is specifically and exclusively dedicated to publishing full trial design and results papers.”
Independent peer-reviewed journals can’t, and won’t, publish everything due to the effect it would have on their Impact Factor (IF). The IF is generated by how often their publication is cited in other peer-reviewed publications.
Also, if a journal publishes a lot of irrelevant, boring, or rehashed data (resulting in a low IF), authors are reluctant to submit because publishing in such a journal holds little prestige.
Absolutely agree - greed drives these drugs to market with the FDA’s blessing and sometimes underwhelming warnings later on.
Case in point - SSRIs/SNRIs. Negative drug trials are quashed and drug reps are instructed not to inform doctors of such, but rather to gloss over and promote the positive. Common business practice, sure, but we’re talking about human lives (and lots of them - hence the greed factor). As a result, drs are often ill-informed when it comes to (sometimes deadly) adverse side effects of antidepressant use, and almost all are completely ignorant of the probability that antidepressants cause painful withdrawal, sometimes very severe and prolonged.
And yet an estimated ten percent of the US population is currently taking antidepressants for not only depression, but for anxiety, bipolar disorder (even though ADs can actually CAUSE mania in BP patients and CREATE mania in patients with no history of BP), incontinence, autonomic disorders, fibromyalgia, nerve pain, insomnia, severe PMS, and to stop smoking - to name but a few off-label uses.
It is THE number one prescribed class of drugs in the US today. And recent studies say that ADs are prescribed to patients with no history of depression anywhere from 42% of the time (one study) to a truly alarming 75% of the time (another study).
This despite the fact that there’s no documented information available concerning long term use of SSRIs and SNRIs - we simply have no idea what long term effects these drugs, only developed within the last couple decades, might have on an unsuspecting populace.
Meanwhile, Cymbalta (SNRI only several years old) print ads state the following - “How does Cymbalta work? The exact way Cymbalta works is NOT KNOWN. Cymbalta is THOUGHT to affect seratonin, which is THOUGHT to affect moods.”
Are you kidding me? With that dubious endorsement by Eli Lilly itself, let’s all take drugs that alter brain chemistry!
I agree, and this is actually the point I'm trying to make. A lot of the data that doesn't get published winds up this way because it's not that exciting, not because of a conspiracy to suppress it. This is especially true for negative data. That's why I think it would be helpful for the FDA to set up a medium for the publication of all major clinical trial data. It doesn't even have to be a print version. It could just be an on-line clearing house for clinical trial results. They could set it up in such a way that wouldn't preclude data from being published elsewhere first, if done in a specific time frame (maybe within 3 years after the trial ends). It would be required that when you receive an IND from the FDA and approval to go forward with a drug trial you agree to submit the full data set to the FDA for publication/public distribution.
This is the “clearinghouse” to which you refer:
http://clinicaltrials.gov/
And yes, I know for a fact that pharma submits negative data (data that does not reflect well on the study drug, for those of you in Rio Linda) to journals in good-faith transparency, but many journals will not publish due to the data not being “novel.”
“There is no incentive along the way to question a new drug.”
Apparently you’ve never read about what it takes to get a drug to market. Seriously, this isn’t a flame. You should do some research into the time, cost, and how restrictive the FDA is with approving new drugs.
There is only ONE industry that is more heavily regulated than pharma: Nuclear power.
I presume you are a conservative, so you understand the effects on regulation on any business. Operating and administrative costs increase and a huge amount of your resources are used in dealing with the regulation.
Yes, the pharma/research company makes money (as do shareholders), but much of that goes back into R&D. Pharma reinvests more profits back into R&D than most businesses.
Are there adverse events? Absolutely. Sometimes the prevalence of the AEs isn’t known until it’s in the much larger general population. Sometimes the AEs can be managed and/or monitored.
Suppression of adverse reactions by big Pharma?
Glaxo got more bad news on the Avandia front when a Congressional Committee Report found that company executives made a concerted effort to intimidate Dr. John Buse, a diabetes expert, into keeping quiet about some of the Avandia’s safety problems. The report alleged that Glaxo Chief Executive Jean-Pierre Garnier and former research chief Tachi Yamada were involved in the intimidation.
Avandia was once Glaxo’s second biggest selling drug, but sales in the US dropped 48% after the Cleveland Clinic published its heart attack study.
Big Pharma price fixing?
Schering- Plough Pays $31 Million to Resolve Pharmaceutical Fraud Allegations
The State of Missouri filed a lawsuit against Schering-Plough in May 2005 and alleged in its complaint that the company did not accurately report drug prices for drugs sold to pharmacies involved in the Missouri Medicaid program. This is the largest settlement figure the State of Missouri has ever recovered in a pharmaceutical pricing fraud. This is one of a number of lawsuits filed by state AG’s office against pharmaceutical companies alleging pharmaceutical fraud. They typically follow qui tam lawsuit fact patterns.
“Yes, the pharma/research company makes money (as do shareholders), but much of that goes back into R&D. Pharma reinvests more profits back into R&D than most businesses.”
Drug companies spend more on marketing and advertising than on R&D.
Yes, we hear about how costly it is to get pharmaceuticals tested and brought to market but it’s hard to take that seriously when they spend even more than that on marketing and advertising.
Where did you get your figures of R&D vs. marketing and advertising?
Interesting....just had a house guest who had to have heart surgery for 5 blockages....and is on Lipitor....HE said "it should be in the water"....His total cholesterol is 130 (his other readings are good too, I guess)....BUT, I said to my husband later...SO WHAT...I doubt it matters much since it's an artificial lowering and not addressing whatever the real problem is...(inflammation?)....I follow this because I have the NON-buyoant type of LDL, and although my cholesterol is normal am waiting to hear a doc say I need Lipitor, or some such thing for prevention....but....I'm just not buying it...CRP seems more important and I don't know if Lipitor helps that. Sorry I rambled....suffice to say....it seems drugs are PUSHED a lot.
http://www.amsa.org/hp/RandD.cfm
http://angrybear.blogspot.com/2008/01/pharma-research-versus-adminmarketing.html
http://www.sciencedaily.com/releases/2008/01/080105140107.htm
Go to your family doctor any day of the week around lunchtime and see if someone is bringing in lunch for the staff. Pharma companies cater lunch to lots (most?) doctor offices every day of the week. The reps fight over who gets to bring in lunch. They still give docs free trips to conferences which are really just vacations. My hat is off to any doctor who refuses to take perks from the pharma companies, but they are in the minority.
I know that pharma companies are in business to make a profit, and I have no problem with that. But I can’t stand to hear them whining about how much R&D costs when they are really just trying to find more and more people who “need” their product, even though there is often little or no benefit to the patient. Example: giving statins to children where this is no benefit shown but the companies expect to make billions of dollars off this new market segment anyway.
“HE said “it should be in the water”.”
Does he mean we should add it to water so that significant numbers of people can get muscle pain, weakness, and dementia for a therapy which has not been shown to even increase life span?
I think I’ll skip that therapy.
YES...he means EVERYONE should have it, but like a good liberal he doesn’t do the research himself.....alas...we’ll probably hear sometime in the next 5 years about his other health problems...he’s about 69.....and skinny, but I fear for him....
Pharma reps bringing sandwiches to an office is happening but I still want to know where you get your figures of marketing vs R & D?
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