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August 2nd, 2010
10:40 PM ET

Study raises questions about industry funded trials

 

Drug trials funded by the pharmaceutical industry usually have positive outcomes according to a new study in the Annals of Internal Medicine.

Researchers from the United States and Canada looked at 546 drug trials registered in ClinicalTrials.gov, a registry of both federal and private trials in the United States and abroad.  346 of them, or 63 percen, were funded by the drug industry. The remaining 200 were paid for by government or non-profit organizations.  Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.

"We did this study in order to determine whether there is an inherent bias because pharmaceutical companies fund trials on products in which they have a financial interest," said study co-author Dr. Kenneth Mandl of Children's Hospital, Boston. "The most reassuring result would have been that the rate of favorable outcomes would be the same regardless of funding sources. In a very dramatic way that was not the case and what we need to ascertain is if the cause of this shift toward favorable findings among trials funded by pharmaceutical companies is related to the details of the protocols and study design."

Dr. Florence Bourgeois, also of Children's Hospital, Boston and lead author of the study says typically trials sponsored by drug companies are more efficient and well funded. Still, she found the result stunning. "The implications of these findings are that we need more oversight in the way clinical trials are designed as well as in the analysis and reporting of the results. One option may be to make study protocols directly available on clinicatrials.gov as well as the comprehensive reviews complied by the FDA on trial results."  She continued, "While we cannot specifically point to which factors contribute to the association between funding source and positive results reporting, our findings speak to the need for more disclosure of all elements of a study."

Most of the trials were Phase 3 or 4, meaning they were large studies to confirm effectiveness and safety. In Phase 4, studies are done after the drug is already on the market but more information is being gathered on things like side effects. Researchers looked at trials for cholesterol medications, antidepressants, blood pressure medication, antipsychotics used for mental disorders like schizophrenia and bipolar disorder and a number of other drugs used to treat other conditions.

According to Mandl, industry funded trials also were less timely in terms of providing public information including trial results.  He says even though drug trials are overseen by the Food and Drug Administration, there are still some variables  that could favor pharmaceutical companies, including placebo comparisons, dosing and duration.  "The concern is the pharmaceutical industry is funding the studies of the drugs in which they have a vested financial interest."

The Pharmaceutical Research and Manufacturers of America (PhRMA) says their member companies are committed to increasing transparency by reporting more information about clinical trials. "The study, published today by the 'Annals of Internal Medicine,' demonstrates one more way that patients and the public health can benefit from increased transparency: The study would not have been possible without the large volume of information about ongoing and completed industry-sponsored clinical trials provided through ClinicalTrials.gov and supported by PhRMA and its member companies."

Dr. Deborah Zarin, Director of ClinicalTrials.gov at the National Institutes of Health says most of the trials used in this study were registered prior to the enactment of the FDA Amendments Act (FDAAA) and therefore were not covered by newer, more stringent registration requirements. "It is clear, however, that some level of selective publication is occurring, so that the public (as well as medical experts) only have access to a biased sample of studies for any given class of drugs. It is therefore urgent that all sponsors of trials, whether government, industry, or others, make strenuous efforts to implement the requirements under FDAAA,"  she said.  "Once this is done, the public will have access to the basic results of key drug and device studies, without being dependent on the interests of the sponsors."

 
 
 

 


soundoff (28 Responses)
  1. Terry from West Texas

    Unless a federal regulator is holding a gun to the head of the CEO, every corporation will lie, cheat, steal, cook the books, bribe legislators, lie to inspectors, bribe inspectors, lie to consumers, lie to investors, buy pretty girls for influential friends, bribe the county commissioner for a zoning variance, deliver cheap asphalt when high quality asphalt was called for in the contract, and never, never, never, never tell the truth about anything to any audience. They deliver one message to consumers, another to investors, another to government, another to competitors, and another to suppliers.

    Global corporations are beasts to be tamed and put in harness. We have to forget that Libertarian/Ayn Rand/Gary Cooper romantic vision of the brilliant entrepreneur. It does not describe what we see happening in front of our eyes. Our CEOs are not brilliant Edisons who invent new technologies. They are just highly paid salesmen. They are not like Henry Ford who could assemble one of his cars by himself. They don't understand their own products and the only thing they can make are deals. We are so accustomed to corporate lying that we think it is unremarkable when the corporation always downplays problems. It never just tells the damn simple truth. They say the leak is only 5,000 gallons, knowing it is much more, but hoping to cover up the difference. They say there is no defect in the product, but finally they admit that a number of people have been killed and very reluctantly they order a recall. They admit the truth only when they are unable to cover up the reality.

    August 3, 2010 at 09:31 | Report abuse | Reply
    • used2b-middleclass

      and this is "regulator" is somehow not controlled by congress which is not controlled by lobbyists? yuck. there was a time when the fda was independent and the medical profession was not in the thrall of pharma or the control of insurance (premium collections) companies. these are the good old days *grin*.

      August 3, 2010 at 14:15 | Report abuse |
  2. Rick McDaniel

    When the Fox is asked to guard the hen house, you can expect trouble.

    August 3, 2010 at 09:40 | Report abuse | Reply
  3. django

    I strongly agree with both the previous posts – when the fox guards the hen house you can definitely expect trouble...am wondering if they had a little integrity in there testing maybe they could see these lawsuits, recalls and/or adverse reactions sooner..but then, the money to be made robs them of any professional integrity they might have had.

    August 3, 2010 at 09:57 | Report abuse | Reply
  4. Stacy from NJ

    What is the alternative? If we eliminate industry sponsored clinical trials, we will limit the innovation in medical science decreasing the likelihood that life saving medications will be developed. Of course Phase 3 and 4 trials are going to report positive results. If a new drug development fails phase 1 or 2 trials is won't make it to Phase 3 and 4. What pharma company would fund research for a drug that does not work. And with Phase 4 trials, if a drug is approved by the FDA, it better have proved to be safe enough for the public. If not, and Phase 4 trials have concluded otherwise, the FDA should be looking harder at their approval process. Pharma is not the enemy, they are creating life saving drugs that otherwise would not be developed.

    August 3, 2010 at 10:02 | Report abuse | Reply
    • Sam

      Never EVER forget Stacy their bottom line- money....and lots of it. They have proven themselves to be filthy liars that cook books and do all that the first poster mentioned. Yes there are life-saving medications out there but how do we know it was not created that way? There have been numerous accounts of our corrupt government poisioning people and then offering medication to combat it. Look at the most obvious one: Cancer. Scientists who manufacture chemical cleaning products and other chemical agents KNOW that they DO cause cancer. Do not be mistaken. Its a sick and twisted game.

      August 3, 2010 at 12:09 | Report abuse |
    • comment

      You might like the book, Selling Sickness. (That's just a start.)

      August 4, 2010 at 01:08 | Report abuse |
    • comment

      and the documentary, The Corporation.

      August 4, 2010 at 01:09 | Report abuse |
  5. RiskAnalyses

    Pharma IS the Enemy, they Are creating Life-Ending and Life -Altering (ethical?) Drugs that otherwise Should Not be in the marketplace. In the past 2 years there have been At Least 6 heavily prime-time advertised (TV other media) such Drugs which w/in 6 months Are Disclosed as "more dangerous, with more patients experiencing more life-altering or life-ending complications than the Pharma companies CHOSE to reveal to the public (& likely the FDA as well)!! Not just pulled from oyur TV – pulled from the market "for further study"
    Pharma companies are well known for thorough Risk Analyses GAMING the expected Financial Costs of lawsuits and settlements (perhaps some re-engineering) against Maintaining the Revenue Stream and Large Profit Contributions!!
    What is so Urgent about "The Latest & Greatest (ethical?) Drug" for so many conditions & symptoms for which Older, Proven less Harmful, but less profitable, continue to be cabable of working well – With Less Danger to Consumers ??

    August 3, 2010 at 11:07 | Report abuse | Reply
    • Sam

      Another ploy is they will make up an illness so that they can have a patent on the treatment. I saw one recently that had me almost laughing: Work Shift Disorder. It is an 'illness' that people who work shifts or nights and cannot sleep properly take this dangerous pill that can cause all sorts of problems. Un-freakin-believable. NIGHT SHIFT DISORDER? Give me a freakin break! Also, when they make up a disease, then the FDA says they are the only ones that can treat it...as if they created the illness itself.

      Look at vitamins and minerals that GOD GAVE US OUT OF THE EARTH FREE OF CHARGE. No one is allowed to say that a bottle of Fish Oil can prevent heart disease and other issues because 'the FDA has not evaluated it'. Well, why haven't they evaluated it? Its FISH OIL! Been around for millions of years! Oh, thats right. Because it actually works and they can't make a buck off of it. Whereas if they put you on heart medication that causes diarrhea, then they can give you diarrhea meds. Then the diarrhea meds cause migraines so they give you migraine meds. And the rest as they say.. is history. Meaning, you'll be history.

      August 3, 2010 at 12:16 | Report abuse |
  6. Terry from West Texas

    I think medical trials can simply be outsourced. Let the research be assigned at random to any one of several private labs supervised by FDA. Let Big Pharma pay the FDA to support the research.

    August 3, 2010 at 11:08 | Report abuse | Reply
    • MoreRiskAnalyses

      Terry I like each of your posts and ideas for improvements are always good!! However it seems to me, as we have come to know of the "incestual staffing and relationships" between Federal oversight agencies in the Financial & Banking industries, already we hear of the same "good chemistry"between Pharma and the FDA and CPSC. It would be an enourmous challange to manage & staff truly Independent Testing Reporting Labs / entities with the necessary "qualified knowledge-workers" who do not have biases or allegiance to the industry players. Just my analysis!

      August 3, 2010 at 11:19 | Report abuse |
    • Terry from West Texas

      You have put your finger on the problem, MoreRiskAnalyses. Corporate lobbyists are aways pressing expensive scotch and pretty girls into the open hands of Congressmen and government regulators. They are always there with campaign contributions, vacations for the family in Hawaii, and expensive box seats. Those Congressmen and regulators who are not responsive to corporate affection can expect private detectives to be scouring through their college transcripts, discovering whether the Congressman's children are gay or straight, and financing opponents in the next election.

      America's corporate leadership is subverting and corrupting our elected government.

      August 3, 2010 at 12:01 | Report abuse |
    • Janet

      That's why its sad that people bow before the 'God of Money' instead of their own God-given consciences. There are those that have and had to leave the Big Pharma they were working for because of their moral obligations. That is a REAL MAN/WOMAN. I would NEVER work for a drug company if I knew they were buying my silence as they slaughtered innocent people. I would rather go broke. My integrity is not for sale.

      August 3, 2010 at 12:21 | Report abuse |
    • comment

      That's the problem...they use our money against us and then we have to come up with more money to get to the actual truth. Boy are we ever dumb...

      August 4, 2010 at 01:16 | Report abuse |
  7. The Truth

    You only need to read "The Cholesterol Myth" to understand the lies we are being told. The FDA is a rubber stamp for large corporate drug companies.

    August 3, 2010 at 11:28 | Report abuse | Reply
  8. Kelly

    Industry generally won't sponsor pilot studies. You have to have pilot studies that show promise first to support a large industry sponsored trial. Non-profits tend to fund pilot studies, not industry. So only drugs that have already shown promise even make it to pivotal (industry sponsored) trials. Of course it's biased and the industry-sponsored studies are more likely to have favorable results! Out of 10 pilot studies (non-industry sponsored), 8 might not go farther and 2 might make it to a larger (industry sponsored) trial so of course those 2 are going to have better odds for a positive outcome.

    August 3, 2010 at 12:31 | Report abuse | Reply
    • Daniel

      This is exactly correct and seems to be what people on this post do not understand. The private industry trial already has an inherent bias for success built in before the trail starts because money is an option, and that is exactly why there is more chance for a successful outcome. A private firm will not waste money on a drug that they have absolutely no efficacy information on, as the government most certainly will with a pilot study. For a valid argument, from a statistical standpoint, the authors of this paper should compare private studies and government studies of the same drugs, this is the only way to make a valid comparison.

      August 4, 2010 at 11:30 | Report abuse |
  9. MG

    As someone who uses a new drug created by the evil pharmaceutical empire, let me just say this...I'd be blind right now if not for that drug so its not all bad. In fact, almost all the innovative new drugs begin right here in the states even though most of those corporations are global. Why? Because there is the potential for big financial rewards which don't exist in other countries because drugs are so heavily regulated there. Do those incentives need to be monitored? Yes and likely more than they are now but what happens if the opportunity for large financial gain is removed entirely. Those of you who aren't sick, and that's most of the country, don't realize what it means to need a drug. Unfortunately, I do.

    These issues are complex. Can we please stop acting as if things are all good or all evil? It doesn't help solve the very real problems that exist

    August 3, 2010 at 12:36 | Report abuse | Reply
  10. FoxInDaHenHouse

    "Study raises questions about industry funded trials" - Study authors found that more than 85 percent of industry-funded trials in their sample posted favorable outcomes and were 4 times more likely to report findings that favored their drug.
    4X (good or evil?) sure leaves A-Hell-ofa-Smell in Da HenHouse!! Seems to be Risk Aversion beyond risk-analysis!

    August 3, 2010 at 13:12 | Report abuse | Reply
  11. Pirogi

    Safety and efficacy testing done by a company on their own products usually reveals those products to be safe?? Nooooooooo!

    August 3, 2010 at 13:26 | Report abuse | Reply
  12. Bradford

    Interesting article...this company here claims to have the CURE for diabetes and is about to start human trials in a few months (early next year some time) makes you wonder: http://www.sernova.com/s/Home.asp

    August 3, 2010 at 13:41 | Report abuse | Reply
  13. Just a PhD

    Unfortunately, there isn't enough federal money to pay for controlled pharmaceutical research. Those of us in academia have come to rely on pharmaceutical and device company sponsored research in order to do our work. The majority of us do this day in and day out, and do our best to remain objective. We will also turn down money from pharmaceutical and device companies if we sense that their motives are unscientific, or if they want to direct the research or control the data themselves. There are some bad apples out there who do research for the money, and fabricate the results. Those are the ones you read about in the papers and hear about on TV. As things stand currently, academia has to rely on the pharmaceutical companies for money to finance our research, and industry needs us to provide credibility. I would love to see a source of revenue to properly conduct unbiased research. Aside from a few generous philanthropists, the source simply isn't there.

    August 3, 2010 at 16:01 | Report abuse | Reply
  14. blondephd

    There is another way to look at this though. A pharmaceutical drug study, even Phase IV runs into the many, many millions of dollars. No company will bother studying a drug if they don't think it works because it is just too darned expensive to do the study. Plus, if they do the study on a dog drug and it turns out bad, stock prices plummet. So they don't study drugs unless they are pretty sure they are going to work. Doesn't mean they are lying, cheating or stealing, just means they won't spend the cash on drugs that lab or animal studies suggests won't work.

    August 3, 2010 at 19:30 | Report abuse | Reply
  15. Ed

    Lets pounce all the pharma companies.
    With this study you are seeing some of the same as to why government is paying $10 for a roll of toilet paper, as you are paying less than $1.

    Pharma companies have to hedge, place bets on most promising drug candidates, therefore higher sucess rate. Government pays for studies that pharma companies won't do, typically, because they don't believe in sucess of them. That's the key ot the difference in outcomes. Any drug researcher would tell you this...

    August 3, 2010 at 23:16 | Report abuse | Reply
  16. charls

    The drug companies says that it takes millions or hundred of million dollars to produce a new drug for market. Do you really think that the drug companies have a problem with this cost? They use if for justification for the high cost of drugs that they sell. It also guarantees that getting a new drug passed FDA approval is almost impossible except for Big Pharma doing it. So anything that might work as well but lies in the public domain will not ever be approved by the FDA since no one will spend millions of dollar on a medication that does not have patent protection. The US spend almost twice as much per person as any other country in the world. Yet the US ranking in morbidity is about 15th in the world.

    August 4, 2010 at 00:29 | Report abuse | Reply
  17. In the Industry

    95% of all compounds never make it to clinical trials because of side effects or inefficacy. Then there are phase I and phase II trials for the compounds that show promise that test small population for safety and efficacy. Only compounds that are proven safe and have a good potential for benefical results make it to phase III trials and are posted on clinicaltrials.gov. This article is only proof that the system works and industry takes the safety of clinical trials very seriously.

    August 4, 2010 at 08:07 | Report abuse | Reply
  18. Dan Sfera

    Of course sponsors will not invest the big bucks for the phase 2 and phase 3 trials unless the results have been good from the phase 1 trials. Therefore, by the time a drug makes it to phase 3, it has a very good chance of being effective and safe enough to be approved by the FDA. Of course industry sponsors are running these trials like a business, unlike government funded studies. Why does this surprise anyone? I have a blog dedicated towards demystifying clinical trials at http://www.theclinicaltrialsguru.com for those interested.

    September 1, 2010 at 12:04 | Report abuse | Reply

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