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March 9th, 2010
04:45 PM ET

With new medicines, doctors don’t know what works best

By Caleb Hellerman
CNN Medical Senior Producer

When your doctor is choosing among treatments – whether it’s deciding the right drug to help lower cholesterol, or which pain medication to use when you’re lying in the ICU – you’d like to think he or she is weighing pros and cons, based on carefully compiled medical evidence. Unfortunately, that picture is far from reality.

A new study in the Journal of the American Medical Association helps to quantify the problem. The paper, by researchers at the University of Southern California, says that fewer than a third of research studies published in the most influential medical journals even look at whether a prospective treatment is safer or more effective than what’s already in use.

Some people think the FDA should require drug makers to prove that a new drug not only is effective, but that it works better than existing treatments on the market. However, in a JAMA commentary published alongside the new study, Dr. Alec O’Connor of the University of Rochester School of Medicine says that federal regulations can be interpreted to mean that the FDA is not even allowed to reject a drug’s application, as long as it works better than a placebo.

Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who has written extensively about the drug approval process, says that the results aren’t surprising and that a better system might have caught the problems with blockbuster drugs such as Avandia and Vioxx, before they came into wide use. Avandia, a drug to treat diabetes, has been linked by the FDA to more than 80,000 heart attacks. Vioxx, an arthritis medication, went on sale in 1999 but was pulled from the market in 2004 after studies showed it caused a higher risk of cardiovascular problems.

“If you’d been shown the facts about Vioxx and Avandia in Year One instead of Year Five, it would have saved a lot of lives,” Avorn says.

Study author Michael Hochman, an internist at Los Angeles County Hospital, says he was struck during his training how little research there was to guide decisions that he and his colleagues had to make every day. “Take diabetes,” says Hochman. “You have to decide what’s the first medicine to use, when to start insulin, what’s the proper blood sugar level to target, what’s the appropriate way to monitor someone’s blood sugar – when, most of the research in diabetes is geared towards the development of expensive new drugs. I wonder if we might be getting too far ahead of ourselves.”

Hochman and his co-author found that most so-called “comparative effectiveness” research is funded by universities or government agencies, as opposed to being done by pharmaceutical companies. Not only did he find that most researchers ignore established therapies, Hochman says that of the 328 studies that he looked at in the major journals, only two included a formal analysis of cost.

The findings have to be discouraging for those who support a bigger role for so-called “comparative effectiveness” in the practice of medicine. The health care overhaul being promoted by President Obama envisions a system under which vast amounts of data on different treatments would be collected and analyzed, with evidence pointing to the most helpful and cost-efficient therapies, which might also shape the decisions made by insurers and by the federal government in its role as the overseer of the Medicare and Medicaid programs. The health care bill passed by the Senate gives $165 million over three years, to a new agency, to fund and oversee comparative effectiveness research. The president’s 2011 budget includes $286 million for the same research.

Avorn says the proposed new funding is just a drop in the bucket, compared with the $2.3 trillion that Americans spend annually on medical care. “It’s just a matter of the research not getting done. The trouble is, it’s not a high priority for the pharmaceutical industry to fund a cost-effectiveness study of its new drug, if there’s a generic that’s just as good, and much less costly.”

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soundoff (25 Responses)
  1. Ginger Blymyer

    Great article. This past year I returned from living in Mexico and my daughters insisted I see "real" doctors. Bad move. the internist gave me prediabetic medication Actomed Plus, got nausea. He changed to Actomed, I gained 2o pounds. Now isn't it better to lose weight. I told him and he answered I have something, shots that will take the weight off. I said stop it all. I also had a colonoskpy a round the same time when I was nausea. That doc said it should not cause it but gave me pills for my belly. It was actually from some pills the Rheumatologist gave me.At least she said just try this. I called the doc, and when I asked side effects, he actually said, "we don't study that." I almost fainted. My eyes, after three surgeries for detatched retina the surgeon realized that the former surgeon had done a lazar surgery that let debris out left over from cataract surgery years before. So the autoimmune system keeps attacking the retina to clean that out. I do take prescriptions for arthritis darvocet, thyroid, blood pressure medication and even some for cholesterol, but those are all old one, fully tested. I feel I will not even use a new medication. I have never felt worse than this year.

    March 9, 2010 at 17:42 | Report abuse | Reply
  2. Dr Paul A Liberti

    Sanjay: In your piece on the cost of eating well, you showed a family looking at the prices of fresh veggies. Yes they are expensive. However frozen ones are cheap. You can buy frozen spinach for 90 cents which is equivalent to 3 -4 bucks fresh. Same is true for almost all others.

    March 9, 2010 at 20:09 | Report abuse | Reply
  3. Michaelmatunc

    I do believe you. Medicine in the third world probably far surpasses the immersed quackery that is now 'first world' 'medicine'.

    March 9, 2010 at 22:39 | Report abuse | Reply
  4. Mark

    Outstanding article; I'm sure the drug companies will deny all of it.

    March 9, 2010 at 23:37 | Report abuse | Reply
  5. Reasearcher/Previous Pharma Rep

    This is a Catch 22. As a current clinical researcher and past pharmaceutical representative, I see a huge dilema. The research is extremely costly (the pharma companies aren't lying), so if a "new drug" isn't any better than an old one, the pharma company is out a huge amount of money. That becomes a disincentive for discovering better therapies in general. On the other hand, how many "me too" drugs do we need? It is true that certain people fair better on certain drugs, so a "one size fits all" approach isn't the answer either. The cheapest drug will not always work for everyone; what if you're the person who truly needs the expensive drug to save or greatly improve your quality of life? Hopefully with personalized medicine drugs can be specifically targeted to individuals, but that of course is going to take more research (and ... more money). I think part of the problem of "cost" is the true monetary waste associated with much of the marketing of the drugs. I haven't been a rep for a while, but when I was, so much money was spent on "Madison Avenue" brochures, so many trees were killed in the manufacture and shipping of the advertisements (which were pretty unscientific to say the least) and so much money was spent on FedEx and fuel, not to mention the affect on the environment. The drug companies would argue they have to "sell" in order to have the money to do research, which is partly true. But, having relatives still in the pharma sales business, there is still fat that can be trimmed. I think the companies need to be more economically prudent in both their sales and research arenas. The entire country is tightening its belt. Pharma needs to do so as well, instead of merely passing their "costs" on to the consumers. Drug costs (and profits) are still climbing in the double digits year after year. Something is very wrong with that picture. So, I think the best we can hope for is pharma to tighten their belts.

    Just some thoughts. If I had the magical remedy, I would certainly share it (though pharma is slow to change their ways, so even if there was a good answer, I don't know if they would jump on the band wagon in any hurry).

    March 9, 2010 at 23:37 | Report abuse | Reply
  6. Are you serious?

    Unbelievable! This article is ridiculous. Does not even mention manage care being an issue. One of the reasons pharmaceutical therapy is so expensive is because managed care almost always requires step therapy...meaning the before a patient can use a newer more effective drug, they must try and fail on existing ,usually generic therapies. It often takes many years of consistent failure on a generic med before a patient is put on the new drug. All the while the patient isn't getting better resulting in physical deteriation, wasted doctor visits, and the wasted pharmaceutical cost. All of this costs money. If you cut to the chase and put the patient on the clinically proven more effective drug the perceived high expense whould be offset and the patient, and all of us save money in the long run. It is also important to mention that physicians receive bonuses based on the percentage of generic prescriptions the write. Don't believe everything you hear people. This article is ridiculously biased!

    March 9, 2010 at 23:48 | Report abuse | Reply
  7. Mervyn Long

    Add into this mix the barrage a physician faces from drug company reps fronting a new drug, pushing hard, and the chances of a physician taking time to judge effectiveness compared with older drugs along with cost effectiveness are very slender.

    March 10, 2010 at 00:28 | Report abuse | Reply
    • Melvyn Sutton Living in Scotland

      How are you Mervyn, remember me?

      July 14, 2010 at 15:25 | Report abuse |
  8. William

    The whole premise of "comparative effectiveness" is not very realistic. Since only a small percentage of all people will respond to any given approved drug due to differences in our genetics and metabolism, we all should be thankful that pharmaceutical companies create the vilified "me too" drugs since often slight differences in similar molecules will often mean the world of difference to a patient who did not respond to the first drug. Therefore, comparing a new drug to an existing drug does not really tell us anything. The data would only conclude that the new drug was better than the existing approved drug – but ONLY for the same type of people who responded to the existing approved drug! This means that the patients who had never received benefit from the first drug would STILL not have a drug that helped their condition. Comparative effectiveness laws will only serve to stifle innovation and prevent true "breakthroughs" from occuring.

    A related problem with trying to institute comparative effectiveness policies is the issue of deciding which older, existing drug should the new drug be compared to? For example, if a new cholesterol-lowering medication (i.e., statins) was to be tested via a mandated comparative effectiveness policy, which existing drug should the new drug be compared to – Lipitor? Crestor? Zocor? For the patients who only respond positively to Crestor, they would not benefit from knowing that the new drug outperformed Lipitor in a clinical trial.

    March 10, 2010 at 00:43 | Report abuse | Reply
  9. Matthew Lopez

    To those that want to know what drugs are less expensive, just as safe and work just as well..I have 3 words.

    ASK YOUR PHARMACIST!

    March 10, 2010 at 00:50 | Report abuse | Reply
  10. Deborah Wong

    Your articles are greatly appreciated. I now take six different medications. It took me three months to wean myself from a 6-year Vicodin habit. Two of my women friends who are nurses encouraged me to "kick the habit." I want to stay better informed about new developments in medicine, i.e. drugs and surgeries. I am facing a difficult decision regarding knee replacement surgery. Since I do not have pain, but tolerable discomfort, I am postponing the surgery until such time as it is unavoidable. I am grateful to CNN for providing medical updates online. Thank you.

    March 10, 2010 at 00:54 | Report abuse | Reply
  11. Janet Knox

    More patients should insist on tried-and-true generic prescriptions; ask your doctor what med.s have been around the longest and which ones are generic. We'll all save some money and avoid the tragic side effects of a new "untested" drug. (We'll also send the pharmaceutical companies an important message.)

    March 10, 2010 at 01:40 | Report abuse | Reply
  12. Warren, Minneapolis

    Efficacy isn't the only consideration. Safety profile is a major factor in choosing alternative medication; i.e. a medication that may not work as well but is significantly safer may be a better alternative to the existing standard. It is also important to remember that effectiveness isn't absolute. Some medications work better for certain people than would be expected from large population data. Allergies are another reason why certain medications may be preferable for particular patients. Having more alternatives is a good thing and setting the high huddle of requiring new treatment to be more effective than existing care sets too narrow a restriction that may suppress beneficial therapy. Later refinement of newer medications could very well make it more effective in the long run. Physicians are astute. Through experience, they develop a great deal of knowledge about different medications that they weigh in choosing appropriate care without necessarily relying on formal research studies. After all, it is no possible to explore every eventuality. Choice is a good thing.

    March 10, 2010 at 01:48 | Report abuse | Reply
  13. joe

    best to not take any and live out a natural life.. the movement is growing.. sorry doc... keep your pills...

    March 10, 2010 at 02:55 | Report abuse | Reply
  14. A. Smith, Oregon

    President Barack Obama said Tuesday he'll bring in high-tech bounty hunters to help root out health care fraud, busting corrupt Doctors, Insurance Agency's and Medical Centers that over-bill, milk their patients for unnecessary treatments and phantom charges.

    I hope President Obama makes it very easy for laypersons to police and detect fraudulent medical doctors that have made millions by fraudulent medical claims which the Insurance industry and American taxpayers ultimately must pay for.

    Bust a fraudulent Doctor and receive a reward for doing so? This is clearly a winner for all law abiding Americans.

    March 10, 2010 at 04:00 | Report abuse | Reply
  15. Michael Sanders

    If Drugs X, Y and Z are developed for the same disorder, sample sizes of trials to study their effects on race, influence of a variety of other therapies, and phenotypical differences in patients would make the research conducted by the pharmaceutical industry nearly impossible to pay for if Obama's desires become reality.

    One of America's best exports, medical and pharmaceutical wisdom, is rapidly being eroded by lawyers in DC.

    March 10, 2010 at 04:14 | Report abuse | Reply
  16. Beverly H Tatum

    I knew already that drug companies were not properly running test trials on new drugs. I take meds for anxiety, depression and I always go the drug company's website and down into the clinical trials to see how many people were in it and how long they tested it.

    It would scare most Americans to death to know how little new drugs are properly tested. 350 patients for 90 days is not a valid trial, especially when it can take 8 weeks for a medication to reach its full potency in a patient.

    Basically, the drug companies are using the public for testing to see what happens. It's wrong and it's dangerous and the FDA should be doing their job.

    When Cymbalta came out my Psych wanted me to try it. Against my better judgment I did and almost had to be hospitalized. I ended up with serotonin syndrome with it and thought I was dying.

    Never again will I take a new drug that has not been on the market at least 5 years. I will not be a guinea pig for the greedy and careless drug companies. If you see a drug advertised on TV with 20 possible side effects, that is the clue it has not been properly tested. A solid drug will only have a handful of side effects and only one or two that most people experience intially.

    Never trust the drug companies. They are after profit and are willing to risk your life as part of a cost/benefit analysis to get something on the market.

    March 10, 2010 at 04:19 | Report abuse | Reply
  17. Sick of it

    At the beginning of what are now extensive health problems I was given Vioxx back in 1999. Within less than an hour I had extensive palpitations and frightening low blood pressure. When I told my doctor of my reaction to the medication his response was "well the drug companies report it as safe and that was never mentioned as a side effect so it probably wasn't related to the Vioxx." He did however go on to prescribe me Celebrex – which had a similar but not so dramatic effect. After reporting that side effect he determined I was a nut case and shooed me off. I was eventually diagnosed with CIDP but not for another 14 months. I do understand the pressure doctors are under, I have several in my family, but in my opinion it's an ethical decision rather than the fact they are too busy to compare new drugs themselves. I know for a fact that some doctors get kick backs from the drug companies they promote – not all – but some do and that certainly tailors their thinking and decision making when it comes to which drug to prescribe. Now when I see a doctor for the first time I ask to meet in his office where I take note of what kinds of junk he has lying around from which drug companies... what kind of samples he has etc. If his first response is to prescribe me one of those pills I head out the door without looking back.

    March 11, 2010 at 05:11 | Report abuse | Reply
  18. Maria H-Miami

    Please stop thinking we’re dumb – So now they tell us that a new system, a new agency, new funding under the health care overhaul by Pres. Obama, $165 million, $286 million is the answer to gathering large amounts of data to be analyzed so that doctors will give us the correct medicine because doctors do little research on their own. What kind of salaries/benefits are we going to pay this new agency staff to do the same thing the FDA is already supposed to be doing?

    How convenient that Avorn fails to mention/address that we also spend $2.3 trillion on medical care because of people's own lack of concern, attention, responsibility to taking care of their bodies. A new agency, health care overhaul is not going to stop people from excessive drinking, drugs, bad eating habits/bad nutrition, lack of exercise, getting infections, smoking, sexually transmitted diseases, stress,etc.. How convenient to blame doctors, especially when we all know that patients are not completely truthful with their doctors nor follow the instructions. It’s not until people begin to take care of their bodies that our health care costs won’t come down.

    March 16, 2010 at 10:40 | Report abuse | Reply
  19. Charlene

    I have read each and every post here and though some are a little "far fetched" I do agree a lot of money could be saved by everyone involved if the physicians treating you would simply prescribe the most effective "medications to their patients." Which in turn saves "everyone" money...

    July 11, 2010 at 22:17 | Report abuse | Reply
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.