When the Government Does What Drug-Makers Won’t Do

Today, Bloomberg News reported that “Deadly Staph Germs May Be Cured by Old, $1-a-Day Antibiotics.” It turns out that generic, World War II-era antibiotics are becoming “the newest weapon of choice in the fight against deadly, drug-resistant staph germs.”

Physicians have discovered that drugs costing less than $1 a day can be very effective when treating methicillin-resistant Staphylococcus aureus, known as MRSA. The bacteria, once found only in hospitals and nursing homes, recently made news by showing up in schools and gyms. Last month, MRSA was linked to the deaths of a student in New York and one in Virginia.  Annually, more than 18,000 Americans are killed by MRSA.

The physicians who mounted the studies of the older drugs were funded by the federal government. Meanwhile, in the for-profit private sector, Bloomberg observes, “drug-makers are spending hundreds of millions developing medicines that cost more than $100 a day to treat advanced cases.”

But physicians know the older, cheaper drugs work. “We have used these
older drugs with success for years,” says Gregory Moran, one of the
study leaders. He is a professor of emergency medicine at the Olive
View-UCLA Medical Center in Sylmar, California, affiliated with the
University of California at Los Angeles.

The advantage of the older generics, Moran explains, is that bacteria
haven’t developed broad resistance to them. Thus, the medicines can
forestall complications that would require more expensive drugs, such
as Wyeth’s Tygacil, an antibiotic that won FDA approval in 2005 and
costs about $100 a day. A typical daily dose of Pfizer Inc.’s Zyvox, a
synthetic antibiotic used to treat MRSA, is two $60 pills, taken for a
duration of 10 to 14 days.

“We know the generics kill bacteria in a petri dish, and we know they
work in people,” Moran adds. “They are already in wide use. What we
don’t have for them are clinical trials.”

But now, thanks to federal funding, formal trials of the older drugs
will start next year, In August, the National Institutes of Health
awarded $19 million to a research group led by Moran at UCLA and to
another led by Dr. Henry Chambers III at the University of California
at San Francisco. They aim to show that two families of older
antibiotics—sulfa drugs, in use since the 1930s, and clindamycin, first
prescribed in the late 1970s –should win Food and Drug Administration
approval for MRSA.

Moran reports that the five-year trials will each include at least
1,200 emergency-room patients with skin or soft tissue infections. The
trials will confirm the effectiveness of what doctors who now use the
drugs are doing, and perhaps change behavior by encouraging other
physicians to use the less expensive generics.

The NIH provided the funding because it realizes that there is a “gap
in the current knowledge” about the older drugs and that “government
needs to step in when market conditions may discourage drug companies from filling in,” says Moran.[my emphasis]

According to Bloomberg, Dr. Anthony Fauci, director of the U.S.
National Institute of Allergy and Infectious Diseases, a division of
the NIH, confirms that the grants are intended to fill a vacuum left by
pharmaceutical companies. Drugmakers, he says, don’t have an economic
incentive to study drugs with expired patents or to develop antibiotics
that have limited market potential.

Fauci emphasizes that the older drugs “are a temporary stopgap.”
Sooner or later, “the microbes will develop a resistance to them, and
at the end of the day we’ll need permanent solutions.”

For-profit drug-makers are looking for those more permanent (and no
doubt expensive) solutions. In the meantime, the government is doing
what needs to be done to save lives—once again highlighting the
difference between the NIH and the private sector.

Drug-makers exist to generate earnings for their shareholders.
Legally, this is a publicly-traded corporation’s first responsibility.
Public health needs are a secondary concern. If what the public needs
isn’t profitable, pharmaceutical companies usually won’t work on it.
For government-run health agencies, by contrast, improving the health
of the public is a first priority.

16 thoughts on “When the Government Does What Drug-Makers Won’t Do

  1. Maybe we should thank the drug companies for driving down use of older drugs before resistance develops 🙂

  2. There is clearly a need for more of this type of research in the public sector. This became very apparent when the federal goverment funded a study a few years back comparing various anti-hypertensive medications that showed a very inexpensive diuretic that costs pennies was most efective at lowering blood pressure. Now we find that it is the older and less expensive antibiotics that are most effective against MRSA. With a larger and larger segment of original research being funded by pharmaceutical companies, we are not getting the comparitive studies that look at these new, more expensive medications in comparison to their cheaper alternatives. After all, who stands to gain from such studies economiclly? Possibly the health insurance industry which might save significnt amount of money by encouraging the use of cheaper medictions, but there seems to be little interest in the United Health Cares of the world to get involved in this arena. It falls to public health agencies and goverment to fund such studies to counterblance the outpouring of big paharma research designed and possibly mnipulated to push sales of high cost drugs.

  3. “there seems to be little interest in the United Health Cares of the world to get involved in this arena.”
    I think the insurance industry would love to save the money if far cheaper older drugs work just as well. However, they fear (probably correctly) that there would be a widespread perception among the public that the insurers are just trying to save money by steering people to the cheapest medicines and not the best. This is the same perception that they face today with their efforts to identify the most cost-effective doctors and hospitals and then create incentives (like tiered copays) for insureds to use them.

  4. Barry and Keith–
    Thanks for your comments–
    Keith, You write: “with a larger and larger segment of original research being funded by pharmaceutical companies, we are not getting the comparitive studies that look at these new, more expensive medications in comparison to their cheaper alternatives. After all, who stands to gain from such studies economiclly?”
    I think you are absolutely right. Also, a large percentage of studies done by academic studies are financied by for-profit drug-makers, and as a result, tend to avoid the head-to-head comparisons that we need.
    Barry– Yes, the insurers could save money on less expensive medications–but they don’t need to. They can always just raise premiums instead.
    As long as the for-profit insurance industry and the for-profit drug industry are completely unregulated, drug-makers will charge more for their products, and insurers will just hike premiums to accomodate them.
    When insuers tried to save money, in the 1990s, they were as you suggest, attacked. They are widely distrusted and just don’t have the moral or political standing to cut the waste from your health care system. Doctors are in a better position to do that–by refusing to prescribe the more expensive medication.

  5. Barry and Keith–
    Thanks for your comments–
    Keith, You write: “with a larger and larger segment of original research being funded by pharmaceutical companies, we are not getting the comparitive studies that look at these new, more expensive medications in comparison to their cheaper alternatives. After all, who stands to gain from such studies economiclly?”
    I think you are absolutely right. Also, a large percentage of studies done by academic studies are financied by for-profit drug-makers, and as a result, tend to avoid the head-to-head comparisons that we need.
    Barry– Yes, the insurers could save money on less expensive medications–but they don’t need to. They can always just raise premiums instead.
    As long as the for-profit insurance industry and the for-profit drug industry are completely unregulated, drug-makers will charge more for their products, and insurers will just hike premiums to accomodate them.
    When insuers tried to save money, in the 1990s, they were as you suggest, attacked. They are widely distrusted and just don’t have the moral or political standing to cut the waste from your health care system. Doctors are in a better position to do that–by refusing to prescribe the more expensive medication.

  6. Maggie,
    I think you’re wrong on this one. Insurers get plenty of push back from employers as premiums continue to rise faster than general inflation. Many employers mitigate the proposed rate increases through benefit buydowns which include raising deductibles and/or copays and, perhaps, narrowing the scope of coverage. Employers are also asking employees to contribute more toward the premium. Smaller companies (less than 200 employees) are increasingly dropping health insurance altogether as it becomes unaffordable for them. Insurers are well aware of all this and recognize that unless they can drive medical cost growth (and premium growth) down to a level more in line with nominal dollar GDP growth, their business model is not sustainable on a long term basis. So, as a practical matter, they can’t just raise premiums without adverse consequences. It is in their interest to find as many ways as possible to safely drive down utilization of healthcare services in order to slow the increase in the cost of insurance.
    For doctors, there is no effect on their own income if they prescribe a brand name drug instead of a generic. They bear no penalty for prescribing the brand and reap no benefit if they prescribe the generic. That is, unless insurers start to track their overall utilization – referrals, prescriptions, tests ordered, hospital admissions, etc. in order to determine whether or not the doc will earn the insurers premium designation which could result in bonus payments and more patients as insurers encourage consumers to use the premium providers through lower deductibles and copays.

  7. Barry:
    I think that the real answer is that there are insurers, and there are insurers . . .
    Depending on the market, and the amount of clout the insurer has, some are much more sensitive to push-back by employers than others. It also depends on the size of the employer.
    But The Wall Street Journal has published a couple of good stories on how some (though no doubt you are right, not all) insurers are simply passing higher costs along, in the form of higher premiums, without fighting them.
    You are right that “Insurers recognize that unless they can drive medical cost growth (and premium growth) down to a level more in line with nominal dollar GDP growth, their business model is not sustainable on a long term basis.” But Wall Street doeso not reward CEOs who fret about the long term. Short term earnings growth is the name of the game.
    As for doctors, you are right that they suffer no financial penalty if they prescribe the more expensive brand, but as I patient I notice, and complain.
    This is the sort of thing that undermines my trust in a doctor and causes me to change doctors (which I recently did in the case of a dermatologist.)
    My pharmacist is also up to date on whether a generic is available and sometimes volunteers the information.

  8. Tamoxifen is a drug that’s gone generic and has been replaced by other patented drugs for preventing re-occurrences of breast cancer.
    Recent genetic test advances allow women who will respond poorly to tamoxifen be identified. For women with the right genetic profile tamoxifen may be several times more powerful than AI drugs.
    Oddly, it mostly seems to be Italian researchers who are looking into this, at least initially. Perhaps they have more motivation to squeeze more utility out of less expensive drugs?

  9. Ginger B–
    You have a good point– I suspect you are right that Italian researchers “have more motivation to squeeze more utility out of less expensive drugs.”
    In Italy, everyone realizes that they are paying for everyone else’s health care. (We are too, but we operate under an illusion that we’re each rowing our own boat.)
    In Italy health care really isn’t seen as a business; it’s a social service that taxpayers fund.

  10. Ginger B–
    You have a good point– I suspect you are right that Italian researchers “have more motivation to squeeze more utility out of less expensive drugs.”
    In Italy, everyone realizes that they are paying for everyone else’s health care. (We are too, but we operate under an illusion that we’re each rowing our own boat.)
    In Italy health care really isn’t seen as a business; it’s a social service that taxpayers fund.

  11. I haven’t seen the detailed reports on these proposals, but, even from what you post, the pure medical aspects may be more complex than they look. Let me put aside cost as the primary cost consideration, and deal with other aspects.
    Remember my list of “13 deadly sins” for which there might be no reimbursement? One of them was Clostridium difficile infection. Clindamycin is the drug that is probably most associated with suppressing normal intestinal bacteria, and allowing the Cl. difficile to overgrow. Cl. difficile itself is getting more virulent and more resistant; when I had an intestinal bleed last year, probably due to an infection, I discussed that organism with the gastroenterologist — and he said it’s really making him scared, because it’s more and more lethal.
    The warning sign of Cl. difficile is usually violent diarrhea developing during oral antibiotic therapy. If you get it early, oral metronidazole — far cheaper than the other alternative, oral vancomycin — will often stop it. On an outpatient basis, a patient may not report diarrhea as quickly as seen in a hospital, and phone calls or doctors’ office visits may eat up critical time before getting a prescription — and then someone may need a bathroom in their car.
    One alternative would be to give metronidazole along with clindamycin, but that may get us more metronidazole-resistant strains. It may be that patients with MRSA belong in a hospital, for an assortment of reasons from isolation to early recognition of Cl. difficile. Of course, that would raise costs.
    MRSA isn’t as bad as staph gets; the really scary form is VRSA, which is also resistant to vancomycin. We have some new drugs that will still hit VRSA, but this entire issue has a lot more ramifications than antibiotic cost.

  12. To Ginger as followup,
    Something very right seems to have been happening with Italian cancer research, some with US funding and some not. I remember Italian researchers publishing the first low-dose adjuvant chemotherapy protocol (CMF), to be used after breast cancer surgery to give a better chance of getting rid of cells that had not been removed; it’s one of those what-ifs in my mother’s case, who had her surgery several months before CMF was published.
    Of non-US programs, other than for specific medical research, I’ve tended to look most at Germany for its financing system. Italy may be something to look at again.
    The Italians have a cultural issue, which may or may not have changed, where there is an interesting collision between generally accepted standards of informed consent, and the way many Italians deal with cancer. According to what seemed a very sincere letter in a bioethics journal, in Italy, it is not customary to tell a patient he or she has cancer. Instead, very strong family support is assumed, and the diagnosis and treatment questions are addressed to the head of the family.
    According to the Italian oncologists, their culture is such that if a doctor told a patient that he had cancer, he would interpret that as a warning to prepare for death, even though the condition was quite treatable. Other cultures have problems, as well, with the disclosure associated with informed consent. The informed consent rules come from the Helsinki Declaration and other responses to the Nazi “experiments”, but what if they are not culturally appropriate for all people? No simple answer.
    An even more difficult question, incidentally, comes up with respect to the Nazi experiments. There’s little question that most should be called murder, but most also were poorly designed and produced meaningless results even for their ideological or sadistic purposes.
    The one exception is their murderous experiments with hypothermia. There is a continuing debate: these appear to be scientifically valid, although their collection was totally unethical. Should they be used, with appropriate disclaimers, as background to ethical experiments in this area, and the design of protective gear? Would using those data make some of the deaths more meaningful, or is it more ethical not to use those data even though they might now save people?
    I freely admit I don’t know.

  13. Howard–
    What you say about Italian oncology and the cultural issues is very interesting.
    Thanks for the comment-
    Maggie

    • A-MEN.I consider meylsf educated above-average in the politics behind health care reform. My husband has a masters in Health Administration. We both agree with most of Obama’s plan.One thing people are forgetting: We should be able to disagree without being disrespectful. There IS such thing as a healthy debate. There should be a new rule in Washington: Don’t complain without offering a solution. Oh, and it goes without saying that LIES are NOT OK.I’m not put off about people having opposing views. It’s the complete lack of respect for the President of the United States that bothers me the most. It’s sending a message to our kids that they only need to respect authority when they agree with them. Apply that to your own homes and see if that makes sense.I don’t agree with my curfew mom, so I’m not going to listen to you.

      • Carlota–

        Thank you for commenting.

        I agree; people in Washington who don’t like Obamacare should offer a better
        way to make high quality health care affordable for nearly everyone while containing costs.
        (Obamacare does contain many provisions that should contain costs–some definitely will.
        We need to implement it, see which ones work, and do more of the same.

        Finally, the outright lies have muddied the conversation and confused many Americans