Abbott Drops AIDS Drug Price in response to Thailand's hardball.

Byoliveridley

Moral of the story, you have to play hardball with the drug companies. Use your power as a sovereign country. You are a market to them, their threats to stop selling their drugs in your country cannot be taken seriously because if the drug is made unavailable in your country, that gives you even more right to make it yourself (or better, buy it from India!). I mean what are they going to do, invade you? The worst you will get is a scolding and lecture from the U.S ambassdor on patents and free trade, just ignore it, or better still, protest outside the embassy!

Chemical & Engineering News: Latest News – Abbott Drops AIDS Drug Price

Abbott Drops AIDS Drug Price, move follows compulsory licensing decision by Thailand

Jean-François Tremblay

Abbott Laboratories will drop its price for Kaletra, a protease inhibitor used to treat AIDS, to the equivalent of $1,000 per patient per year in 40 developing countries.

The move, facilitated by the World Health Organization, is apparently Abbott’s response to a decision by Thailand earlier this year to resort to compulsory licensing of Kaletra, a practice that reduces health care costs in a way that pharmaceutical companies view as patent infringement (C&EN, Feb. 5, page 11).

Following Thailand’s decision, Abbott announced that it would stop selling Kaletra and other patented drugs in Thailand, a move that the nongovernmental organization Doctors Without Borders called “a major betrayal of patients.”Abbott had already been under fire for not supplying Kaletra to several other low-income countries.

The price of $1,000 per year per patient, Abbott says, is 55% less than the average price at which the drug is now sold in the 40 countries. The company says it wants to increase drug affordability while “preserving the system that enables the discovery of new medicines.

Compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies (AIDs is a national emergency, isn’t it?). More importantly, governments in poorer countries really should invoke this provision as much as they can. Because every time they invoke it, they make big pharma come to the bargaining table.

$1000 per patient per year is still a lot of money, though, I would encourage Thailand to play even more hardball!

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    Sugar Pills, now more effective!

    Byoliveridley

    Well, all sugar is not bad for you. Apparently, when given to you in pill form by someone wearing a white coat with a pleasant demeanour, it can cure all kinds of ills.

    It’s not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

    Via Wired

    An interesting article that takes the reader through a recent history of placebos, why they seem to work better now than they used to, and tangentially, why the competitive research paradigm of the pharmaceutical industry delayed recognition, and continues to delay possible fixes and therapies.

    A few things about the placebo effect:

    1. There appears to be a physiological and neurological basis to the effect, something that can actually be turned off by deactivating the body’s natural production of opioids.
    2. This effect is triggered by various patient stimuli, including exposure to advertising, faith in the medicine, doctor bedside manner, etc. It appears that for minor ailments, these effects could be as strong as the medication prescribed.
    3. It is not short lived, the effects can linger well after consumption of sugar pills.
    4. Despite all this, the article states that we are no closer to finding the most appropriate way to administer placebos (Hmm, or are we? Read on!).

    Pharmaceutical companies conduct hundreds of clinical trials every year. They are not required to publish them in most countries, so negative results, failures, etc. which reflect badly on the company’s stock price are routinely hushed up. This means that the mounds of data that show tested drugs as no better than placebo are not accessible for research. This is one of the greatest drawbacks of competitive research paradigms, the lack of cooperation, the inefficiency that comes from duplication of negative results, and the lack of statistical power that comes from inability to use all the data available. In a milieu where knowledge = stock price, this is the logical approach, but something to note next time an Ayn Rand acolyte comes bleating to you about the beauty and perfection of the market. You might ask “What are some options to the current patent exclusivity driven regime”? My favourite economist Dean Baker of the Center for Economics and Policy Research has written extensively about the drug development process and alternatives in his excellent (and free to download) book The Conservative Nanny State, I suggest reading at least the chapter on drug development and patents!

    Anyway, back to placebos, what to do? How to administer sugar pills in a quasi-official setting for minor ailments. It’s almost like you need a parallel paradigm of medicine that dispenses sugar pills that did not have to go through double blind randomised clinical trials. it would help if this paradigm uses vaguely scientific terminology while doing very little harm. It would work in conjunction with the conventional approach, not in competition so there is little danger of people taking sugar pills for malaria!

    I give you, Homeopathy!!! This blog(ger) is no stranger to this wonderful form of medicine, involving concepts such as the memory of water, similars, dilution, etc. When I wrote about homeopathy last year, it was more in relation to the psychological aspects of my experience with it. I (and I assume you did not click through to read!) wrote about my parents’ great and enduring relationship with their homeopath, and the benefits it brought them. Back in India this time around, it was suggested that I take some homeopathy for a cold I was developing, which I did (yum, sugar!). The cold went away in a few days 🙂 There was some swine flu medicine being passed around as well (I did not partake), which worked too, nobody at home got swine flu 🙂

    So, how to make it work? It already works in India because belief in the efficacy of homeopathy is well established. As long as the homeopath is well qualified in basic diagnosis, and crucially, knows when to punt the patient into conventional therapy, the system works to a certain extent. But what about a society with no such foundation? Do you go to a clinic with both an allopath and a homeopath, and if your ailment is one where placebo works about as well, let the homeopath make some well diluted similars for you to consume? How to settle turf wars? Would it be better for the allopath to feign develop an expertise in homeopathy and make that work for her in treating the patient? Would they apply the most important lessons in homeopathic treatment, Listen, Empathise, Soothe?

    I don’t know. It is not my nature to believe in sugar pills, faith, or advertising. So it is hard for me to say what would work. But given that sugar pills work well, it is vital for society to find a way.

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    Weight Loss drug linked to suicide and anxiety?

    Byoliveridley

    Bloomberg.com: Worldwide

    Sanofi-Aventis SA’s weight-loss pill may raise the risk of suicide and suicidal thoughts, U.S. regulators said in documents that may help an expert panel decide whether the three-time delayed drug should be approved.

    The FDA noted two suicides in clinical trials of volunteers testing the drug. The panel will be asked to discuss whether it can establish a causal link between the medicine and suicidal thoughts or actions.

    Some patients who took part in clinical trials of Acomplia suffered from mood swings, anxiety and depression. Trial volunteers given the highest dose lost an average 5.3 kilograms (11.7 pounds) over a one-year period compared with a weight loss of 1.4 kilograms (3.1 pounds) among patients given a control pill. Acomplia significantly lowered the level of HbA1c, a measure of blood sugar, to within a safe range.

    So, here’s the classic case for the FDA, as discussed earlier today! Accomplia is a drug designed for weight loss, what I would call a “life management” drug. In clinical trials, which are strictly controlled, and where patients/volunteers are selected and carefully monitored, it seems to increase the incidence of suicidal thoughts, increase anxiety, mood swings and depression. The drug acts by blocking certain receptors in the brain, which should hint at other unforseen effects on the brain. The FDA has been more cautious on this drug than the European regulators, who have approved this drug.

    What would I do if I were the FDA? I would wait 2-3 years for post approval studies in Europe to catch any mental health effects. After all, out in the real world, people take drugs imperfectly. The ones who should not qualify take it any way, doctors over-prescribe to patients who would hardly need the drug, things just don’t work as well. So, the best thing for the FDA to do is, nothing! In fact, the FDA is expected to punt the decision to 2010, good job!

    Let’s put the benefits of this drug in perspective, all it did was make people lose 10 pounds more than placebo over the course of a year. This is the functional equivalent of eating 100 calories less per day for the period. Is that worth taking a pill everyday to keep that weight off and risking depression, anxiety and suicide?

  • Biologic Generics Closer to Market

    Byoliveridley

    Congress Seeks Compromise on Generic Drugs – New York Times

    Biotech drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion. Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original. Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.

    It is a complex issue, and clearly, proteins and large molecules that would not be synthesized, but “grown” are subject to larger batch by batch variation, especially when the generic company does not have access to the top-secret proprietary information that genentech, or J&J used to grow their molecule. So, some level of judgment is going to be required on the part of the FDA, which has the information from both the original, and the generic manufacturers. It looks like the FDA needs to, and is prepared to deal with each generic on a case by case basis, which is how it should be.

    Protein characterization and analysis have come a long way in the last 10 years, with your fancy mass spectrometers and proteomics. It is a lot easier now to compare proteins with each other, to look for changes and differences. Mass spectrometric technology, improved electronics and huge increases in data processing and computing power make protein characterization increasingly routine. It would be up to the FDA to decide at what level of change would a protein behave so differently that its effect on humans could change significantly from the original drug, but they seem to be ready to do it.

    “Some level of clinical testing should be required in all cases,” said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech. Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: “I would never take a biologic that had not been tested in humans. The risks are too high.”

    Yes, I would absolutely trust the word of the people who had the most to lose in this case, no conflict of interest here! To be fair, Dr. Siegel is understandably cautious. We have enough problems even with small molecules (think Vioxx!). But as I mentioned previously, it should be possible to come up with good enough metrics to decide when/where human re-testing is appropriate, instead of doing it always.

    But Dr. Woodcock (of the FDA – inserted for context) said: “Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.”

    People tend to forget that we’re experimenting on humans here, thanks Dr. Woodcock! Note that this is an issue where the established biologicals companies can use the safety card with impunity to protect their enormous profits. But they are not the ones who get to decide, it’s the FDA, and ultimately, Congress.

    The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.

    Oh really, how many times has this argument been raised, and proven to be false (see plutocracy-protectionary principle!). To believe this argument, we would have to believe that the 1984 generics law completely killed the small molecule industry. Not really, Glaxo, Pfizer, etc are still bigger and badder than ever.

    Assuming a multiple sclerosis treatment costs $20,000 a year (from the article). If generics come in and there’s a 10% (low end) decline in price for the treatment, the amount saved is $2000 per patient. MS is estimated to have a prevalence rate of 0.1% in North America. So, that makes 0.3 million in the US. If half of them are on this treatment (random fudge factor), you (or your insurer) will save $300 million on one disease treatment option per year (and the biologics manufacturers will lose some portion of that). This is pretty big money, no wonder they’re throwing up roadblocks!

  • FDA to add warnings on Anemia Drugs

    Byoliveridley

    Oncologists are being bribed to over-prescribe these drugs, which seem to cause more harm than good when over-prescribed. The FDA is going to add a “warning” label. Let’s see what it does.

    FDA panel urges curbs on 2 anemia drugs – The Boston Globe

    Best-selling anemia drugs from Amgen Inc. and Johnson & Johnson should have their use restricted because of dangerous side effects, a US advisory panel said. Amgen shares fell the most in five years.

    The panel of expert advisers to the Food and Drug Administration voted 15-2 in favor of new prescribing restrictions and 17-0 for new clinical trials during a meeting yesterday in Silver Spring, Md.

    Shares of Amgen fell $5.77, or 9.1 percent, to $57.33 in Nasdaq Stock Market composite trading. J&J shares fell $1.61, or 2.5 percent, to $62.50 on the New York Stock Exchange.

    The drugs raised the risk of heart attacks, strokes, and death when used at high doses, studies released in the last six months showed. An FDA warning in March prompted the US health program for the elderly and disabled to stop paying for treatments in certain patients, and doctors cut back on use. The products accounted for $6.6 billion, or 47 percent, of Amgen revenue in 2006.

    “Many of us are concerned on the committee and have a lot of questions,” said Gail Eckhardt, an oncologist at the University of Colorado in Aurora, and the advisory panel’s chairwoman.

    The questions concerned the design of trials, why regulators have limited access to results from company studies, and why the drugs have been marketed for improving quality of life if there isn’t sufficient evidence for the claim, Eckhardt said.

    The FDA usually follows the recommendations of its advisory panels, although it isn’t required to do so.

  • |

    Snake Oil Comes a Full Circle

    Byoliveridley

    Ah, back to the good old days of snake oil..

    ScienceDaily: Snake Venom As Therapeutic Treatment Of Cancer?

    This certainly sounds unusual, but Dr. Son and colleagues report on the effectiveness of the snake venom toxin (SVT) Vipera lebetina turanica in the inhibition of androgen-independent prostate cancer (AICAP) in the journal Molecular Cancer Therapeutics.

    These novel findings suggest that SVT can inhibit the growth of AICAP through the induction of cell death.

    I am glad they put the question mark at the end, lest people extrapolate from a few cells in a petri dish (or a small animal study) to a cancer cure, as happened recently with dichloroacetate! Health reporting is very tricky because the average reader cannot understand much more than the headline. It almost seems like every health article should have the following things clearly labeled:

    1. Human, animal or cell?
    2. Clinically tested, or anecdotal?
    3. Double blinded, controlled, etc, or not?
    4. Any chance that this result applies to people?
    5. How far away are we from a real cure?
    6. DO NOT TRY THIS AT HOME!

    At least viper venom is hard to find! The Madras crocodile bank helped start a venom extraction cooperative run by the Irula Tribe, so I’ve seen viper venom being extracted, pretty cool. India is home to two vipers, the Russell’s and the Saw Scaled vipers.

    Russell's
    Russell’s viper

    saw scaled
    Saw scaled viper.

    The Russell’s is 3-5 feet long, and slow, but a big hisser! The saw scaled viper is tiny, a feet or two, but aggressive and very venomous. One of my favorite wild snake sightings was a saw scaled viper, looked very innocuous curled up in a parking lot in Pondicherry.

    Cool, snake oil and venom for all…

  • |

    Brazil successfully hardballs Abbott on AIDs drug

    Byoliveridley

    I mentioned in May that Brazil had introduced compulsory licensing on a Merck AIDs drug Efavirenz, and heartily recommended that Brazil and other third world countries continue to play hardball with big pharma whenever they could. It looks like Merck decided to not bargain, but Abbott did on Kaletra. Note that Abbott got into a similar controversy with Thailand, and agreed to drop the price when Thailand rejected the Kaletra patent.

    Keep it coming, third world countries. Bargaining is perfectly acceptable in the marketplace!

    Brazil says Abbott to cut price of AIDS drug | Health | Reuters

    razil’s health ministry said Wednesday that Abbott Laboratories Inc. agreed to cut the price of its Kaletra AIDS drug by 29.5 percent.

    The lower price for the drug, also known as lopinavir and ritonavir, will help Brazil supply free drugs for its AIDS treatment program.

    In May, President Luiz Inacio Lula da Silva authorized Brazil for the first time to break the patent on an AIDS drug, one made by Merck & Co.. It then started importing a generic version of the drug Efavirenz from India.

    Under WTO rules, countries can issue a “compulsory license” to manufacture or buy generic versions of patented drugs deemed critical to public health.

    Drug makers often reduce prices to keep countries as clients and avoid compulsory licenses.