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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  • Drug makers and the FDA don't want you to find out about adverse trials

    Byoliveridley

    if you have not been following the Avandia story, an article published in the New England Journal of Medicine revealed that Avandia, a popular drug used in diabetes control significantly increased the threat of heart attacks and heart failure. A couple of things to note here, firstly, this fact was known to the FDA in 2002 per this memo obtained by Public Citizen. So, why the FDA (and GSK) thought that no one would notice, is beyond me. Secondly, when the drug was introduced in Europe, it was contra-indicated for people with heart disease. This fact must have been known to the FDA and GSK as well. It is one thing for GSk to not want to run long term epidemiological and safety studies on their drugs, but other people did the work, and the FDA just stood by and watched until the work was published in the US. The European Drug agency had acted on this information quite a while back.

    So, when I come across this article in the NY Times about a “downside” to full disclosure, I don’t really know what to say. I don’t care whether there is a downside to GSK or not. If I work as a waiter in a restaurant, there is a “downside” to reporting my tip income to the IRS (yes, higher taxes!). This does not mean I should not pay my taxes! This is a matter of life and death for people. Diabetes and heart disease go together in thousands of people, they needed to know if the drug they were taking to control one disease would kill them off with the other disease.

    For Drug Makers, a Downside to Full Disclosure – New York Times

    This week, GlaxoSmithKline learned what that greater disclosure could mean.

    A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

    “It was a treasure trove,” Dr. Nissen said about the Web site.

    GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.

    Also, note this “concern” from the FDA, no less:

    “I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.

    Yes, respond to results in a very prestigious peer reviewed journal by pretending that some dude with a computer in his basement (yes, all computers reside in basements) randomly picked up a couple of clinical trials and created “mass confusion”. The FDA should at least pretend to care…

    The risks and benefits involved with taking a drug to control a chronic condition are completely different from those you would take for an acute, immediately life threatening condition. If you are treating cancer, you expect side effects, and deal with them because the alternative is certain death. When you’re dealing with diabetes, you have alternatives that will not kill you. In addition, millions of people have diabetes and use Avandia. So, a small percentage increase in a side-effect can affect thousands. And, they need to know because there are alternatives that would work for them.

    GSK is not going to tell them because there is an obvious conflict of interest. They need to sell their new and expensive drug even if other alternatives work. This is why we have the FDA, and full disclosure of all clinical trials, not just the ones that worked for you.

  • |

    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.

  • | |

    Indian firms push down global vaccine prices – Lessons for Canada

    Byoliveridley

    Cheaper vaccines from India are forcing global giants to slash prices. GSK announced its rotavirus vaccines at $2.50 per dose — or $5 to fully immunise a child — in response to a current tender administered by UNICEF.The offer is a 67% reduction in the current lowest available public price.

    Hindustan Times

    This is good news for many reasons. Preventable diseases kill over a million people every year, and one of the biggest factors in getting vaccinated is cost. India’s healthcare spending was estimated at US$ 40 billion in 2008, going up to 300+ billion in 2023. Forty billion is less than $40 per person, so saving 7-8 dollars on vaccinations alone for every one of the 26 million children born every year is a huge deal.

    Development costs of vaccines and drugs are high and success is often uncertain. Pharmaceutical companies have used this to justify government enforced monopolies and per dose prices that are sometimes a 1000 times higher than the incremental cost of production. While this makes for good profits, it means severe lack of access in India, many African countries, and many excess deaths that could have been prevented. For years, India had what was called a process patent, not a product patent, which meant that if you could make a drug with a slightly different process, it would not get patent protection any more. How did this help India?

    1. Affordable drugs – Indian companies could make and sell drugs at a fraction of the cost without paying for drug development.

    2. Pharmaceutical Industry – This enabled the industry to grow and mature.

    Of course, this also meant that India was considered an outlaw, and Indian pharmaceutical industry came under great pressure from the WTO to tighten patent laws, which it did. At the time, the concern (rightly) was that tightening patent restrictions would harm India’s pharmaceutical industry and reduce access to drugs. Has this come to pass? In some ways, yes. But the Indian pharmaceutical industry has also matured, and with government help, has been able to do its own development, clinical trials and production (which it was always good at). The focus on tropical diseases like rotavirus also means that US, European Companies, which have since moved away to treating chronic conditions like high cholesterol, erectile dysfunction, etc., have much more competition in the tropical diseases area and cannot charge premium prices to poor people any more.

    So dear Canada, while you are negotiating with Europe about “free trade”, and trying to give European companies much greater patent protection for their drugs, know that this will very surely raise costs in the short term. Two important questions:

    1. Will Canada’s drug companies benefit?

    2. Will Canada’s consumers benefit?

    Um, let’s take a look at Canada’s top 10 in 2009:

     

    Rank Leading Companies Country Market Share (%)
    1 Pfizer US 13.4
    2 Apotex Canada 7
    3 AstraZeneca UK 6.6
    9 Merck US 6
    4 Johnson & Johnson US 5.3
    6 Novopharm (Teva) Israel 4.2
    7 Novartis Switzerland 4
    5 GlaxoSmithKline UK 4
    8 Abbott US 3.9
    10 Roche Switzerland 3.1
    Source: IMS Health

    There is one Canadian company in the top 10, and four European companies. Our pharmaceutical industry is not well positioned to be independent, or work to reduce Canadian drug prices, especially if laws strengthening patent protections for European companies come into effect. This will serve to weaken Apotex, and Canada does not have a big independent pharmaceutical company network born out of years of “isolation” to take advantage of any competition, or competitive advantages. So, while patent “reform” seems to not have hurt Indian industry as much as feared, it sure will hurt Canadian consumers.

     

  • Doctors Take Bribes to Prescribe Drugs

    Byoliveridley

    This is the headline I would have used on this story. An incentive scheme to use a paticular product in a situation like this is a bribe.

    Doctors Reap Millions for Anemia Drugs – New York Times

    Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

    The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

    Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

    So how does this kickback scheme work?

    Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

    Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.

    The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

    Wow, that’s a scheme that would be illegal in almost any situation. I buy 10 widgets from the manufacturer for $100. The manufacturer then gives me $50 in “rebate”. I charge the person on whose behalf I am buying these widgets $200 even though I am not supposed to make a profit on this transaction, and pocket $150 from a transaction. I also promise to use more of this widget, on people who may or may not need it, but on whom I have such a knowledge gap and power gap that I know that they will use it whether it is actually good for them or not. I also promise not to use a competitor product even though I know that there are cases where one product will be better than the other. Well, who pays, all of us in increased health insurance premiums and healthcare costs so a bunch of rich doctors can drive their Range Rovers around.

    The USA is no different from India when it comes to schemes like this. The money involved is greater, and somehow, this is not called a bribe by the media.

    What does the pharma spokesperson have to say?

    Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.

    Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.

    Yes, it’s competitive out there, and to ensure that our product gets used, we will bribe people.

    The “consumer” is the person who pays for the product or service. The “consumer” here is the end user, the patient. The patient does not get the rebate, instead having to pay high prices so doctors can add to their six figure incomes. Nice!

  • | |

    What can the U.S learn from homeopathy?

    Byoliveridley

    Homeopathy was all around me growing up in India, so I read this article with interest as it jogged many memories of visiting the family homeopath with my parents.

    Faith Healing with Homeopathy — In These Times

    Homeopathy rests on three unproven tenets: First, “Like treats like.” Because arsenic causes shortness of breath, for example, homeopaths prescribe its “spirit” to treat diseases such as asthma. Second, the arsenic or other active ingredient is diluted in water and then that dilution is diluted again and so on, dozens of times, guaranteeing—for better and worse—that even if the dose has no therapeutic value, it does no harm. And third, the potion is shaken vigorously so that it retains a “memory” of the allegedly curative ingredient, a spirit-like essence that revives the body’s “vital force.”

    Fooey, the description of the science is hilariously pseudoscientific, but homeopathy is no laughing matter in India. It is estimated to be a Rs. 250 Crore (that is 2.5 billion rupees or about $58 million) industry as of 2002-2003.  I do not think this includes doctors and clinics. This website lists 158 colleges in India offering the  valid (it is like an MD!) degree of Bachelor of Homeopathic Medicine and Surgery, or BHMS. My parents swear by it, most of my family living in India has either visited, or regularly visit one. It is hugely popular for hepatitis and liver disease, more so than conventional medicine in India.

    What’s the deal? Why is it so popular? I think Terry Allen is on the right track, this sentence here, buried in the middle, hits the nail on the head…

    Part of the effect comes from the ritual of consultation with a practitioner who treats the patient like a person rather than a body part on an assembly line.

    Allen does not quite grasp the significance of this sentence and tracks away into placebo effects and evil pharma. But here’s the deal: A lot of Indians (who can afford $4-$5 consultation fee) visit their homeopath every month. When I tagged along with my parents, we would go on a Sunday afternoon at 2 PM to this homeopath’s office, which was a wing of his house (a big house, I might add!). It was a relaxed and leisurely time, he spent 10-15 minutes with each of us (yes, my parents made me!) talking about the previous month, what we were up to, how stressed we’d been, how our ailments from the previous month were doing, had we noticed any changes to our health over the month, etc. We would be interrupted occasionally by his little kid, or his assistant relaying a message from his wife, it was as far removed from a doctor’s visit as possible. And yes, he would take your blood pressure, run simple blood tests, etc. At the end of it, he would give you little sugar pills/sugar coated powder formulations to take home. The formulations were individually dosed, it was all categorized and labeled for you.

    This is like having a mini physical every month. Surely, just the act of talking to someone made you feel better, the act of ritually opening up little packets of “medicine” and following detailed instructions for 5 days helped, surely the homely and relaxing atmosphere of visiting a family friend helped, I don’t know.

    Metrics? both my parents occasionally had their hypertension treated with homeopathy. This worked as long as they were borderline, and simple stress management would get the numbers down. This doctor was/is very good at stress management because he talked calmly, yet firmly, he would listen and tease their little everyday stressors out of them and that was probably good for a 10 point reduction. But I remember the homeopath sending mom off to a doctor for a more conventional treatment regimen as soon as she hit 160.

    It never ever worked for me because I was way too sceptical to buy into the process, so I would not listen, or relax enough to talk. I would take my pills, but it would make absolutely no difference whatsoever. Of course, he was trying to treat me for severe sinus related issues probably brought on by pollution, and by sleepless nights spent on a beach looking for turtles!

    I am sure that for every good homeopath, there were two bad ones who just handed out pills of sugar. But my parents’ homeopath was, and continues to be part Dr. Phil, part candyman, part cheerleader!

    Homeopathy probably “works” because it makes people take the time to think about their life and what’s ailing them. It’s a lesson that American primary care providers could do well to learn.

  • |

    FDA Issues Dietary Supplements Final Rule

    Byoliveridley

    The FDA issues rules that will finally make dietary supplement manufacturers conform to some rules in the manufacturing of the products.

    Which ones?

    1. Accurate potency and labeling – 30 mg glucosamine will now contain something close to 30mg
    2. Impurities Testing – All the raw materials will now be tested for impurities/contaminants. They will probably follow USP guidelines.
    3. Adverse event reporting – Manufacturers/sellers will need to report adverse events. This is after the fact safety testing, wholly inadequate, but better than what we had previously.

    See something missing? Efficacy!! You do not have to prove that your product actually works! Basic safety? What is the overdose level? Interactions with other medicines/supplements? Is your dosing form actually bioavailable? Meaning, if you swallow a pill, will it actually get into your bloodstream and reach the intended target?

    Who knows, but standardizing, cataloging and auditing manufacturing processes is a start, I guess. 1.5 cheers for the FDA!

    I would be curious to find out how these companies are going to get audited by the FDA to prove that they’re following the quality control measures they’re supposed to implement. Guess I have to read the 815 pg bundle of joy that is the actual rule to find out more. A cursory word search on audits suggests that the manufacturers do audits on their suppliers, that the quality control unit of manufacturer perform audits on their manufacturing process, but nothing about the FDA conducting audits. Of course, calling yourself a GMP (good manufacturing processes) manufacturer is usually enough to trigger an FDA audit if you’re in pharma. I wonder how the FDA will deal with this one.

    FDA Issues Dietary Supplements Final Rule

    The U.S. Food and Drug Administration today announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled.

    “This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D. “In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement related adverse events to FDA.”

    The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints.

    “The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Applied Nutrition.

    Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

    The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling.