China Sentences Former Drug Regulator to Death – New York Times
The former head of China’s top food and drug safety agency was sentenced to death today after pleading guilty to corruption and accepting bribes, according to the state-controlled news media.
That’s barbaric, we may have our problems with the FDA, but kill someone for taking a bribe? That’s medieval justice.
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!
The New York Times has an article on the FDA’s competing needs of safety and speed in drug approval.
Potentially Incompatible Goals at F.D.A. – New York Times
Safety and speed are the yin and yang of drug regulation. Patients want immediate access to breakthrough medicines but also want to believe the drugs are safe.
These goals can be incompatible. Race a drug to market and much is likely to remain unknown when patients take it. Test a drug thoroughly to assess all possible risks and its release may be delayed by years.
A series of drug-safety scandals has led many on Capitol Hill to question whether the Food and Drug Administration has failed to strike the right balance between speed and safety. A clear sign of this imbalance, these critics say, is the increasing number of F.D.A. drug-safety officers who say they have been punished or ignored after uncovering dangers of popular medicines.
Safety and speed may be mutually incompatible. The biggest culprit is the Prescription Drug User Fees Act (PDUFA) which stipulated that in exchange for fees paid by pharma to the FDA for speedy approval, pharma would get a say in how that money was used. They used this say to cut down on post approval monitoring, weaken post approval data analysis and generally hide unfavorable results.
Do patients always benefit from speed? Again, you have to make distinctions between acute life threatening conditions and chronic, life management conditions. A delay in the approval of a cancer drug may result in the immediate death of the people affected with the cancer. But, a serious safety issue overlooked in this hasty approval would not hurt a healthy person. Yes, it would affect the cancer patient, but they would accept that risk. Something like Vioxx, or Avandia, on the other hand is a drug potentially consumed by millions of people to treat chronic conditions that can be managed in other ways. Since safety issues affecting these drugs could adversely affect otherwise healthy people, the approval process needs to be much more deliberate, involving more patients, and has to include lengthy post-approval monitoring, adverse event reporting, the availability of all data for meta-analysis, etc.
So why does this not happen? Because pharma makes much more money on that blockbuster “lifestyle” drugs taken by millions of otherwise healthy people. The pool of healthy people is much bigger than the pool of cancer victims. It is in their best interest to get a speedy approval.
The answer I guess is to make a clear distinction between these two different types of drugs and have completely different standards, somehow, I don’t think that will happen.
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:
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.
Legal wrangle puts India’s generic drugs at risk – health – 29 January 2007 – New Scientist
Tens of thousands of people being treated for AIDS will suffer if Swiss pharmaceutical company Novartis succeeds in changing India’s patent law, the humanitarian agency Medecins Sans Frontieres warned on Monday. Novartis is challenging a specific provision of India’s patent law that, if overturned, would see patents being granted far more widely, heavily restricting the availability of affordable generic medicines, MSF says.
In 2000, antiretroviral (ARV) treatment cost was estimated at $10,000 per patient annually. But the availability of generic drugs produced mainly in India, allowed costs to plummet to about $70 per patient per year, Mwangi adds.
You’ve got to love the friendly multinational arguing to make extra billions while people die. But I don’t think any Indian judge will overthrow Indian patent law. And there is a national interest exemption built into most patent statutes, per the TRIPs agreements.
Interesting news coming out of Canada from a Dr. Anselm at the University of Alberta about a well known chemical dichloroacetic acid (like vinegar with two chlorines!).
Cheap, safe drug kills most cancers – health – 17 January 2007 – New Scientist
It sounds almost too good to be true: a cheap and simple drug that kills almost all cancers by switching off their “immortality”. The drug, dichloroacetate (DCA), has already been used for years to treat rare metabolic disorders and so is known to be relatively safe.
It also has no patent, meaning it could be manufactured for a fraction of the cost of newly developed drugs.
Here’s the PubMed citation for the article, filled with biology I will have no hope of understanding! I read the press release on sciencedaily a few days back and did a little background digging.
A clinical trial conducted by Colombia University studying the effects of dichloroacetate on MELAs (stroke like symptoms) was halted early because everyone taking the medication showed significant effects of neural toxicity. This study was commented on by Dr. Anselm who theorized that the effect could be caused by a specific gene mutation not seen in a lot of the patients he works with.
So, there is some reason for caution on this wonder drug, it may be toxic at certain doses to certain people. Most chemotherapetic drugs are horrendously toxic too. But if this is not a concern, Dr Anselm, meet Sunil Shaunak and his wonderful proposal to setup an alternative pipeline for drug approval that does not involve big/small pharma. I Am sure between Bill Gates, or George Soros, a few million bucks can be rustled up for a cancer cure.
Would have been my headline. Apparently, the New York Times byline writer was more concerned about a multi billion dollar company losing a small amount of money than the fact that a different ruling in this case would have made life saving drugs unaffordable for millions of people. When did American newspapers become shills for the elite?
Setback for Novartis in India Over Drug Patent – New York Times
Indian companies will be free to continue making less expensive generic drugs, much of which flow to the developing world, after a court rejected a challenge to the patent law on Monday.
Aid organizations declared the ruling a victory for the “rights of patients over patents,” but the Swiss drug company Novartis, which filed the case, warned that the ruling would discourage investments in innovation and would undermine drug companies’ efforts to improve their products.
At issue is the degree of innovation required for a drug to be regarded as truly “new”, where there is a significant enough chance for failure that the company would never develop it unless afforded monopoly rights for 10 years. A very well known tactic by drug companies is to make a slightly different formulation of an existing drug, say an extended release form of a drug which takes a little longer to dissolve, and hence is available to the body at a different time. Under US patent law, this qualifies for full patent protection on the extended release form. By now, the science of making an extended release tablet is well known, it’s just a question of formulating the drug with a different set of inactive ingredients that take longer to dissolve, or sometimes, through a differently engineered tablet. The chemistry of this change is predictable, published and not really innovative. Why should these small changes have patent protection?
Bonus Note: Madras is my home city, so I’m glad it was decided there!