Pharma

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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.

 

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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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Chip Implants Linked to Animal Tumors

Byoliveridley

Thinking about implanting an RFID microchip under your skin? Don’t do it! Why would the FDA approve something that was linked to cancers in rats?

Chip Implants Linked to Animal Tumors – washingtonpost.com:

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients’ medical records almost instantly. The FDA found ‘reasonable assurance’ the device was safe, and a sub-agency even called it one of 2005’s top ‘innovative technologies.’

But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had ‘induced’ malignant tumors in some lab mice and rats.

‘The transponders were the cause of the tumors,’ said Keith Johnson, a retired toxicologic pathologist, explaining in a phone interview the findings of a 1996 study he led at the Dow Chemical Co. in Midland, Mich.

Leading cancer specialists reviewed the research for The Associated Press and, while cautioning that animal test results do not necessarily apply to humans, said the findings troubled them. Some said they would not allow family members to receive implants, and all urged further research before the glass-encased transponders are widely implanted in people.

To date, about 2,000 of the so-called radio frequency identification, or RFID, devices have been implanted in humans worldwide, according to VeriChip Corp. The company, which sees a target market of 45 million Americans for its medical monitoring chips, insists the devices are safe, as does its parent company, Applied Digital Solutions, of Delray Beach, Fla.

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India Rejects Obvious Patents

Byoliveridley

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!

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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.

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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.

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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?

Potentially Incompatible Goals at F.D.A. – New York Times

Byoliveridley

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.

Brazil offers AIDs drug factory to Mozambique

Byoliveridley

Brazil is positioning itself as a major manufacturer of generics, and offering to build this factory is a very good move because it will provide AIDs treatment options for Mozambique at affordable prices (well, better prices than the pharma giants would provide, at any rate). Is there expertise available in Mozambique to staff this factory and run it at the level of quality a pharmaceutical production facility needs? I don’t know the answer, but I sure hope so. Alternatively, is there any plan for Brazil to train and equip the personnel as well? It is good news, at any rate.
Brazil offers drug factory to AIDS-ravaged Mozambique – Yahoo News

Brazil has offered to build a $23 million pharmaceutical plant in Mozambique that will provide drugs to treat HIV/AIDS, malaria and other diseases, Mozambique’s national newspaper said on Tuesday.

Brazil, a leading pharmaceutical manufacturer, will monitor quality and transfer technology to the proposed plant, which would produce a range of drugs, including generic antiretroviral drugs (ARVs) to fight HIV/AIDS, Noticias reported.

The plan was presented to the Mozambique government by Brazil’s ambassador in the southern African nation.

Mozambique, one of the poorest nations on the continent, is struggling to find the money to rebuild its dilapidated health-care system, which was neglected during a 17-year civil war that ended in 1992.

The former Portuguese colony has been hard hit by the AIDS epidemic, with an estimated 1.6 million of its 18 million people infected with HIV. Only a fraction of those requiring ARVs are on treatment, with most of the drugs imported from India.

The offer to build the pharmaceutical plant was first raised by Brazilian President Luiz Inacio Lula da Silva during his 2004 official visit to Mozambique. Lula said he wanted drugs from the plant to be available to other African nations as well.

Brazil claims the use of generic anti-retrovirals has cut its AIDS mortality rate in half.

Mozambican Health Minister Ivo Garrido said the government would decide next month whether to approve the Brazilian proposal. “We will have to study it very carefully,” he was quoted as saying by Noticias.

China Sentences Former Drug Regulator to Death

Byoliveridley

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.