FDA to add warnings on Anemia Drugs

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.

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    An off patent miracle cancer cure?

    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.

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    Indian firms push down global vaccine prices – Lessons for Canada

    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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    India Rejects Obvious Patents

    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 offers AIDs drug factory to Mozambique

    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.

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    Bill could block some ads for new drugs – Not so Fast!

    Bill could block some ads for new drugs – Yahoo News

    Pharmaceutical companies could be prohibited from advertising new drugs directly to consumers for the first two years they are on the market under a bill moving through Congress this week.

    The goal, supporters say, is to ensure medicines are safe before allowing industry to promote them to consumers in the hopes they will request prescriptions from doctors.

    But a reduction in TV and print advertising, which helped transform medications for heartburn and arthritis into blockbusters, would be a serious financial blow to drug makers. According to one study, every $1 spent on pharmaceuticals advertising often adds more than $2 in sales.

    While the Food and Drug Administration already screens a small portion of ads voluntarily submitted by drug companies, consumer advocates favor much tougher regulation, arguing that the studies companies use to test the safety of new drugs are not always large enough to spot dangerous side effects.

    “We don’t know, and we won’t know, how truly safe a drug is until it’s been used in millions of people,” said Consumer Reports analyst Bill Vaughan. “The real testing of these drugs takes place after a pill hits the market and that’s why the advertising needs to be regulated.”

    This is pretty significant. Big pharma is increasingly reliant on the blockbuster drug that addresses chronic and/or lifestyle diseases affecting the a large proportion of the affluent adult population. To reach this population, you need to target it with massive advertising blitzes that

    1. Alert you to the fact that you might have a problem – Restless leg syndrome, anyone!. This might be something that may be important, but nothing you might have noticed.
    2. Prod you to get treated for it.
    3. Convince both you and your doctor that the flashy new drug, which is 100 bucks per month is so much better than the other drug that is 10 bucks a month (Not much science is necessary here, just a major advertising blitz and continuous access to doctors through visits, “seminars”. “gifts”, etc.)
    4. Work with insurance companies to make this drug the treatment of choice
    5. Lather, rinse and repeat!

    Note that advertising is a huge part of this circle, and any restrictions to this said advertising will have pharma crying foul, and free speech. Call me old fashioned, but free speech protects an individual from surveillance, imprisonment, torture, execution, etc. by his oppressive government of choice due to views he/she might have and/or express. All corporate speech is regulated by definition because it involves a flow of information from a party that has a knowledge edge to one, that does not. To the extent that corporate speech helps the end user, it is beneficial. To the extent it hurts, it is not. So regulation of this speech should be a line drawn by government/regulating authority based on maximizing the benefit to the consumer, not to the industry.

    Davidson has urged Senate staffers to eliminate the provision on advertising, arguing that the Supreme Court has already struck down similar attempts to regulate commercial speech.

    I do not think that in the current regulatory and judiciary environment, this provision has any chance of passing. As long as “commercial” speech is as free as “individual” speech, we will forever be exploited by organizations that have a knowledge gap on us and use this knowledge gap to make us buy/do things that may not necessarily be in our interest.

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    Colonialism, Pharmaceutical style

    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.