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.

Similar Posts

  • |

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

    Byoliveridley

    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.

  • |

    Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

    Byoliveridley

    As I mentioned previously, compulsory licensing is a perfectly legal option underlined by TRIPs (Agreement on Trade-Related Aspects of Intellectual Property Rights) in response to national emergencies for governments to authororize the bypassing of drug patents. Thailand threatened to do it recently, Brazil goes one better.

    Brazil bypasses patent on U.S. AIDS drug – Yahoo! News

    President Luiz Inacio Lula da Silva took steps Friday to let Brazil buy an inexpensive generic version of an AIDS drug made by Merck & Co. despite the U.S. drug company’s patent.

    Silva issued a “compulsory license” that would bypass Merck’s patent on the AIDS drug efavirenz, a day after the Brazilian government rejected Merck’s offer to sell the drug at a 30 percent discount, or $1.10 per pill, down from $1.57.

    The country was seeking to purchase the drug at 65 cents a pill, the same price Thailand pays.

    This story fits the script in every possible way. Here’s the drug company’s “disappointed” response:

    Amy Rose, a spokeswoman for Whitehouse Station, N.J.-based Merck, said earlier that the company would be “profoundly disappointed if Brazil goes ahead with a compulsory license.”

    “As the world’s 12th largest economy, Brazil has a greater capacity to pay for HIV medicines than countries that are poorer or harder hit by the disease,” Merck said in a statement after Silva’s announcement.

    Ah, the irony of a large pharma company appealing to Brazil’s sense of fairness!

    The usual US government/chamber of commerce type’s scold and threat to withold further foreign investment:

    But the U.S.-Brazil Business Council said the decision was a “major step backward” in intellectual property law and warned it could harm development.

    “Brazil is working to attract investment in innovative industries … and this move will likely cause investments to go elsewhere,” the council said in a statement.

    Who are the US-Brazil Business Council? It is an affiliate of the U.S Chamber of Commerce. Its website reveals it to be a lobbying and networking group of high powered U.S executives “fostering” U.S-Brazil trade relations. Hmm, I wonder who’s side they will take!

    But, we forget what this is about, the health of thousands of AIDs patients (and the money it costs to treat them).

    Brazil provides free AIDS drugs to anyone who needs them and manufactures generic versions of several drugs that were in production before Brazil enacted an intellectual property law in 1997 to join the WTO.

    But as newer drugs have emerged, costs ballooned and health officials warned that without deep discounts, they would be forced to issue compulsory licenses.

    Efavirenz is used by 75,000 of the 180,000 Brazilians who receive free AIDS drugs from the government. The drug currently costs about the government about $580 per patient per year.

    Brazil is doing absolutely the right thing by bargaining and playing hardball. it wants to pay the same prices Thailand pays, and should continue to bargain till it gets there. There’s no sense in being a sovereign powerful nation if you can’t shakedown a pharma company, is there!

  • |

    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.

  • | |

    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.

  • 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!

  • |

    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.