Business and management
Cancer drugs
Big Pharma's gripes about the FDA
Jul 1st 2011, 8:58 by C.H. | NEW YORK
TALK to anyone in the pharmaceutical industry—a private-equity investor, a drug executive, a scientist—and within three minutes Mr Pharma will start griping about the Food and Drug Administration (FDA). The agency is incredibly powerful. Its judgment of a drug's safety and efficacy is the single biggest “X Factor” in America’s enormous pharmaceutical market. In recent years, Mr Pharma will complain, the FDA’s approval process has become slower, its decisions more erratic. A few expletives will follow.
This tension was on dramatic display this week in Washington, DC. The FDA held a two-day hearing on Avastin, a cancer drug that last year generated more than $7 billion in global sales for Genentech, a biotech firm in California, and its parent company, Roche. Avastin treats a variety of cancers, including those of the lung and kidney. In 2008 the FDA gave accelerated approval for Avastin to be used in breast cancer patients. Final approval would depend on further studies that proved Avastin’s beneficial effect.
But the glowing studies never materialised. What is more, some patients experienced severe side-effects, such as haemorrhages and holes in their gastrointestinal tracts. Last year an FDA panel decided that Avastin’s risks to breast cancer patients outweighed its benefits. Uproar followed. Genentech challenged the FDA on its decision, a remarkable move. Even more surprising, the FDA agreed to hold this week’s hearings.
But the panel upheld the earlier decision. Patients will still be able to obtain Avastin, as the drug is approved for other uses. However it is less clear that insurers will continue to cover the drug, which costs about $88,000 a year. Genentech is appealing to Margaret Hamburg, the FDA’s commissioner, who will make a final decision.
The FDA has its flaws. Big Pharma’s complaints about the agency are often justified. But in its evaluation of Avastin, the FDA has served a legitimate role. However Avastin is only the first chapter in a larger fight. The debate over oncology drugs is one of the thorniest in American health care. Americans’ spending on cancer may rise from $125 billion last year to up to $207 billion by 2020, according to Medco, a pharmacy-benefit manger. Some of the new cancer drugs hold immense promise, but others have limited efficacy and are exorbitant.
Nevertheless, a rational debate is elusive. The FDA does not consider drugs’ costs (beware talk of “rationing”). Cancer arouses intense emotion. Patients and their doctors desperately try treatments that have little chance of working. At the Avastin hearing, one patient sobbed and others booed the panelists. Regulators and politicians have a tough job. They must protect patients’ safety, encourage innovation and—soon—have a serious conversation about how much society should pay for a small extension of life. The fight over Avastin has been bitter. Much more is to come.
Read on: New cancer drugs are technically impressive. But must they cost so much? (May 26th)
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Cancer…No Cure Yet….Why?
Tell me, why haven’t there have been a cure for cancer found yet. I don’t mean the multiple drugs on the market that inhibit the growth of some cancers. Is cancer a money game? Big pharmaceutical companies making trillions of dollars….Does a cure want to be found….There’s so much money to be made, why find a cure. Think about it!!
Who benefits the most from this awful disease? The healthcare industry right….Doctors, hospitals and pharmaceutical companies. Am I right? The cancer survivor rate is far less than the new cancer diagnostic rate, instead of it being the other way around. Listen my friends; cancer is at an epidemic level. 1 in 3 people are now diagnosed with some form of cancer. The World Health Organization has publicly stated the number of cancer deaths is expected to double in the next 20 years. In 2006 the costs of cancer was about 260 billion dollars and in 2010 the overall costs for cancer was over 263 billion dollars, according the Agency of Healthcare Research & Quality reports. And, according to University of Washington the number of breast cancer cases has raised from 640,000 in 1980 to over 1.6 million in 2010….This is just one type of cancer.
What the hell is going on here!! Are we just the pons in the biggest money game that has ever existed?? Who are the winners here? It’s certainly not us, the average man, woman and child. Let’s not mention the suffering little children whose lives are made miserable by this unnecessary disease called cancer. Have you ever seen a child dying of cancer….I have…Its freaking awful too see… For parents to endure…, and, for the strong, gentle, powerful nurses who care for them.
What would happen if a cure for cancer was found? Well, let me tell you what would happen…There would be no further need for research….There would be no need for most cancer charity foundations…The power and glory would be gone….There would be no need for chemotherapy, surgeries, and the associated likes….and most of all, there would be no more money made by pharmaceutical corporations.
Can you imagine what the world would be like not to hear of any of your family, friends, and patients dying from cancer ever again. How much happier of a civilization we would be on this planet, if there was no-more-cancer.
One would think in a 40 year history of research & investigation of cancer, costing trillions of dollars that a cure would have been found for cancer of all forms and types.
It is my personal belief that there is a cure for every ailment that mankind has and if we take greed and avarice out the equation, a cure would have happened years and years ago. When the almighty dollar took the driver’s seat in medicine, that is the day that healthcare died. Let’s demand eradication cancer now!
First of all, I work for a pharmaceutical company, so I have seen how this business works first hand.
The FDA plays a very important role in regulating the pharmaceutical industry and overall the public gets much better value out of their drug products as a result of the FDA. However, the system is not perfect. It seems to me that one of the biggest problems is how the current patent law meshes with FDA regulation. After a pharmaceutical company spends billions of dollars discovering a new drug product, they can apply for a 20 year patent for their molecule. In theory, the pharmaceutical industry is supposed to use their exclusive production rights over this 20 year period to pull in the cash to recoup their significant research investment.
However, the pharmaceutical industry can't sell newly discovered drugs until they go through animal testing, clinical trials, and receive FDA approval. The process of moving a drug from discovery to market can take 15 -20 years, which is equivalent to the lifespan of the patent. So, by the time the FDA finally approves your new drug, you may only have 2 or 3 years to sell it before your patent expires... it can be hard to recoup a 1 billion investment on something that you can only sell for 2 to 3 years, even if it is revolutionary.
People always complain about the exorbitant costs of new drugs, but big pharma discovers many extraordinary new drugs for little or no compensation on their investment, for the reasons outlined above. Sometimes pharmaceutical companies will stop developing a revolutionary new product because they can not get it approved before their patent expires, and it's no longer worth the investment. I'm not saying we should get rid of the FDA, because they are a very important protection for consumers. However, there are definitely reforms that can be made to the system.
Big Pharma is fraud. They don’t deliver what they claim and their exorbitant prices have nothing to do with consumer value and everything to do with regulatory capture, bribes, and rampant corruption on every level. FDA is a bribed puppet to Big Pharma and they have systematically helped Big Pharma to cover up lethal side effects that have killed 1000s of people (Vioxx, Trasylol and a long list of other drugs).
The core of the medical scientific process is broken. Governments base their approval of new drugs on alleged “peer reviewed” “evidence based” medicine. It is all a bluff. Articles in top medical journals are written by PhDs at PR firms paid by Big Pharma. (Called medical ghostwriting.) The famous professor whose name appears as author is just paid (bribed!) to put his name on an article to lend credibility and get the article published. He has never seen the raw empirical data.
All throughout the system, doctors and medicine professors have extreme financial conflict of interests to bias and manipulate studies in order to cover up side-effect and exaggerate the positive effects of Pharma Drugs. And they are blind to the culture of corruption they live in.
The room for manipulation is endless: selectively exclude patients to manipulate the statistics, use active placebo containing harmful substances, run several identical trials and only publish the ones with the desired outcome, change the period of the trail ex post to hide side effects, use intimidation, bullying and threats to silence dissenting critical voices, etc. (more info from Marcia Angell, MD at Harvard).
A study in JAMA some years ago showed that preventable medical errors were one of the largest killers in society (on par with cancer, and cardiovascular deaths). The medical-pharma industrial complex is a fraud, sell all stocks.
Squire Maldunne said:
@Nightscroft "I'm not knowledgeable about the FDA. But I can certainly assure you that the lack of weight-loss pills is not the reason for American obesity.It's called a salad, google it sometime."
Amazing that this needed saying but apparently it did.
@unintentional good
I will never know what twisted process led you to interpret my comment "the fda is making america fat by restricting weight loss pills". My point was that this avastin debacle is only the latest action the FDA has taken in its war on pharmaceuticals, not the least of which is weight loss drugs, which are highly effective for treating obesity and its comorbities, i.e. high blood pressure, diabetes, and heart disease which kill more Americans every year than cancer.
By your own admittance you don't know anything about this sensitive subject but I'm sure even with your limited understanding you can realize that sarcasm in this context is highly inappropriate.
Most people are probably un-interested of the threat from new Super-bugs in which the Big Pharma's relentless search for the profits may unwittingly contributed to the rise of multi-biotic resistant bugs with the probable escape of genetic engineered bugs from their labs.
Bacteria From Dutch Poultry Linked to Superbugs in People, Scientists Find
By Jason Gale - Jun 30, 2011 3:37 PM GMT+0800 .
...Bacteria on raw poultry meat in the Netherlands may be a source of superbugs in people, according to a study that suggests the use of antibiotics in food animals is causing life-saving drugs to lose their potency.
Multidrug-resistant bacteria were found in 80 percent of raw chicken bought from grocery stores in the southern Netherlands. When the researchers compared the germs with specimens collected from hospital patients, they found the predominant resistance genes were identical.
The findings, reported in the July edition of the journal Emerging Infectious Diseases, indicate drug-resistant bacteria in food are leading to harder-to-treat infections in people. While human use of antibiotics in the Netherlands is among the lowest in Europe, the country is one of the region’s biggest users of the medicines in farm animals, the researchers noted.
Was working in oncology. Was not impressed by avastin statistics. It could well be placebo effect. It's like taking some alternative medicine except avastin costs more. FDA should withhold the standard of drug approval but they probably should improve their communications of their decisions.
I think we should not simply put money and life to both sides of a scales, and weigh which one is much more important to the state. Finance may mean a lot to a powerful state, but to survive one more day may equal to everything to a sick person. After all, i think entertprises and the nation should take more responsiblity upon this issue.
@Nightscroft Squire Maldunne
I'm not knowledgeable about the FDA. But I can certainly assure you that the lack of weight-loss pills is not the reason for American obesity.
It's called a salad, google it sometime.
@intman
Lack of negotiation leverage leads Americans to pay more for drugs. If big pharma could get away with higher rates in Europe they would.
Impeding cancer drug development, while especially disturbing, is the least devastating thing the FDA does to America's health. Far worse is the FDA's war on drugs designed to cure America's most prevalent disease, Obesity. Countless valuable weight loss drugs are categorically shot down by the FDA, even when their negative effects are far outweighed by their benefits and far less than many other approved drugs. Its to the point that a physicians best pharmaceutical tool to deal with obesity, the source of infinite co morbidities, is phentermine, a drug developed in the 1950's.
The inefficiency of the FDA leads to Americans subsidising drugs for the rest of the world. As a citizen of the rest of the world, I aint complaining.
When you put politicians in charge of regulating the drug industry and keeping costs under control, this is what's going to happen. A politician with a backbone in this arena is an unelectable one.
In no other field are the flaws of the patent system as obvious as within the pharmaceutical business, but solving the patent problem will be at the core of solving the economic crisis too.
Apps markets are actually leading the way to a more generalized system that can be applied to all forms of innovation.
Se:
http://unifiedscience2.blogspot.com/2011/02/single-algorithm-can-save-we...
http://unifiedscience2.blogspot.com/2011/02/market-for-ideas-within-firm...
http://unifiedscience2.blogspot.com/2011/02/deeper-causes-of-downturn.html