Protecting Pharmaceutical Profits: The Cost Is Human Lives

The public option has received the lion's share of attention in the health care debate, but there is an equally important issue relating to generic drugs that could mean innovative, lifesaving drugs remain too expensive for all but the wealthy.

Biologics are drugs made from living organisms, and they are considered the miracle drugs of the future. They are the new "blockbuster" drugs for the pharmaceutical industry. Herceptin, for breast cancer, costs $48,000 a year, and many insurance companies won't cover it -- or people quickly hit their limits and must pay for it out-of-pocket or go without.

Embrel and Remicade, for rheumitoid arthritis, Rituxan, for Non-Hodgkin's lymphpoma, Avasta, for metastatic colorectal cancer, Lantus, for diabetes, and Avonex, for multiple sclerosis, are just a few of these biologics. When I was on chemotheraphy, I took Neulasta to boost my white blood cell count and keep my immune system going.

I spoke with Dr. Anthony D. So, the Director of the Program on Global Health and Technology Access at Duke University. While at the Rockefeller Foundation's Health Equity program, he played a key role in fighting for fairer intellectual property rights to make HIV/AIDS drugs available worldwide. He says that if an AIDS vaccine were developed, it would also be a biologic. And under the Eshoo/Barton amendment that passed in the House (Hagen/Enzi/Hatch in the Senate), it could "evergreen" and not be sold in generic form -- virtually forever.

Pharmaceutical companies are trying to use health care reform to make sure these drugs never become "generics," and thus stay extremely profitable. No surprise there.

But young medical and public health students across the country feel their hands are being tied as healers of the future, and they are coming out in protest. Eric Butter, a biostatistics major at UNC, led one of many such protests around the country last week.

"It is a really important issue that might not affect us now, but 10 years down the road it will be huge," Butter said.

Laura Musselwhite, a medical student at Duke University and a member of the American Medical Students Association, writes:

Earlier this year, as a medical student at Duke University, I saw a patient with Crohn's disease, an inflammatory intestinal disease associated with substantial disability and mortality that affects more than 500,000 individuals nationwide. This patient required hospitalization for a flare that she attributed to not being able to afford the month's Humira, a biologic medicine used to treat severe, active Crohn's disease.

The drug is priced by Abbott Laboratories at a staggering $22,000 a year. This patient would clearly have benefited from the availability of an affordable, generic version.

Current biologics proposals, as they stand, will undermine one of the primary objectives of health care reform -- to limit costs -- by in many instances creating almost indefinite monopolies. This will cost billions of dollars and more important, will leave expensive medicines unaffordable to the vast majority of Americans.

That's just wrong. POP is working with artists to make the case for health care as a human right, and will also be joining with these students to help them fight for affordable drug prices. These inspirational young people who want to heal the world shouldn't have their hands tied by protectionist legislation that puts corporate profits over access to health care.

If you are someone you know are on any of these drugs and are having to foot the bill, or should be taking one but can't afford to, please let us know.

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Comments

[Jeff Joseph]

Providing a company with data exclusivity does not give it or extend any sort of monopoly. Products that compete with innovative biologics can still be introduced during the period of exclusivity. They just cannot piggyback off the research conducted by the innovator company. They can't ask the FDA to approve their product based on the innvoatr's research (Research that costs $100s of millions of dollars). They must conduct their own safety and efficacy research and testing to obtain FDA approval and, obviously, not infringe the patents of the pioneering company.

The innovator biotechnology industry actively supports efforts to expand competition in our sector through our strong support of the bipartisan Committee-passed regulatory pathway for biosimilars. This debate is not about monopolies or preventing competition. If that were the case, we'd be opposing any pathway to biosimilars. We are advocating for a provision that will increase competition in our industry and bring the accompanying benefits - namely, lower prices and expanded access. We want to make sure the pathway also provides the necessary protections that will allow for continued innovation and believe a 12 year period of data exclusivity strikes the right balance between promoting competition and promoting continued innovation. Universities and government conduct a lot of critical primary research, but private companies also conduct research, and, perhaps more importantly, these companies spend hundres of millions of dollars to work with the primary research created by govt. and universities to turn the promise of that research into the reality of medicines.

[doodlefarbe]

Jeff, you know, I've read all you've written here and can't help but think you're just whistling in the wind.

Mind, everything you write is true. After reading through the majority of the posts here (3 pages so far), I just don't think anyone wants to hear the truth.

Thanks for bringing it, though!

[tompoe]

You forgot to share your absolute terror over the thought that the FDA or any government might require all drug applications utilize a nonproprietary automated clinical trial data collection system. That singular step would lower research and development costs by 70% or more. It would put patients first, and needless deaths (>100,000 a year) would be eliminated. It would make it possible for controlled post-market surveillance of products, and allow small bio firms to compete on equal footing with larger firms. All things good. Your terror, though, lies with having to lose your control of the approval process, and maximized profits in the hands of a few companies. Right? Maybe you should be telling readers the truth. Pharma industry is a scam.

[Jeff Joseph]

Opening disclaimer: I work within the Biotech industry.

The facts here are all wrong.

The truth is the biosimilars provisions passed by a bipartisan majority in key Committess in the House and Senate do not, under any circumstances, permit a manufacturer of an innovative biologic to obtain an additional 12-year period of "protection" by making minor changes to the structure of an approved product. The language is in the bill's First Licensure provison - Section 7, Subparagraph C of the bill as passed out of the House Energy and Commerce Committee.

The provisions very specifically prohibit an innovator to extend their data exclusivity on the original product as a result of a change in indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength. They go on to prohibit an extension for a "modification of the structure of the biological product that does not result in a change in safety, purity or potency." In no case will any change to the original innovator product preclude biosimilar competition against the original product after the initial 12-year exclusivity period expires.

-cont -

[cant55]

I see many posts discussing generics and how they are much more affordable they are but has anyone asked themselves how do we get to the generics. These companies invest years and sometimes decades in research, and hundreds of millions of dollars to create the original before a generic can be developed. Not to mention an absurdly high percentage of drugs never pan out or cannot get FDA approval. The prices are not only paying for the drugs that make it to market but also for all those the company never made a dime on. I do believe that generics are important but the Pharma companies also need to make profits or I feel we will see a huge decline in life saving medicines.

[BunnyX]

Apparently you skipped over the posts where people pointed out that these new drugs were mostly the product of university research, mostly publicly funded, medical schools, and government labs - and not the drug companies at all. The drug companies complain constantly about the high cost of research in order to justify their high prices, but they spend far less than they would have you believe on research, and far more on advertising and marketing.

Not that the drug companies don't develop a lot of products - they do, just not the groundbreaking new drugs. Their research is focused on repackaging and reformulating existing drugs in order to extend their patents. They are most definitely not interested in doing research on cures. What drug companies want are treatments, not cures. Drugs that treat diseases without curing them are much more profitable, as people will take them their whole lives.

And last, but not least - did you even bother to read the article? If they have their way, there will never be generic forms of these biologics - ever. They will have a government­-guarantee­d monopoly in perpetuity on these life-saving drugs that they didn't even develop in the first place. How is that fair?

[doodlefarbe]

"Apparently you skipped over the posts where people pointed out that these new drugs were mostly the product of university research, mostly publicly funded, medical schools, and government labs -"

Apparently you failed to notice that the people making these claims didn't bother to support their claims with any sort of proof.

Why are you so willing to believe unsubstantiated allegations? Because "hey, I read it on the internet so it must be true"? Because they fit your preconceived notions?

University research is funded by industry and by government. When industry funds the research, they generally own the inventions. The trade-off is the university gets staff funding and gets publication rights. But if the government funds research, patents coming from it are encumbered by government rights.

[squinky]

Get the HPV vaccine and you won't get cervical cancer. That's a cure. People are CURED of cancer every day with chemotherapy. Your point is stupid. Most diseases are chronic conditions so turn your argument around:
How do you get arthritic bones to regrow normally?
How do you get a diabetic's spleen to be sensitive to insulin again?
How do you cure osteoporosis which is a normal aging process in post-menopausal women?
How do you cure an occluded heart?

There is prevention of disease which is great but what do you do for those that have it? Cure is often not an option because it's taken years to develop.

[ConjureMan]

So long as corporate money is allowed in elections(ie a plutocracy), and we allow 6 lobbyist for every congress-person on the hill; nothing will change. Having absolute power holding the House, the Senate and the Whitehouse has only helped magnify the weaknesses of my Democratic party. The ineptness that the conservative snicker and smirk about are sadly true.

[PlaceboStudman]

There's another rarely discussed issue here. We can do as much as we can to reduce the prices of our pharmaceutical drugs, talk all we want about generic and biologics, but the fact of the matter is, until we find true alternative options to pharmaceutical drugs, it isn't going to matter how much or how little we pay for the same dangerous poisons we're receiving, we're still receiving dangerous poisons as drugs.

But then again, I seem to be the only one who is comfortable with the facts that many "treatments' for a disease or disability are actually worse than living with the disease untreated. Nothing is going to change so long as people receiving cancer treatments die IN The hospital from contracting a staph infection because their immune system is destroyed. Nothing will change so long as there are heart medications that cause kidney and liver damage (which in turn does more damage to the heart). Nothing will change so long as antidepressants continue to increase a person's depression leading to suicide.

When THESE issues of *QUALITY* are addressed in our medication, then let's start talking about price people

[fredamae]

SEE: Joe Lieberman, Olympia Snowe, Susan Collins, Mary Landreiu, and etc, etc...they are the "Super Protectors" of BIGCorp/In­s/BigPharm­a, Right?

[blueken]

Once these miracle biocentric drugs become available France, England, Germany, Spain, Portugal, Sweden, Norway, Holland and Finland will sit down at the negotiating table and get them as much as 50% less than the American people. Nice......­..No need to change anything there. Just saying....­.

[SEQUOIABISON]

"if we doctors threw all our medicines into the sea, it would be that much better for our patients and that much worse for the fishes."
Oliver Wendell Holmes, M.D.

"The cause of most disease is in the poisonous drugs physicians superstitiously give in order to effect a cure." -- Charles E. Page, M.D.

"Every educated physician knows that most diseases are not appreciably helped by medicine." -- Richard C. Cabot, M.D. (Mass. Gen. Hospital)

"Drugs never cure disease. They merely hush the voice of nature's protest, and pull down the danger signals she erects along the pathway of transgression. Any poison taken into the system has to be reckoned with later on even though it palliates present symptoms. Pain may disappear, but the patient is left in a worse condition, though unconscious of it at the time." -- Daniel. H. Kress, M.D.
. "Our figures show approximately four and one half million hospital admissions annually due to the adverse reactions to drugs. Further, the average hospital patient has as much as thirty percent chance, depending how long he is in, of doubling his stay due to adverse drug reactions.­" -- Milton Silverman, M.D. (Professor of Pharmacology, University of California)

"Let food be thy medicine, and let thy medicine be food."
Hippocrates

http://www.doctorbob.com/famoushealthquotes.html#

[mamalisa38]

The top ten drug company executives earned $199.4 million in 2008. JUST TEN PEOPLE!

PER HOUR PAY:

Miles White - Abbott - $17,395
Fred Hassan - Schering-Plough - $15,677
Bill Weldon - Johnson & Johnson - $$13,022
Bob Essner - Wyeth - $12,552
Robert Parkinson - Baxter - $8,854
Daniel Vasella - Navartis - $9,166
Richard Clark - Merck - $7,552
Frank Baldino - Cephalon - $7,031
Sidney Taurel - Eli Lily - $6,770
Jeff Kindler - Phizer - $6,562

[Cleo Creech]

The Generics rules seemed to be working pretty well for most people, the drug companies got to make exclusive profits for X number of years, then they went generic - it's hard to understand why the drug companies are trying to get so greedy. Patents expire eventually, copyrights too. The whole notion is that with something so important, sure the owners/developers have aright to profit, but not indefinitely. There's a point where community good and access outweighs profit motives.

Also, let's not forget that when we talk about drug companies spending all this money and "deserving" the profits, that a huge chunk sometimes most of the development money actually comes from us the tax payers. They get huge tax incentives for developing some drugs, and much and sometimes most of the R&D are actually done in government labs and university studies. The approval processes and safety tests are also done with government resources.

What a sweet deal for these companies. What other industry get's tax breaks and huge expensive government assistance programs, then get to argue that they should keep all the profits indefinitely because they "earned" it.

[elbzee]

",,,hard to understand why the drug companies are trying to get so greedy."
Hell no! It's the American corporate way. Demonstrated graphically every damned day. When it comes to pharmeuciticals, it's down right obscene!

[VikingQuest]

Seriously people, where do you think these drugs come from? A magical ferry?

Profit motive drives much of the innovation in this country whether it be drugs or technology. You can't expect to see any strides forward if those that create the product, aren't allowed to realize gains from their time, effort and money.

[iblogleft]

I was taught this in school as well. But can you give me some examples of how capitalism drove innovation in the last 50 years?

Sure there are examples of great innovations in things people want (IPODs), but what about the innovations in what people need? When was the last time we "Cured" a disease?

Funny thing about Capitalism. When the status quo is more profitable then innovation, we stagnate.

When private profit demand is so great that innovation stagnates because its returns do not match those of current technology, we must make changes.

Yes, I can make a 20% return on current energy, and only 5% on new technologies, does that mean new technologies are not viable? Of course not. It just means we sacrifice investment returns for better technology.

When better technology is only better for the people using it, not for the bankers and traders and corporate executives, who will demand we change?

[VHammon]

Dr. Jonas Salk, developed the polio vaccine, released in 1955. Refused to patent it so that it could be used as widely and as inexpensively as possible.

There was a time when America valued human life over profits. That day can come again.

[lastpost]

A recent documentary showed the progress and potential of using an individual’s personal supply of routine maintenance stem cells. For the repair and replacement of their own body parts. Hopefully to the extent of rewiring severed spinal conductors, and initiating the re-growth of severed limbs. If the pharmaceutical industry wants to concentrate its efforts into holding the nation to ransom. Rather than diversifying their approach, to meet the realities of the healthcare needs of the people. In whatever diverse fields that chemical discipline applies. They may soon find their relevance eroded, and their influence swept aside entirely.

As shown by the Australian doctors. Who had to demonstrate by infecting themselves with, then curing themselves of, stomach ulcers. The attempted suppression of medical progress by commercial concerns not only denigrates the perpetrators. It is also ultimately futile.

[redplanet]

The really sad part here is what no one is talking about: the REAL drug for Crohn's disease is less than a dollar per day and it stops it forever. No flares. And it has been proven in a clinical trial. And the clinical trial was so successful it is going to be tested on kids with Crohn's . And it has no side effects.

Why does everyone have to be kept in the dark - even our noble humanitarian student at Duke mentioned above. Why do I know more than she does? Why?

Because no one believes anything can be so good and work so well and they want to keep anyone from believing in it. Humira is awful, just awful. Lucky people who don't get it! Oh and profits of course.

The drug that stops Crohn's is low dose naltrexone. The clinical trial was at Penn State.

This page needs updating but its a place to start:
http://www.lowdosenaltrexone.org/ldn_trials.htm

[iblogleft]

I hear people use Cannabis for Crohn's.

[S1m0n]

Jane, I get it that you want the world to be perfect, and you that now, but Prescription drug prices and medical insurance are two things, not one. It's makes sense to tackle them sequentially rather than simultaneously.

Politics is the art of the possible, not the ideal. Making a deal with big pharma takes them out of the play for this battle with the Insurance companies. That's smart divide-and-rule tactics, and even the bravest heroes prefer to slay dragons one at a time. Two dragons together can blow an awful lot of smoke up your butt.

~~

And the truth is that the government has a lot more leverage with drug companies, because patents are a government-created monopoly. They were invented by government to fulfil a public policy objective, and if they're impeding rather helping, the government has total control over the terms. What federal legislation created, federal legislation can alter or eliminate at will.

[BunnyX]

Would make sense, except that they are tackling them in the wrong order. The big problem is costs - huge costs. Control those costs, allow competition across state lines, and the insurance problem will largely take care of itself.

As for leverage, the threat of a public option is as much a threat as eliminating patents, and the way insurance companies are given a territory is as big a government-created monopoly as big pharma has.