How Big Pharma is slowing cancer research

By Carlos Moreno
March 31, 2014

In a March 27 article in the New England Journal of Medicine, a team led by physicians at Massachusetts General Hospital revealed that a new cancer drug from Novartis has shown exciting clinical results in a small trial of lung cancer patients. While additional trials are necessary before the drug can obtain approval from the Food and Drug Administration, this type of success story demonstrates why research to develop new cancer therapies is critically important.

Researchers in academia, biotech and pharmaceutical companies are making remarkable discoveries to help identify new drugs and drug targets for cancer patients. Many new compounds are under investigation — including those that inhibit the growth of cancer cells, block the blood supply to tumors and prevent tumors from evading the immune system.

Even as scientists seek to bring new cancer treatments to market, however, drug patent issues are holding back some researchers. A major hurdle is in combination drug trials that test two or more therapies at once. Pharmaceutical companies often shy away from trials that have great potential, because the drugs may not generate profits if they are used together with a generic drug or a drug patented by a different company.

Recently, there have been major advances in our understanding of how cancer progresses. As scientists have sequenced thousands of cancer genomes, patterns are starting to emerge. One clear insight we have gained is the likelihood that no single drug will be able to defeat cancer. The reason most cancers become drug resistant and come back is because their DNA mutates quickly. Cancer cells that are not killed by the drugs survive, continue to grow and replace the cells that have been wiped out.

So how can we beat the evolution of cancer cells? Most cancer researchers believe that the way to do it is to use the same approach that holds HIV in check for AIDS patients: with combinations of drugs. These drug cocktails, if used appropriately, may someday control many cancers because the cells resistant to one drug will be sensitive to another.

The great challenge is figuring out which drug combinations are likely to work the best. But when it comes time for clinical trials that are necessary to bring drug combinations to market, there are two major hurdles.

The first hurdle occurs when two drugs have been patented by two different pharmaceutical companies. When this is the case, quite often neither company wants to fund the trial. This reluctance is because only 8 percent of new drugs obtain FDA approval, clinical trials can take many years to complete, and there can be legal conflicts regarding ownership and publication of results — resulting in the fear of litigation from the other company. There can also be squabbles over how to divide expenses and profits, with one or both parties looking for a bigger cut of the potential financial gains, and both putting profits before patients.

The second obstacle can arise when there is no patent protection, and thus no financial incentive to test the cocktail and market it if it works. There is only a financial incentive to move forward if all patents are active and held by a single company, and with drug combinations, this is often not the case.

For example, a 2013 study showed that patients who take a generic diabetes drug called metformin have a much lower risk of dying from prostate cancer. However, since the patent for metformin expired in 2003, no drug company has been interested in funding studies of combination therapies that include metformin because there will not be a new, patented drug at the end of the study.

Currently, there are at least 38 clinical trials testing metformin in therapeutic combination studies, but not a single one of them is sponsored by a drug company. Instead, cancer centers, hospitals and universities are searching for support from the government and foundations to finance the trials on their own.

Meanwhile, drug companies are looking for ways to modify metformin, so that they can patent those versions and test them. Those modified versions may or may not perform better than metformin, or have fewer side effects. But they will definitely be more expensive for patients. Development and testing of these drugs will also take considerable time and money.

Of course, patents and intellectual property are essential to the process of bringing new treatments and drugs to patients. My point is not that we should eliminate financial incentives. Those incentives are necessary to pay for the huge cost of ensuring that drugs are both safe and effective for patients, and to fund the research behind new discoveries that will someday defeat cancer.

While pharmaceutical companies have a legal responsibility to their shareholders, they also have a moral responsibility to do their best to help patients’ lives — even if it may not be the most profitable course of action. The mission statements of drug companies usually have two goals: the second focuses on growing their business, but invariably the first goal is something like “to help people…live longer,” “to care and cure” or “to save and improve lives.”

Cancer patients do not have the luxury of waiting until legal battles can be settled, or derivatives of existing drugs can be patented. Cancer drug combination trials should go forward without delay, and drug companies should be in the forefront of making that happen. Doing so will not only save lives, but also generate the good will and favorable publicity that could improve the pharmaceutical industry’s poor public image.

It is time for drug companies to put helping patients first.

PHOTOS: A scientist prepares protein samples for analysis in a lab at the Institute of Cancer Research in Sutton, July 15, 2013. Picture taken July 15, 2013. REUTERS/Stefan Wermuth 

Scientist Paul Clarke looks at a picture of labelled cells on a monitor at the Institute of Cancer Research in Sutton, July 15, 2013. Picture taken July 15, 2013. REUTERS/Stefan Wermuth 

 

18 comments

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This article often refers to the ‘financial incentive’ to pursue drug development – this may explain why many new life-saving drugs are so expensive (some costing over $100,000). The enormous cost of life saving medicines is a worldwide problem . Instead of pointing fingers at Governments, Pharma, Insurance, we need innovative solutions.

We are trying to raise awareness of this issue and get all stakeholders to come together to solve this problem.Please sign the declaration at accessourmedicine.com, we really need every signature that we can get.

Posted by Accessourmeds | Report as abusive

First class article . The last paragraph say it all . Action needed , and now .

Posted by Burn1938 | Report as abusive

When greed is the driving force, good gets pushed aside.

Posted by euro-yank | Report as abusive

Unfortunately “responsibility to shareholders” seems to be the only “moral responsibility” that modern corporations feel compelled to fulfill. No one takes pharma companies seriously when they include goals like “saving lives” in their mission statements. If that were true then they wouldn’t be constantly getting slapped on the wrist by the FDA for corrupt business practices. In this and many other ways, the 21st century is rapidly finding cracks in the neoliberal capitalist model that severely undermine its capability to address the major technical, environmental and social challenges of our time. Real change (not the 2008 faux version) will have to occur, the only remaining questions are whether it will happen in time and how much destruction and carnage will be involved.

Posted by BartFargo | Report as abusive

I never read the article but from the heading I want to know why anyone would research Cancer? Personally I would prefer the research dollars to be spent on something else. Like a cure for Cancer.

Posted by BidnisMan | Report as abusive

I would like to report BidnisMan’s post as abusive. Wait, I mean STUPID. A cure from cancer comes from studying cancer.

Posted by LoboPreto | Report as abusive

there probably is a cure for Cancer..but the Medical Industrial complex doesn’t care for it..it would kill the golden goose..and they don’t want that.

Posted by rikfre | Report as abusive

Welcome to the United States of Corporate America! The USCA.

Posted by tmc | Report as abusive

Trouble with drug companies is they want to recoup all their investment money quickly which means higher prices…All the best medicine in the world is useless if you cant afford it.

Posted by akita96th | Report as abusive

Nonsense. Drug companies spend millions to develop and test drugs, and have every incentive to get them out there. Instead, the author wants them to spend God knows how many more millions to do more testing that HE wants, and he whines that they’re not founts of altruism. Ever hear of killing the goose that lays the golden egg?

Posted by YKLWEF | Report as abusive

Once again corporatism rears it’s giant, ugly head. So there’s no concept of a greater good anymore? You’ll only do something if you can make money off of it? And corporations wonder why the masses despise them. It’s the same reason why AIDS in Africa is such a big problem; there’s no money for the pharmaceutical companies to be made because people are so poor, so they don’t care. Having a recent cancer diagnosis, I think this is criminal, not to do medical research because you won’t make any money doing it.

Posted by TheGCU | Report as abusive

@YKLWEF has a point, but I think its more like the old proverb; There are two sides to every story and the truth lies somewhere in-between. So both are partially right.

Posted by tmc | Report as abusive

Many of these companies holding back are getting funding worldwide from donations of people that have had family members and friends die from cancer and actual cancer patients themselves. It is sickening BS that they need massive amounts of more cash for pills that they wouldn’t even have and jobs they would not have developing these if not funded by people worldwide that already paid in full.It doesn’t matter if generic pills can be made at cheaper price. THE PRICE HAS ALREADY BEEN PAID and still money pouring in from donations to fight cancer. These filthy money bags just rolling in the dough donated for research while people are still suffering.

Posted by Realinfo4u | Report as abusive

Sounds like a natural monopoly to me.

Posted by notnews | Report as abusive

Without big pharma there is no manufacturing of complex drugs. The research is done by a variety of hospitals, and universities and itself is very complex and expensive. Or is that something of a myth?

Is there a possibility for small science and research and would it be possible for a “small pharma” to exist at all? Not all countries are tied to big pharma, either. And big companies worry about satisfying investors.

Evidently it is possible to buy “desktop” gene sequencers. The price dropped enormously and I recall reading that one can be got by a laboratory for about $75,000 today. Maybe other equipment can be had much cheaper today? Big Pharma has big overhead costs. Big government does too so they worry about how to pay for the behemoths. And they make big profits.

Would it be possible to have small Pharma that could produce great changes like the garage startups that built companies like Raytheon, or Microsoft,or even Amazon etc.

Maybe it’s already there and we just don’t hear much about it? Perhaps someday doctors themselves could design their own drug therapies? They do it now in a way by prescribing drug combinations. Maybe big Phrama can be cut down to size by allowing physicians more control over the combinations tried, They do that now. What is the problem with reducing all drugs to basic components and letting them be more creative? The fact that two drug companies can have the patent to the same drug means they are already there somehow? Somehow the drugs are inventing themselves. The patent process and clinical trials may be far more cumbersome than they have to be and there may not be that much of a difference between one drug and another, and I’m just thinking of the over the counter stuff that all seems to have about the same ingredients yet can come with a variety of labels by different manufacturers and all seem to be expensive, and in fact can have the same ingredients and be widely different in price. What is the mark up on that stuff? The same may be true for the drugs that require a prescription?

Posted by paintcan | Report as abusive

The present “system” of world drug research is to loose the greed of “rich American companies” to chase big profit as they will. This, in turn, has meant that those areas of research where no big (or at least predictable) profit exists are either completely ignored or short-changed.

The same situation exists with the ongoing lack of new antibiotics. It takes huge investments of cash and time to get approval through a needlessly complex and long term approval process, and there is no pot of gold at the end of that rainbow.

Presently, every area in which there MIGHT be competition is simply avoided. “Big Pharma” can’t make “big profits” in a competitive situation. Once “rich Americans” (those whose insurance or personal wealth allows them access to non-generic discoveries) feed “Big Pharma” their “pound of flesh” through the patent period, then the world benefits (decades later) from resulting low priced generics.

Perhaps some of the money presently expended on endless unemployment benefits, per-head increases in welfare payments, and immortal but useless government programs and their hoards of union bureaucrats shuffling endless paperwork could be better utilized to fund research noon-grants. I would think colleges would jump at the chance to give students and graduates paid research positions to progressively accomplish (not everything at once) with reasonable priority that which gives greatest results from least funding.

Our government is frighteningly inefficient in doing anything but shoveling out money, so the only way at this point in time to get changes of this magnitude underway in the foreseeable future is to redirect funds already being spent wastefully to better use. Of course to politicians, one’s waste is another’s absolute necessity.

Still…public money spent to actually benefit the public? What a radical idea!

Posted by OneOfTheSheep | Report as abusive

Correction: “noon-grants” was supposed to be “non-profit grants”. I really HATE admitting this, but “for-profit capitalism” has proven thus far incapable of providing health care, medicines and even justice in our courts at reasonable cost.

Lawyers have their lobby, Doctors theirs, politicians theirs, unions theirs, and “big business”. Who today represents the “common man”? Not the freeloader, but those CITIZENS who work and contribute to our society.

Who represents US? Why is there no ombudsman entity properly funded and charged with the responsibility of leveling the playing field for the “common man”, acting as his/her advocate to counter the voices of well funded and clearly adverse “special interests”?

Posted by OneOfTheSheep | Report as abusive

YOU CANT convince me, that with sll the untold hundreds of BILLION dollars of tax money “tossed” to these companies, there is NO CURE for cancer????
Nothing more then GREED and KICKBACKS to government officials !!!!!!!!!!!!!!!!!!!!!!!

Posted by jerryjohns | Report as abusive