“Me-Too” Drugs: Why India’s Pharmaceutical System is a Teacher for America

Matthew Kavanagh of the Huffington Post provides an excellent article on what America can learn from India’s recent patent decision surrounding cancer drug Gleevec. Novartis was denied its patent for the drug, with the India Supreme Court ruling that the drug was not original as a cancer drug. Natco Ltd. has been known for producing drugs under a generic label to offer them at a low, affordable cost.

Kavanagh attempts to explain in his article the reason why the India Supreme Court made the decision it did regarding Novartis’s Gleevec:

“In the U.S., 75 percent of ‘new’ drugs approved by the FDA are actually so-called ‘me-too’ drugs — a medicine designed to compete directly with an existing profitable drug with some changes to make it more appealing. Once we had Viagra, we quickly had Cialis that acts more quickly, Levitra that lasts longer, Stendra that acts quicker and lasts longer, and Staxyn that dissolves in your mouth instead of swallowing a pill…but what if you want to incentivize investment in bold new drugs instead of me-too drugs? What if you want to encourage research into new areas that tangibly improve people’s health? Then maybe, like India, you would only grant patents when that higher standard is met. Instead of decrying India’s ‘deteriorating’ innovation, maybe those of us who care about health should be taking a hard look at India and asking what the country can teach us about our own broken innovation system” (Matthew Kavanagh, “The Economics of Cancer: Learning From India About Innovation; The Huffington Post).

It is interesting that here in the United States, these “me-too” drugs that are created cost thousands of dollars, while countries such as India can sell these drugs at affordable prices. What stops countries from selling them here for more affordable prices? And if American pharmaceutical corporations cannot sell them for more affordable prices, then Americans cannot blame patients who rely on generic drugs (cancer medication) when battling life-threatening diseases. American pharmaceutical companies could best fight the rise of generic drugs if they offered brand-name drugs at more affordable prices.

India, therefore, is not wrong for denying Novartis its Gleevec drug patent; after all, the drug was invented to compete with other pharmaceutical companies that have a similar drug on the market. It is easy to develop drugs that are the same as others on the market (with a few tweaks here and there). It is another thing entirely to create a drug that is the first of its kind, a unique drug that is not easy to imitate. Drugs that are imitations of existing market drugs are not worthy of a drug patent.

India is known for providing 80% of the world’s generic AIDS medications. The country has a duty to provide drugs at an affordable price to patients. This may not protect innovation enough, but it certainly does what pharmaceutical companies were meant to do: that is, save lives.

Novartis Loses Patent Grant, Natco Scores Another Victory

Novartis AG filed a patent application for its cancer drug (Gleevec) recently. Natco has been in the news recently for its approval of generic cancer drugs that resell cancer brands under a different name — with a lower cost attached. The India Supreme Court said some near ten days ago that Gleevec does not have the innovation required of new drugs that receive patents. Novartis disagreed, saying that the molecule imatinib (the chief molecule in Gleevec) is a result of Novartis’s research. The molecule has not been found in any other drug. The India Supreme Court, however, ruled that all cancer drugs have distinctive molecules. This is still not enough of a contribution to separate Gleevec from the numerous other cancer drugs on the market.

Justice Aftab Alam and Ranjana Prakash Desai provided the decision, stating that “repetitive patent is not permissible on the same drug. The drug is neither new nor complies with provisions of the patent law” (Eva Von Schaper and Pratap Patnaik, “Novartis Cancer-Drug Patent Denied by India Supreme Court,” Bloomberg News).

The decision, while scoring a victory for companies like Natco Ltd., which produces generic drugs using the same ingredients and the name-brand drugs, will only serve to isolate the India pharmaceutical companies from the rest of the world — particularly Western pharmaceutical companies. According to Cenkos Securities analyst Navid Malik,

“The worst thing about this is that pharmaceutical companies won’t want to partner with Indian pharma or generic players, because they’ll be significantly concerned about protection of their intellectual property. The government is basically trying to create an industry with no investment as generics don’t require much R&D” (von Schaper and Patnaik, “Novartis Cancer-Drug Patent Denied”).

I think the issue with cancer drugs in India is not so much an issue of patent protection and innovation as it is offering drugs at low costs for India citizens who cannot afford the expensive prices on pharmaceutical drugs offered elsewhere around the world. What good does it do for large pharmaceutical companies to manufacture drugs to fight cancer if the majority of cancer patients cannot afford access to them?

Patents vs. economics has become the new battle for pharmaceutical companies and the Supreme Courts to fight. I just hope that they do not focus on the medications themselves at the expense (pun intended) of human lives.

Soy for Joy: Why the Healthy Ingredient May Reduce Your Risk of Lung Cancer

It has been said that a healthy diet consisting of vitamins, vegetables, water, protein, and even fruits can fight sickness, disease, and even cancer. Now, studies suggest that you may want to add one more ingredient to your healthy diet: soy.

A study conducted by Professor Gong Yang along with the Vanderbilt University Medical Center, the National Cancer Institute of Health (NCIH), and the Shanghai Cancer Institute showed that women who eat high levels of soy protein are 40% more likely to survive lung cancer than those who eat low levels of soy. 444 lung cancer, Chinese, female patients participated in the study. Of those who participated in the study, 318 died within a three-year period; the other 126 women who survived were shown to have absorbed high levels of soy into their daily diets. Women who said that they ate low soy amounts were 1.8 times more likely to die, while those who ate more soy were 11% less likely to die.

The researchers used Chinese women because they are far more likely to contract lung cancer without smoking than American women. They reported that the stats, in combination with the soy intake, are a positive shield against lung cancer.

Cancer studies are wonderful in that they help doctors and medical researchers determine what foods can be helpful to the body as part of a regular regimen. At the same time, such studies must not forget to mention that genetics are part of an individual’s constitution. If an individual has strong genetics with regard to cancer, he or she may still get sick — even if high levels of soy are part of the overall diet. The study of 444 Chinese women (who contract lung cancer) is a study in environmental factors. Environmental factors play a role in cancer contraction, but genetic structure does as well.

At the same time, it is wise to advise patients on organic solutions to battle cancer — something other than drugs, injections, and medications. Cancer research is moving in the area of the body’s own T-cells, for example, that when reinjected, can fight cancer. It makes sense that medical researchers continue to push organic solutions to cancer.

Mathematical Algorithm Serves a Dual Purpose: To Detect Web Traffic and Battle Cancer

Mathematical equations have been known to help in many practical ways. When I was a high school student, I learned that physics equations were useful to determine things like the angle of a ramp that needed to be built, as well as the water temperature at which something can melt or freeze. Physics for me at least, was the science of taking real-life practices and reducing them to mathematical equations. There was nothing glorious about reducing a real-life situation into a mathematic equation, but there was something marvelous about using those reduced mathematical equations to figure out real-time solutions.

The same can be said for the Google PageRank algorithm. Using an equation that matched that of Google’s pagerank software and the Viterbi Algorithm to determine what places in the human body serve as “spreaders” of cancer and which places in the human body serve as “sponges” of cancer. The places designated as “spreaders,” such as the kidneys and adrenal gland, are those that, when cancer is detected in them, are an indication that cancer is found elsewhere in the body. The sponges, such as lymph nodes (at least with lung cancer), are “sponges”; although they may contain cancer cells, they are unlikely to spread cancer to the rest of the body. Lymph nodes, while ineffective in lung cancer to spread the disease, are “spreaders” when it comes to breast cancer. Depending upon the place in which the cancer first appears, doctors can learn how to better combat the cancer as well as predict where it may go should it spread to other parts.

The “living” mathematical equation is similar to the living organism it is studying, according to Paul Newton, USC Engineering Professor. Newton, along with his school (University of Southern California), Scripps Clinic, Memorial Sloan-Kettering, and the University of California, San Diego Moores Cancer Center, conducted the research between the algorithm and the spread of cancer in the body.

The results of the study showed that cancer, contrary to popular thought, does not shoot in one direction when activated but rather, many directions — which explains why cancer can show up in any place in the body if the individual has battled the disease once before. To conduct the study, the doctors used autopsy reports (of New England lung cancer patients) from 1914-1943 (a time that predates chemotherapy) to test out the Google PageRank algorithm.

This study is important for two reasons. First, to have algorithms accurately predict where in the body cancer has spread as well as whether or not it has progressed or retreated can help doctors focus on more patient-specific forms of treatment that will save the individual’s life — rather than focus on one general course of treatment for each cancer patient. Some courses of treatment may help some patients recover while others die. The second reason why this study is important pertains to the use of mathematics and the sciences in cancer research. Physics has always shown society the importance of numbers in everyday processes, but its use in cancer research will also save lives.

Teenage Cancer Deaths Drop, Further Research Needed for Rare Cancers

One of the goals of cancer treatment is to reduce the number of cancer deaths experienced by humans of all ages — whether infant, young child, teenage, adult, or elderly person. If humanity intends to continue fighting the good fight against cancer, then there must be some tangible mark of progress. Cancer studies both encourage and motivate: while they encourage by showing positive results, they motivate humanity that the current medications and treatments are not enough; more is needed.

In the first cancer studies on children (1975-1977), 580 children between the ages of 15-24 died from cancer. From 2008-2010, the number decreased from 580 to 300 child cancer deaths, according to Cancer Research UK. The Cancer Research UK Study also tested leukemia deaths to determine if the numbers had fallen over time; the results showed that leukemia deaths fell from 54 to 39 (by approximately 28%). The results are positive, showing that eighty percent of all children diagnosed with cancer have excellent chances of survival today, as opposed to thirty or forty years ago.

Despite the positive cancer survival rates, there are not enough teenagers used in cancer studies. According to Professor Jillian Birch, a Cancer Research UK teenage cancer expert, the presence of teenage cancer patients in cancer studies is an important area of medical research:

“We’ve made great progress in helping more teenagers and young adults survive cancer, and today over 80% will beat the disease. But there remains a problem with getting teenagers and young adults on to clinical trials – less than 20% are on trials compared to around 50 to 70% of children. We need to drastically improve this so that we can develop better treatments, help more teenagers and young adults survive the disease and offer hope to patients with harder to treat cancers” (“Number of Teenage Cancer Deaths Almost Halved in Last Three Decades, Figures Show”).

Birch’s observation of the absence of teenagers in clinical studies is extremely significant: doctors and medical researchers focus more on young children, adults, and elderly patients; at the same time, there is much good that could be done if doctors and researchers would focus on teenage cancer patients and how they can be helped (develop treatments, new medications, and so on). Without testing, there is no way to know whether or not teenage cancer rates are declining or increasing, nor is there any way of knowing how effectively teens are battling cancer and winning the war.

Of the studies performed, there was no change on random cancer cases.  More studies need to be done in this areas as well. Currently, medical researchers are increasing the number of rare cancer drugs made available on the drug market, but there is always room for more.

Nevada Bill Places Oral Medication and Intravenous Medication on Same Plane

If you have had to pay for the cost of oral cancer medication, you are aware of the medical costs oral medications incur that intravenous medications do not. Intravenous medications are administered in a hospital or doctor’s office and have become so common that intravenous medications come at an affordable cost. Oral cancer medications, new to the medical field, come at a premium cost because of their novelty and their special use. Cancer patients who have to use oral cancer medication end up paying more on their out-of-pocket costs and deductibles than cancer patients who require intravenous medication.

The disparity between oral and intravenous medication in terms of financial costs, however, are about to change. Senate Majority leader Mo Denis has introduced a Nevada bill into Congress that would require insurance providers to equalize insurance coverage for both intravenous and oral cancer medications. The bill is known as SB266, and the disparity between both types of drugs could not be more apparent than in the state of Nevada. Oral cancer medications cost thousands of dollars; patients who are forced to pay the exorbitant fee for oral medications will either choose intravenous medications or refuse to purchase the new medication — worsening their medical condition. According to a recent study, “25 percent of patients didn’t fill their initial prescriptions if the co-payment amount was more than $500″ (Martin Griffith, “NV bill would help cancer patients on oral drugs”).

American Cancer Society Cancer Action Network Executive Tom McCoy said that the mandate for the legislation comes down to the fact that government legislation does not often line up with technology and progress:

“What it comes down to is the business model of most insurance carriers hasn’t kept up with medical innovation. You should not have to pay any more for your cancer treatment because you were prescribed to be on an oral drug rather than IV medication. We’re trying to achieve parity” (Griffith, “NV bill would help cancer patients on oral drugs”).

I agree with Griffiths; whether the cancer medication is administered orally or intravenously should have no bearing on the financial coverage provided. Different medical procedures are similar to different forms of drugs — liquid, pills, powders, etc. These are different forms of medication, but it is the same medication. Oral cancer medications provide another convenient way for cancer patients to receive their medications without reporting to a hospital or doctor’s office each time a drug is administered. The sole reason for the invention and production of oral drugs is to prevent cancer patients from incurring additional financial costs (hospital stays incur a lot towards the medical insurance costs) that come with hospital visits. The goal, then, is to reduce financial costs, not add to them or grow them out of control. To add high premiums and out-of-pocket expenses to oral medications is to exacerbate the problem (not relieve it).

It is true that medical laws are often light years behind medical technology, and something needs to be done about it. The truth is that, as hospital visits become more and more expensive, and intravenous drugs become more and more inconvenient, the medical field will continue to research ways to take medications that do not interfere with the routines of everyday life. I think that there is a psychological component to medical research: the less cancer patients must report to a hospital and feel as if they are helpless, the more empowered (and the better the self-esteem) they will become. Feeling good about themselves and confident in their ability to fight cancer, their attitude will have a positive impact on their current condition. More than medicine even, a healthy attitude (and a confident self-esteem) is key to longevity and progress.

Brides Against Breast Cancer Weds Concepts of Marriage and Cancer Survival

When a bride thinks of marriage, she thinks of an exciting event, a new chapter in her (and her fianc√©’s) life. As a bride tries on her wedding gown, the bride’s mother often stands there, looking at her daughter, and returns to the time when she, too, was fitted for her wedding gown. Some mothers pass their wedding gowns down to their daughters along with expensive jewelry that the daughter often prefers to wear at her wedding. Getting fitted for a bridal gown turns into part of the journey from dating to marriage, and it is a time worth remembering for bride, mom, sisters, aunts, and other female relatives.

Brides Against Breast Cancer, a non-profit organization that raises money for breast cancer patient recovery programs, offered designer wedding gowns (25 to 85% below their original price) to future brides at the Hilton hotel in Greenville, South Carolina. The event ran from noon to 6pm and the proceeds went to recovery programs for breast cancer patients who survive their breast cancer surgeries and want to know how to proceed after recovery. The dresses will be discounted somewhere between $100 and $800, with a selection of 700-1000 bridal gowns to choose from.

The Brides Against Breast Cancer is a marvelous event for both breast cancer patients and brides-to-be alike. There are many brides-to-be who want to have a gorgeous dress but cannot afford designer dresses for their wedding day. Purchasing designer dresses through the Brides Against Breast Cancer event is an excellent way to get amazing dresses while giving to a good cause.

Brides Against Breast Cancer event and organization support a cause that many cancer organizations should take up: breast cancer patient recovery. According to Allison Moore, media relations specialist for BBC, told WYFF News that very little money, if any, goes to patient recovery: “Money that is put toward research doesn’t help someone already diagnosed with cancer. Seventy-one cents of every dollar from the sale will go directly to support programs that help a patient after a diagnosis” (“Bridal Gown Sale to benefit breast cancer patients”). Events such as this pay (pun intended) in a big way.

Brides Against Breast Cancer will have their next event in cities such as Anaheim CA (March 29-30), Atlanta GA (April 6-7), Minneapolis MN (April 19-20), St. Louis MO (May 11-12), Chicago IL (June 22-23), and Tampa FL (June 23-24).

Shaving for a Good Cause: Provo Hosts the St. Baldrick’s Head-Shaving Event

Head-shaving was considered in ancient times to be a form of mourning, a physical representation of loss. In today’s world, however, head-shaving has been used as a fashion statement for men who want to be “cool” and hip with the times. Young men often do it in order to impress their girlfriend or wife. Older men often lose hair over their lifetime, so for some, baldness becomes a natural state.

How unfortunate the case for some small children who suffer from cancer at an early age! Cancer is a life-threatening disease that is known for hurting adults. We cry and mourn when someone else we know or love (or someone we don’t) becomes diagnosed with any form of cancer. We would never wish it upon a small child who is innocent, born into the world a few years before, and has not had a chance to live and enjoy life. Yet, many children find themselves in this unfortunate position. I have a small cousin who was diagnosed with cancer at five, so child cancer stories hit home for me in a very real way.

What a joy to know that some shave their heads in order to honor and sympathize with child cancer patients. Just four days ago, Provo, Utah hosted the St. Baldrick’s head-shaving event to honor children who have been diagnosed with cancer. The event works as follows: those who want to donate funds to cancer research get their head shaved. Having your head shaved not only means that you want to donate to the cause, but also that you identify with child cancer patients. Head-shaving for children with cancer becomes a cool thing — if for only a few days each year.

Nine-year old Andy Stanley was grateful for all the support he has been given at the St. Baldrick’s head-shaving events (held annually). He was diagnosed in 2010 with leukemia, and has experienced constant leg pain since his diagnosis. He has one year of treatment left, however, and has been improving since undergoing chemotherapy and radiation. “I was really excited people are supporting kids like me and shaving their heads. I look forward to it every year” (Mark Green,”Shaved heads earn dollars to fight child cancer”; Fox 13 News).

Four-year old Carson Hancock hits the heart even harder. He was given his leukemia diagnosis in 2011 and has two-and-a-half years of treatment left before he can be in remission. His grandmother decided to shave her head so as to celebrate his cancer fight — a precious experience for both grandmom and grandchild.

The St. Baldrick’s event started as a means of giving back to the community for the success of three people — Tim Kenny, John Bender, and Enda McDonnell– on July 4, 1999. The first head-shaving event (March 17, 2000) saw 19 head shavings and $104,000 raised towards cancer research. The second head-shaving event raises $140,000, but is stained with tragedy because the founders lost numerous friends in the 9/11 terrorist attacks on the World Trade Center. Thirty-seven had their heads shaved in 2002, with more than $1 million raised toward the cause. Since its early days, St. Baldrick’s has gone on to raise an unprecedented amount of money towards cancer research. Because of the efforts of three men, there are many children in the world who will fight and be victorious in the battle against cancer. Who knew the influence that three individuals could have on the world?

Estrogen Patches For Women and Men: New Prostate Cancer Study Says So

Sometimes, the most interesting medical finds come out of nowhere and prove to be useful in more ways than one. This is what makes medicine and science such interesting fields to study. When researchers discover drugs and medications that are useful in two or more ways, the medical community can present these findings to individuals who have a condition that mandates the use of an unusual drug. This month, researchers have discovered that estrogen patches containing estrogen have an additional purpose to add to their feminine usefulness.

Estrogen patches have been used to aid women who are experiencing menopause and suffer estrogen deficiency as one of their many symptoms associated with the later-in-life condition. A new study suggests, however, that “what’s good for the goose is good for the gander”: that is, estrogen patches may be what male prostate cancer patients need to fight off the disease.

The current treatment for prostate cancer consists of what are called luteinizing hormone-releasing hormone analogues (or LHRHa injections). LHRHa injections are effective because they reduce testosterone levels in men, allowing cancer tumors to shrink in size and possibly disappear. While these injections are effective in fighting cancer, they produce a medical trade-off for patients: while treating and fighting the cancer, they produce a whole host of side effects and illnesses: diabetes, hot flashes, bone fractures, and osteoporosis. Diabetes arrives in the human body because cholesterol levels soar as a result of the injections; hot flashes in men is an unusual side effect, but one that prostate cancer patients experience as a direct result. My grandfather was diagnosed with prostate cancer six months after my mother was diagnosed with breast cancer, and he experiences hot flashes and night sweats unlike anyone I know. He cannot sit in a warm room for fifteen minutes without sweating and has to wipe the sweat from his face constantly when he is out in the sun. Grandpa has always had terrible sweat in the sun, but it is now terrible indoors as well as outdoors. The injections have proven successful for his health, but the side effects are noticeable. Doctors have longed for better prostate cancer treatments that remove the cancer while preventing such critical side effects.

Medical researchers may have found the answers they have been anticipating for years. According to a new study published in The Lancet Oncology tested 254 prostate cancer patients (either in advanced stages or metastic situations) with estrogen patches over a period of twelve months. After the one year time frame expired, participants were subjected to medical testing so doctors could examine the effects (if any) on the prostate tumors of the male patients. The Lancet study found that the estrogen patches prevented large spikes in cholesterol and glucose levels (high levels symptomatic of diabetes) and reduced the amount of heart and blood clot complications in participants while reducing tumors by approximately the same amount as the LHRHa injections.

Estrogen medications (such as tablets) were prescribed in the 1960s for patients, but came with their own set of problems. Here, however, estrogen could be prescribed with few side effects — a sign of progress for cancer patients who do not want to survive cancer in order to battle another sickness or life-threatening disease.

Side effects can only serve to further wear down and exhaust the human body. It is no secret that a person can survive cancer, only to die of pneumonia or a cold — verified by the number of patients who have survived cancer and died of communicable sicknesses. The last thing a patient needs is to experience more sickness after coming through one of the worst diseases known to man. Any medication that can fight cancer with few side effects is a medication worth developing. Such medications can only aid humans in long life and create new memories post-cancer.

“X” Marks the Spot: Fluorescence Study Maps Cancer Behavior, Path, and Progress

Maps are used to help individuals find their way to and from certain locations. While many individuals used navigation systems and turn-by-turn directions via voice command today, there was a time when families would stop at gas stations and “mom-and-pop” stores for paper copies of maps when they found themselves in a place they had never been before. Maps are still used in Disney theme parks as well as Carowinds, King’s Dominion, Busch Gardens, and Six Flags. Theme parks are still large places and require maps with numbers and “keys” at the bottom of them so as to correspond with numbers and letters at each important diagram or symbol.

Cancer detection is becoming similar to geography maps. Doctors have spent time analyzing what they know about cancer but still have many questions unanswered and unexplained. A new fluorescence method may pave the way in detecting cancer, monitoring its progress, or watching its path of travel within the human body.

The cancer fluorescence method takes a small amount of tissue (5 microns thick) from a cancer tumor, places fluorescent dyes on the small tumor tissue sample, and then examines the tissue samples under a fluorescent-lit microscope. According to Global Research Center cancer researcher Michael Gerdes, the fluorescence-detection method regarding tissue samples helps medical create what are known as cancer maps:

“We can define the boundaries of the cells, give each cell a unique identifier, look at proteins active in different functions of the cell, and monitors different metabolic activities” (Tomas Kellner, “Everything Illuminated: New Method to Light Up Pieces of Cancer Puzzle”).

Gerdes also believes that there are different markers for different cancers, and the new cancer-mapping strategy can also show how tumors form. If doctors can assess how tumors form, then they can assess what needs to be done to kill the tumors or fight them as soon as they are created.

What is the benefit of this new fluorescence-detection cancer method? Dyes can be used to highlight the path of the cancer, whether or not it has shifted in the body, and so on. The greatest benefit of this new method is that it will allow medical researchers and doctors to develop more patient-specific treatment plans in the future. Doctors care about the health of their patients, but current medications and drug treatments are prescribed for the general cancer public. The result of common drug treatments is that some work for those who fit the profile of the ideal patient, while other patients do not fare so well on those same treatments. It is important, thus to know how to treat each patient based upon his or her cancer condition and health condition. Cancer mapping is yet another medical find that will further society’s goal of longevity.

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