Medications

A clear distinction exists between gentle or mite phytopharmaceuticals on the one hand, and powerful or forte phytopharmaceuticals on the other. Between them lies a wide transitional field, i.e. the many medicinal plants with actions somewhere between ‘gentle’ and ‘powerful’- Liquiritia, Arnica and Khella, to mention just a few. These might also be referred to as ‘intermediate’ phytopharmaceuticals. The situation is the same for phytotherapeutic agents as it is for chemotherapeutic ones. With these we have a similarly wide spectrum from gentle and largely non-toxic drugs such as calcium carbonate, or even aspirin, to the modern cytostatics with their very powerful actions. Here too the majority of drugs are in the middle. Like everywhere else, life swings between two poles. It is wrong, or at least one-sided, to think only of gentle phytopharmaceuticals when speaking of phytopharmaceuticals, and to belittle them, if not in words, then at least in one’s thoughts. It is nevertheless true, with most gentle phytopharmaceuticals, that there is no standardized active principle that solely or largely determines the drug action. The gentle pharmaceuticals in particular demonstrate that with plant remedies one very often has a comprehensive complex of active principles, with individual components interacting with others, so that only the complex as a whole will produce the therapeutic action. One might speak of a bio-pharmaceutical. The diagram overleaf will help to illustrate this.
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Where Did the Term Phytotherapy Originate?

The term was introduced by the French physician Henri Leclerc (1870-1955). He had published numerous essays on the use of medicinal plants, most of them in La Presse Medicale, a leading French medical journal. These essays were outstanding for their style, and superb examples of the art of presenting a subject. He summed up his life-time experience in Pr&s de Phytothkrapie, a concise work that has since become a classic. Leclerc’s life and work were described in lively terms in an obituary which appeared in La Presse Medicale on 14 May 1955. Herbal medicine has come a long way since the days of the ancient ‘herbalism’. The study of the use of medicinal plants is now a scientific subject, a field of medicine in the same way as chemotherapy, hydrotherapy, electrotherapy and others. Knowledge of medicinal plants and their uses has been recorded from antiquity – by Imhotep, the priest-physician of ancient Egypt who devised the Step Pyramid of Sakkara, by Galen, personal physician to the Roman emperor Marcus Aurelius, and later by Paracelsus, the Abbess Hildegard of Bingen, and the authors of the great herbals of medieval times, right to the present day. The rise of chemistry, the development of numerous synthetic chemical drugs, and the possibilities opened up by experimental pharmacology have caused herbal knowledge to be neglected. A new climate was created by methods evolved on the basis of modem physiology, concerned predominantly with effects that were measurable under experimental conditions. In this framework it was difficult to know what to do with the medicinal plants. Chemical compounds could always be exactly analyzed giving results in parts by weight of so and so many milligrams, etc. In phytotherapy this method on the whole applies only to medicinal plants with powerful actions – great difficulties arise in other aspects of the work, particularly with many of the plants with gentle actions.

Catalent Expert to Present Drug Delivery Solutions

Jeffrey E. Browne, Ph.D. Technical Director, Pharmaceutical Softgel Business Development, Catalent Pharma Solutions, will be presenting at the Controlled Release Society’s (CRS) Product Development Forum for Poorly Soluble Drugs, January 27-29, 2011, in Miami, FL. Dr. Browne’s presentation, “Drug Delivery Technologies for Lipid-based Drug Delivery Systems – Current and Future Approaches” will take place on Friday, January 28, 2011 at 12:30 PM.

The presentation will focus on the use of lipid-based formulations for poorly water soluble drugs filled into softgels to enhance bioavailability. Dr. Browne will include a general review of bioavailability-enhancing technologies with an emphasis on the development of lipid-based delivery systems and the important role that dispersion and digestion play as formulation considerations. Additionally, the presentation will discuss the current utilization of softgel technology for the oral delivery of lipid-based systems as an immediate release dosage form. The presentation will conclude with a discussion of future uses of softgels including the encapsulation of lipid semi-solid/solid systems for modified release of drugs and the coating of softgels with functional film coating systems for targeting the release of lipid-based formulations in the gastrointestinal tract.

Throughout his career, Dr. Browne has held various positions in pharmaceutical manufacturing & technical services, as well as drug delivery R&D, with a focus on topical, transdermal, inhalation, and oral liquid dosage forms. In 1994, Dr. Browne joined Catalent Pharma Solutions (formerly RP Scherer and Cardinal Health Pharmaceutical Technologies & Services) and has expanded his expertise in a variety of positions and sites including: VP Softgel R&D in St. Petersburg, FL; Executive Director & Division Head of Pharmaceutical Development in Research Triangle Park, NC; Director of Technical Services in St. Petersburg, FL; Account Director, Business Development; and most recently, Technical Director, Pharmaceutical Softgels. Dr. Browne holds his Ph.D. in Industrial & Physical Pharmacy from Purdue University. He is active in the American Association of Pharmaceutical Scientists (AAPS), serving on several Focus Group committees and has presented frequently at regional and national AAPS meetings. He also serves on the Industrial Advisory Board of the Dane O. Kildsig Center for Pharmaceutical Processing Research, a center which encourages cooperative research between academia and industry.

Otonomy Adds Key Product and Industry Experience with Appointment of New Vice Presidents

Otonomy, Inc., a developer of innovative therapeutics for disorders of the ear, today announced the appointments of G. Michael Wall, Ph.D., as the company’s vice president of product development and Cindy Berejikian as the company’s vice president of program management. The appointments of Dr. Wall and Mrs. Berejikian, each of whom possesses extensive global pharmaceutical product development and commercialization expertise, further advance Otonomy’s efforts to establish the company as the industry’s leader in the development of novel treatments for disorders of the ear. Along with the recent appointment of David A. Weber, Ph.D. as chief executive officer, these additions provide the company with key experience to guide the continued development of OTO-104 and OTO-201, Otonomy’s lead product candidates.

“Otonomy’s ability to attract individuals of the caliber of Cindy and Mike speaks to the tremendous opportunity and potential for success that we are cultivating at the company. Our objective is to establish Otonomy as the global leader in the development of therapeutics for the treatment of disorders of the ear and the additions of Mike and Cindy demonstrate our commitment to attaining that goal,” stated David A. Weber, Ph.D., president and chief executive officer of Otonomy. “Their combined experience is clearly impressive, but more importantly, it is incredibly relevant to the work that we are undertaking as we strive to break ground in the virtually untapped otology market. We look forward to the contributions that they will make not only to our ongoing development programs for OTO-104 and OTO-201 but more broadly to the overall success of Otonomy.”

Dr. Wall brings to Otonomy extensive pharmaceutical industry leadership experience spanning the entire lifecycle of pharmaceutical development from preclinical research to global regulatory approval and product launch. Having served most recently as senior director of pharmaceutical development at Alcon Research, he contributed to the development, registration, approval and post-approval activities of numerous major ophthalmic drug products. Over the last several years, he led Alcon’s otolaryngology research and development program leading to the approval and commercialization of several novel otic and nasal drug products, including Ciprodex®(1) Otic Suspension and Patanase®(2) Nasal Spray. Ciprodex® Otic Suspension is the only topical combination antibiotic/corticosteroid drug product approved by the United States Food and Drug Administration (FDA) for the treatment of external and middle ear infections and is the most widely prescribed branded eardrop by pediatricians and ear, nose and throat specialists in the U.S. Dr. Wall’s education includes the Harvard Business School Advanced Management Program, Ph.D. in medicinal chemistry from the University of Mississippi School of Pharmacy and M.S. in medicinal chemistry from the Auburn University School of Pharmacy.

Mrs. Berejikian possesses more than 20 years of biotechnology and pharmaceutical experience overseeing the critical project management elements associated with advancing a product from the development stage to the commercial market. Throughout her career, she has overseen the filing and approval of four biologic license applications, as well as two global product launches. Mrs. Berejikian most recently served as principal of biopharmaceutical consulting at DrugDevPM where she assisted clients in developing and executing successful strategic programs related to regulatory filings, clinical development programs, product launches, positioning and marketing. Prior to her work with DrugDevPM, she spent over 15 years with Amgen, Inc., most recently as director of global R&D project management. In this position Mrs. Berejikian was responsible for leading the operations of a global cross-functional product team to ensure worldwide filing, approval and launch of the novel cancer treatment Kepivance®(3). While at Amgen, she also led the operations of the product team responsible for securing global approval and launch of the blockbuster Aranesp®(4) in the area of oncology. Mrs. Berejikian earned her Master of Business Administration degree from the Anderson School of Management at the University of California, Los Angeles.

About Otonomy

Otonomy is a clinical stage biopharmaceutical company developing novel drug therapies for disorders of the inner and middle ear. The company’s core technology is a sustained release formulation developed for optimal delivery of drugs from a single intratympanic (IT) injection. Broad applicability of this delivery and formulation technology has been established across a range of therapeutic classes and two products based on this platform are in active development. Otonomy’s lead product candidate, OTO-104, is a sustained release formulation of the steroid dexamethasone. A Phase 1b clinical trial is ongoing in Meniere’s disease patients, and future studies are being planned for acute onset hearing loss. OTO-201, the company’s second product candidate, is a novel sustained release antibiotic being developed for the treatment of recurrent otitis media in patients requiring tympanostomy tube placement. OTO-201 clinical trials are expected to begin in 2011. Additional product candidates are expected to target acute and chronic forms of hearing loss, balance disorders, and tinnitus.

The Alarming State of AIDS in America

I listened to President Obama’s recent State of the Union address with both ears cocked wondering if his commentary on health care reform would indicate what may be in store for people, like me, who are living with HIV in America.

I was particularly attuned in light of the GOP-proposed budget cuts for HIV/AIDS programs because we are starting to see proof that taking the scalpel to AIDS funding constitutes real and imminent, “death panels” for people with HIV.

As I write, there are currently more than 5,550 Americans living with HIV/AIDS on waiting lists for the Ryan White AIDS Drug Assistance Program (ADAP) in 10 states. ADAP is a federally subsidized, state-run program that covers the cost of antiretroviral treatment for 165,000 low-income Americans with HIV.

Temporary solutions have been found to ensure that, to date, people living with HIV placed on ADAP waiting lists have not gone without their drugs: the federal government and the pharmaceutical companies who manufacture the drugs have come to the rescue. In 2010, when the ADAP crisis began, Congress passed a resolution in support of $126 million in emergency funding; Secretary of Health and Human Services Kathleen Sebelius freed $25 million in emergency funding from the Department of Health and Human Services and the president’s midyear budget request called for an additional $30 million. As a result, to date, most of those on ADAP waiting lists have not had interruptions in their lifesaving treatment. That may change as early as this week.

The convergence of more effective HIV testing efforts, the recession — which has left many jobless and without health insurance — AIDS budget cuts, rising drug prices and the fact that people with HIV are living longer thanks to treatment, have dramatically increased patient burden on ADAP.

While the right-wing media would have its “FOX Nation” believe that the Democrats’s health care reform is designed to “kill grannies,” the truth is, GOP-proposed budget cuts will ensure the United States is no longer the safest place in the world to have HIV/AIDS. Because soon, even in the United States, if you have HIV you could die because you can’t get your pills. Unchecked by medications, HIV can progress to AIDS, and eventually, kill you.

For three decades, America has led the world by example with its bipartisan generosity while fighting the AIDS pandemic. But the United States is about to join the ranks of the developing nations we have provided emergency support to through programs like the Global Fund to Fight AIDS, Tuberculosis and Malaria and The President’s Emergency Plan for AIDS Relief (PEPFAR).

Lack of state funds and impending further budget cuts in Florida, Michigan, North Carolina, Ohio, Virginia, Washington state and others may soon raise the number of people on ADAP waiting lists (or kicked out of the program altogether) to nearly 20,000 — and there is no emergency plan in place to cover the cost of treatment for so many. It’s important to note that the figure of 5,550 people currently on waiting lists is deceiving because some states reduced their formularies and changed eligibility criteria to disenroll patients from ADAP, making their ADAP crisis seem less dire. But whether a person is technically disenrolled from ADAP or is on an ADAP waiting list matters little when, in either case, the person can’t afford the medicines that can save his or her life.

One of the prime battlegrounds where people are fighting for access to care is in House of Representatives Speaker John Boehner’s own backyard of Ohio. There are 1,000 people on Ohio’s ADAP waiting list, many in Boehner’s district. The local HIV-positive community’s fight to save lives in the heartland may well set the standard for battles to come nationwide.

In the face of all this, certain members of our federal and state governments are saying we need to spend less money on HIV/AIDS.

In his State of the Union address, the president said, “I recognize that some in this chamber have already proposed deeper cuts, and I’m willing to eliminate whatever we can honestly afford to do without. But let’s make sure that we’re not doing it on the backs of our most vulnerable citizens.” (Here, I felt a flicker of hope that our Commander-in-Chief was promising to protect us.) He continued, “And let’s make sure that what we’re cutting is really excess weight. Cutting the deficit by gutting our investments in innovation and education is like lightening an overloaded airplane by removing its engine. It may feel like you’re flying high at first, but it won’t take long before you feel the impact.”

Had I been his speech writer (a girl can dream!) I would have revised the line thus: “gutting our investments in innovation, life-preserving health care and education is like lightening an overloaded airplane by removing its engine.”

Butchering HIV/AIDS budgets now would have a similar effect to ripping the Pratt & Whitney out of a flying 747. But rationing support for HIV/AIDS today could kill a lot more people than a single downed plane — and it’s likely to cost our nation a lot more money in years to come.

I understand that we all must tighten our belts to survive. But as expensive as it is to treat HIV infection (a Johns Hopkins study found it can cost as much as $600,000 over a person’s lifetime in the United States), it’s a far costlier proposition if treatment is not given and the person progresses to AIDS. Because before people die of AIDS, they become very sick and require often exorbitant end-of-life care.

Beyond the argument that untreated HIV results in higher health care costs, there’s another very good reason to consider funding treatment: treatment can prevent the spread of HIV. Antiretroviral treatment can lower a person’s viral load thus diminishing the chances that HIV can be spread to others. The one-two punch of effective treatment (keep a person alive; keep others from getting it) brings enormous cost savings. When treatment is stopped, as could happen due to the ADAP crisis, people can develop resistance to medications and their available arsenal of effective treatment options is reduced.

Treatment is efficacious enough as a prevention tool that global research is exploring its use to prevent HIV-negative people from contracting HIV (an approach known as “PrEP” for “pre-exposure prophylaxis”).

Given the efficacy of treatment, possibly for both HIV-positive and HIV-negative people, and the resulting cost savings, I struggle to understand why some in the GOP are championing budget cuts that will force people off drugs.

One answer is that by doing so, they advance their own political agendas. For example, Michigan GOP state Representative Dave Agema (R-Grandville) has proposed rerouting HIV/AIDS funding to airports in his state. Agema introduced a bill to eliminate state funding for HIV prevention, testing and care, proposing the elimination of the Michigan Health Fund Initiative (MHFI), a $9 million budget used to fund HIV services in the state. Agema proposed channeling the MHFI money into the Michigan Aeronautics Fund, a move he said will help pay for upkeep and expansion projects at state airports, will create jobs and keep fuel taxes down.

It is not fiscally responsible, let alone humane, to increase the likelihood HIV could spread. Doing so undermines public health and could cause HIV care costs to skyrocket. Which, in turn, could mean more people who can’t afford care. And when the word on the street is you won’t be able to get drugs to save your life, why would you get an HIV test? And, since people who are unaware of their status are more likely to unwittingly pass HIV to others and are more likely to have higher viral loads and be relatively more infectious, anything that blocks testing and care for HIV leads directly to potentially more cases, and the need for more money.

There’s no question there are very sound economic arguments for continuing to spend money to fight HIV: in short, pay now, or pay a lot more later.

I fully appreciate the grim economic reality of our country and accept that sacrifices must be made. But where do we draw the line? Shouldn’t it be argued that when budget cuts put thousands, maybe tens of thousands, of Americans’ lives on the line, the cuts are too deep?

Okay, so where do we get the money?

An organization of AIDS advocates known as the Fair Pricing Coalition (FPC) working in concert with the National Alliance of State and Territorial AIDS Directors (NASTAD) have negotiated with the pharmaceutical companies who manufacture antiretroviral HIV drugs; as a result, drug pricing has dropped sufficiently in some states struggling to afford care for their people on ADAP.

The pharmaceutical companies have stepped up further by expanding their own patient assistance programs (PAP) to people with incomes up to 500 percent of the federal poverty level. The FPC has also successfully persuaded most of the pharmaceutical companies to participate in Welvista’s program that streamlines treatment access for people living with HIV on ADAP waiting lists. Welvista is a pharmacy that delivers AIDS medicines within a day to a person who has been wait-listed by ADAP. Based in North Carolina, Welvista is licensed to distribute AIDS drugs in any state where people are unable to access treatment through ADAP.

It is feared that lack of funding will lead the state of Florida to announce — next week — the termination of access for the majority of its 10,000 ADAP clients — possibly more than 6,500 people — from February 1st (when ADAP funding runs out) until mid-April (when emergency funds kicks in) to offset a $14.5 million budget deficit.

The FPC, NASTAD and Welvista have worked with the pharmaceutical industry to bridge that gap, but even with the help of the pharmaceutical companies who have agreed to participate (as we go to press: Abbott Pharmaceticals, Bristol Myers-Squibb, Gilead Sciences, Merck, Viiv Healthcare), the fix in Florida is a) temporary and b) very clearly intended as a one-emergency solution that the drug manufacturers are not looking to replicate across the nation.

The Florida-Welvista deal is just a Band-Aid. And it means shifting the burden of care for thousands of people with HIV from the state and federal government to pharmaceutical companies. Which means the lives of people on Florida’s ADAP waiting list depends on the largesse of for-profit businesses. It is a legitimate, and arguably understandable, concern that the pharmaceutical companies may one day decide not to subsidize ADAP.

Are the pharmaceutical companies worried that if they bail out Florida, other states may expect similar treatment? It’s a fair question.

Access to affordable care aside, there is also great concern that Florida’s existing health care infrastructure is incapable of making a seamless migration of 6,500 people from ADAP to the pharmaceutical PAPs via Welvista. And those who fall through the cracks in the system are likely to cost the state more money.

In the midst of this situation, Florida State Senator Joe Negron (R-Stuart), chairman of Florida’s Senate Budget Committee’s subcommittee on Health and Human Services Appropriations said, “There needs to be a transfer in priority in revenue from health and human services to education.” He added, “I’d like to see several billion less in HHS.”

According to reports, Negron said he thought “health care lobbyists had done a better job making their case over the years than education lobbyists, pointing out that health care lobbyists are good at painting ‘apocalypses’ as results of health care budget cuts.”

Well, Senator Negron, I’m a journalist, not a lobbyist. We deal in facts. And the fact is, the lives of 10,000 Floridians hang in the balance of your state’s unbalanced budget. If you don’t think AIDS Armageddon America Part II is a real possibility, think again.

Negron claims deficit reduction is his highest priority. But help me with the math here. Where will Florida find the money in the future to pay for people with HIV who end up in emergency rooms and in hospitals or get transferred to Medicaid because they became too sick to work and pay for their own health insurance if Florida doesn’t even have the much smaller sum of money needed to keep them healthy today? Isn’t Negron’s willingness to cut millions now from state funding for AIDS merely a political stunt that will ensure his tax payers will be left holding the bag for millions more later? Is this intelligent, responsible, conservative fiscal policy?

Don’t get me wrong. I think Negron’s idea of bolstering education is key. Had Florida, and our nation as a whole, done a better job teaching comprehensive sex education, America’s HIV caseload would likely be far lower than it is today. Nearly 34 percent of all new HIV/AIDS cases in America occur in people under the age of 30. The AIDS epidemic in Florida can be tied, at least in part, to Florida’s lack of a statewide minimum standard for sex education and, as a result, its programs fail to be culturally competent and are restricted, unable to teach anything other than “abstinence-only until heterosexual marriage” — an approach that has been well-documented to increase, not decrease, risk to sexual health. However, I don’t think Negron is talking about funding comprehensive sex education.

The critical questions are: Who can, will and is responsible for funding the survival of low-income Americans with HIV? The federal government (by tapping HHS stimulus dollars)? State governments? Pharmaceutical companies (by dropping drug prices or offering higher rebates)? All of the above? While the various groups duke it out, people with HIV are at risk for getting sick and dying.

Maybe we should apply for international aid.

Here’s an idea: If the GOP leadership wants to appeal to their fiscally minded constituents (thus bolstering their chances for re-election), perhaps they should consider supporting the FPC’s and NASTAD’s efforts to negotiate with pharmaceutical companies to make AIDS medicines affordable to states and individuals. What about providing tax incentives to pharmaceutical companies that agree to participate in the Wellvista program and support people on ADAP wait lists?

We should look hard and deep into programs like those provided by the Ryan White CARE Act and see what efficiencies can be realized and how we can do more with what we have. We should also scrutinize states’ administration of AIDS funding to ensure it’s being handled in the most impactful way. And, we must analyze state’s contributions to ADAP. Over the years, they have declined significantly, furthering the problem.

There’s no easy answer to how we pay for AIDS in America. But there must be a solution. If we had the drugs to cure cancer and people were having trouble accessing them, don’t you think we’d fix the roadblock? Yes.

So why is AIDS different?

In a word: stigma.

2011 marks the 30th anniversary of the first reported cases of HIV and we’ve made progress on the scientific front of AIDS. But deadly stigma prevails, evidenced by the fact we still have people like Representative Larry Brown of North Carolina, who said, when discussing legislative priorities, he does not condone using taxpayer money to treat HIV/AIDS patients if they contracted the illness because they were “living in perverted lifestyles.” He has agreed to fund health care for babies born with HIV and those who contracted the disease through “no fault of their own” but apparently no one else.

We’re in a most challenging position: In one of the most economically constricted times in our country’s history we are asking rich, mostly white, socially conservative people who will assure their political futures by slashing budgets to increase funding for the care of poor people, largely people of color, who have a disease most of them contracted through sexual contact or the sharing of needles.

Talk about an uphill battle.

Yet it’s high time to answer once and for all whether this nation will rise above discrimination and stigma and a selfish desire for political power on the part of some politicians to honor what should be every American’s unchallenged right regardless of their color, gender, socioeconomic status or sexual orientation: access to life saving health care.

In short, we must balance the budgets, yes. But not, as President Obama so compassionately put it, “On the backs of our most vulnerable citizens.”

Here’s hoping we see bipartisan leadership from our nation’s government to solve our AIDS funding crisis. If our leadership steps up, we will show the world that the state of our union is such that in America we won’t let you die when we have a way to save your life.