Introduction

Greetings and welcome. I’m Michael Cervieri and this is the HealthDot Pharma Report.

Today’s report is brought to you by Knowledge Source, a leading provider of healthcare business information and analyses services for executives.

You can find them at KnowSource.Com

Sit back and relax. Today’s tour is through the body.

Along the way we’ll get the skinny on all things fat, take a close look at novel uses of viagra, discuss market implications of a failed diarrhea medication, and observe the good, the bad and the ugly throughout the Pharma world.

Along the way we’ll chat with Pharma Girl and learn how art and pharma intertwine.

Skinny on the Fat

Lipo-dissolve

Maybe it’s because it’s summer time and I find myself beach side in my bathing suit. Or maybe it’s the barley and hops diet they have me on here at the Pharma Report that’s added some squish to my tush.

Either way, everywhere I turn I see fat.

For example, a feature from National Public Radio highlights fat dissolving injections.

This isn’t liposuction where cosmetic surgeons suck out the fat.

Instead, it’s lipo-disolve… as in, inject your fatty areas and watch them melt away.

Does it work? Maybe. Anecdotally, at least. But the compound used to melt fat away doesn’t have FDA approval and until large scale studies are done, there’ll be continued concern about how the body breaks down fat and clears the compound. For example, just how do the broken down fatty chunks make their way through your body?

And until there’s FDA approval, there’ll be questions about whether lipo-disolve is even legal.

Alli

GlaxoSmithKline does have an FDA approved diet pill. It’s the first ever approved for over the counter sale.

Alli is based on the prescription drug Xenical which has been around since 1999. And now that you and I can walk into our local drug store and pick it up whenever we want, Glaxo thinks they can crack $1.5 billion in annual sales.

Not so fast, say some. Xenical never became a breakthrough drug because of certain, shall we say, unpleasant side effects.

We bring Pharma Girl aboard to discuss.

Pharma Girl: Like Xenical, Alli blocks enzymes that digest fat and prevents the body from absorbing about a quarter of all fat eaten.

The undigested fat is then excreted. This leads to certain side effects like gas, diarrhea, uncontrollable bowel movements and “anal leakage.”

Rimonabant

Fat’s one thing and obesity’s another and it’s not just limited to the United States. The whole world’s getting fat. The BBC has even taken to calling it Globesity.

Over in Europe, there’s a drug called Rimonabant that’s marketed under the brand name Acomplia. No word on whether it causes anal leakage but the FDA’s health advisory panel rejected the drug because studies show it increases the risk of suicidal thoughts in some patients.

Fat Conclusion

Where do I go from here. I don’t know. Maybe I’ll start by getting some exercise.

Good Pharma / Bad Pharma

Here at the Pharma Report, it always amazes us how an industry that does such good, that develops life saving and life changing medicines, can so often, and so clearly fall flat on its face.

Let’s take closer look with a little something we call, “Good Pharma / Bad Pharma.”

Good Pharma

I have researchers making progress in finding therapies to combat Alzheimers, the 7th leading cause of death in the United States and the third most expensive condition after heart disease and cancer.

For example, Wyeth has 350 scientists across 23 research projects investigating the disease.

Good Pharma

39 pharmaceutical companies dropped a case against the South African government that challenged the legalized use and imports of generic medicines free from patents.

Oxfam director of policy Justin Forsyth says that the “drug giants seem to have listened to reason in this case, which is good news for AIDS sufferers in South Africa.

Bad Pharma

I overcharged Medicare and marked up drugs 28 to 1,000%. A US District judge in Boston just ruled that AstraZeneca, Bristol-Myers Squibb. and Schering-Plough must pay damages.

Judge Patti Saris wrote that “pharmaceutical companies unfairly took advantage of the system by setting sky-high prices with no relation to the marketplace.”

Bad Pharma

I mislead the public about how addictive the painkiller OxyContin can be. I told doctors that the it was less addictive and less subject to abuse than other painkillers.

A US District Judge just ordered three of us to pay a $634.5 million fine. We’re former Purdue Pharma President Michael Friedman, general counsel Howard Udell and chief medical officer Paul Goldenheim.

The judge placed the executives on three-year probation, and ordered them to perform 400 hours of community service related to the prevention of prescription drug abuse.

Viagra

Did you know that if you place cut flowers in a a low-concentration of sildenafil and water it prevents them from going limp and wilting? Sildenafil, of course, is Viagra.

We’ve always liked Viagra at the Pharma Report. It’s kind of the gift that keeps on giving.

For example, it not only keeps our flowers looking fresh and perky, but researchers are discovering that it may keep the travelers among us perky too.

Argentinean scientists completed studies that show that Viagra may help people recover from jetlag. The scientists injected hamsters with the drug and exposed them to shifting light cycles to emulate travel. The viagra hamsters were extra perky and the researchers believe that viagra blocks a molecule that has a role in setting the body clock.

Meanwhile, over in Australia, some enterprising oyster farmers are taking things to a whole new level. Just like our Sildenafil - water concentration, the farmers are growing oysters in a viagra bath.

The result, Viagra-fed oysters called “sex in a can”.

“It really works,” says George May, who came up with the idea.

Pfizer though, is less than amused and says it might take legal action against May. Australia’s Daily Telegraph reports that food safety officials say that feeding medication to oysters violates safety regulations and may take action as well.

Markets

Markets rise and markets fall as we see from recent losses due to sub-prime lending in the housing market. Bowels can make the market move too. Market watchers here at the Pharma Report call this Bowel Movement.

For example, personal fortunes took a hit due to diarrhea. At least that’s what happened to those holding Genzyme stock back in July. Shares fell 5% when researchers announced during late stage trials that a once promising diarrhea drug worked no better than that which already exists.

Art - Damien Hirst

We here at the Pharma Report consider ourselves a sophisticated bunch.

We like our art, we like our culture.

Today we have the one and only Pharma Girl to connect some dots and show us where the Pharma and art worlds intertwine.

Wrap

That’s it for the HealthDot Pharma Report. I’m Michael Cervieri.

Stay well.

Say informed.

Be Healthy.

ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The company’s focused strategy is to apply new insights from molecular biology to already validated cancer-fighting medications with the objective of developing safer and more effective oncology treatments.

ZIOPHARM has a portfolio of three compounds in development with a combined North American market potential of over $2 billion. The three compounds are: ZIO-101 (darinaparsin), a new class of organic arsenic (in Phase II for treatment of advanced myeloma, leukemias, and liver cancer); ZIO-201
(isophosphoramide mustard or IPM), a proprietary metabolite derivative of ifosfamide (in Phase II for treatment of sarcoma); and ZIO-301 (indibulin), a novel anti-cancer agent called a tubulin inhibitor that prevents cancer cells from dividing (in Phase I).

In episode one of Outside the Lab, show host Michael Choi interviews Dr. Gregory Stock, CEO of Signum Biosciences. Dr. Stock provides insight into Signum’s business strategy, which is to first focus on the cosmoceutical market and reinvest short term cash flow towards the more lucrative, yet more costly pharmaceutical applications of its discoveries.

Outside the Lab explores the business side of the life sciences industry. We interview CEOs, Venture Capitalists, Consultants and other industry professionals on the dynamic and ever changing lifesciences landscape.

If you know someone who would make an interesting guest on an upcoming show, feel free to contact us.

About Signum Biosciences

Signum Biosciences is a private biotechnology company dedicated to acquiring and developing effective, innovative, economical medicines to prevent and treat diseases of aging. Through research on protein networks that control biological systems, we are developing therapeutic candidates for Alzheimer’s , Parkinson’s, arthritis, cancer, cardiovascular disease and a variety of skin conditions.

All cellular activity is coordinated by cellular communication networks, so when these networks go awry, disease results. In cancer, cells mutate and their growth becomes unregulated. In Alzheimer’s, imbalanced expression of a secreted protein in the brain brings inflammatory responses that lead to memory loss and neuronal cell death. In vascular disease, damage to the vascular endothelium generates inflammation that causes atherosclerotic plaques. In skin, neutrophils aggregate in localized areas and cause damage. Each disease develops from progressively more serious imbalances in regulatory and signal transduction processes.

We have developed a strategy to modulate signal transduction networks globally instead of through specifically targeted receptors and other components. This approach is feasible because cellular networks have their own built-in global regulatory mechanisms that can be tuned to modulate the activities of all components at once with minimal deleterious effects.

More global approaches to regulating human biochemical networks are gaining traction for the treatment of disease, and the cutting-edge biochemistry embodied in our proprietary assays offers an efficient new platform for drug discovery in multi-billion dollar disease markets. Our approach will speed the development and commercialization of innovative new drugs and allow us to spin off validated, well-characterized skin care products during the process.

Daniel Carlat, a professor at Tufts Medical School, and editor in chief of The Carlat Psychiatry Report, wrote a telling op-ed in the New York Times a few weeks ago.

In it, he argues that pharmaceutical involvement in doctors’ continuing medical education is having dangerous side effects for the very simple reason that the dangerous side effects of various drugs rarely make it onto contemporary curriculums.

Most states require that doctors obtain a minimum number of credit hours of continuing medical education each year to maintain their medical licenses. Not so long ago, most of these courses were produced and paid for by universities and medical associations. But this has changed drastically over the past decade.

According to the most recent data available from the national organization in charge of accrediting the courses, drug-industry financing of continuing medical education has nearly quadrupled since 1998, from $302 million to $1.12 billion. Half of all continuing medical education courses in the United States are now paid for by drug companies, up from a third a decade ago. Because pharmaceutical companies now set much of the agenda for what doctors learn about drugs, crucial information about potential drug dangers is played down, to the detriment of patient care.

On the face of it, this seems to be a conflict of interest, and a precursor to bad medicine. Carlat mentions as much, writing how Merck promoted Vioxx through various CME programs, just as GlaxoSmithKline promoted the now-troubled Avandia while downplaying both the drug’s side effects on the increased levels of lipids associated with heart disease, and a competitor’s drug (Takeda Pharmaceuticals’ Actos) that actually improves lipid levels.

While the Accreditation Council for Continuing Medical Education prohibits pharmaceutical companies from directly paying doctors to teach CME courses, the industry’s not so very hidden secret is that they simply pay a third party, who, in turn, pay the doctors.

Carlat’s idea to close this loophole is relatively straightforward:

The solution could hardly be simpler: any continuing medical education that is paid for by the drug industry should not be accredited. Drug companies could still pay for any educational event, article or pamphlet they choose, but their courses and materials would no longer bear the imprimatur and implied credibility of accreditation.

Doctors, in turn, would be encouraged to seek medical education from sources that are not financed by drug companies. A renewed commitment to unbiased education would allow doctors to learn about drug risks sooner. This would be good for doctors, and even better for their patients.

Sounds reasonable, and the guidelines for commercial support of CME are being reviewed after a report released by the Senate Finance Committee drew attention to the problem.

We’re cautiously optimistic as we await the results.

Michael Cervieri is ScribeMedia.Org’s Executive Producer and host of the HealthDot Pharma Report.

Resource Alert

HealthDot Pharma Report sponsor Knowledge Source has a new publication that provides consumer insights on the leading 25 drugs not readily available elsewhere.

Called “Pharmaceutical Brand Briefings,” this quarterly series of pharmaceutical drug brand briefings is a unique source of market intelligence for the pharmaceutical and healthcare industry. Each report integrates MedTrackAlert’s exclusive consumer insights with Knowledge Source’s analysis on the leading pharmaceutical drug brands’ performance and activities.

“Pharmaceutical Brand Briefings” is available at Knowledge Source’s Web site. You can access it here.

In Episode IV of the HealthDot Pharma Report we travel from the United States to Africa to Asia and back with a focus on diabetes debates (Avandia), online pharma fraud, the dangers of counterfeit malarial drugs, Nigeria’s lawsuit against Pfizer, a sensitive case of erectile malfunction and close it out with a look at Pharma Med (or combination) devices.

Diabetes Drug Avandia May Increase the Risk of Heart Attack

We start in Washington with a growing controversy surrounding GlaxoSmithKline’s diabetes drug Avandia. The company’s on the defensive after a report in the New England Journal of Medicine said that Avandia can increase the risk of heart attack by more than 40 percent.

Glaxo dismisses the report and says its own patient studies are more reliable and prove the drug’s safety.

Outside experts say that the company’s studies are inconclusive.

Rep. Henry Waxman, a California Democrat and chair of the House Committee on Oversight and Government Reform, had enough of the back and forth and called for a congressional hearing.

In it, he chastised the Food and Drug Administration for failing to protect consumers, and called for stricter industry regulation.

But where the proverbial poo really hit the poverbial fan was during testimony by Dr. John Buse, the soon-to-be president of the American Diabetes Association.

Dr. Buse testified that company executives threatened to sue him in 1999 when he first raised questions about Avandia’s safety. He stated that that executives wanted to hold him accountable for a $4 billion drop in the company’s stock.

In a letter to SmithKline at the time, Buse wrote: “Please call off the dogs. I cannot remain civilized much longer under this kind of heat.”

For it’s part, Glaxo said in a statement: “We regret if, at any time, Dr. Buse felt the conduct of any employee was contrary to the spirit of open, scientific debate.”

At the hearing, the FDA reported that it is ordering Glaxo and rival Eli Lilly to add black box warnings to their respective diabetes drugs. Black box warnings are the most serious a drug label can bear.

Online Pharma Fraud

We here at the Pharma Report love incoming mail, especially those that outline business opportunities.

And that’s why we were especially excited to gain the acquaintance of Mr. James Lugard, a Nigerian resident and self-declared Head of Foreign Operations at a well known bank.

While he hasn’t told us what this well known bank actually is, he has told us that he has upwards of $10 million that’s been laying dormant in in the bank coffers. Better yet, he wants to share the bounty with us. All we have to do is send him some federal IDs and social security numbers to get the process started.

We think this sweet. And we thank Mr. Lugard for providing us access to easy cash.

And while we may be discerning purveyors of all things Internet, we worry that others aren’t quite so savvy. So too does the FDA.

The agency recently issued a warning against 24 Web sites it says peddle counterfeit drugs of all varieties, from weight loss pills to antidepressants.

Many of these sites operate outside the geographic and regulatory borders of the United States, leaving it up to consumers to judge their authenticity.

So while we all receive email advertising cheap Viagra, Cialis and Valium, the FDA now tells us that buying pills from virtual pharmacies is probably not a good idea.

Our low-cost pharma stash may really end up being very different and potentially harmful drugs.

Counterfeit Drugs

Counterfeit drugs may hit our pocket books at home, and leave us anxiously waiting if the Viagra we think we bought is actually a dud.

Around the globe though, fake drugs are leading to health catastrophes.

So says a a collaborative project involving Oxford University, Bankok’s Mahidol University and the Welcome Trust as the study the fake anti-malarials in South East Asia.

The group has discovered that in some areas 30-50% of drugs bought from pharmacies are actually fakes.

To make matters worse, the fakes contain low levels of anti-malarial drugs in order to bypass detection.

These trace amounts aren’t strong enough to kill parasites. Instead, they increase parasite resistance to real anti-malarials. In turn, global resistance to the last generation of malaria drugs has emerged in Cambodia, Laos, Vietnam and Burma.

The criminal network flooding the market is transnational and in southeast Asia, a common thread is that the network is predominantly ethnic Chinese.

The Chinese government is becoming more open about the problem. It recently announced a five-year plan to combat a wave of international health scandals such as a recent case where fake drug ingredients from a Chinese company ended up killing over 300 in Panama.

In late May, the former head of the national food and drugs agency, Zheng Xiaoyu, was sentenced to death for taking bribes and dereliction of duty.

Nigeria Sues Pfizer

Back in Africa, Nigeria sued Pfizer, accusing it of carrying out carrying out improper trials for an anti-menegitis drug in 1996.

The case stems from a period where thousands were dying across northern Nigeria and thousands more were paralyzed by the disease.

Pfizer tested a new antibiotic called Trovan which was given to some of the sick children. About 200 died and more developed deformities.

The Nigerian government now wants $7 billion in compensation, and says that Pfizer never had the authority to conduct the trial.

Pfizer denies this, saying the trials were carried out according to local and international law.

Erectile Malfunction

If there’s one thing Viagra and Cialis have taught us, it’s that an erection can be a beautiful thing.

Blue skies, midnight moons and streaming sunshine on a Sunday morning.

On the flip side, Christopher Woods learned the hard way that erections aren’t always all they’re built up to be.

According to court papers, the Massachusetts native is suing pharmaceutical giant Novartis AG over a health drink it makes called Boost Plus.

Evidently, Woods bought the vitamin infused beverage at a local pharmacy, drank it and woke up the following morning with, quote, an erection that would not subside.

This is known as severe priapism, a painful and potentially harmful medical condition in which the erect penis does not return to its flaccid state.

How harmful? It can lead to impotence, or worse, blood clotting and thus gangrene and therefore penis removal.

As a result, Woods underwent surgery to have a Winter shunt implant. The procedure moves blood from one area to another and is used. The lawsuit say that Woods had subsequent problems requiring further surgery.

His lawsuit seeks unspecified damages.

This specific case study on the use of the nanotechnology as it transforms the pulmonary drug delivery market will provides key insights on the use of these innovative technologies in drugs and devices. It also provides pertinent updates on how the FDA views nanotechnology products and current FDA research in the nanotechnology area.

Watch This Presentation (in new window).

Raj Bawa PhD is President of Bawa Biotechnology Consulting LLC, a biotechnology and patent law firm with offices in Ashburn, Virginia and Schenectady, New York. The firm has broad expertise in biotechnology, nanotechnology, drug delivery, medical device technology, HIV/AIDS, and biodefense-related scientific, legal and business issues. In addition, the firm specializes in all aspects of biotechnology and pharmaceutical patent law, including prosecution, application drafting, prior art searching, freedom-to-operate searching and technology research opinions. Dr. Bawa has over fifteen years of patent experience. He has been a researcher for more than twenty years. Since 2002, Dr. Bawa has served as a technology and patent consultant to national and international biotechnology and pharmaceutical companies. Since 1998, as a Visiting or Adjunct Assistant Professor at Rensselaer Polytechnic Institute. Dr. Bawa is a registered patent agent (Registration No. 51,385) licensed to practice before the US Patent and Trademark Office in Washington, DC. Dr. Bawa has previously held various positions at the US Patent and Trademark Office in Washington, DC, including Patent Examiner; Primary Examiner; Supervisory Patent Examiner (acting); and Instructor at the US Patent Academy. At Rensselaer, he also serves as Advisor/Patent Agent to the Office of Technology Commercialization where his principal roles include patent strategy, research opinions and prosecution. He is an Adjunct Professor of Natural and Applied Sciences at Northern Virginia Community College in Annandale, Virginia. Dr. Bawa attended Panjab University in India, earning a B.Sc.in Microbiology (1985). He earned his M.S. and Ph.D. degrees in Biology from Rensselaer Polytechnic Institute in Troy, New York. He is the author of around 40 scientific, legal and business publications in journals and books and presently serves on the editorial boards of the peer-reviewed journals, Nanotechnology Law and Business and International Journal of Nanomedicine. He is an associate editor of the peer-reviewed journal, Nanomedicine: Nanotechnology, Biology and in Medicine. He is co-editor of a new book titled Nanotechnology Law to be published in 2007 by Law Journal Press. Some of Dr. Bawa?s awards include: Talbot Award of the US Biophysical Society (1988); Research Fellowship/Teaching Assistantship from Rensselaer (1985-90); Sigma Xi Travel Award (1988, 1990); Appreciation Award from the Under Secretary of Commerce, US Department of Commerce (2001); Service Recognition from the American Society for Microbiology (2006); Director?s Award (2001) and Key Award (2005) from the Rensselaer?s Office of Alumni Relations.

In Episode III of the HealthDot Pharma Report we focus on black market medicines that lead to death, Mylan Laboratories’ acquisition of Merck’s generics unit, the (over) medication of US children and wrap it all up with a trip to Las Vegas and a conversation with Pharma Blogger John Mack.

Blackmarket Poisons

As has been reported, diethylene glycol was exported from China to Panama and killed over 360 people when it was mixed with medicine.

Eight mass poisonings such as this have occurred over the past 20 years and the death toll leads directly to companies in China where 3 out of the last 4 cases originated. The Chinese companies marketed their poison as 99.5% pure glycerin, the real ingredient used in cough syrups, toothpaste, food and other products.

Mergers and Acquisitions

Mergers and acquisitions’ the name of the game in the global generic drugs business as companies seek increased scale and geographical reach.

With that in mind, Mylan Laboratories is buying Merck’s generics business to for approximately $6.6 billion in cash.

Merck’s generics unit is number 4 in the world with 2006 sales of $2.43 billion but, according to Merck Chief Executive Karl-Ludwig Kley, the company is looking to focus its resources on further growth with its pharmaceutical and chemicals business sectors.

Mylan Chief Executive Robert Coury calls the purchase a “one-of-a-kind opportunity“ and says that the shear size of the new generics unit will allow Mylan to achieve immediate scale to compete in the global generics pharmaceutical space.

Medicated Children

If children are our future our future’s a medicated lot.

A study conducted by Medco Health Inc shows that the number of adolescent girls taking drugs for Type 2 diabetes has nearly tripled, while use of chronic medicines for psychotic behavior and insomnia roughly doubled among boys and girls.

The 2001 - 2006 study looked at 370,000 insured children aged 10 - 19.

Tom’s Real-time Thoughts While Editing the Video Late at Night

Why doesn’t Michael hold still in front of the damn screen? All he has to do is say the lines and stand there, but he’s sashaying left and right like it’s prom night.

Oh, s***, this deadline’s coming up fast.

Why does Photoshop keep crashing? Reboot the computer, again…

Terry Gilliam is a genius. Must keep animating.

How to make Pharma policy fun? Fire! Fire and pills! More pills! Reboot the computer.

Oh, s***, this deadline’s coming up fast…

One of the greatest impacts of nanomedicine is likely to take place in the context of drug delivery, which is poised to deliver to the market both evolutionary and revolutionary nanomedicines and devices. Early forecasts for nanomedicine commercialization are encouraging. However, there are challenges as well - formidable legal, policy, ethical and regulatory questions as well as emerging thickets of overlapping patent claims.

Currently, patent systems are under greater scrutiny and strain, with patent offices around the world continuing to struggle with evaluating the swarm of nanomedicine-related patent applications. Given this backdrop, it is natural to question whether advances in the laboratory will result in viable commercial products that benefit society.

Watch This Presentation (in new window).

Alan Minsk JD is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia.

Prior to returning home to Atlanta and his association with Arnall Golden, he worked with a Washington, D.C. food and drug law firm.

Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission.

He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports.

He serves on the editorial advisory boards of the Pharmaceutical Formulation & Quality and the Law Journal Newsletters’ Product Liability Law & Strategy journals and was recently appointed to the University of Georgia College of Pharmacy Regulatory Affairs Advisory Board.