Pharma Ethics, My Foot!

IDSA and ICAAC to join together for their annual meeting in 2008

2007-08-11T11:26:00.000-04:00

FYI, since we do quite a bit of ID work, IDSA and ICAAC will be FINALLY joining back together in 2008. Both societies split in the late 90's, IDSA having always been part of ICAAC since I think the 1950's...The reason for the split then was for corporate money sponsorships and for power and for political reasons...Don't you know power politics is involved with everything in business today. At the time of the spilt, ALL the ICAAC and IDSA membership were totally against the split, because as you can surmise it is difficult for ID physicians to take off two weeks for two separate meetings each year...Since the split both organizations have suffered in my opinion from a drop in total attendance for both meetings...Let's hope that this "reunion meeting" in 2008 will continue beyond next year !!

Reunions are great like CREAM, EAGLES, DOOBIE BROTHERS !! Music for all too !!

Why aren't meded agencies held to ethics standards as well?

2007-08-11T11:03:00.000-04:00

I have run a meded agency for 20 plus years now and run many symposia pre OIG and post OIG...I have always found and most of my client's agree that for a meded program to be effective "the higher the science" the better...The less commercial the programs are the bigger the audiences and the better value there is for the sponsoring company...It is like that today and it was like that in the 70's !!

I have seen however much of my competition, create bogus agencies, create transparent divisions, create in house CME accreditation and say to the clients we have appropriate "firewalls set up" within our organization to adhere to the OIG guidelines !!

What a load of crap !! How can an agency who is making money from its labor (hopefully), from a promotional service for let's say for example Novartis, create a "New Division" with a new name, at the same address, do CME now for ie... Novartis and be legitimate ?? I have even heard of examples where agencies have even created new corporate filing structures to "get around" rules set in place by Pharma companies to separate CME from promotional sides of activities.

These things are all a sham to subvert the OIG and to basically shaft the pharma companies who would be slapped by Surbane-Oxley and the OIG. There isn't a day that goes by that I don't see or hear some medical promotions agency bending the "rules"..that is why we (my agency) either do just promotions for a client or just med ed for a client. I have to look at myself in the mirror every morning and work with the client's best interest in mind (sorry for the self plug)...but it just gauls me how these mega agencies get away with this crap ! And screw their clients in the process. We always try to use a university affiliation for our CME and that we we have no fiduciary connection to the Med ed accreditor at all.

Cost of Antibiotics a Double Edged Sword

2007-02-16T11:55:00.000-05:00

For over 30 years, I have worked with pharma companies on promoting their developing and launched antibiotics. Since 1977, I have heard the same mantra from hospital pharmacists, " We can't use expensive new drugs ! We will blow apart our budgets!" A recent article in the Wall Street Journal discussed, hospital acquired infection rates and the inherent costs associated with patients who are admitted into a hospital for a procedure and then if they catch an infection emanating from the hospital (from central lines, ventilators, post op surgery, etc) the cost of therapy goes from an average of $31,389 to an astounding $185,260 ! It is the opinion today with proper education and techniques, these infection rates can be cut down in frequency...None of these costs have anything to do with the type and cost of antibiotics initially. Epidemiology associated with these infections and surveillance of these rates will help to cut down on the huge expense of treating these patients.

More Bad News at Pfizer Today !

2007-01-23T15:56:00.000-05:00

Pfizer will cut 10,000 jobs and close facilities in an effort to cut costs. Patent problems will also plague this pharma giant. In the months ahead, Zithromax and Zoloft will become generically available. In September of this year, Norvasc will also come off patent. Between 2010 and 2012, Lipitor, Aricept, Viagra, Detrol and Geodon will all lose patent protection. Things look bleak for the largest pharmaceutical company. These patent expirations will put a lot of pressure on Pfizer management in commercial development to in license new drugs for future development. Also expect to see Pfizer acquire another company. Maybe a biotech company this time ?

Even Pfizer can stumble !

2006-12-05T11:22:00.000-05:00

As we have all read Pfizer has pulled its newest investigational drug torcetrapib from further trials because of side effect issues(patient deaths). This drug was touted as the replacement for Lipitor, the next new wonder drug from Pfizer drug development. Well as we have seen with many other companies ,drug studies are often a crap shoot. If a serious side effect arises during the study process, the drug can often be pulled. What does this mean to thousands of Pfizer employees and vendors that support Pfizer? It means a lot of pain. Employees will be laid off and vendors will be fired. This is a hard fact of life for the industry that is often described as capitalistic and profit driven. As this news shows not all new compounds reach approval by the FDA and there is a ton of risk and expense incurred when pharmaceutical products fail during development.

Rodmann and Renshaw Healthcare Conference-What does it mean ?

2006-11-11T09:46:00.000-05:00

I just attended the R&R Healthcare economic conference in NYC this past week. After attending about 35 presentations on small pharma and biotek startup companies, it occurred to me the amount of risk associated with the development of new ground breaking compounds. At every presentation I attended, the one question that the economic analysts asked was, " When does your study data come out ???".

As we all know this business is driven by research and FDA approvals period. The future of all these small companies relies on positive data for drugs and medical equipment that is innovative and life saving.

Merck Wins Another Case !

2006-08-04T08:38:00.000-04:00

"Merck & Co. Inc. won its eighth case related to the COX-2 inhibitor Vioxx (rofecoxib), which was taken off the market in September 2004. In Los Angeles, a state court jury found that Vioxx could not be blamed for a 2001 myocardial infarction that occurred in a California man who had taken the drug intermittently since 1999. Merck produced evidence showing that the man had atherosclerosis and a family history of cardiac problems." This was just reported in the medical media. Of course you won't hear it on CNN, MSNBC or the major networks. The Vioxx case is sad in the fact that many of the men who had fatal heart problems were on multiple meds for many underlying cardiac conditions and that there was no deliberate effort by Merck to "hide" negative data about Vioxx. With the huge liability issues facing the pharmaceutical industry, it is a wonder that any new drugs are developed! Vioxx was a helpful drug that a lot of arthritis patients used for their inflammation and subsequent pain, that no longer is available.

Drug Companies Don't Give Anything Back ! !

2006-07-25T13:42:00.000-04:00

Let's look at the facts.....The pharma industry invests more in R&D as a percentage of revenues than computer companies, aircraft manufacturers, electronic companies, automotive companies and telecommunications firms. 79% of the Pharma R&D is for new products. Pharma develops 91% of the most widely used products vs NIH funded technologies. In 2004, pharma patient assistance programs helped over 6 million people. Over 4 billion dollars worth of free medications were provided to low income patients. These are the facts..I think Pharma can do better with the PAP's but they are on the right track !!

Pharma Patient Assistance Programs

2006-07-18T12:13:00.000-04:00

I just attended a pharma meeting in Morristown NJ, where about 100 industry managers discussed media issues and the industry and public perceptions. Most of us agreed that the industry is not always held in a positive light by the public. (Actually one of the purposes of this blog.) Bob Franks, President of the HealthCare Institute of NJ and past US congressman, spoke about the PAP programs offered by the pharma industry to assist patients that are in the lowest economic levels ways to receive free prescriptions. There are more than 30 plus companies that offer free prescriptions to patients that fall in the neediest category ! This www.RX4NJ.org campaign as well as a toll free number 1-800-RXforNJ can start the process where qualified patients can get their meds for free !

Billy Preston passes June 2006

2006-06-27T10:51:00.000-04:00

Those of us who love music were saddened at the passing of one of the greatest keyboard players in the history of popular music. Preston was mentored by Ray Charles and is the only musician who had played with the Beatles, the Stones and Eric Clapton. Preston wrote many songs as well including the classic Joe Cocker "You are so beautiful". Billy suffered from renal hypertension had severe kidney problems. He was undergoing renal dialysis for the last few years, after a kidney transplant failed. You may be asking what does this have do on my pharma blog ? Well, Bristol Myers Squibb (belatacept) is working on a new transplant drug that is similar to Sandimmune (Novartis), without the major side effects of these older drugs. Unfortunately Billy will not have a chance to be treated with these new agents. When these new drugs get approved, they will hold new promise for renal patients in the future.

What's it worth to Charlie ?

2006-06-16T15:44:00.000-04:00

I have a lunch buddy I eat with from time to time at a diner close to my office. Charlie is a spry individual in his 80's. He still works, he still plays golf, fishes, hunts and spends as much time as he can with his family. Charlie works in his own business as a middle man selling sporting equipment and he especially likes selling personal back yard putting greens ! Over the last 5 years or so Charlie has been having heart problems and most recently (about six months ago) he was admitted to a local NJ hospital for a major heart condition. His cardiac surgeon operated on him putting a few stents in his blood vessels. Since then he has been admitted to the hospital for complications (pneumonia). Just this week I had lunch with Charlie and the subject at the lunch counter was the high cost of his meds. What he is paying for and what his insurance pays for. Charlie said that his internist(cardiologist) has him on 4 or 5 different drugs and his cardiologists says " Charlie we are just fine tuning your meds, you are doing just great ! " Yes, Charlie is doing great, even with his problems, he is still active and his quality of life so far has not changed !! The vascular surgeon can take some credit for his condition but also the Pharma companies can take a bow for the advanced cardiac meds that have been developed over the past 10 years...Yes they are expensive...But what's it worth to Charlie ?? And to Charlie's family !

Toronto APA meeting

2006-05-31T16:31:00.000-04:00

On the Road Again !! I just returned from Toronto having worked and attended the 159th annual meeting of the American Psychiatric Association. One of the most fascinating happenings was before the meeting itself a group of about 150 people were picketing the Toronto convention center, waving banners that were denigrating the psychiatrists and also the drug companies for "addicting" children, creating social "monsters" and many other negative comments that showed the lack of knowledge this group had for the industry and for the physicians who attended the meeting. As I further inquired about this group, I was informed that most of them belonged to The Church of Scientology. The group that Tom Cruise has been promoting of late. It so happens that Mariel Hemingway was also featured as a key note speaker at the congress and who spoke on her family connection with mental illness and its future impact on future generations. The congress itself was filled with the latest research in the areas of psychotherapy and I found it one of the better congresses I have worked on this year from a stand point of new science and industry involvement.

Flu Pandemic-Who you gonna call ??

2006-05-14T19:29:00.000-04:00

Over the past 24 months, I have been reading articles about the Influenza A(H5N1) virus subtype that occurs mainly in birds. Although rare, human cases have been showing up in areas of the world such as Africa, Europe, Eurasia, East Asia and the Near East. The CDC is tracking these out breaks.

Back in 2003 and 2004, as my memory recalls there was a dire situation in the US concerning flu vaccine where one of the two remaining research pharma companies who produce this vaccine each year manufactured a bad batch and their was a severe shortage. The reason that there was this type of shortage is most of the vaccine companies went out of business or the large pharma companies discontinued this type of research and development do to extreme liability cost, (thank you ABA) and the US government(the largest purchasers of vaccines) asked for extremely low vaccine prices. This is what happens when the government sets prices and forces competitors out of the market. Shortages can occur and companies that can develop new vaccines for the avian flu won't be around. Let's hope that the avian flu does not develop into a severe pandemic. Although hoping will not develop new vaccines and drugs that are needed for new diseases and resistance that is developing in the infections that are killing thousands of hospitalized patients each year.

U.S. Records Big Decline in Death Rates

2006-04-21T15:25:00.000-04:00

In new exciting data just released in an internet article in HighBeamResearch.com, the annual number of deaths in the US dropped by 50,000 in 2004. The largest such decline in more than 60 years. Drops in death rates for heart disease, cancer and stroke accounted for most of the declines in this surprising development. I know having attended the heart meetings this past year (ACC,AHA), the recommendations for cholesterol levels has been decreasing as shown in the mega trials for cholesterol lowering agents. One wonders if the industry research and recommendations from these cardiac trials has helped the mortality numbers decrease with the implemented changes in drug prescribing ?? What is truly remarkable is these numbers have decreased when obesity and weight problems in the US are increasing. Another triumph for the US healthcare system which Pharma is a big part of.

Breast Cancer Breakthrough-STAR trial

2006-04-17T21:04:00.000-04:00

It was reported in the media today (4/17/06) that research done by Astrazeneca showed Raloxifene(an osteoporosis medication) is just as effective as Tamoxifen in preventing breast cancer in postmenopausal women. Another Pharma breakthrough that the industry can take credit for.

Those of us in the industry know that these kinds of phase IV trials are expensive and often times do not show such dramatic results. Hopefully this new indication for a safer drug will save many woman from getting this disease !

This kind of research spend is performed yearly by the top drug companies that are in constant search to develop new drugs that are truly life saving. These companies are committed to this development for two reasons...The first is to develop successful compounds that will benefit patients...the second is to provide a profit for these corporations...That is what pharma does best !!

I am not against Altria (a tobacco company) for making a profit if tobacco is sold to adults,even though tobacco is a known carcinogen or Anheuser Busch for selling beer to adults, even though their are thousands of DWI deaths on the highways each year...But yet again I digress, the Pharma companies are continually knocked for their ethics and marketing practices??

Ask any cancer survivor what they think of the drugs they have taken and the drug companies that have developed them...I am sure Pharma has no stronger advocates.

I welcome your comments. !

Pharma ethics what gives ?

2006-04-14T09:47:00.001-04:00

This is my first post on Pharmaethicsmyfoot. I felt that there is a dirth of opinion on how great the pharma industry is. Being a 30 plus year pharma veteran(dynosaur), I have seen the great things pharma has done in my lifetime for the young, elderly, sick and indigent. Yes... and you could say I am biased from the stand point of making my livelihood in the industry since 1973 !!

Has anyone noticed what the price of gas has done in the past two weeks. In NJ for instance, the price of regular grade gas has gone up to at least $2.40 a gallon. Why is that ?? Yes you hear Katrina, the war in Iraq, increased demand from China etc etc.....I have read that the entire Pharma industry sales do not match what EXXON sells each year !! And by the way, a lot of the gas price is tax !! So our federal and state government friends share in the increase in the gas and energy price gouge !! I don't hear much complaining about these abuses from legal groups or government watch dogs !!

Anyway I digress...The pharma industry has produced medical miracles daily in the areas of cure rates and life expectancy and quality of life. And yes the industry is profit driven. What industry isn't ?? If the industry has problems it is because we have done a poor job in educating the public on what the industry does, what it takes to development drugs, the huge liabilities the industry carries and how instrumental the industry has been on the great healthcare system we enjoy here in the US.

From time to time I will post information and opinions here that will support how terrific the industry is and how we can make it even better. I welcome your thoughts !!

Paul Marinelli
President
ALLIANCE
www.alliancemp.com