Life-Science Panorama

A Journal for Industry Executives

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December 26th, 2006

Top 7 questions for Pharma and Biotech in 2007

It’s that time of the year.  Mike Huckman, CNBC Pharmaceutical Industry Reporter, shares his outlook on the industry as part of CNBC’s top 7 for 07 series.

Here are Mike’s top 7 Questions on Medicine and Money in 2007:

Could the next diet pill craze start in 2007?

Will big Pharma keep doing deals with BioTechs?

Will Pfizer have to think big and do another huge deal?

Could Bristol-Myers Squibb and Sanofi-Aventis loose the patent on Plavix?

Will Generic Drug competition continue to threaten big Pharma’s profits?

Will the new Congress legalize prescription drug importation?

Will the new Congress let the government negotiate lower drug prices?

Want to know his predictions?  See the complete CNBC story

December 20th, 2006

That will be 1,053 Dollars for your 4 Dollar prescription

By Daniel R. Matlis

No, it is not a typo.  If you are uninsured, that $4 prescription will probably cost you $1,053.

Why so much you ask?

It’s pretty straight forward. Uninsured people often wait until they are much sicker than the insured to seek medical care. This medical care is typically in the form of an Emergency Room visit, and according to Blue Cross Blue Shield, the average Emergency room visit costs $1,049.

So why should you care, you have health insurance.

According to CNN:

  • 41% of Middle Class Americans had no insurance for part of 2005 (up 28% in 4 years)
  • 46 million Americans have no health insurance
  • Healthcare costs are the number one reason Americans file for bankruptcy
  • 92% of Healthcare Dollars in the US are spent after a person gets sick

In today’s environment, it does not take much for any one of us to become one of them.

Wal-Mart to the Rescue?

By now you have no doubt heard that Wal-Mart has completed the rollout of its $4 prescription program to all of its 3,810 pharmacies across the US.  What has not made big news is that Wal-Mart launched a pilot in-store health clinic program in the Northwest Arkansas region. In the first six months of the program, three clinics had treated 4,300 patients, nearly half them were uninsured.

Wal-Mart’s CEO Lee Scott said: “Wal-Mart is stepping up with solutions to the health care challenges facing America’s working families. We’re using our business strengths to make health care more affordable and accessible for our customers and our communities.”

I recently had the chance to speak with Kevin Gardner, spokesman for Wal-Mart Stores Inc., to get a better understanding of his companies “in-store health clinic” program. Gardner commented that Wal-Mart is on track to open 60 in-store health clinics be the end of January 2007.  Due to regulatory requirements, Wal-Mart does not run the clinics directly, but rather rents the space to third party clinics. During the pilot phase, Wal-Mart is testing a number of clinic models, including some staffed by Physicians and others staffed by Nurse practitioners.

The clinic charges a flat rate, averaging $45 per visit, and treats most common health ailments. If your condition warrants it, the clinic’s staff will write you a prescription, which Wal-Mart hopes you will fill at their pharmacy.

The trend is catching on with retailers and drug store chains like CVS, Target, Rite Aid and Walgreen offering similar services.

Will in-store health clinics single handedly solve the healthcare crisis in America? I don’t know, but I would pay $49 for a $4 prescription over $1,053 any day.

December 13th, 2006

My Body, My Choice?

By Daniel R. Matlis

No, it’s not what you think; I’m not going “pro” this or “anti” that on you.

I am referring to the Food and Drug Administration’s (FDA) proposal to make experimental drugs widely and easily available to seriously ill patients.

According to Dr. Andrew C. von Eschenbach, Acting FDA Commissioner “This proposed reform is carefully designed to balance several objectives.” von Eschenbach added “One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.”

The proposed rule is a direct response to a 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturning a lower court’s ruling in a case brought by the Abigail Alliance for Better Access to Developmental Drugs.

The court ruled that “barring a terminally ill patient from the use of a potentially life saving treatment impinges on the right of self-preservation.” Further, the court held that once drugs have passed safety trials, they should be made available if they might save someone’s life.

Judge Judith W. Rogers wrote “If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded ‘life’.”

Dr. Janet Woodcock, FDA’s Deputy Commissioner for Operations stated “FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients,” she added that “By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them.”

The proposed rules, which are open for comment for 90 days, are described in detail at the following FDA web address: http://www.fda.gov/cder/regulatory/applications/IND_PR.htm

I hope and pray that none of us ever face such a choice, but if we do, it should be our choice to make.

December 10th, 2006

Senate Confirms von Eschenbach as FDA Commissioner

Last week, Dr. Andrew von Eschenbach was confirmed by the Senate to head the U.S. Food and Drug Administration. Dr. von Eschenbach is 65-year-old oncologist, surgeon and cancer survivor. He has been acting commissioner at the FDA since September 2005, and is the former director of the National Cancer Institute.

His appointment will provide the agency with strong leadership as it heads into a potentially tumultuous year in light of legislative changes on Capitol Hill. The nomination, which passed the Senate by a vote of 80-11, will now be sent to the president.

Dr. von Eschenbach is a strong proponent of transforming the FDA to keep pace with changes in healthcare. He commented that the Agency must establish itself “as the bridge that supports new molecular-based interventions as they move across the discovery, development, and delivery continuum.” His vision for the Agency calls for aligning, adapting, and recognizing the importance of FDA’s leadership role and its responsibility in the metamorphosis that will define a new era in Healthcare.

 “This healthcare system of the future will be personalized by developing a sophisticated understanding of not only the disease process, but also of the individual patient. In understanding both the disease and the person at the molecular level, physicians will be able to provide treatment options uniquely suited to a patient’s particular needs. Instead of empirically prescribing a pill and hoping it works, patients will receive treatments designed specifically for them. We will use the new tools of molecular medicine to develop new individualized interventions and in the very process of molecularly monitored delivery to patients our understanding of the biology of disease in individual humans will be elucidated. In this way, delivery will become, in itself, a platform of discovery” commented Dr. von Eschenbach in a recent speech. He went on to say “I expect that this healthcare system will be much more participatory. Increased utilization of information technologies and improved communication strategies will allow patients to assume a substantially more active role in their healthcare.  It will be important for us at FDA to consider how we can work together with doctors and patients to make sure that they have the greatest opportunity to maximize the benefits of new medical products in a way that preserves their ability to make individualized choices free from restrictive burdens, and that the data derived from health care can be used to further enhance the safety and effectiveness of these products.”

It is clear from his comments that he has the right ideas to lead and transform FDA. However, implementing these ideas is not going to be easy. Although Industry and Agency staffers agree that the FDA is in need of increased funding, allocating resources may prove to be difficult under the current budget pressures.

December 6th, 2006

Pharma’s Business Model Doesn’t Seem to Be Working

That’s not just me saying it. Alan Murray, Managing Editor at the Wall Street Journal agrees.

In an Interview on CNBC, Mr. Murray said “The Fact of the matter is the way they (Big Pharma) develop drugs, the way they sell drugs and the way they interact with government regulators and the public all needs to change”. 

His comment on “The era of the blockbuster looks like is probably over” conveyed a similar message as of my last article on the “Beginning of the End for Big Pharma”. 

Click here to see the complete interview. By the way, you can fast forward the commercial to get to the interview.

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