07Jan/07

Democrats First 100 Hours May Have a Big Impact on Life-Sciences

By Daniel R. Matlis

The Democrats are coming in full force with a very ambitious agenda for their first hundred hours in control of the senate and house.

During the first 100 legislative hours of the 110th Congress, Democrats plan to bring to the floor the following issues:

  • Tuesday, January 9 – Implement the 9/11 Commission Recommendations
  • Wednesday, January 10 – Increase the Minimum Wage
  • Thursday, January 11 – Expand Stem Cell Research
  • Friday, January 12 – Allow Negotiation for Lower Prescription Drug Costs
  • Wednesday, January 17 – Cut Interest Rates on Student Loans
  • Thursday, January 18 – End Subsidies for Big Oil and Invest in Renewable Energy

From a Life-Science perspective two of these stand out. Stem Cell research and Lower Prescription Drug Costs.

A Republican Executive and Democratic Legislative are going to make for an interesting two years for our industry. But as a Zen master would say:”Who is to know what is a blessing and what is a curse?”

26Dec/06

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

20Dec/06

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.

13Dec/06

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.

13Dec/06

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.