A new report from the Center for Public Integrity, “Drugmakers’ Dime Funds Congressional Travel,” finds that members of Congress and their aides accepted more than $600,000 in free travel from pharmaceutical interests during a 5½-year period (from January 2000 through June 2005) in which drug company profits climbed, in part due to federal legislation favorable to the industry.

This has the potential for peddling influence on lawmakers. Nothing is more demonstrative of this that new revisions to the Medicare program. Once lawmakers added the prescription drug benefit for senior citizens to Medicare, the pharmaceutical industry found a reliable consumer for its products. Meanwhile, a provision in the law — for which the pharmaceutical industry lobbied heavily — prevents the federal government from negotiating price discounts with drug companies.

That means Pfizer, Inc. (NYSE: PFE) and Nektar (NASDAQ: NKTR) stand to benefit enormously if Medicare recipients have their endocrinologists prescribe Exubera inhaled insulin for treatment of their Type 2 diabetes.

Some members of Congress show a conflict-of-interest by having a personal stake in the outcome of certain drug manufacturers.
For example, Sen. Orrin Hatch, R-Utah, and his aides took seven trips, totaling $12,000, sponsored by Pfizer, Inc. (NYSE: PFE) and GlaxoSmithKline plc (NYSE: GSK), as well as two industry trade groups, the California Healthcare Institute and the Healthcare Leadership Council. As of May 15, when Hatch filed his 2005 financial disclosure form, the senator held at least $18,000 worth of stock in Pfizer and Novartis, the Swiss-based manufacturer of Ritalin, the attention-deficit drug.

Hatch co-sponsored the Medicare bill in the Senate while holding at least $3,000 worth of shares in Pfizer and Novartis, according to his 2003 financial disclosure forms.

For 2006, Hatch is fourth on the list of Congressmen receiving funds from the pharmaceutical industry
The Senate and House ethics manuals state that having personal assets or holdings, such as stocks in industries that also have significant legislation pending, is not automatically considered a conflict of interest. The manuals state that legislation spans a wide range of business and economic endeavors, and they specifically do not require complete divestiture.

But many drug industry critics disagree. The argue that maintaining a personal interest in legislation creates a clear bias. That potential conflict is heightened when a lawmaker accepts trips sponsored by an industry with business before Congress, critics say.

It’s also significant because, as one commentator on a patent blog observed:

Senator Hatch is the Chairman of the Senate Subcommittee on Intellectual Property…This committee handles all intellectual property bills in the Senate, and will certainly be the committee that controls any and all patent reform bills. As Chair, Senator Hatch will preside over markups of such bills.

Very interesting indeed. Do hundreds of thousands of dollars in pharmaceutical companies’ and their lobbying groups’ nickels and dimes fund congressional travel? You bet your insulin they do. Could this impact the cost of your insulin, whether analog or inhaled? If you’re on Medicare, it may have.

With Hurricane Ernesto poised to strike Florida from the Caribbean, Type 1 diabetics who take insulin injections and Type 2 patients on pills are probably thankful that Exubera isn’t supposed to be available for until September 2006.

That’s because Pfizer warns that the new Exubera insulin inhaler and blister packets “should [be] store[d]..at room temperature, in a dry place, free from humidity. Do not refrigerate.”

Imagine how difficult it would be trying to keep Exubera dry, humidity free, and at room temperature in the middle of a hurricane!

According to the American Association of Clinical Endocrinologists (’AACE’) and Eli Lilly & Co. (NYSE: LLY):

People with chronic medical conditions that require daily medications are among the most vulnerable victims of natural disasters, as access to their homes, medical supplies and even medicines may be interrupted or compromised.

The AACE and Lilly put together a list of things that diabetics should try to prepare, pack, and take care of so that they can weather through the storm as best as possible.

Here is the list they put together for diabetics (parts of it may be helpful for people with other chronic medical conditions):

• Ensure that your medications and supplies are stored in a defined location and can be easily gathered if you must quickly evacuate your home or place of work
• If you use insulin, keep cool packs or ice in your freezer that can be easily reached to keep your medicine cool while on the go
• Compile an easy-to-identify, easy-to-reach kit that includes:
  • Extra medical supplies, such as syringes, cotton balls, tissues, alcohol swabs, blood glucose testing strips, blood glucose meter, lancing device and lancets, urine ketone testing strips and any other items relevant to your therapy and blood sugar monitoring
  • An empty hard plastic bottle to dispose of syringes and lancets
  • Small cooler to store your insulin while away from refrigeration
  • Pen and small notebook to record blood sugars
  • Extra pair of glasses (if you wear glasses)
  • Extra copies of prescriptions and health insurance cards
  • Emergency medical information and emergency contact list, including your caregiver’s and physicians’ names and phone numbers. If you are a parent of a child with diabetes, keep a copy of the physician’s orders for your child’s care on file with the school, as well as in your disaster kit
  • Up-to-date glucagon emergency kit (if using insulin) and fast-acting carbohydrate (such as glucose tablets or orange juice)
  • Non-perishable items such as granola bars, unsweetened cereal, hard candies, peanut butter and crackers, and water
  • Typical emergency items such as a First Aid kit, flashlight, whistle, matches and candles, radio with batteries, and work gloves
• Keep the kit up-to-date and ensure you have enough supplies to last at least a week
• Keep something containing sugar with you at all times in case you develop low blood sugar
• Maintain your meal plan to the best of your ability and keep hydrated. However, food and water supplies can often become contaminated during a disaster and it may be necessary to boil water before drinking
• Monitor your blood sugar frequently and record your numbers
• Increase your food intake during periods of excessive physical exertion (such as lifting heavy objects or walking longer-than-usual distances) by eating appropriate snacks between meals
• Wear shoes at all times and examine your feet often, as people with diabetes are more vulnerable to developing infections. If you have a foot wound, seek medical attention immediately
• If you are relocated or affected by a disaster, call your doctors as soon as possible to touch base and maintain the continuity of your medical care
• If you are a parent of a child with diabetes, make sure that you clearly identify which school staff members will assist your child in the event of an emergency
• If you are displaced or need to evacuate, identify yourself immediately as a person with diabetes and report any related conditions so that authorities can provide for proper medical care

Be sure to contact your endocrinologist, diabetes educator, and health care team to find out if you may have some local options to help you manage your diabetes during the storm. Be prepared, be ready, and stay safe.

Imagine selling a drug in a country whose government regulatory agency hasn’t even approved its usage. In the U.S. that’s a risky proposition for pharmacists and snake-oil sales people. The U.S. Food & Drug Administration and Federal Trade Commission can do more than just slap your wrists: they might slap you with court injunction shutting down your business or prohibiting you from selling unapproved products.

So imagine living in the U.S. and being able to buy Pfizer Inc.’s Exubera from a pharmacy outside of America, located in a country whose drug regulators haven’t even approved the new inhaled insulin. Pretty weird, huh? Guess where you can get it:

That’s right: O, Canada! Even though Pfizer has remained tight-lipped about whether it submitted an Exubera drug approval application to Health Canada, and the country hasn’t yet approved it’s safety and availability for the public, one pharmacy in Winnipeg, Manitoba is selling the inhaled insulin, and publishing prices for the drug.

CanadaDrugs.com is already selling Exubera insulin foil blisters packets and inhalers to folks with prescriptions for the diabetes drug, even though it hasn’t been approved there. That’s a real conundrum, eh? Health Canada restricts drug advertising and sales:

Regulatory Requirements for Advertising

Only drugs that Health Canada authorizes for sale in Canada may be advertised. Specific requirements exist for advertisements of prescription drugs to consumers.

The Canadian mail-order pharmacy must be after the U.S. market for the inhaled insulin, especially since Pfizer already pushed back Exubera’s U.S. launch from July 2006 to September 2006.

CanadaDrugs.com is charging the following U.S. prices for Exubera:

• Exubera 1 mg - $ 72.18 USD (90 blisters @ $0.80 each)
• Exubera 3 mg - $178.43 USD (90 blisters @ $1.98 each)
• Exubera Inhaler Kit - $150.93 per kit
  (Each Exubera Kit includes 1 Exubera Inhaler, 1 Replacement Chamber, 1mg x 180 tablets, 3mg x 90 tablets, and 2 Exubera Release units)

Not surprisingly, the pharmacy notes that “All prescription products REQUIRE A VALID PRESCRIPTION be mailed, faxed or emailed to CanadaDrugs.com to complete your order.

How the heck can the diabetes drug be available for sale to U.S. folks by mail-order when the Canadian government hasn’t even yet approved the insulin insulin’s safety via its regulatory channels?

Pfizer, Inc.’s (PFE) new inhaled insulin Exubera will be part of the focus at next month’s 11th Annual Drug Delivery Technologies and Dealmaking Conference in New Brunswick, N.J.

Presenters at the conference will include a number of pharmaceutical industry folks and investment analsysts. People who will talk about Exubera’s development and approval by the FDA include:

• Keith R. Horspool, Ph.D., Assistant Director, Pharmaceutical R & D, Pfizer, Inc.
• Christopher Searcy, PharmD., MBA, Vice President Corporate Development, Nektar Therapeutics; and
• Andrew Forman, Senior Analyst and Managing Director, WR Hambrecht + Co

While it’s not showcased on the conference agenda’s overview, it’s interesting to note that the meeting’s more detailed agenda shows that several attorneys will be speaking on the second day of the conference about a drug’s safety approval process before the U.S. Food & Drug Administration (’FDA’). Thomas Saunders and John Serio of Brown & Rudnick, LLP will be discussing:

505(b)(2) — Facilitating Approval for Enhanced Drug Delivery

Modifications in product drug delivery profile does not leave the innovator starting from zero. For modified drugs, 505(b)(2) approvals are easier than an NDA and harder than an ANDA— with elements of both. Section 505(b)(2) is a path to approval which permits reliance on both (i) literature and (ii) an FDA finding of safety or effectiveness for an approved drug product. One can rely on the predicate compounds drug safety data — likely leaving some bridging tox and efficacy studies to be done. As a bonus, 505(b)(2) approval provides for 3 years of formulation exclusivity. This process may (or may not) be the back door for generic — non-identical— biologicals or naturally derived products.

This conference panel is currently the only one slated to discuss safety issues for new drugs like Pfizer’s Exubera.
The discussion of how drug companies might be able to use federal law in their new drug applications by relying on the “predicate compounds drug safety data” should be of inerest.
A mention of “some bridging tox[icology] and efficacy studies to be done” should be of keen interest to physicians, drug companies, federal lawmakers and government regulators , as well as trial lawyers.

Does that suggest that drug approval can be pushed throught the FDA, predicated on additional follow-up studies by the drugmaker? That appears to be exactly what was done with Exubera.

When Pfizer, Sanofi-Aventis, and Nektar received FDA approval for Exubera inhaled insulin back in January, the drug approval was conditional: it was predicated on the drugmaker completing 5-10 year long-term safety studies addressing a host of safety concerns, including studies assessing long-term pulmonary risks, use by diabetics who smoke, diabetics with asthma, as well as children.

You can find more information about the conference speakers and agenda here:

11th International Drug Delivery Technologies & Deal-Making

If a new post on CafePharma’s message board is really from a Pfizer, Inc. (PFE) sales rep., the company could be in for Exubera inhaled insulin insurance coverage problems.

According to the anonymous poster:

Insurance issues will come back to bite us in the ass. Getting folks pulmonary testing done without a diagnosis will be a challenge, and it isn’t like the T2 diabetics are sitting on a big pile of cash to pay for spirometry out of pocket.

It’s probably too early to see whether health insurance companies like Aetna, Inc. (AET) will be ready to put this kind of initial and follow-up testing for pulmonary risks on Type 2 diabetics before they can start using Exubera.

We’ll have to wait and see.