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Discussion of “Industrial Policy for Big Pharma” in the Washington Note. The point of the article seems to be that this poor industry, which happens to be one of three most profitable sectors in our economy, is somehow suffering from relatively few new drugs being approved in the last year. Something must be done!!!

A more relevant consideration, in my view, is how to afford the new technology–pricing of new drugs is beyond the means of our system. More on this in future posts.

When I was in practice the the drug industry’s promotional efforts at meetings, in the hospital, in our offices, even as a sponsor of information on the internet was overwhelming. In evaluating recommendations, medicynic found himself always reviewing the declared conflicts of interest of speakers/authors/researchers (if they were available) and frequently deciding that their conclusions were unduly influenced by the sponsor.

Financial interactions between physicians and the drug industry (this could also refer to insurers and other suppliers as well) compromise our integrity and that of the entire health care system. Not only must we avoid frank conflicts of interest but we must also avoid even the appearance of these conflicts in order to maintain our role as fair, ethical, and independent patient advocates.

Jerome Kassirer a former editor of the New England notes the extent of the industry’s influence in On the Take–How Medicine’s complicity with Big Business can Endanger your Health (Oxford Press 2005). It’s a good educational read. His suggestions for addressing this issue follow.

“Items for immediate implementation:

1. Exclusion of all gifts from industry (by law if necessary), even including items that might be considered useful in a doctor’s practice or education; elimination of physician participation in company-sponsored speaker’s bureaus.

2. Prohibition of consultations with industry for anything except scientific matters, and outlawing of marketing by physicians of drugs or devices in which they have a financial interest.

3. Full disclosure to patients in all doctors’ private offices of any and all financial incentives for patient care or clinical research.

4. Elimination of “finder’s fees” for identifying patients to drug companies or their intermediates; no “farming out” of patients for clini-cal research.

5. Permission to conduct clinical research on devices or drugs in which the investigator has a financial interest should be proscribed.

6. The requirement of full accessibility for independent analysis of all data in any published clinical trial in which the investigators had a financial conflict.

7. A requirement of full, detailed disclosure in legible handouts at all teaching events of the type (drugs or devices), dollar amounts, and duration of all financial ties of the lecturer that relate to the subject at hand; full disclosure of the sponsorship of all such events.

8. The selection of journal editors, officers of major professional o-ganizations, and leaders of academic institutions among; physicians who have no financial conflicts.

9. A demand for increased scrutiny by medical editors of all financial conflicts of authors, with full disclosure not only of the com-pany relationships but also the specific relevancy of the conflicts to the subject matter (specific drugs and devices).

10. Pressure for a comprehensive analysis of the problem by the Institute of Medicine that would include drafting principles and guide-lines for all types of financial conflicts, not just those associated with research.

Items for further analysis and debate:

1. If CME lectures by individuals with financial conflicts cannot be prohibited, should physicians boycott courses given by financially conflicted lecturers?

2. If clinical-practice-guideline committees cannot be constituted exclusively by non-conflicted individuals, what safeguards can be introduced to reduce the chance of biased recommendations?

3. If ownership of stock in a company that could benefit from a researcher’s work and scientific consultations with a company create conflicts, what is the basis for any specific “minimally acceptable” amount that researchers can hold in stock or receive yearly in compensation for consultations?

4. How could a universal Web-based registry of physicians’ financial conflicts of interest be implemented?

5. How can the financial arrangements of professional organizations with industry be disclosed, including the amounts, duration, and purposes for which the funds were used?

6. How can the dependence of professional organizations on industry support be reduced?

7. Can industry be convinced that in the long run the harm of physicians’ collusion with their marketing practices is more serious than the short-term gain in sales?

None of these questions will be addressed without strong pressure of the public and the avid participation of leaders of professional organizations and academic medicine. I challenge them to take up the battle.”

Read the book for the details.

The FDA has approved the papilloma virus vaccine. It’s cost will be a burden if mandated.

Good article in NY Review of Books, Marcia Angell is a former editor of the New England Journal of Medicine–one of Medicine’s most prestigious jounals.

Some interesting references from the article–a medicynic reading list.

Merrill Goozer, The $800 Million Pill: The Truth Behind the Cost of New Drugs (University of California Press, 2004);

Jerry Avorn, Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs(Knopf, 2004);

John Abramson, Overdosed America: The Broken Promise of American Medicine (HarperCollins, 2004);

Jerome P. Kassirer, On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health(Oxford University Press, 2004);

No Child Left Different, edited by Sharna Olfman (Praeger, 2006);

Ray Moynihan and Alan Cassels, Selling Sickness: How the World’s Bigest Pharmaceutical Companies Are Turning Us All into Patients (Nation Books, 2005).

The Truth About the Drug Companies: How They Deceive Us and What to Do About It (Random House, 2005).

Double digit increases in drug spending on new “specialty” drugs is noted here.

In the article it is noted that “Spending on cancer drugs known as antineoplastics, which were administered outside a doctor’s office, rose 19.2 percent, the third largest jump. The price per prescription rose by almost 15 percent to nearly $1,600 on average, making inflation the primary driver of the spending increase.”

I hadn’t noticed inflation at over 15% in other sectors.  Remember, the fiduciary responsibility of drug industry executives is not providing quality health care, rather it is to maximize profits. This needs to change!

On a recent road trip to Yellowstone, the price of gasoline to ranged from $3.27 in Washington State to $2.77 in Montana and Idaho. There is no explanation or for the price differential and we’ve heard all manner of outrage and protests about it from the media and our elected representatives!!!

Meanwhile at the ASCO (American Society of Clinical Oncology) meeting “major” progress in the treatment of kidney cancer was announced. See also here.

Nexavar (sorafenib) Sutent (sunitinib malate) and temsirolimus all seem to have activity against kidney cancer. This is real progress but it should be noted that these drugs do not cure the cancer and the survival improvement appears to be limited to be only a few months. Yet Nexavar will be sold to the public at a cost of over $4000/,month and Sutent at $38,000/year. Temsirolimus has not yet been approved for sale in the U.S.

We do not have a free market in pharmaceuticals. The government provides patent protection for 20 years to manufacturers developing new products. During this protected period the company can charge whatever it wishes for the product. It has a monopoly.

One would think that the quid pro quo of such a system would be that the companies price the medications fairly not take advantage of their government protected market. Yet these new drugs that have yet to show major benefit are priced higher than the average and median incomes in our country. Who can afford them? Where is the outrage?

Overdosed on therapy! We are when you consider traditional medicine with its overstated benefits and overwhelming costs; watch the television ads for medications and “health aids,” consider the overabundance of “non-traditional” approaches, health hucksters and such, therapists of every ilk almost with limited to no basis in science and no proven health benefit. We’re spinning our wheels to the tune of over 15% of our GNP.

Cancer, like all other medical problems is treated best and most cost-effectively with prevention. Therefore, it is great news that a vaccine to prevent HPV (Human Papilloma Virus) infection, a cause of cervical cancer, has been recommended for approval by the Food and Drug Administrations’s (FDA) expert panel—the FDA usually but not always follows these recommendation. A decision to allow marketing is expected by June.

This Guttmacher report outlines the world situation with cervical cancer. There are about a half million new cases each year with half dying of the disease.

In the U.S. there are 12,000 new cases each year with about 1/3 dying of the disease. However, each year there are “approximately 5.5 million new genital HPV transmissions representing about one-third of all new sexually transmitted infections” with an estimated 20 million men and women thought to have genital HPV at any given time. Access to PAP smear early diagnosis technology is successful in limiting the number of those developing the invasive dangerous disease.

The cost of this vaccine , $300 and $500 per patient, is prohibitive for people living in third world locales where yearly expenditures per capita for health may be as low as $5.00/year. As this drug moves to market the question will be how to provide it in the places where it is needed most.

The broader question here and most notably with HIV treatment, is how to bring modern medical technology to people who need it most. Our system of government sanctioned monopoly, i.e. patents, is not up to the task.

Darksyde at the daily Kos reviews the Christianist right’s changing view of this vaccine.

A significant decrease in transmission of HIV in Kenya has been reported.

It’s not clear what is actually working. But combining prevention strategies of abstinence education, condom use and testing, with treatment available makes sense to me.

However, the U.S. funded program limits those under 15 year old to abstinence education alone –unless they ask. In a culture where HIV is highly prevalent and early sexuality is common and in some situations expected, we need to provide the full gamut of HIV prevention information.

The PSI policy statement doesn’t own up to it’s limitations.

There may be problems with this medication and careful monitoring and study of it’s effects are essential. Perhaps at some point there will be enough adverse data to remove it from the market. (Washington Post 5/17)

The groups opposing it in the Post article today, however, lack credibility. They believe that contraception of any kind encourages promiscuity and that all types must be opposed. Many of them believe that the only acceptable contraception is the rhythm method which was rejected as ineffective two generations ago.
Hopefully the FDA will objectively evaluate and use the evidence not preconceived notions to guide their decisions.