Whose Fox Will Guard the Generic Drug Hen House?

In large type, The New York Times made a page 1 announcement of a "Deal in Place For Inspecting Foreign Drugs."  The article details that generics producers would pay yearly fees of $299 million to finance inspection of non-U.S. based manufacturing plants every 2 years.

This announcement gives me no comfort. The major pharmaceutical company payers control too much of the offshore inspection budget of the FDA and that power of control raises too high a risk of corruption of the system. If Congress approved a fee structure with dollars flowing into the U.S. general fund, rather than being earmarked specifically for FDA offshore inspections, and reasonable appropriations were made by Congress to support the FDA offshore inspection program, there would be a healthy separation between the payers and the FDA/Inspectors. As the proposal now stands, it sounds as if the pharmaceutical industry has strengthened its stranglehold on the FDA, offshore inspections, control of generics, and perhaps on Congressional campaign budgets and solicitations. Keep your eye on that hen house and remember that the foxes are only interested in taking care of themselves.

Does NY Times Editorial Demonizing Doctors Signal That Health Reform Is In Trouble?

If you haven't seen the NY Times Sunday (6/12/09 p. 7) editorial "Doctors and the Cost of Care," you should check it out. It focuses on a report by Harvard-affiliated Dr. Atul Gawande who concluded, after investigating high Medicare health care costs in McAllan Texas (population-141,000 with 103 physicians per 100,000 which is less than the U.S. average), that doctors' over-treatment of patients was responsible. Citing Dartmouth Research, the editorial echos the opinion that " . . . more costly areas and institutions provide a lot more tests, services and intensive hospital-based care than the lower cost centers . . . . yet their patients fare no better and often fare worse because they suffer from the over-treatment."

Numbers? Where are the numbers? Whose doctor is it that is testing too much and over-treating? Is the indictment applicable to 2 percent of the physician population, 98% of the physician population, or 50 percent of the physician population. Are these doctors practicing outside the standard of practice for their specialties (these days, even family practice is a specialty)? If they are, the solution is medical board investigation and disciplinary action, medical staff investigation and disciplinary action at the local level, and (unfortunately) appropriate lawsuits for poor practice conduct resulting in injury. But if these physicians are practicing within the standard of practice one must ask, what is the problem? Or is there a problem?

Yes, there is a problem. In part, it is in the education system that provides basic medical education and continuing medical education which is often influenced by pharmaceutical and medical device companies (through their detail personnel, hired-hand expert speakers, subsidized medical journal articles). There is also a problem with direct-to-patient advertising which is focused on having the patient demand the sponsor's product on his or her next visit to the doctor's office or even the urgent care clinic or emergency room. Pharmaceutical companies and device manufacturers, and in some cases universities trying to corner the medical market, set a "standard of medical practice" which is profitable for them and implicitly threatens those doctors who don't prescribe their products as "practicing outside the professional standard" which these companies have conned physicians and the public into believing is appropriate.

It also involves the marketing departments at HMOs, which measure health care quality in terms of "patient satisfaction" which is an entirely different concept. Under the marketing perspective, if a patient is disappointed because her doctor doesn't prescribe an antibiotic for influenza, the doctor is not satisfying the patient and is not providing the quality of care that sells HMO reenlistment. If a 20 year-old male is embarassed when the doctor checks for testicular cancer, the HMO marketing department may be unhappy, though the doctor may be saving lives through this 30 second examination.

When the Times labels physician behavior as "profligate" without providing a carefully investigated factual basis for its serious charge, and when the White House is referenced, I have to conclude that health reform is so threatened that political forces have stooped to demonizing physicians. The American public deserves better from the White House and the Times.

California Senator Defends Pilaging of Patient Confidentiality

In a June 2, 2008 interview on a local San Francisco area news program, California's Don Perata, Senator and Senate President Pro Tem, defended his vote in favor of S.B. 1096 which would grant vaguely defined parties, including pharmaceutical, research and marketing companies, access to confidential patient records in the guise of providing information to patients, saying that he voted for the bill because mental health groups wanted it. He didn't say which mental health groups. He didn't say whether they were organized independent patient/family groups, or whether they were fake non-profits organized, subsidized and controlled by pharmaceutical companies. He sidestepped the issue of the loss of confidentiality by all patients (the bill has a laundry list of medical conditions), not just patients with mental disorders, although he did mention that there was some consideration of requiring an "opt-in" rather than proceeding with the "opt-out" now contained in the bill. The vague terms of the bill would permit pharmacies to provide (for payment) confidential individual patient medical information to pharmaceutical companies through intermediaries, giving them access not only to confidential medical information, but more importantly from a pharmaceutical manufacturer's perspective, to the prescribing practices of physicians so that they can be targeted for intensive marketing efforts.

Note that the medical conditions described are those for which many prescriptions are written. The drugs prescribed provide enormous revenue to pharmacies, marketing companies, pharmaceutical companies, and communications media. This is a big money bill.

I suggest reading S.B. 1096 in full. In part the bill reads (emphasis supplied):

(20) The information may be disclosed as described in Section
56.103.
(d) Except to the extent expressly authorized by the patient or
enrollee or subscriber or as provided by subdivisions (b) and (c), no
provider of health care, health care service plan, contractor, or
corporation and its subsidiaries and affiliates shall intentionally
share, sell, use for marketing, or otherwise use any medical
information for any purpose not necessary to provide health care
services to the patient. For purposes of this section, a written
communication mailed to a patient by a pharmacy shall be deemed to be
necessary to provide health care services to the patient and shall
not require prior authorization, if all of the following conditions
are met:
(1) The written communication encourages the patient to adhere to
the prescribed course of medical treatment as prescribed by a
licensed health care professional and may include information about
that particular pharmaceutical drug as authorized in this section.
(2) The communication is written in the same language as the
prescription label produced by the pharmacy when the medication was
dispensed.
(3) The written communication instructs the patient to contact the
prescribing or dispensing health care professional if:
(A) The patient has questions about the medication.
(B) The patient is having difficulty adhering to the medication
due to adverse effects, dosing requirements, or other causes.
(4) The written communication pertains only to the prescribed
course of medical treatment, and does not describe or mention any
other pharmaceutical products. The written communication shall be
limited to the following diseases:
(A) Diabetes.
(B) Osteoporosis.
(C) Asthma.
(D) Chronic obstructive pulmonary disease.
(E) Cancer.
(F) Gastric disorder.
(G) Hypertension.
(H) Cardiovascular disease.
(I) Thyroid disorder.
(J) Organ transplantation.
(K) Chronic eye disorder.
(L) Rheumatoid arthritis and osteoarthritis.
(M) Renal disorders.
(N) Parkinson's disease.
(O) Seizures.
(P) Multiple sclerosis.
(Q) Depression.
(R) Schizophrenia.
(S) Bipolar disorder.
(T) Anxiety disorders.
(U) Attention deficit disorder.
(5) Further written communication shall not be provided if there
are no refills remaining on the prescribed course of therapy and
there are no doses remaining on the final prescribed refill, or the
pharmacy has been notified by a health care provider that a
prescribed course of therapy has been discontinued or substituted
with a different drug.
(6) All product-related information in the written communication
shall be consistent with the current federal Food and Drug
Administration (FDA) approved product package insert, and provide
fair and balanced information regarding the product's benefits and
risks in accordance with the FDA requirements and policies.
(7) A copy of each written communication version shall be
submitted to the FDA Center for Drug Evaluation and Research,
Division of Drug Marketing, Advertising and Communications, prior to
program implementation.
(8) Evidence-based or consensus-based practice guidelines shall be
the basis of any information that is provided to patients in order
to improve their overall health, prevent clinical exacerbations or
complications, or promote patient self-management strategies.
(9) All personally identifiable medical information collected,
used, and disclosed pursuant to this subdivision shall be
confidential and shall be used solely to deliver the written
communication to the patient. Access to the information shall be
limited to authorized persons. Any entity that receives the
information pursuant to this subdivision shall comply with existing
requirements, including Sections 56.101 and 1798.84, concerning
confidentiality and security of information. The pharmacy must have a
written agreement with any entity that receives the information. The
written agreement shall require the entity to maintain the
confidentiality of the information it receives from the pharmacy and
prohibit the entity from disclosing or using the information for any
purpose other than to deliver to the patient the written
communication that is the subject of the written agreement.
(10) If the written communication is paid for, in whole or in
part, by a manufacturer, distributer, or provider of a health care
product or service, the written communication shall disclose whether
the pharmacy receives direct or indirect remuneration, including, but
not limited to, gifts, fees, payments, subsidies, or other economic
benefits from a third party for making the written communication and
shall disclose, in a clear and conspicuous location, the source of
any sponsorship in a typeface no smaller than 14-point type.