Deadly "Herbal" Health Supplements - Don't Buy, Give or Take Them

Today's New York Times had a well written article by Natasha Singer about the dangers of imported supplements Americans take for a variety of reasons (a common one seems to be weight reduction) and the risks that these supplements may be deadly, rather than helpful.

Hematologists see patients with very abnormal blood counts (at life-threatening levels) who steadfastly deny taking any medicines and then, after careful questioning by the doctor, admit that they buy and take Chinese origin "herbal" health supplements for their aches, pains, joint problems, excess weight and other non-life threatening conditions. Several years ago I attended a San Francisco hematologists' meeting at which the problem of an "epidemic"  of life-threatening aplastic anemia was discussed. A meticulous investigation at the University of California disclosed that medicines sold as "herbal" contained an antiinflammatory agent, butazolidine, which  wiped out patients'' bone marrow's blood production. Butazolidine was one of  many pharmacologically active ingredients in all purpose pills bought at local shops, not pharmacies.

Read The Times article. Don't take miracle drugs, for which the only miracle is that you survive their serious side effects. Speak to your doctor, nurse or pharmacist for good solid medicine based on science, not the need to make a quick profit on the powerful drugs on the shelf in the back room.  And tell your physician about every medicine you take, whether the medicine is by prescription, over the counter, from a health food store, or from the back room shelf of a local shop.

Added 8/31/2011: Read this FDA warning letter to an Asian manufacturer and learn about the seriousness and the magnitude of problems relating to offshore drug manufacture.

A Good Morning

This morning, as I prepared for a visit to my doctor, I thought about a patient whom I had not seen in many years. He had presented with a complex problem, involving an incorrect diagnosis, given by reputable physicians at a reputable medical center, and treatment proposal, and my job was to establish the correct diagnosis, tell him that he did not need chemotherapy, tell him that the most appropriate treatment at that time was surgical, and help him get on with what turned out to be a long, well-lived life. Early on, I had presented his "case" at an academic conference at a nearby University Medical Center.  My last thought about him this morning was that our experience had taught me that no physician should be arrogant about establishing a patient's diagnosis, particularly if in the process meant correcting another physician's diagnosis.  After all, the second doctor is always smarter because he has the work of the preceding doctor to look back on and a time interval between that doctor's evaluation and the time the patient presents for further advice, to clarify the situation.

On my arrival at my doctor's office, the nurse brought me to his examining room. She asked me questions appropriate to my visit and that told me that, as his daughter,  she had accompanied the patient described above to my office on several visits. She described her father's opinion concerning the way I practiced.  She told me about her father's death, a number of years after my retirement from active practice. I did not remember her trips to the office with her father, and told her that,  though I did remember significant elements of what he had related to me.  I mentioned that I had thought about her father this morning and demurred when she asked me why I had thought about him, questions I later answered.

This time, I was the patient. She and the doctor in the office were the health care professionals. It was a good morning.

An Unrecognized Danger For Patients and Physicians

Physicians: reading the linked article on Borderline Personality Disorder may save your career.

During my professional work as a health care attorney, representing physicians about whom there had been complaints to the state Medical Board (and occasionally, to the police) I observed a disturbing pattern.A number of the complaints about physicians' behavior came from patients who clinically seemed to have "Borderline Personality Disorder."  These were generally new patients to the affected physicians who noticed nothing unusual in their interactions with the patients who subsequently complained, but the results were serious and had serious professional, legal and financial consequences.  Physicians and other health care professionals should read this National Institute of Mental Health information guide.

This information may save your professional career and help you to better care for people with borderline personalities.

"Mission Accomplished" and New York Streets' Shell Games

If you grew up in New York City, or have wandered its streets as a visitor, you have seen people in front of small tables on which there are shells, one of which covers an object (small, like a pea). The object is to get the mark to wager that he can guess which shell covers the pea as the con man moves the shells around, delivers rapid fire patter, and uses distraction and a partner to separate the mark from his money.  The keys to this fraud are rapid movement, distraction, and the appearance of simplicity.  The shell game is a con which separates people from their money because they don't understand what is going on in front of them.

I  wonder whether the well-publicized announcement that our Iraq mission had been accomplished was part of a shell game in which the American people were distracted from the real purpose of their government's executive, advisers and political party while the significant plan was to separate our citizens from $3 billion (and many lives) that the Iraq "mission" has cost, making social and health programs unaffordable and unavailable.  We are now told that we cannot afford schools for kids, health care for seniors, medical care for our poor, or even a clean safe environment because our country has been plunged into near bankruptcy by our social programs.  Was the real plan to be accomplished on the aircraft carrier during the mission accomplished show a carefully staged charade to deplete our financial resources so that the wealthiest country in the world could not afford social justice programs?  Are our pockets now empty - and our ability to provide health care for the poor, sick and elderly wasted - because of  a sophisticated con carried out by a politician who appears to have vanished from the national stage and seems to be forgotten (or hidden?) by his political party?

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.

Considering Robotic Prostate Surgery - Read This Before Seeing the Doctor

Are business considerations, rather than expertise and patient care considerations, driving robotic surgery. Read this NIH article  (National Cancer Institute)  before agreeing to where the prostate surgery is to be done, who will be your surgeon and the type of prostate surgery.  And good luck!

A Good Question

A reader asks: "What of Congressional/presidential action that would prevent minor [or major] generic drug price increases."  I have waited a few days before responding because I think this serious question deserves thought, rather than a glib answer.

Some of my readers may have read Ezekiel J. Emanuel's "Opinion"article in the Sunday Review section of August 7, 2011's New York Times which touches on some of the issues related to a shortage of generic drugs effective against some cancers.  If you haven't read it, you should for it illustrates some of the complexities in this troubling area. [Some of my readers may recall my discussion of the Thursday lunch discussions at which oncologists described their difficulties in obtaining chemotherapy drugs to give their patients, which they ascribed to their purchasing drugs which patients were unable to pay them for, inability to get authorization from some insurers to pay for the drugs (or insurer authorization presenting expensive time-consuming bureaucratic hurdles to authorization), or difficulties accessing the drugs or being paid for their time, energy and staff whose burned up financial resources in the process.]  Several of my oncologist colleagues, who were superb physicians, have retired from their practices because (as they expressed it) of dissatisfaction with their ability to properly treat patients under the existing health care practice conditions  and because they were operating their practices at a financial loss.)

I have discussed some of the issues concerning the scarcity of generics, and their rising prices (inadequately offset for Medicare Part D  patients by price increases for generics which offset any savings the government may have garnered for them  when they reach the doughnut hole (i.e., 7%).  Congress and the President have the capacity to use governmental tools to answer significant questions and take action based on their findings: 1) has there been significant consolidation among generic drug producers (including those offshore) which reduces competition in the industry to the detriment of patients?  2) have large pharmaceutical companies acquired generic drug producers, or entered into joint operating agreements with them, which effectively reduces competition to the detriment of patients? 3) is the federal trade commission carrying out its intended function of promoting competition, or has it been sidelined to protect drug manufacturers from competition? 4) is the legal strategy of certain large pharmaceutical companies inhibiting the appearance of generic versions of their "branded" drugs when they go "off-patent"? 5) is the generic drug approval process inhibiting adequate public access to generics in reasonable quantities and at appropriate prices? 6) does the public have adequate information about the sources (country of origin, capability of the manufacturer, and quality of drug) of generics currently being sold in the United States and is that information based on appropriate investigation of those companies by an FDA which is adequately funded by Congress to carry out those functions? 7) Is the Orphan Drug Law being subverted through the introduction of a drug as a treatment for a rare serious disease and then the application of that drug to other treatments at a protected artificially high price? 8) is there financial transparency throughout the entire drug pharmaceutical production and distribution process or are there numerous unknown intermediaries who jack up the price of drugs without tendering services of commensurate value? 8) is our patent law artificially creating shortages of life saving generic drugs? 9) is the rebate, discount and kickback system applied by pharmaceutical insurers, the government and other actors in this field destructive of consumer protection?  10) and finally, does anyone with political power and authority really give a damn?

Judge For Yourself

I have reproduced the entire minutes of this FDA meeting for your review. My questions include: what was the real subject of discussion?  What was accomplished.  Were our citizens' interests represented? What will be the next substantive step? Did Americans get their moneys' worth from this meeting?  If you have a sense of disquiet, don't complain to me: direct your comments (with a complete copy or link to this blog) , laudatory or otherwise,  to your Congress people.

 

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Minutes From Negotiation Meeting on MDUFA III Reauthorization: July 15, 2011

FDA - Industry MDUFA III Reauthorization Meeting
July 15, 2011, 10:20 - 2:10 pm
FDA White Oak Building 1, Silver Spring, MD
Room 4101-4105

Purpose

To discuss MDUFA III reauthorization.

Participants

FDA
Malcolm Bertoni	Office of the Commissioner (OC)
Ashley Boam	Center for Devices and Radiological Health (CDRH)
Nathan Brown	Office of Chief Counsel (OCC)
Kate Cook	Center for Biologics Evaluation and Research (CBER)
Natalia Comella	CDRH
Christy Foreman	CDRH
William Hubbard	FDA Consultant
Elizabeth Hillebrenner	CDRH
Toby Lowe	CDRH
Thinh Nguyen	OC
Tracy Phillips	CDRH
Don St. Pierre	CDRH
Ruth Watson	Office of Legislation (OL)
Nicole Wolanski	CDRH
Barbara Zimmerman	CDRH
Industry
Hans Beinke	Siemens (representing MITA)
David Fisher	Medical Imaging Technology Alliance (MITA)
John Ford	Abbott Laboratories (representing AdvaMed)
Elisabeth George	Phillips (representing MITA)
Donald Horton	Laboratory Corporation of America Holdings (representing ACLA)
Tamima Itani	Boston Scientific (representing MDMA)
Mark Leahey	Medical Device Manufacturers Association (MDMA)
Joseph Levitt	Hogan Lovells US LLP (representing AdvaMed)
David Mongillo	American Clinical Labs Association (ACLA)
Jim Ruger	Quest Diagnostics (representing ACLA)
Patricia Shrader	Medtronic (representing AdvaMed)
Janet Trunzo	Advanced Medical Technology Association (AdvaMed)

Meeting Start Time: 10:20 am
To provide context for FDA’s proposed approach to mitigate program uncertainties and advance negotiations, FDA started by summarizing the status of where MDUFA reauthorization discussions stand. From January through April, FDA provided more data and analysis on program performance than ever before. While FDA and Industry did not always agree on the interpretation of these data, the parties engaged in a robust exchange of viewpoints that furthered FDA’s understanding of program performance and Industry’s concerns. Based on these discussions, FDA developed a comprehensive proposal package, which FDA presented in April. In May, FDA presented an initial estimate of resources needed to support the proposal package. Although Industry stated that they do not support the initial estimate, FDA noted that the proposal package was carefully designed to address the concerns identified during the program analysis and voiced by Industry. It represented FDA’s good faith estimate of what is needed to address the needs of an under-resourced program to improve transparency, consistency, and predictability, and to achieve the public health outcomes on which all agree. FDA also noted that the proposal package was intended to address core program needs without any “frills,” and was prepared by FDA without having the benefit of seeing Industry’s detailed proposals. FDA believed that on May 4 th Industry had agreed to present at the next meeting its detailed proposals for a 5-year program based on the topics Industry had presented on May 4th. On June 1 st, Industry proposed a different approach, which FDA indicated on June 17th that it could not accept. FDA expressed appreciation for Industry’s June 27 th presentation, which FDA believed reflected forward movement. FDA stated that its proposed approach for today’s meeting was intended to build on that forward movement. FDA indicated its concern, however, that Industry had introduced a new condition to be met before presentation of Industry’s remaining proposals, which it had not originally indicated was a condition for introducing its proposals: agreement on the uncertainty mitigation plan. FDA stated this conditionality could further delay progress on substantive negotiations. FDA explained that timing is critical as, unlike previous MDUFA (re)authorizations, the MDUFA III process includes a sequence of statutory reauthorization process requirements. FDA described this tight timeline to Industry dating back to September 2010, and the FDA remains committed to meeting the statutory timeline despite missed milestones.
FDA responded to Industry’s June 27 th proposal for mitigating uncertainties. FDA indicated that uncertainties will always exist in the oversight of innovative technologies; nobody can predict the exact nature, scope, quality, or volume of submissions over a future five-year period. In the June 17 th meeting, FDA provided a detailed assessment of those initiatives identified by Industry as sources of uncertainty, indicating that they are not expected to have a significant impact on workload or performance in MDUFA III. FDA, in turn, faces substantial uncertainties regarding budget appropriations and legislative uncertainties. FDA suggested that the best way for all parties to manage uncertainty is to accelerate progress on substantive issues in these negotiations.
FDA’s proposed plan for mitigating uncertainties therefore begins with advancing negotiations to reach an understanding of what both parties want the program to look like in MDUFA III, such that the impact of uncertainties can be evaluated in that context. To this end, FDA recommended discussing proposals based on current assumptions and discussing potential impact on workload of initiatives as they are released. FDA asked Industry to present their complete set of detailed proposals on July 26 th so that FDA and Industry can move forward on substantive negotiations, with the goal of reaching an agreement, based on best available information and current assumptions, by the end of August. This timeline would allow FDA to seek expedited Administration clearance prior to publishing draft recommendations in the Federal Register (FR) in October, in order to meet the statutory requirements for public input before delivering final recommendations to Congress by January 15, 2012. FDA is targeting a public meeting in early November during the public comment period. Industry asked what the Agency believed would happen if it transmitted the recommendations to Congress after the statutory deadline. FDA indicated that it is committed to meeting the January 15, 2012 deadline, and that key members of Congress have specifically emphasized this deadline with the Commissioner.
FDA noted that the draft recommendations can be appropriately characterized in the FR notice to accurately reflect contingencies regarding the assumptions underlying any draft agreement. FDA clarified that negotiation meetings may continue after the draft recommendations are published, to the extent necessary to address any potential workload or performance impacts that could arise as more information becomes available during the Fall and FDA resolves several key pending initiatives identified by Industry in their June 27 th presentation. FDA would follow the statutory process currently in place for MDUFA negotiations, including publication of meeting minutes, and concurrent monthly meetings with patient and consumer advocacy groups to obtain ongoing input. If there is a need to revisit any draft recommendations based on workload or performance impacts of newly released initiatives, or in response to public comments or other changes in assumptions (including FDA’s budget authority appropriations), then negotiation meetings would continue. At such meetings, both parties would come prepared with their analysis of a given initiative’s implications for workload and performance. FDA noted that issues unrelated to workload and performance, such as policy, would not be discussed within the MDUFA negotiations but rather, through public comment and meetings directly with Center staff.
FDA reiterated that the Agency does not expect any of the areas of uncertainty identified by Industry to have a significant impact on workload or performance during MDUFA III. Industry asked FDA to define “significant.” FDA clarified that no significant impact refers to impact within the normal level of submission variance or fluctuations experienced from year to year, and they therefore fall within FDA’s ability to manage. Industry also asked what percentage increase in submissions would constitute a “significant” impact. FDA indicated that it is not referring to any fixed percentage change in submissions, and that the size and complexity of submissions would also factor into impact. Industry indicated the need to consider all potential changes, such as those stemming from the 510(k) modifications guidance, 510(k) paradigm guidance, and IOM report together. FDA noted that these documents discuss high-level principles that frame how the program is applied and do not address data requirements. Industry suggested that the 510(k) paradigm guidance could result in an increased number of pages per submission if clinical data are required in more situations. FDA explained that this document simply outlines current practices in more detail. For example, the Agency has historically required clinical data to support a new indication (but not intended use, as that would be NSE). Industry also inquired about the timing and substance of the LDT guidance documents. FDA noted that the Agency had provided information that was available about LDTs on June 27 th, and that this topic could be discussed further prior to reaching a final agreement, once there is more information or the LDT policy is announced. While FDA believes that all initiatives raised to date collectively are not likely to have a substantial impact on workload or performance in MDUFA III, FDA offered to meet with Industry to discuss their concerns with workload or performance after the initiatives in question are released. FDA offered some potential meeting dates in the Fall to hold if further negotiations are needed after the release of draft recommendations.
FDA also noted that the level of budget authority (BA) appropriations for fiscal year 2012 represents a substantial uncertainty for FDA, and could trigger the need for an additional negotiation meeting as it could affect FDA’s ability to meet performance goals at the end of MDUFA II and adversely affect the baseline for MDUFA III going forward. Industry questioned why the FY 2012 appropriations should impact resources available during MDUFA III. FDA responded that the FY 2012 budget will serve as the starting point for the budget at the beginning of MDUFA III, and any significant reductions could affect FDA’s ability to meet goals. Industry questioned whether the proposed House bill with a 12% cut to CDRH would hit the appropriations trigger reauthorized in MDUFA II for the Devices and Radiological Health program line of the FDA budget. FDA indicated it would not; the trigger would only be reached at a 27% cut. Industry indicated that, based on concerns of missing triggers in MDUFMA I, the language in MDUFA II was specifically written to allow minor variation so that the Agency could continue to collect fees under those circumstances and Industry supported that. FDA noted that the appropriations triggers no longer provide their intended level of protection for the program because of increases to BA appropriations in recent years. . FDA also noted the concerns expressed by many outside observers that the Agency has been chronically underfunded. FDA noted that the Government Accountability Office (GAO) criticized the Agency for not doing a better job of identifying the resources needed to address our full set of statutory and regulatory responsibilities. In response to that criticism, the Agency commissioned a study by Booz Allen Hamilton to develop an evidence-based estimate of the resources needed to accomplish all of our medical product oversight responsibilities, which was completed last year. Results showed that all medical product areas, including CDRH, are significantly under-resourced. Industry responded that any chronic under-funding of FDA is a matter for the Administration and Congressional appropriators to address.
FDA provided a formal response to Industry’s June 27 th presentation on proposed enhancements and the use of working groups. FDA agreed with Industry that working groups may be helpful and noted that the Agency initially proposed such groups in April. Based on the current timing, FDA suggested that the purpose of these groups should be to accelerate the process by allowing technical experts on various topics to work in parallel between negotiation meetings. FDA agreed that not all proposal areas may need working groups, and proposed that the structure of the working groups be decided only after Industry has presented its remaining detailed proposals so that an efficient and coherent work plan can be developed taking into account the full scope of discussions. FDA proposed that the negotiators provide a charge to each working group and that each group report back during negotiation meetings.
FDA also agreed to further discuss all proposed enhancements from Industry’s June 27 th presentation: pre-Submission meetings, Refuse to Accept (RTA) procedures for 510(k)s, Refuse to File (RTF) procedures for PMAs, and an independent analysis of review process management. FDA noted, however, that further discussion should take place in the context of a complete set of proposals. Given that many topics are inter-related and resources are limited, FDA suggested that an efficient and coherent approach would mean deferring initiation of work on these proposal areas until the full scope of negotiations has been identified after Industry presents the remainder of their detailed proposals.
FDA proposed a specific path forward and associated timeline. FDA first suggested that a financial working group begin work as soon as possible. Once all proposals are on the table, FDA suggested that both parties agree on the structure and charge for each working group by August 2 nd and that all groups begin work as soon as possible thereafter. FDA noted that some topics may be addressed collectively by a single working group. The working groups should accelerate the process towards a draft agreement which can be cleared by HHS and OMB in time to be published in October.
Industry provided an initial response to FDA’s presentation. Industry stated that the information provided by FDA was encouraging, particularly the Agency’s willingness to meet quickly after issuance of IOM report, 510k modifications guidance, and other important relevant milestones to discuss workload impact. Therefore, Industry will put forward a substantive proposal to cover performance goals, both qualitative and quantitative, on July 26 th. Industry also plans to prepare financial estimates relating to the proposals it shares on July 26th, but it would not be able to provide its financial estimates until after the financial working group is initiated. Industry therefore agreed with FDA that a financial working group meeting should take place soon. Industry indicated their need to discuss FDA’s proposed plan for mitigating uncertainties with their members and ratifiers prior to formally responding; however, Industry stated their agreement on the need to move forward in good faith and come to agreement on a package.
The concept of working groups was discussed further and both parties agreed to establish a financial working group as soon as possible. This group will discuss the MDUFA II spend plan and estimated cost per FTE for MDUFA III.

Next Meeting

The next meeting will take place July 26, 2011.
Meeting End Time: 2:10 pm

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Page Last Updated: 08/02/2011
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