Latest Drugwonks' Blog
Some argue that there is no difference between buying gasoline or heating oil which indirectly supports nation states that indirectly support organizastions that support terrorists and passing legislation the directly defunds federal law enforcement agencies that are actively going after Hezbollah cells in Canada that are using fake web sites and shipments of counterfeit drugs from Canada to the US to fund its war against Israel and the US…That is being naive or deliberately obtuse….
CMS, which has lead the way in promoting transparency in health care is apparently allowing a group that CHARGES organizations to belong to a so-called quality alliance and itself is closed mouthed about it’s quality standards to set policy about pharmacy quality. The group is called the Pharmacy Quality Alliance.
Founding members of this new organization are the AHIP, American Pharmacists Association, the National Association of Chain Drug Stores, and the NationalCommunity Pharmacists Association. The goal of the PQA is to “agree on a strategy for measuring and reporting data that will help consumers make informed choices and appropriate healthcare decisions.” Membership is open to all stakeholders but on a fee basis only.
Initially the PQA has formed two work-groups:
Quality Metrics Work Group which is responsible for identifying the areas of measurement development and work with organizations who have demonstrated expertise in the design and specifications of performance measures. They will initially focus on seven disease-specific metrics: diabetes, hyperlipidemia, asthma, mental health, hypertension, heart failure.
Initiatlly their work centers on “generic efficiency”/formulary management whatever this means…What is generic efficiency? How does it differ from effectivness or just plan therapeutic benefit. And why would CMS even agree to such a group independent of total health benefit or such a group independent of other sorts of health care providers?
“Reporting Work Group which will recommend principles and methods for reporting meaningful information to consumers, pharmacists, health insurance plans, pruchasers and other interested stakeholders. …”
This is stupid and silly…as if these groups don’t have their own methods or sources of data…Why is CMS doing this?
Apparently patient groups have been cut out of the processes of the PQA…There is little patient / consumer organization representation on the Steering Committee Level and on PQA workgroups / Their is no transparency and unclear how decisions are made even though patient groups are paying members…The PQA is working on a very aggressive timeline with a goal to have its work product (metrics) completed by November.
One of the goals of the “Quality Metrics” work group is cost containment and the establishment of tighter formulary standards using evidence based medcine. One of the cochairs of the work group is John Coster who worked with Senator David Pryor in 1990 to create the Medicaid rebate program complete with restrictive formularies, prior authorization and clinical holds all of which had nothing to do with quality of care….
No transparency, reliance on EBM, cost containment….a focus on drug spending independent of quality of care and total cost….what is going on here?
Attention Senator Vitter:
The August 12, issue of the Lancet details the case of a patient who severely damaged her vision by taking a drug she bought on the Internet for four years.
In February 2006, a 64-year-old woman presented to the doctors with a 6-month history of decreased vision. The woman had no past or family history of eye disease. When the doctors examined her eye they found features consistent with a diagnosis of glaucoma and cataract caused by steroid use.
On subsequent questioning, the women disclosed that she had been purchasing the oral steroid prednisolone from an online pharmaceutical company in Thailand. She had taken the drug for 4 years after she had made a self-diagnosis of chronic fatigue syndrome. When the doctors last saw her in July 2006, she was due for a cataract operation.
Prompted by the case, the authors (Philip Severn and Scott Fraser from the Sunderland Eye Infirmary, UK) found that they were able to find 1000 tablets of prednisolone (5mg) online for Â£25.23 using the search engine Google. The authors warn that some drug therapies sold on the Internet may be counterfeit.
They conclude: “The expansion of the Internet is relentless and, from the perspective of patients seeking information, in the main positive. However, the online availability of controlled and uncontrolled drug therapies needs to be carefully monitored.”
U.S. Gov’t Investigation Ties Illegal Drugs to Middle East Terrorists
By Fred Jackson
August 13, 2002
The head of the U.S. Drug Enforcement Administration says Middle East terrorists are getting funds from a cold medication ingredient that is sold legally in Canada but then used to manufacture an illegal drug in the United States.
Canada’s Globe and Mail newspaper quotes DEA head Asa Hutchinson as saying, “It’s the first time we’ve seen drug proceeds going from the U.S. to a terrorist organization.” In previous interviews, Hutchison has identified Hezbollah as the prime benefactor.
According to reports, the chain of activity works something like this. Various groups smuggle the cold medication ingredient — pseudoephedrine — into the U.S. where other criminal elements then use it to manufacture what is commonly known as “speed.”
In one of the latest incidents, the U.S. Customs Service seized 21 million pseudoephedrine tablets at a Michigan border point. The pills were in boxes labeled “Fragile,” loaded on a truck headed for illegal methamphetamine labs in California. According to the newspaper report, Michigan authorities say they have made nine such seizures in the past year.
The Globe says earlier this year, investigators identified many of the suspects involved in the operation as being of Middle Eastern origin. The newspaper reports Hezbollah is believed to have also figured in a recent cross-border scheme involving smuggled cigarettes.
And what if the pills were in boxes labeled prescription drugs for seniors? Customs officials are prohibited from seizing or inspecting them thanks to Senator Vitter and his pals because they care more about pandering to seniors than national security or the fight against terror….. And we worry about dumping Poland Spring water bottles before boarding a plane?
I had the priviledge of working with Senator Lieberman on the development of his bioterrorism legislation which at this posting is still stalled in the Senate by members of his own party who believe that the bill gives too much to drug companies and doesn’t allow trial attorneys enough room to sue innovators who develop bioterror countermeasures. Here is the bill and Lieberman’s own words on the measure.
Ã¢The best way to combat the very real and serious threat of bioterrorism is to utilize our greatest strength Ã¢ the entrepreneurial talent of our nation Ã¢ in our national defense. The BioShield law enacted last year takes the first step, but without additional reforms, companies are not likely to risk their own capital to fund this research, leaving us with a government-funding model that will be exceedingly expensive and not likely to produce the results we need,Ã¢ Lieberman said. Ã¢The concepts in our legislationÃ¢ including tax, intellectual property and liability reforms Ã¢will give us important additional tools to enlist the entire industry in this vital research.Ã¢
Ã¢This bipartisan bill shows that we consider bioterrorism to be a deadly threat to America and the world,Ã¢ Hatch said. Ã¢We need to do more to combat natural threats such as AIDS, SARS, Avian Flu, malaria, antibiotic resistant organisms, and other agents, including genetically manipulated materials, which, in the hands of terrorists, could create a public health catastrophe. Comprehensive legislation is needed today to thwart tomorrowÃ¢s biological threats, including bioterrorism attacks.Ã¢
Ã¢Specifically, the Project BioShield II Act of 2005 authorizes:
Ã¢Â¢ Tax incentives to spur capital investment in this research;
Ã¢Â¢ Intellectual property protections, including patent incentives that could help spur crucial countermeasures or a cure for AIDS or a new class of antibiotics;
Ã¢Â¢ Liability protections to companies who produce vaccines that cannot be fully tested in clinical trials because of the nature of the deadly diseases they are designed to combat.
The legislation does not allocate a specific funding amount for these provisions but promises government funding only for final products that meet the government specifications. Thus the risk is shifted to the industry and its investors to produce the products. “
In crafting the legislation, Lieberman and his cosponsors Senators Hatch and Brownback consulted with more than five hundred national and international infectious disease and biodefense experts and many of them, including the International AIDS Vaccine Initiative (IAVI), the Infectious Disease Society of America (IDSA) and the American Society of Tropical Medicine and Hygiene (ASTMH), have expressed their support for the bill. “
In the wake of the most recent attempt to attack our nation, an effort to pass what Lieberman termed Bioshield II should be a top legislative priority for Congress when it returns in September…
The Stroke Prevention by Aggressive Reduction of Cholesterol Levels (SPARCL) is very impressive in terms of design and what it demonstrated: The SPARCL study included 4,731 patients with no history of heart disease who had experienced a stroke or TIA (mini stroke) within six months of study enrollment. Patients had mildly elevated cholesterol levels, and received either 80 mg of Lipitor or a placebo; they were then monitored for an average of five years.
Study findings indicate that patients taking Lipitor experienced a 16-percent reduction in the risk of secondary stroke compared with patients taking a placebo. Lipitor patients also saw a 35-percent reduction in the risk of major coronary events (cardiac death, non-fatal heart attacks, or resuscitated cardiac arrest) compared to the patients taking placebo. “These cardiovascular results are remarkable in a population not known to have had heart disease,” said principal investigator, Dr. K. Michael Welch.
The SPARCL study researchers conclude that their results support the initiation of statin (i.e., Lipitor) treatment shortly after a stroke or TIA. “We believe that the findings indicate that Lipitor 80 should become an established part of secondary stroke prevention,” said Dr. Welch.
Our comment on this release from Rosalind Franklin U, which did the research…. this is stunning stuff which once again makes the case for taking statins as a preventative measure in specific at risk populations….when is our health care system going to start paying doctors for taking care of people before they have strokes?
Wide variations in NHS spending may be denying patients fair access to drugs and treatment.
The King’s Fund think tank found that some English trusts spent four times as much on certain diseases than others.
The research by the health think-tank looked at spending by 303 primary care trusts (PCTs), which are responsible for 80% of the NHS budget and fund hospital, GP and community treatment.
The report said there were differences in spending which only appeared to be “partially explained” by need and therefore raised questions over whether spending variations were having “adverse effects on equity and efficiency.”
Cancer Backup chief executive Joanne Rule said: “What people will want to know after seeing this research is, will I receive good cancer care in my area if I need it?”
That is certainly what I would ask.
Here comes the spin. Nigel Edwards, director of policy at the NHS Confederation, said: “The healthcare priorities of the people of Brighton will be different to the priorities of those living in Bradford.”
Um, no. Their health care priorities are the precisely same — to have access to the best health care (including the most appropriate and effective medicines) when and where required.
That being said, today’s award for bureaucratic health care doublespeak goes to Health Minister Lord Warner who clarified the situation by stating that, “Some variations in spending across the country are to be expected as people respond to the different needs of local communities.”
Good Lord, Lord Warner! You are Britain’s answer to Casey Stengel!
And in the words of the ‘Ol Perfessor,
“The key to being a good manager is keeping the people who hate me away from those who are still undecided.”
The Washington Legal Foundation has filed a petition with the Food and Drug Administration challenging the agency’s right to send warning letters to drug companies whose advertising it finds misleading.
The WLF believes the letters — which carry no legal weight but are routinely obeyed — contravene the First Amendment by making it impossible for drug marketers to advertise information that is not reviewed by the FDA even though it may be truthful and accurate.
Rather than having the WLF file a petition that will not go anywhere, individual pharmaceutical companies should muster the pluck to energetically challenge DDMAC when they receive letters they feel are unfair.
Qui tacet consentit. Silence implies consent.
In our continuing efforts to bring you important regulatory news from around the globe, here’s a story that just came over the wires from the FDA … of Thailand —
Racy condom name rubs FDA wrong way
The Food and Drug Administration has no intention of allowing a condom brand to go on sale with a trade name that carries a sexual connotation, secretary-general Dr Pakdee Pothisiri said yesterday.
He was speaking just one day after the Culture Ministry publicly commented that the request for the name “Tom Dundee” was inappropriate and offensive to Thai culture.
“Tom Dundee” is singer Puntiwa Pumiprathet’s stage name. He had hoped to manufacture and distribute the condoms, with some of the proceeds going to Wat Phra Baht Nam Phu. The temple is also known as the Aids Temple because it has cared for patients living with HIV.
However, “dundee” also translates as “good penetration” in Thai.
And don’t even ask about the translation of “DDMAC.”
Mediamatters.org states that in an August 7 editorial, The Washington Times made two false claims regarding Sens. Hillary Rodham Clinton (D-NY) and Patty Murray’s (D-WA) Senate “holds” on Dr. Andrew von Eschenbach’s nomination to head the Food and Drug Administration (FDA). The Times falsely claimed that “[t]he FDA and von Eschenbach have decided that women 18 and over should have … access” to the contraceptive pill known as Plan B, “while younger women can still get it with a prescription.” In fact, the FDA has not “decided” anything; instead, the agency has announced it will “proceed to work” with Plan B’s manufacturer, Barr Pharmaceuticals, to “discuss” a “framework for potential approvability” of allowing women 18 and over to obtain Plan B without a prescription.
The editorial also claimed that Clinton and Murray are “blocking the nomination until the FDA agrees to make the contraceptive Plan B … available without a prescription and without any restrictions on age or access.” But that is not what the two senators have said. They issued a press release demanding only that the FDA reach a final decision on the issue.
The blog cites our op-ed of the same day as the source of these ‘falsehoods’ so let us clarify: In his testimony Andy clearly stated that he had decided on an 18 and over OTC restriction and there was a lot of questioning about that decision. As to the Clinton and Murray stance. it is quite clear that if it was simply a matter of a decision, yes or no, the 2004 decision “no” decision would have been the end of the matter…But it was not. Citing the GAO report on the Plan B decision — excuse us — the LA Times spin on the GAO report — Mediamatters claims that federal drug regulators compromised their usual science-based decision-making process…”.. To which I have always said, what about the home HIV test that was held up on policy grounds under the Clinton administration FDA? What about limits on tobacco? Does anyone really believe that a hold would be lifted if the FDA issued a “no” or “yes, but” decision? Would the folks at mediamatters claim that the decisionmaking was science-based unless the decision was yes, yes, yes…?
Drugwonks was not born yesterday.