FDA, MIT to collaborate on drug safety
Associated Press

WASHINGTON - The Food and Drug Administration and Massachusetts Institute of Technology announced Thursday an agreement to develop an automated system to detect unanticipated problems with prescription drugs and medical devices.

The system would scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns.

The current system relies on the largely manual assessment of reports voluntarily submitted to the FDA, sometimes months or years after an event has occurred. As a result, potential problems typically are underreported, said Dr. Scott Gottlieb, the FDA’s deputy commissioner for scientific and medical affairs.

A more automated system capable of mining on the fly multiple databases, including those compiled by health insurance providers and agencies like the Veterans Administration, would be better at recognizing patterns suggestive of emerging problems, Gottlieb said.

The system would build on methods developed to identify infectious disease outbreaks, detect bioterrorism attacks and model the spread of bird flu, he said.

The FDA also plans to begin publishing reports for doctors that would alert them to potential problems with drugs and devices, Gottlieb said. That could prompt doctors to watch for similar problems and report them when found to the FDA. The reports would resemble the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, which regularly alerts doctors to outbreaks of disease.

Lawmakers and others have stepped up their criticism of FDA safety monitoring efforts in the wake of the pain killer Vioxx being pulled from the market in 2004.

One problem is the FDA cannot require that drug makers conduct studies on the safety of prescription medications already on the market, a recent Government Accountability Office report concluded.

Gottlieb said he did not think the FDA needed additional authority to improve its safety monitoring, according to a copy of a speech he gave Thursday at MIT’s Center for Biomedical Innovation.

I see today that Merck lost a lawsuit in which the plaintiff claimed that his coronary was caused by Vioxx; the fact that the patient needed a mutiple bipass operation apparently was used against Merck, the theory being that Vioxx never should have been prescribed for him, and would not have been had adequate warning been given.

Well. Assume all that to be true. Precisely how do we know that the heart attack would not have happened had the patient not taken Vioxx? As best as I can tell, we do not. And since the doctor presumably would like to avoid a malpractice suit, his testimony ought to be taken with a small grain of salt, even if in truth he is being wholly sincere. As the burden of proof is on the plaintiff—-even if only by a preponderance of the evidence—-it strikes me that yet again jackpot justice has reared its ugly head. Clinical trials can have only so many enrolled patients, as resources are limited always and everywhere, and so if an adverse effect of a drug emerges in, say, 1 out of 100,000 patients, it might not show up in a clinical trial substantially smaller than that. Is that “negligence?” The larger fear is that the pharmaceutical sector writ large will go the way of the vaccine sector, effectively destroyed because of litigation threats. Whom are future patients going to sue because better medicines were not available?

On the heels of an article in which she ridiculed Bristol Myers Squibb for being out negotiated by Apotex, the generic drug firm which is producing a copycat of the BMS blood thinner Plavix and a previous article about drug reps in which she failed to disclose one her main sources was also promoting a movie and book about her life as a drug rep, Stephanie Saul has hit a “gag me with a spoon” low with this weeks article lionizing the chairman of Apotex, Bernard Sherman. I will spare you all the details but give you all the delicious irony…

“….The opening chapters of a draft autobiography sit amid the hundreds of pill bottles and mound of legal documents in Bernard C. Shermanâs office. It will be the story of a brainy kid born in Toronto who becomes Canadaâs richest generic drug mogul.

Though a work in progress, it has the makings of a page turner. One chapter will recount how an employee from a brand-name drug company offered to sell him secret files. Another, he says, will describe how Mr. Sherman caught a rival stealing the recipe for a blockbuster generic developed by his company, Apotex.

But what promises to be the bookâs most riveting chapter is still unfolding. It is the part where Mr. Sherman seemingly outsmarts two big drug companies, Bristol-Myers Squibb and Sanofi-Aventis, to market the first generic form of the big-selling drug Plavix five years before its patent expires. And it could conceivably end with someone in jail….”

In jail? Gee, the last time anyone was tossed in the slammer in the pharmaceutical world, I think it was in 1989 after generic drug company employees were caught bribing FDA inspectors. Does Stephanie have any basis for asserting that anyone involve could be sent to prison? Any indictments? Convictions? Guilty pleas?

And as for illegality, it was Sherman (as Saul grudgingly notes) who was linked to a company that forked overr 500K for selling drugs illegally from overseas via the mail. A man ahead of his time. What a visionary. He tells our truthseeking reporting that he just gave the firm the drugs and didn’t know where they were headed.. Really.

Anyways, we also find out in this hardhitting piece that Mr. Sherman is Canadaâs “richest men with a net worth that magazines estimate at nearly $4 billion. He and his wife, Honey, give millions to charity each year. ” Somehow Stephanie has never mentioned (she had two chances) to note that BMS gives away hundreds of millions each year.

What does Mr. Sherman do for his dough? He launches lawsuits, Lots of them, in an effort to trip up a drug company on the soundness of a patent. He spends hundreds of millions a year in legal fees to make his money. A company like BMS has been pumping Plavix profits into new drugs for cancer, schizophrenia, arthritis, etc (I know, I know, spending money on marketing medicines too, G-d forbid)

All of which has nothing to do with why Apotex and BMS were dealing. Apotex launched a lawsuit to terminate the patent life of Plavix earlier than 2011. It was trying to negotiate money to cover the fines it would have to pay if the court ruled their lawsuit as without merit. And then at the same time he was writing Congress criticizing the sort of deals he was engaging in and explaining why — though his deal with BMS seemed like more the same, it really wasn’t. Stephanie takes this letter as proof that he was dealing in good faith. Or she puts it:

“The letter â addressed to Senator Charles E. Grassley, Republican of Iowa, and the Democrats Charles E. Schumer of New York and Herbert H. Kohl of Wisconsin â accurately predicted that the refusal would come within weeks.”

Bernard Sherman, a prophet in our time. And in Stephane Saul he has found his acolyte and Boswell.

http://www.nytimes.com/2006/08/15/business/worldbusiness/15drug.html?ex=1156392000&en=6a3e4b940f8d33ec&ei=5070&emc=eta1

This week Ben Cardin, a Democrat house member in Maryland and senatorial candidate in the Nov. election held a townhall meeting with seniors on health care and Social Security. Promises not to privatize Social Security received a lot of applause but a pledge to provide full Rx coverage under Medicare by imposing price controls on drug companies received a tepid response… Oops.

Meanwhile Cardin also promised to help cure cancer by 2015, doing Andy von Eschenbach one better (he set as a goal the end of suffering and death due to cancer by the same date)… Now given that all price control regimes limit access to cancer drugs and discourage innovation, just how does Cardin propose to achieve that?

According to our colleague Sally Pipes over at the Pacific Research Institute, “Gov. Arnold Schwarzenegger is promoting his new discount drug plan as a voluntary agreement between pharmaceutical companies and the State of California. But it’s more like a raw deal.”

“The California Prescription Drug Initiative calls upon drug manufacturers to offer five million low-income Californians huge discounts on prescription medications — up to 40% on brand-name drugs and a whopping 60% on generics.”

“Presumably, drug companies should offer these discounts out of the goodness in their hearts. But if they don’t comply? Well, then they’ll be coerced by the Terminator.”

Sally, as always, has a workable, free-market solution. She writes, “There is a better way.”

And here it is …

http://www.opinionjournal.com/federation/feature/?id=110008767

Medco, the largest U.S. pharmacy benefits manager, whose clients include large corporations, state and local governments, health insurers and unions, has created a very troubling partnership with Consumer Reports.

Beginning today, Medco is pointing its 60-million members to Consumer Reports’ online Saving Advisor —the same program that suggests a “best buys” approach to Alzheimer’s medications.

Maybe Medco will even throw in a toaster for free.

The news story on this misadventure (which can be found at www.northjersey.com) reports that the Savings Advisor “was conducted as part of Consumer Reports Best Buy Drugs program, which is funded by the private Engleberg Foundation and the government-sponsored National Libraries of Medicine.”

What it doesn’t report is that the Engleberg Foundation is profoundly conflicted. Alfred Engleberg has earned over $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits earned by generic drug makers. He is pro-compulsory licensing and against tort and medical liability reform.

The Savings Advisor generally recommends generic drugs. Surprise! Mr. Engleberg served as patent counsel to the Generic Pharmaceutical Industry Association (GPIA).

Here’s what Al Engleberg e-mailed to our buddy Jamie Love regarding implementation of the Doha Declaration,

“I thought it might be useful to put forth an idea for bridging the gap between the approach suggested by the EU and the US trade negotiators. In many respects, the idea is an obvious corollary to my paper on the importance of the use of price controls as a means of avoiding the adverse impact of full TRIPS implementation.”

And here’s something else that’s both absent from the article and not on the Consumer Reports website — this saintly not-for-profit organization receives massive funding from trial lawyers.

Yes — Medco is now married to the Mob.

(For further edification on how Consumer Reports is bastardizing evidence-based medicine, please see the drugwonks.com April 6, 2006 commentary, “Crash-Test Dummy Medicine.”)

Two good articles today about how seniors are continue to transform Medicare Part D by making better choices with better information. The first by Carol Campbell of the Newark Star-Ledger (hometown paper)

Options are available for seniors in medi-gap
Monday, August 14, 2006
BY CAROL ANN CAMPBELL
Star-Ledger Staff
Ruth Gross plans to cancel her AARP Medicare Part D drug plan and select a different one for next year. This time, she will choose a plan without a “doughnut hole.”

You can read the rest of the article here:

http://www.nj.com/news/ledger/index.ssf?/base/news-8/1155530782173740.xml&coll=1&thispage=3

Ruth is not alone. Seniors are likely to shift to higher premium plans with more coverage and begin to be even more focused on the relative cost and value of the medicines they are on. My guess is that a larger percentage of seniors will choose Medicare plans with gap coverage or joint managed care plans while the increasing transparency in prices and shift to generic will move drug and premium prices down further. Armed with information about generic and brand alternatives, price competition will become fierce. Read the article in the San Francisco Chronicle about how seniors are adjusting to and learning from their Medicare Part D experience.

A ‘hole’ lot of frustration
Gap in Medicare prescription drug plan leaves some seniors with a $2,850 surprise

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2006/08/15/BUGMSKIHCF1.DTL

Remember when the usual suspects in the heatlh care policy establishment deemed part D as doomed because seniors were too senile to make intelligent choices and that the program would wind up being MORE expensive than projected and how seniors would raise hell in October right before the election as they hit the donut hole?

Seniors are discovering that shopping and saving makes more sense than the pundits who predicted they couldn’t do either under Part D

PS. Mark McClellan just announced that the average premium for Medicare Part D plans will be $8 less than it was last year. He applauds continued plan competition and âinformed choicesâ by beneficiaries

Today’s article in the Miami Herald about the plight of the young adults without insurance is all too typical of the way health care is covered.

Young adults ranked as least insuredWhen it comes to getting health insurance, young adults are left out compared with other age groups.
BY BREANNE GILPATRICK

http://www.miami.com/mld/miamiherald/business/15260321.htm

1. Anecdote

Billie Jean Delpy, 20, never considered health insurance. A hostess at a Miami Beach restaurant, she just couldn’t afford it. Then came an earache. The pain finally sent her to the Mount Sinai emergency room, resulting in a $100 prescription and a $550 bill.

”I don’t know how I’m going to pay it,” Delpy said over the conversations of passing Lincoln Road pedestrians. With her income, rent and other expenses, it will take two to three months of saving to pay the bill, she explained.

2. Definition of a problem that only a government program can solve

With few options, they end up creating the largest uninsured age group in the county, the state and much of the nation. And the numbers aren’t going down. In Florida the percentage of uninsured young adults rose by almost one=third in the last five years, according to the Florida Health Insurance Study. For a young adult just starting out this can mean crippling medical debts that take their entire careers to pay.

3. Skew the sample to the worst possible scenario

”We’re looking at people who are making $10 an hour,” Abbate said. “So even if you’re talking about a co-pay of $10 to $20 a month, that becomes a significant amount.”

4. Ignore the facts that conflict with the conclusion you are driving to:

Such as 25 percent of the uninsured are making 250 percent of the federal poverty level, about $25000 for an individual. Another 25 percent make about 150-250 percent….

5. Don’t connect the dots

The average premium for a health plan without a deductible in Miami is $120. You can get a basic plan for as little as $35 a month and with broad coverage and a $2500 deductible for $73 a month. Which means that even if you are making $15 an hour in Florida you can afford health insurance….And you sure can pay for it if you are single person making $25K or over…

6. Ignore the fact the people have some responsibility to plan for the future.

Paying off thousands of dollars of medical bills because you didn’t want to spend $73 a month? How much do you want to bet most of these folks have cell phones or cable TV? How much of the lack of health care coverage just a failure to do what is responsible?

The global counterfeiting of prescription drugs is nothing short of international health care terrorism — and it needs to be addressed as such.

Here’s a relevant op-ed from today’s edition of the Baltimore Sun:

http://www.baltimoresun.com/news/opinion/oped/bal-op.drugs15aug15,0,3781776.story?coll=bal-attack-headlines

Remember: Caveat Emptor is bad health care practice — and even worse health care policy.

I am quck to criticize awful reporting about medicine and medical innovation and I try to be even faster in pointing people to the best reporting on the same issues…So I apologize for not writing sooner about about Jeff Donn’s thoughtful and often moving article “Costly Drugs Force Life-Death Decisions” which hit the AP wires this past weekend.

Jeff acknowledges the value of breakthrough medicines but contrasts it with how we deal with an insurance system that fails to recognize or value them similarly or requires people to make life or death decisions about using medicines that can extend life by forcing people to pay a percentage of the cost of a new medicine (never requiring people to make the same contribution to after the fact and less effective hospital care) He writes about a woman who rather than paying nearly $20 k of the cost of Erbitux decided to refuse treatment….

“In her six decades, she had shared in a long marriage, raised three children, worked in a nursing home, painted as a hobby â and wasn’t ready to leave it all behind. But she was also a careful spender who sometimes returned new clothes to the store, deciding she didn’t really need them.

Maybe this new drug, Erbitux, could extend her life by a small fraction, but she wouldn’t be cured. “She was just very frugal, and she said it wasn’t worth it,” her husband Larry remembers.

So she refused the treatment.”

This is a complicated area — insurance has not caught up to the realities of the new technology of medicine and the new technology itself — shifting towards targeted therapies that work well in some but not everybody — is still changing clinical practice and pricing patterns which themselves are tied to outdated ways in which drugs are developed and market expectation…At the same time, it is clear the newer therapies are allowing us to live longer and better lives which cumulatively allows us to be a more productive and humane society…

Jeff Donn manages — in a relatively short article — to capture all these issues. Link to the article is here:
http://news.yahoo.com/s/ap/20060812/ap_on_he_me/spending_to_death

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 £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.

âThe best way to combat the very real and serious threat of bioterrorism is to utilize our greatest strength â the entrepreneurial talent of our nation â 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,â Lieberman said. âThe concepts in our legislationâ including tax, intellectual property and liability reforms âwill give us important additional tools to enlist the entire industry in this vital research.â

âThis bipartisan bill shows that we consider bioterrorism to be a deadly threat to America and the world,â Hatch said. âWe 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 tomorrowâs biological threats, including bioterrorism attacks.â

âSpecifically, the Project BioShield II Act of 2005 authorizes:

⢠Tax incentives to spur capital investment in this research;

⢠Intellectual property protections, including patent incentives that could help spur crucial countermeasures or a cure for AIDS or a new class of antibiotics;

⢠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.