Latest Drugwonks' Blog
From the Financial Times:
“A legal battle between GlaxoSmithKline and Greek wholesalers over parallel trade in drugs – which could have implications for the price of medicine - ended with a mixed result on Tuesday morning at
The European Court of Justice ruled that if a dominant company refused to meet “ordinary” orders for medicinal products, because it wanted to put a stop to parallel exports, it was breaching EU competition law.
But the judges said that it was up to individual countries’ courts to decide whether orders were “ordinary”. They would need to look at both the previous business relations between the drug company and the wholesalers concerned, and the size of the orders in relation to market needs in the country concerned.
Drug prices in
As a result, in 2000, GSK changed its Greek distribution system, and supplies to wholesalers were interrupted. The wholesalers complained that this amounted to anti-competitive conduct and an abuse of a dominant position.
In April, a senior legal adviser at the ECJ largely ruled against the company. Tuesday’s full court decision significantly qualifies that position.”
And via Bloomberg, this add:
“The court ``has confirmed that companies must be able to take reasonable and proportionate steps to protect their own commercial interests, even if they hold a dominant position and such steps must be assessed in the light of the ordinary requirements of the markets,'' London-based Glaxo said in a e-mailed statement.”
Is this the beginning of the end of pharmaceutical parallel trade in the EU? It depends. But one thing is certain, if nations such as the
No matter -- if the EU decides to act in its own best interests perhaps the next Congress can design a plan where we import cheaper drugs from ... India.
The House Energy & Commerce Committee needs to help fix the problem, not the blame.
Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.
But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right. The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.
But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”
That’s not true. It’s not fair. And it’s not helpful.
FDA backs BPA as study links it to heart disease, diabetes
Really, and I thought it was the all the junk food the corporations put in the plastic bottles that were the cause of those diseases. I guess the evil corporations are just hell bent on killing people...and the FDA, which is "backing" BPA is just doing the bidding of it's corporate masters..
And most important a study in JAMA by David Melzer and crew that ostensibly links high levels of BPA with increased incidence of heart disease and diabetes supposedly proves that BPA causes these illnesses. The study found "that higher BPA concentrations were associated with diagnoses of cardiovascular disease and diabetes. We also found associations between higher BPA concentrations and clinically abnormal concentrations of the 3 liver enzymes examined, namely GGT, alkaline phosphatase, and lactate dehydrogenase. Importantly, we observed no associations with the other common conditions examined, suggesting specificity of the associations. A series of sensitivity analyses provided further support for the specificity of the associations found."
Which lead a BPA expert named John Peterson Myers to invoke THE PRECAUTIONARY PRINCIPLE in a side-by-side editorial in JAMA:
"It's impossible to say that BPA is safe,"
http://www.usatoday.com/news/health/2008-09-16-bpa-heart_N.htm
The problem is that the 2003-2004 National Health and Nutrition Examination Survey (NHANES) which were used to estimate daily intake of BPA, shows that most Americans, regardless of age, have a median intake have approximately three orders of magnitude below health-based guidance values of 50 mug/kg-day....
So Melzer et. al stacked the deck with respect to the BPA levels to demonstrate a correlation with self reported claims of having been diagnosed with diabetes or heart disease and snap shots of insulin and C-reactive protein levels...
http://www.ncbi.nlm.nih.gov/pubmed/18414515?ordinalpos=27&\
http://jama.ama-assn.org/cgi/content/full/300.11.1303#SEC5
http://jama.ama-assn.org/cgi/content/full/300.11.1353
Are we all on the same page now?
All good things.
The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs. Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products? That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.
The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.
Particular congrats go out to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
With all the focus on drug safety, what’s gotten lost in the shuffle is the issue of safe use.
Talk about putting profits before patients!
According to a Medical Society of the State of
Of the over 1200 physicians surveyed this month, 90% said they changed the way they treat patients based on restrictions from an insurance company, and 92% said incentives and disincentives offered by insurance companies regarding treatment options "may not be in the best interest of patients."
87% of physicians said they sometimes feel pressure to prescribe a treatment based on cost. About 93% of physicians said insurance companies have required them to change prescriptions in the past.
To see how that plays out when you extrapolate private greed to bureaucratic need, click here.
Representative Henry Waxman (D-CA),
A modest proposal.
And caveat emptor.
http://www.nypost.com/seven/09142008/postopinion/postopbooks/autisms_false_prophets_128960.htm
Meanwhile the NEJM/media's war against Gardasil's approval for use in women up the age of 26 failed...
Gardasil Approved to Target More Cancers
Sept. 12, 2008 -- The FDA today announced that the vaccine Gardasil may be used to prevent some cancers of the vulva and vagina in girls and women ages 9-26.
Gardasil is already approved to help prevent a leading cause of cervical cancer in women of that same age range.
Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.
"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.
"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman says.
http://children.webmd.com/vaccines/news/20080912/gardasil-approved-to-treat-more-cancers
Yeah, well to the media it's all just "hype".
http://well.blogs.nytimes.com/2008/08/29/blaming-the-media-for-gardasil-hype/
Have a look at our latest newsmaker interview with Representative Joe Pitts (R,PA).
AP reports that Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that “officials hope will help it better protect the public health amid rapid technological and scientific change.”
40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.
That’s great news. But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.
It's a good problem to have.
CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.
1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.
Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.
But it’s not all rosy and it’s not as easy as reporting numbers.
The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.
All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
